Trial Outcomes & Findings for More Options for Children and Adolescents (MOCHA): Oral and Long-Acting Injectable Cabotegravir and Rilpivirine in HIV-Infected Children and Adolescents (NCT NCT03497676)
NCT ID: NCT03497676
Last Updated: 2026-01-28
Results Overview
Based on the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Corrected Version 2.1, dated July 2017. The DAIDS grading table provides an AE severity grading scale ranging from grades 1 to 5 with descriptions for each AE based on the following general guidelines: grade 1 indicates a mild event, grade 2 indicates a moderate event, grade 3 indicates a severe event, grade 4 indicates a potentially life-threatening event, and grade 5 indicates death. We present the proportion of participants with at least one grade 3 or higher AE through 4 weeks post-treatment initiation, bounded by an exact 95% confidence interval (CI).
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
168 participants
Primary outcome timeframe
Cohort 1 Treatment Initiation through Week 4
Results posted on
2026-01-28
Participant Flow
Accrual for Cohort 1 occurred between April 2019 and November 2021 at 15 different medical clinic sites across Botswana, South Africa, Thailand, and the United States. Accrual for Cohort 2 occurred between July 2021 and August 2022 at 18 different medical clinic sites across Botswana, South Africa, Thailand, Uganda, and the United States.
55 participants were enrolled into Cohort 1C/1R, and 44 of these participants continued to Cohort 2. An additional 100 participants enrolled into Cohort 2. Parents/caregivers (n = 13) are not included in the participant flow result section because no baseline measurements were collected for these participants. In addition, no data collected from these participants contributed to the reporting of results for primary or secondary objectives.
Participant milestones
| Measure |
Cohort 1C: CAB
Step 1: CAB administered orally as one 30 mg tablet once daily, beginning at the Entry visit, for 4-6 weeks.
Step 2 (Q4W dosing): CAB LA administered as three single intramuscular (IM) injections four weeks apart (600 mg injection at Week 4b, 400 mg injection at Week 8, and 400 mg injection at Week 12).
Step 2 (Q8W dosing): CAB LA administered as two single IM injections four weeks apart (600 mg injection at Week 4b and 600 mg injection at Week 8).
Oral Cabotegravir (CAB): 30 mg tablets administered orally
Long-Acting Injectable Cabotegravir (CAB LA): Administered by intramuscular (IM) injection
Combination Antiretroviral Therapy (cART): Participants continued their pre-study cART regimen. The antiretroviral drugs in participants' cART regimens were not provided through the study.
|
Cohort 1R: RPV
Step 1: RPV administered orally as one 25 mg tablet once daily, beginning at the Entry visit, for 4-6 weeks.
Step 2 (Q4W dosing): RPV LA administered as three single IM injections four weeks apart (900 mg injection at Week 4b, 600 mg injection at Week 8, 600 mg injection at and Week 12).
Step 2 (Q8W dosing): RPV LA administered as two single IM injections four weeks apart (900 mg injection at Week 4b and 900 mg injection at Week 8).
Oral Rilpivirine (RPV): 25 mg tablets administered orally
Long-Acting Injectable Rilpivirine (RPV LA): Administered by intramuscular (IM) injection
Combination Antiretroviral Therapy (cART): Participants continued their pre-study cART regimen. The antiretroviral drugs in participants' cART regimens were not provided through the study.
|
Cohort 2A: Oral CAB + Oral RPV and CAB LA + RPV LA
Step 3: CAB administered orally as one 30 mg tablet once daily and RPV administered orally as one 25 mg tablet once daily, beginning at the Entry visit for 4-6 weeks.
Step 4: First and second injections: CAB LA administered as a 600 mg IM injection and RPV LA administered as a 900 mg IM injection at Week 4b and at Week 8. Subsequent injections: starting at Week 16, CAB LA administered as a 600 mg IM injection and RPV LA administered as a 900 mg IM injection every eight weeks through Week 96 or final safety extension visit.
Oral Cabotegravir (CAB): 30 mg tablets administered orally
Oral Rilpivirine (RPV): 25 mg tablets administered orally
Long-Acting Injectable Cabotegravir (CAB LA): Administered by intramuscular (IM) injection
Long-Acting Injectable Rilpivirine (RPV LA): Administered by intramuscular (IM) injection
|
Cohort 2B: CAB LA + RPV LA
Step 5: First and second injections: CAB LA administered as a 600 mg IM injection and RPV LA administered as a 900 mg IM injection at Entry and at Week 4. Subsequent injections: starting at Week 12, CAB LA administered as a 600 mg IM injection and RPV LA administered as 900 mg IM injection every eight weeks through Week 92 or final safety extension visit.
Long-Acting Injectable Cabotegravir (CAB LA): Administered by intramuscular (IM) injection
Long-Acting Injectable Rilpivirine (RPV LA): Administered by intramuscular (IM) injection
|
|---|---|---|---|---|
|
Cohort 1 Treatment Initiation to Week 16
STARTED
|
30
|
25
|
0
|
0
|
|
Cohort 1 Treatment Initiation to Week 16
COMPLETED
|
29
|
23
|
0
|
0
|
|
Cohort 1 Treatment Initiation to Week 16
NOT COMPLETED
|
1
|
2
|
0
|
0
|
|
Cohort 1 Week 16 Through End of Cohort 1
STARTED
|
29
|
23
|
0
|
0
|
|
Cohort 1 Week 16 Through End of Cohort 1
COMPLETED
|
28
|
21
|
0
|
0
|
|
Cohort 1 Week 16 Through End of Cohort 1
NOT COMPLETED
|
1
|
2
|
0
|
0
|
|
Cohort 2 Treatment Initiation to Week 24
STARTED
|
0
|
0
|
144
|
0
|
|
Cohort 2 Treatment Initiation to Week 24
COMPLETED
|
0
|
0
|
141
|
0
|
|
Cohort 2 Treatment Initiation to Week 24
NOT COMPLETED
|
0
|
0
|
3
|
0
|
|
Cohort 2 Week 24 to Week 48
STARTED
|
0
|
0
|
141
|
0
|
|
Cohort 2 Week 24 to Week 48
COMPLETED
|
0
|
0
|
140
|
0
|
|
Cohort 2 Week 24 to Week 48
NOT COMPLETED
|
0
|
0
|
1
|
0
|
|
Cohort 2 Week 48 to Week 96
STARTED
|
0
|
0
|
140
|
0
|
|
Cohort 2 Week 48 to Week 96
COMPLETED
|
0
|
0
|
137
|
0
|
|
Cohort 2 Week 48 to Week 96
NOT COMPLETED
|
0
|
0
|
3
|
0
|
|
Cohort 2 Safety Extension
STARTED
|
0
|
0
|
117
|
0
|
|
Cohort 2 Safety Extension
COMPLETED
|
0
|
0
|
116
|
0
|
|
Cohort 2 Safety Extension
NOT COMPLETED
|
0
|
0
|
1
|
0
|
Reasons for withdrawal
| Measure |
Cohort 1C: CAB
Step 1: CAB administered orally as one 30 mg tablet once daily, beginning at the Entry visit, for 4-6 weeks.
Step 2 (Q4W dosing): CAB LA administered as three single intramuscular (IM) injections four weeks apart (600 mg injection at Week 4b, 400 mg injection at Week 8, and 400 mg injection at Week 12).
Step 2 (Q8W dosing): CAB LA administered as two single IM injections four weeks apart (600 mg injection at Week 4b and 600 mg injection at Week 8).
Oral Cabotegravir (CAB): 30 mg tablets administered orally
Long-Acting Injectable Cabotegravir (CAB LA): Administered by intramuscular (IM) injection
Combination Antiretroviral Therapy (cART): Participants continued their pre-study cART regimen. The antiretroviral drugs in participants' cART regimens were not provided through the study.
|
Cohort 1R: RPV
Step 1: RPV administered orally as one 25 mg tablet once daily, beginning at the Entry visit, for 4-6 weeks.
Step 2 (Q4W dosing): RPV LA administered as three single IM injections four weeks apart (900 mg injection at Week 4b, 600 mg injection at Week 8, 600 mg injection at and Week 12).
Step 2 (Q8W dosing): RPV LA administered as two single IM injections four weeks apart (900 mg injection at Week 4b and 900 mg injection at Week 8).
Oral Rilpivirine (RPV): 25 mg tablets administered orally
Long-Acting Injectable Rilpivirine (RPV LA): Administered by intramuscular (IM) injection
Combination Antiretroviral Therapy (cART): Participants continued their pre-study cART regimen. The antiretroviral drugs in participants' cART regimens were not provided through the study.
|
Cohort 2A: Oral CAB + Oral RPV and CAB LA + RPV LA
Step 3: CAB administered orally as one 30 mg tablet once daily and RPV administered orally as one 25 mg tablet once daily, beginning at the Entry visit for 4-6 weeks.
Step 4: First and second injections: CAB LA administered as a 600 mg IM injection and RPV LA administered as a 900 mg IM injection at Week 4b and at Week 8. Subsequent injections: starting at Week 16, CAB LA administered as a 600 mg IM injection and RPV LA administered as a 900 mg IM injection every eight weeks through Week 96 or final safety extension visit.
Oral Cabotegravir (CAB): 30 mg tablets administered orally
Oral Rilpivirine (RPV): 25 mg tablets administered orally
Long-Acting Injectable Cabotegravir (CAB LA): Administered by intramuscular (IM) injection
Long-Acting Injectable Rilpivirine (RPV LA): Administered by intramuscular (IM) injection
|
Cohort 2B: CAB LA + RPV LA
Step 5: First and second injections: CAB LA administered as a 600 mg IM injection and RPV LA administered as a 900 mg IM injection at Entry and at Week 4. Subsequent injections: starting at Week 12, CAB LA administered as a 600 mg IM injection and RPV LA administered as 900 mg IM injection every eight weeks through Week 92 or final safety extension visit.
Long-Acting Injectable Cabotegravir (CAB LA): Administered by intramuscular (IM) injection
Long-Acting Injectable Rilpivirine (RPV LA): Administered by intramuscular (IM) injection
|
|---|---|---|---|---|
|
Cohort 1 Treatment Initiation to Week 16
Adverse Event
|
0
|
1
|
0
|
0
|
|
Cohort 1 Treatment Initiation to Week 16
Withdrawal by Subject
|
1
|
1
|
0
|
0
|
|
Cohort 1 Week 16 Through End of Cohort 1
Lost to Follow-up
|
1
|
1
|
0
|
0
|
|
Cohort 1 Week 16 Through End of Cohort 1
Withdrawal by Subject
|
0
|
1
|
0
|
0
|
|
Cohort 2 Treatment Initiation to Week 24
Pregnancy
|
0
|
0
|
1
|
0
|
|
Cohort 2 Treatment Initiation to Week 24
Protocol Violation
|
0
|
0
|
1
|
0
|
|
Cohort 2 Treatment Initiation to Week 24
Non-compliance with study treatment
|
0
|
0
|
1
|
0
|
|
Cohort 2 Week 24 to Week 48
Lost to Follow-up
|
0
|
0
|
1
|
0
|
|
Cohort 2 Week 48 to Week 96
Pregnancy
|
0
|
0
|
2
|
0
|
|
Cohort 2 Week 48 to Week 96
Adverse Event
|
0
|
0
|
1
|
0
|
|
Cohort 2 Safety Extension
Lost to Follow-up
|
0
|
0
|
1
|
0
|
Baseline Characteristics
Baseline characteristics are reported separately for Cohort 1 and Cohort 2 participants.
Baseline characteristics by cohort
| Measure |
Cohort 1C: CAB
n=30 Participants
Step 1: CAB administered orally as one 30 mg tablet once daily, beginning at the Entry visit, for 4-6 weeks.
Step 2 (Q4W dosing): CAB LA administered as three single intramuscular (IM) injections four weeks apart (600 mg injection at Week 4b, 400 mg injection at Week 8, and 400 mg injection at Week 12).
Step 2 (Q8W dosing): CAB LA administered as two single IM injections four weeks apart (600 mg injection at Week 4b and 600 mg injection at Week 8).
Oral Cabotegravir (CAB): 30 mg tablets administered orally
Long-Acting Injectable Cabotegravir (CAB LA): Administered by intramuscular (IM) injection
Combination Antiretroviral Therapy (cART): Participants continued their pre-study cART regimen. The antiretroviral drugs in participants' cART regimens were not provided through the study.
|
Cohort 1R: RPV
n=25 Participants
Step 1: RPV administered orally as one 25 mg tablet once daily, beginning at the Entry visit, for 4-6 weeks.
Step 2 (Q4W dosing): RPV LA administered as three single IM injections four weeks apart (900 mg injection at Week 4b, 600 mg injection at Week 8, 600 mg injection at and Week 12).
Step 2 (Q8W dosing): RPV LA administered as two single IM injections four weeks apart (900 mg injection at Week 4b and 900 mg injection at Week 8).
Oral Rilpivirine (RPV): 25 mg tablets administered orally
Long-Acting Injectable Rilpivirine (RPV LA): Administered by intramuscular (IM) injection
Combination Antiretroviral Therapy (cART): Participants continued their pre-study cART regimen. The antiretroviral drugs in participants' cART regimens were not provided through the study.
|
Cohort 2A: Oral CAB + Oral RPV and CAB LA + RPV LA
n=144 Participants
Step 3: CAB administered orally as one 30 mg tablet once daily and RPV administered orally as one 25 mg tablet once daily, beginning at the Entry visit for 4-6 weeks.
Step 4: First and second injections: CAB LA administered as a 600 mg IM injection and RPV LA administered as a 900 mg IM injection at Week 4b and at Week 8. Subsequent injections: starting at Week 16, CAB LA administered as a 600 mg IM injection and RPV LA administered as a 900 mg IM injection every eight weeks through Week 96 or final safety extension visit.
Oral Cabotegravir (CAB): 30 mg tablets administered orally
Oral Rilpivirine (RPV): 25 mg tablets administered orally
Long-Acting Injectable Cabotegravir (CAB LA): Administered by intramuscular (IM) injection
Long-Acting Injectable Rilpivirine (RPV LA): Administered by intramuscular (IM) injection
|
Cohort 2B: CAB LA + RPV LA
Step 5: First and second injections: CAB LA administered as a 600 mg IM injection and RPV LA administered as a 900 mg IM injection at Entry and at Week 4. Subsequent injections: starting at Week 12, CAB LA administered as a 600 mg IM injection and RPV LA administered as 900 mg IM injection every eight weeks through Week 92 or final safety extension visit.
Long-Acting Injectable Cabotegravir (CAB LA): Administered by intramuscular (IM) injection
Long-Acting Injectable Rilpivirine (RPV LA): Administered by intramuscular (IM) injection
|
Total
n=199 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
Cohort 1
|
15 years
n=30 Participants • Baseline characteristics are reported separately for Cohort 1 and Cohort 2 participants.
|
16 years
n=25 Participants • Baseline characteristics are reported separately for Cohort 1 and Cohort 2 participants.
|
—
|
—
|
15 years
n=55 Participants • Baseline characteristics are reported separately for Cohort 1 and Cohort 2 participants.
|
|
Age, Continuous
Cohort 2
|
—
|
—
|
15 years
n=144 Participants • Baseline characteristics are reported separately for Cohort 1 and Cohort 2 participants.
|
—
|
15 years
n=144 Participants • Baseline characteristics are reported separately for Cohort 1 and Cohort 2 participants.
|
|
Age, Customized
Cohort 1 · 12
|
1 Participants
n=30 Participants • Baseline characteristics are reported separately for Cohort 1 and Cohort 2 participants.
|
3 Participants
n=25 Participants • Baseline characteristics are reported separately for Cohort 1 and Cohort 2 participants.
|
—
|
0 Participants
Baseline characteristics are reported separately for Cohort 1 and Cohort 2 participants.
|
4 Participants
n=55 Participants • Baseline characteristics are reported separately for Cohort 1 and Cohort 2 participants.
|
|
Age, Customized
Cohort 1 · 13
|
5 Participants
n=30 Participants • Baseline characteristics are reported separately for Cohort 1 and Cohort 2 participants.
|
0 Participants
n=25 Participants • Baseline characteristics are reported separately for Cohort 1 and Cohort 2 participants.
|
—
|
0 Participants
Baseline characteristics are reported separately for Cohort 1 and Cohort 2 participants.
|
5 Participants
n=55 Participants • Baseline characteristics are reported separately for Cohort 1 and Cohort 2 participants.
|
|
Age, Customized
Cohort 1 · 14
|
7 Participants
n=30 Participants • Baseline characteristics are reported separately for Cohort 1 and Cohort 2 participants.
|
3 Participants
n=25 Participants • Baseline characteristics are reported separately for Cohort 1 and Cohort 2 participants.
|
—
|
0 Participants
Baseline characteristics are reported separately for Cohort 1 and Cohort 2 participants.
|
10 Participants
n=55 Participants • Baseline characteristics are reported separately for Cohort 1 and Cohort 2 participants.
|
|
Age, Customized
Cohort 1 · 15
|
6 Participants
n=30 Participants • Baseline characteristics are reported separately for Cohort 1 and Cohort 2 participants.
|
4 Participants
n=25 Participants • Baseline characteristics are reported separately for Cohort 1 and Cohort 2 participants.
|
—
|
0 Participants
Baseline characteristics are reported separately for Cohort 1 and Cohort 2 participants.
|
10 Participants
n=55 Participants • Baseline characteristics are reported separately for Cohort 1 and Cohort 2 participants.
|
|
Age, Customized
Cohort 1 · 16
|
4 Participants
n=30 Participants • Baseline characteristics are reported separately for Cohort 1 and Cohort 2 participants.
|
4 Participants
n=25 Participants • Baseline characteristics are reported separately for Cohort 1 and Cohort 2 participants.
|
—
|
0 Participants
Baseline characteristics are reported separately for Cohort 1 and Cohort 2 participants.
|
8 Participants
n=55 Participants • Baseline characteristics are reported separately for Cohort 1 and Cohort 2 participants.
|
|
Age, Customized
Cohort 1 · 17
|
7 Participants
n=30 Participants • Baseline characteristics are reported separately for Cohort 1 and Cohort 2 participants.
|
11 Participants
n=25 Participants • Baseline characteristics are reported separately for Cohort 1 and Cohort 2 participants.
|
—
|
0 Participants
Baseline characteristics are reported separately for Cohort 1 and Cohort 2 participants.
|
18 Participants
n=55 Participants • Baseline characteristics are reported separately for Cohort 1 and Cohort 2 participants.
|
|
Age, Customized
Cohort 2 · 12
|
—
|
—
|
11 Participants
n=144 Participants • Baseline characteristics are reported separately for Cohort 1 and Cohort 2 participants.
|
—
|
11 Participants
n=144 Participants • Baseline characteristics are reported separately for Cohort 1 and Cohort 2 participants.
|
|
Age, Customized
Cohort 2 · 13
|
—
|
—
|
23 Participants
n=144 Participants • Baseline characteristics are reported separately for Cohort 1 and Cohort 2 participants.
|
—
|
23 Participants
n=144 Participants • Baseline characteristics are reported separately for Cohort 1 and Cohort 2 participants.
|
|
Age, Customized
Cohort 2 · 14
|
—
|
—
|
19 Participants
n=144 Participants • Baseline characteristics are reported separately for Cohort 1 and Cohort 2 participants.
|
—
|
19 Participants
n=144 Participants • Baseline characteristics are reported separately for Cohort 1 and Cohort 2 participants.
|
|
Age, Customized
Cohort 2 · 15
|
—
|
—
|
35 Participants
n=144 Participants • Baseline characteristics are reported separately for Cohort 1 and Cohort 2 participants.
|
—
|
35 Participants
n=144 Participants • Baseline characteristics are reported separately for Cohort 1 and Cohort 2 participants.
|
|
Age, Customized
Cohort 2 · 16
|
—
|
—
|
27 Participants
n=144 Participants • Baseline characteristics are reported separately for Cohort 1 and Cohort 2 participants.
|
—
|
27 Participants
n=144 Participants • Baseline characteristics are reported separately for Cohort 1 and Cohort 2 participants.
|
|
Age, Customized
Cohort 2 · 17
|
—
|
—
|
29 Participants
n=144 Participants • Baseline characteristics are reported separately for Cohort 1 and Cohort 2 participants.
|
—
|
29 Participants
n=144 Participants • Baseline characteristics are reported separately for Cohort 1 and Cohort 2 participants.
|
|
Sex: Female, Male
Cohort 1 · Female
|
14 Participants
n=30 Participants • Baseline characteristics are reported separately for Cohort 1 and Cohort 2 participants.
|
12 Participants
n=25 Participants • Baseline characteristics are reported separately for Cohort 1 and Cohort 2 participants.
|
—
|
—
|
26 Participants
n=55 Participants • Baseline characteristics are reported separately for Cohort 1 and Cohort 2 participants.
|
|
Sex: Female, Male
Cohort 1 · Male
|
16 Participants
n=30 Participants • Baseline characteristics are reported separately for Cohort 1 and Cohort 2 participants.
|
13 Participants
n=25 Participants • Baseline characteristics are reported separately for Cohort 1 and Cohort 2 participants.
|
—
|
—
|
29 Participants
n=55 Participants • Baseline characteristics are reported separately for Cohort 1 and Cohort 2 participants.
|
|
Sex: Female, Male
Cohort 2 · Female
|
—
|
—
|
74 Participants
n=144 Participants • Baseline characteristics are reported separately for Cohort 1 and Cohort 2 participants.
|
—
|
74 Participants
n=144 Participants • Baseline characteristics are reported separately for Cohort 1 and Cohort 2 participants.
|
|
Sex: Female, Male
Cohort 2 · Male
|
—
|
—
|
70 Participants
n=144 Participants • Baseline characteristics are reported separately for Cohort 1 and Cohort 2 participants.
|
—
|
70 Participants
n=144 Participants • Baseline characteristics are reported separately for Cohort 1 and Cohort 2 participants.
|
|
Ethnicity (NIH/OMB)
Cohort 1 · Hispanic or Latino
|
0 Participants
n=30 Participants • Baseline characteristics are reported separately for Cohort 1 and Cohort 2 participants.
|
3 Participants
n=25 Participants • Baseline characteristics are reported separately for Cohort 1 and Cohort 2 participants.
|
—
|
—
|
3 Participants
n=55 Participants • Baseline characteristics are reported separately for Cohort 1 and Cohort 2 participants.
|
|
Ethnicity (NIH/OMB)
Cohort 1 · Not Hispanic or Latino
|
30 Participants
n=30 Participants • Baseline characteristics are reported separately for Cohort 1 and Cohort 2 participants.
|
22 Participants
n=25 Participants • Baseline characteristics are reported separately for Cohort 1 and Cohort 2 participants.
|
—
|
—
|
52 Participants
n=55 Participants • Baseline characteristics are reported separately for Cohort 1 and Cohort 2 participants.
|
|
Ethnicity (NIH/OMB)
Cohort 1 · Unknown or Not Reported
|
0 Participants
n=30 Participants • Baseline characteristics are reported separately for Cohort 1 and Cohort 2 participants.
|
0 Participants
n=25 Participants • Baseline characteristics are reported separately for Cohort 1 and Cohort 2 participants.
|
—
|
—
|
0 Participants
n=55 Participants • Baseline characteristics are reported separately for Cohort 1 and Cohort 2 participants.
|
|
Ethnicity (NIH/OMB)
Cohort 2 · Hispanic or Latino
|
—
|
—
|
3 Participants
n=144 Participants • Baseline characteristics are reported separately for Cohort 1 and Cohort 2 participants.
|
—
|
3 Participants
n=144 Participants • Baseline characteristics are reported separately for Cohort 1 and Cohort 2 participants.
|
|
Ethnicity (NIH/OMB)
Cohort 2 · Not Hispanic or Latino
|
—
|
—
|
141 Participants
n=144 Participants • Baseline characteristics are reported separately for Cohort 1 and Cohort 2 participants.
|
—
|
141 Participants
n=144 Participants • Baseline characteristics are reported separately for Cohort 1 and Cohort 2 participants.
|
|
Ethnicity (NIH/OMB)
Cohort 2 · Unknown or Not Reported
|
—
|
—
|
0 Participants
n=144 Participants • Baseline characteristics are reported separately for Cohort 1 and Cohort 2 participants.
|
—
|
0 Participants
n=144 Participants • Baseline characteristics are reported separately for Cohort 1 and Cohort 2 participants.
|
|
Race (NIH/OMB)
Cohort 1 · American Indian or Alaska Native
|
0 Participants
n=30 Participants • Baseline characteristics are reported separately for Cohort 1 and Cohort 2 participants.
|
0 Participants
n=25 Participants • Baseline characteristics are reported separately for Cohort 1 and Cohort 2 participants.
|
—
|
—
|
0 Participants
n=55 Participants • Baseline characteristics are reported separately for Cohort 1 and Cohort 2 participants.
|
|
Race (NIH/OMB)
Cohort 1 · Asian
|
9 Participants
n=30 Participants • Baseline characteristics are reported separately for Cohort 1 and Cohort 2 participants.
|
0 Participants
n=25 Participants • Baseline characteristics are reported separately for Cohort 1 and Cohort 2 participants.
|
—
|
—
|
9 Participants
n=55 Participants • Baseline characteristics are reported separately for Cohort 1 and Cohort 2 participants.
|
|
Race (NIH/OMB)
Cohort 1 · Native Hawaiian or Other Pacific Islander
|
0 Participants
n=30 Participants • Baseline characteristics are reported separately for Cohort 1 and Cohort 2 participants.
|
0 Participants
n=25 Participants • Baseline characteristics are reported separately for Cohort 1 and Cohort 2 participants.
|
—
|
—
|
0 Participants
n=55 Participants • Baseline characteristics are reported separately for Cohort 1 and Cohort 2 participants.
|
|
Race (NIH/OMB)
Cohort 1 · Black or African American
|
21 Participants
n=30 Participants • Baseline characteristics are reported separately for Cohort 1 and Cohort 2 participants.
|
21 Participants
n=25 Participants • Baseline characteristics are reported separately for Cohort 1 and Cohort 2 participants.
|
—
|
—
|
42 Participants
n=55 Participants • Baseline characteristics are reported separately for Cohort 1 and Cohort 2 participants.
|
|
Race (NIH/OMB)
Cohort 1 · White
|
0 Participants
n=30 Participants • Baseline characteristics are reported separately for Cohort 1 and Cohort 2 participants.
|
4 Participants
n=25 Participants • Baseline characteristics are reported separately for Cohort 1 and Cohort 2 participants.
|
—
|
—
|
4 Participants
n=55 Participants • Baseline characteristics are reported separately for Cohort 1 and Cohort 2 participants.
|
|
Race (NIH/OMB)
Cohort 1 · More than one race
|
0 Participants
n=30 Participants • Baseline characteristics are reported separately for Cohort 1 and Cohort 2 participants.
|
0 Participants
n=25 Participants • Baseline characteristics are reported separately for Cohort 1 and Cohort 2 participants.
|
—
|
—
|
0 Participants
n=55 Participants • Baseline characteristics are reported separately for Cohort 1 and Cohort 2 participants.
|
|
Race (NIH/OMB)
Cohort 1 · Unknown or Not Reported
|
0 Participants
n=30 Participants • Baseline characteristics are reported separately for Cohort 1 and Cohort 2 participants.
|
0 Participants
n=25 Participants • Baseline characteristics are reported separately for Cohort 1 and Cohort 2 participants.
|
—
|
—
|
0 Participants
n=55 Participants • Baseline characteristics are reported separately for Cohort 1 and Cohort 2 participants.
|
|
Race (NIH/OMB)
Cohort 2 · American Indian or Alaska Native
|
—
|
—
|
0 Participants
n=144 Participants • Baseline characteristics are reported separately for Cohort 1 and Cohort 2 participants.
|
—
|
0 Participants
n=144 Participants • Baseline characteristics are reported separately for Cohort 1 and Cohort 2 participants.
|
|
Race (NIH/OMB)
Cohort 2 · Asian
|
—
|
—
|
36 Participants
n=144 Participants • Baseline characteristics are reported separately for Cohort 1 and Cohort 2 participants.
|
—
|
36 Participants
n=144 Participants • Baseline characteristics are reported separately for Cohort 1 and Cohort 2 participants.
|
|
Race (NIH/OMB)
Cohort 2 · Native Hawaiian or Other Pacific Islander
|
—
|
—
|
0 Participants
n=144 Participants • Baseline characteristics are reported separately for Cohort 1 and Cohort 2 participants.
|
—
|
0 Participants
n=144 Participants • Baseline characteristics are reported separately for Cohort 1 and Cohort 2 participants.
|
|
Race (NIH/OMB)
Cohort 2 · Black or African American
|
—
|
—
|
106 Participants
n=144 Participants • Baseline characteristics are reported separately for Cohort 1 and Cohort 2 participants.
|
—
|
106 Participants
n=144 Participants • Baseline characteristics are reported separately for Cohort 1 and Cohort 2 participants.
|
|
Race (NIH/OMB)
Cohort 2 · White
|
—
|
—
|
2 Participants
n=144 Participants • Baseline characteristics are reported separately for Cohort 1 and Cohort 2 participants.
|
—
|
2 Participants
n=144 Participants • Baseline characteristics are reported separately for Cohort 1 and Cohort 2 participants.
|
|
Race (NIH/OMB)
Cohort 2 · More than one race
|
—
|
—
|
0 Participants
n=144 Participants • Baseline characteristics are reported separately for Cohort 1 and Cohort 2 participants.
|
—
|
0 Participants
n=144 Participants • Baseline characteristics are reported separately for Cohort 1 and Cohort 2 participants.
|
|
Race (NIH/OMB)
Cohort 2 · Unknown or Not Reported
|
—
|
—
|
0 Participants
n=144 Participants • Baseline characteristics are reported separately for Cohort 1 and Cohort 2 participants.
|
—
|
0 Participants
n=144 Participants • Baseline characteristics are reported separately for Cohort 1 and Cohort 2 participants.
|
|
Region of Enrollment, Customized
Cohort 1 · United States
|
8 Participants
n=30 Participants • Baseline characteristics are reported separately for Cohort 1 and Cohort 2 participants.
|
17 Participants
n=25 Participants • Baseline characteristics are reported separately for Cohort 1 and Cohort 2 participants.
|
—
|
—
|
25 Participants
n=55 Participants • Baseline characteristics are reported separately for Cohort 1 and Cohort 2 participants.
|
|
Region of Enrollment, Customized
Cohort 1 · Botswana
|
0 Participants
n=30 Participants • Baseline characteristics are reported separately for Cohort 1 and Cohort 2 participants.
|
5 Participants
n=25 Participants • Baseline characteristics are reported separately for Cohort 1 and Cohort 2 participants.
|
—
|
—
|
5 Participants
n=55 Participants • Baseline characteristics are reported separately for Cohort 1 and Cohort 2 participants.
|
|
Region of Enrollment, Customized
Cohort 1 · South Africa
|
14 Participants
n=30 Participants • Baseline characteristics are reported separately for Cohort 1 and Cohort 2 participants.
|
3 Participants
n=25 Participants • Baseline characteristics are reported separately for Cohort 1 and Cohort 2 participants.
|
—
|
—
|
17 Participants
n=55 Participants • Baseline characteristics are reported separately for Cohort 1 and Cohort 2 participants.
|
|
Region of Enrollment, Customized
Cohort 1 · Uganda
|
0 Participants
n=30 Participants • Baseline characteristics are reported separately for Cohort 1 and Cohort 2 participants.
|
0 Participants
n=25 Participants • Baseline characteristics are reported separately for Cohort 1 and Cohort 2 participants.
|
—
|
—
|
0 Participants
n=55 Participants • Baseline characteristics are reported separately for Cohort 1 and Cohort 2 participants.
|
|
Region of Enrollment, Customized
Cohort 1 · Thailand
|
8 Participants
n=30 Participants • Baseline characteristics are reported separately for Cohort 1 and Cohort 2 participants.
|
0 Participants
n=25 Participants • Baseline characteristics are reported separately for Cohort 1 and Cohort 2 participants.
|
—
|
—
|
8 Participants
n=55 Participants • Baseline characteristics are reported separately for Cohort 1 and Cohort 2 participants.
|
|
Region of Enrollment, Customized
Cohort 2 · United States
|
—
|
—
|
20 Participants
n=144 Participants • Baseline characteristics are reported separately for Cohort 1 and Cohort 2 participants.
|
—
|
20 Participants
n=144 Participants • Baseline characteristics are reported separately for Cohort 1 and Cohort 2 participants.
|
|
Region of Enrollment, Customized
Cohort 2 · Botswana
|
—
|
—
|
25 Participants
n=144 Participants • Baseline characteristics are reported separately for Cohort 1 and Cohort 2 participants.
|
—
|
25 Participants
n=144 Participants • Baseline characteristics are reported separately for Cohort 1 and Cohort 2 participants.
|
|
Region of Enrollment, Customized
Cohort 2 · South Africa
|
—
|
—
|
43 Participants
n=144 Participants • Baseline characteristics are reported separately for Cohort 1 and Cohort 2 participants.
|
—
|
43 Participants
n=144 Participants • Baseline characteristics are reported separately for Cohort 1 and Cohort 2 participants.
|
|
Region of Enrollment, Customized
Cohort 2 · Uganda
|
—
|
—
|
20 Participants
n=144 Participants • Baseline characteristics are reported separately for Cohort 1 and Cohort 2 participants.
|
—
|
20 Participants
n=144 Participants • Baseline characteristics are reported separately for Cohort 1 and Cohort 2 participants.
|
|
Region of Enrollment, Customized
Cohort 2 · Thailand
|
—
|
—
|
36 Participants
n=144 Participants • Baseline characteristics are reported separately for Cohort 1 and Cohort 2 participants.
|
—
|
36 Participants
n=144 Participants • Baseline characteristics are reported separately for Cohort 1 and Cohort 2 participants.
|
|
HIV-1 RNA
Cohort 1 · <50 copies/mL
|
30 Participants
n=30 Participants • Baseline characteristics are reported separately for Cohort 1 and Cohort 2 participants.
|
24 Participants
n=25 Participants • Baseline characteristics are reported separately for Cohort 1 and Cohort 2 participants.
|
—
|
—
|
54 Participants
n=55 Participants • Baseline characteristics are reported separately for Cohort 1 and Cohort 2 participants.
|
|
HIV-1 RNA
Cohort 1 · >=50 copies/mL
|
0 Participants
n=30 Participants • Baseline characteristics are reported separately for Cohort 1 and Cohort 2 participants.
|
1 Participants
n=25 Participants • Baseline characteristics are reported separately for Cohort 1 and Cohort 2 participants.
|
—
|
—
|
1 Participants
n=55 Participants • Baseline characteristics are reported separately for Cohort 1 and Cohort 2 participants.
|
|
HIV-1 RNA
Cohort 2 · <50 copies/mL
|
—
|
—
|
138 Participants
n=144 Participants • Baseline characteristics are reported separately for Cohort 1 and Cohort 2 participants.
|
—
|
138 Participants
n=144 Participants • Baseline characteristics are reported separately for Cohort 1 and Cohort 2 participants.
|
|
HIV-1 RNA
Cohort 2 · >=50 copies/mL
|
—
|
—
|
6 Participants
n=144 Participants • Baseline characteristics are reported separately for Cohort 1 and Cohort 2 participants.
|
—
|
6 Participants
n=144 Participants • Baseline characteristics are reported separately for Cohort 1 and Cohort 2 participants.
|
|
Quality of Life Dimension Scores
Cohort 1 Physical Functioning Dimension
|
96.9 units on a scale
n=30 Participants • Baseline characteristics are reported separately for Cohort 1 and Cohort 2 participants. Questions used for School Functioning Dimension are only answered by participants who are attempting school at the time of the evaluation. One participant in Cohort 1R and 11 participants in Cohort 2 did not respond to these questions.
|
100 units on a scale
n=25 Participants • Baseline characteristics are reported separately for Cohort 1 and Cohort 2 participants. Questions used for School Functioning Dimension are only answered by participants who are attempting school at the time of the evaluation. One participant in Cohort 1R and 11 participants in Cohort 2 did not respond to these questions.
|
—
|
—
|
100 units on a scale
n=55 Participants • Baseline characteristics are reported separately for Cohort 1 and Cohort 2 participants. Questions used for School Functioning Dimension are only answered by participants who are attempting school at the time of the evaluation. One participant in Cohort 1R and 11 participants in Cohort 2 did not respond to these questions.
|
|
Quality of Life Dimension Scores
Cohort 1 Emotional Functioning Dimension
|
90 units on a scale
n=30 Participants • Baseline characteristics are reported separately for Cohort 1 and Cohort 2 participants. Questions used for School Functioning Dimension are only answered by participants who are attempting school at the time of the evaluation. One participant in Cohort 1R and 11 participants in Cohort 2 did not respond to these questions.
|
90 units on a scale
n=25 Participants • Baseline characteristics are reported separately for Cohort 1 and Cohort 2 participants. Questions used for School Functioning Dimension are only answered by participants who are attempting school at the time of the evaluation. One participant in Cohort 1R and 11 participants in Cohort 2 did not respond to these questions.
|
—
|
—
|
90 units on a scale
n=55 Participants • Baseline characteristics are reported separately for Cohort 1 and Cohort 2 participants. Questions used for School Functioning Dimension are only answered by participants who are attempting school at the time of the evaluation. One participant in Cohort 1R and 11 participants in Cohort 2 did not respond to these questions.
|
|
Quality of Life Dimension Scores
Cohort 1 Social Functioning Dimension
|
100 units on a scale
n=30 Participants • Baseline characteristics are reported separately for Cohort 1 and Cohort 2 participants. Questions used for School Functioning Dimension are only answered by participants who are attempting school at the time of the evaluation. One participant in Cohort 1R and 11 participants in Cohort 2 did not respond to these questions.
|
95 units on a scale
n=25 Participants • Baseline characteristics are reported separately for Cohort 1 and Cohort 2 participants. Questions used for School Functioning Dimension are only answered by participants who are attempting school at the time of the evaluation. One participant in Cohort 1R and 11 participants in Cohort 2 did not respond to these questions.
|
—
|
—
|
100 units on a scale
n=55 Participants • Baseline characteristics are reported separately for Cohort 1 and Cohort 2 participants. Questions used for School Functioning Dimension are only answered by participants who are attempting school at the time of the evaluation. One participant in Cohort 1R and 11 participants in Cohort 2 did not respond to these questions.
|
|
Quality of Life Dimension Scores
Cohort 1 School Functioning Dimension
|
80 units on a scale
n=30 Participants • Baseline characteristics are reported separately for Cohort 1 and Cohort 2 participants. Questions used for School Functioning Dimension are only answered by participants who are attempting school at the time of the evaluation. One participant in Cohort 1R and 11 participants in Cohort 2 did not respond to these questions.
|
70 units on a scale
n=24 Participants • Baseline characteristics are reported separately for Cohort 1 and Cohort 2 participants. Questions used for School Functioning Dimension are only answered by participants who are attempting school at the time of the evaluation. One participant in Cohort 1R and 11 participants in Cohort 2 did not respond to these questions.
|
—
|
—
|
80 units on a scale
n=54 Participants • Baseline characteristics are reported separately for Cohort 1 and Cohort 2 participants. Questions used for School Functioning Dimension are only answered by participants who are attempting school at the time of the evaluation. One participant in Cohort 1R and 11 participants in Cohort 2 did not respond to these questions.
|
|
Quality of Life Dimension Scores
Cohort 1 Psychosocial Functioning Dimension
|
90 units on a scale
n=30 Participants • Baseline characteristics are reported separately for Cohort 1 and Cohort 2 participants. Questions used for School Functioning Dimension are only answered by participants who are attempting school at the time of the evaluation. One participant in Cohort 1R and 11 participants in Cohort 2 did not respond to these questions.
|
83.3 units on a scale
n=25 Participants • Baseline characteristics are reported separately for Cohort 1 and Cohort 2 participants. Questions used for School Functioning Dimension are only answered by participants who are attempting school at the time of the evaluation. One participant in Cohort 1R and 11 participants in Cohort 2 did not respond to these questions.
|
—
|
—
|
90 units on a scale
n=55 Participants • Baseline characteristics are reported separately for Cohort 1 and Cohort 2 participants. Questions used for School Functioning Dimension are only answered by participants who are attempting school at the time of the evaluation. One participant in Cohort 1R and 11 participants in Cohort 2 did not respond to these questions.
|
|
Quality of Life Dimension Scores
Cohort 1 Total Functioning Dimension
|
92.9 units on a scale
n=30 Participants • Baseline characteristics are reported separately for Cohort 1 and Cohort 2 participants. Questions used for School Functioning Dimension are only answered by participants who are attempting school at the time of the evaluation. One participant in Cohort 1R and 11 participants in Cohort 2 did not respond to these questions.
|
89.1 units on a scale
n=25 Participants • Baseline characteristics are reported separately for Cohort 1 and Cohort 2 participants. Questions used for School Functioning Dimension are only answered by participants who are attempting school at the time of the evaluation. One participant in Cohort 1R and 11 participants in Cohort 2 did not respond to these questions.
|
—
|
—
|
91.3 units on a scale
n=55 Participants • Baseline characteristics are reported separately for Cohort 1 and Cohort 2 participants. Questions used for School Functioning Dimension are only answered by participants who are attempting school at the time of the evaluation. One participant in Cohort 1R and 11 participants in Cohort 2 did not respond to these questions.
|
|
Quality of Life Dimension Scores
Cohort 2 Physical Functioning
|
—
|
—
|
100 units on a scale
n=144 Participants • Baseline characteristics are reported separately for Cohort 1 and Cohort 2 participants. Questions used for School Functioning Dimension are only answered by participants who are attempting school at the time of the evaluation. One participant in Cohort 1R and 11 participants in Cohort 2 did not respond to these questions.
|
—
|
100 units on a scale
n=144 Participants • Baseline characteristics are reported separately for Cohort 1 and Cohort 2 participants. Questions used for School Functioning Dimension are only answered by participants who are attempting school at the time of the evaluation. One participant in Cohort 1R and 11 participants in Cohort 2 did not respond to these questions.
|
|
Quality of Life Dimension Scores
Cohort 2 Emotional Functioning Dimension
|
—
|
—
|
100 units on a scale
n=144 Participants • Baseline characteristics are reported separately for Cohort 1 and Cohort 2 participants. Questions used for School Functioning Dimension are only answered by participants who are attempting school at the time of the evaluation. One participant in Cohort 1R and 11 participants in Cohort 2 did not respond to these questions.
|
—
|
100 units on a scale
n=144 Participants • Baseline characteristics are reported separately for Cohort 1 and Cohort 2 participants. Questions used for School Functioning Dimension are only answered by participants who are attempting school at the time of the evaluation. One participant in Cohort 1R and 11 participants in Cohort 2 did not respond to these questions.
|
|
Quality of Life Dimension Scores
Cohort 2 Social Functioning Dimension
|
—
|
—
|
100 units on a scale
n=144 Participants • Baseline characteristics are reported separately for Cohort 1 and Cohort 2 participants. Questions used for School Functioning Dimension are only answered by participants who are attempting school at the time of the evaluation. One participant in Cohort 1R and 11 participants in Cohort 2 did not respond to these questions.
|
—
|
100 units on a scale
n=144 Participants • Baseline characteristics are reported separately for Cohort 1 and Cohort 2 participants. Questions used for School Functioning Dimension are only answered by participants who are attempting school at the time of the evaluation. One participant in Cohort 1R and 11 participants in Cohort 2 did not respond to these questions.
|
|
Quality of Life Dimension Scores
Cohort 2 School Functioning Dimension
|
—
|
—
|
80 units on a scale
n=133 Participants • Baseline characteristics are reported separately for Cohort 1 and Cohort 2 participants. Questions used for School Functioning Dimension are only answered by participants who are attempting school at the time of the evaluation. One participant in Cohort 1R and 11 participants in Cohort 2 did not respond to these questions.
|
—
|
80 units on a scale
n=133 Participants • Baseline characteristics are reported separately for Cohort 1 and Cohort 2 participants. Questions used for School Functioning Dimension are only answered by participants who are attempting school at the time of the evaluation. One participant in Cohort 1R and 11 participants in Cohort 2 did not respond to these questions.
|
|
Quality of Life Dimension Scores
Cohort 2 Psychosocial Functioning
|
—
|
—
|
91.7 units on a scale
n=144 Participants • Baseline characteristics are reported separately for Cohort 1 and Cohort 2 participants. Questions used for School Functioning Dimension are only answered by participants who are attempting school at the time of the evaluation. One participant in Cohort 1R and 11 participants in Cohort 2 did not respond to these questions.
|
—
|
91.7 units on a scale
n=144 Participants • Baseline characteristics are reported separately for Cohort 1 and Cohort 2 participants. Questions used for School Functioning Dimension are only answered by participants who are attempting school at the time of the evaluation. One participant in Cohort 1R and 11 participants in Cohort 2 did not respond to these questions.
|
|
Quality of Life Dimension Scores
Cohort 2 Total Functioning
|
—
|
—
|
94.6 units on a scale
n=144 Participants • Baseline characteristics are reported separately for Cohort 1 and Cohort 2 participants. Questions used for School Functioning Dimension are only answered by participants who are attempting school at the time of the evaluation. One participant in Cohort 1R and 11 participants in Cohort 2 did not respond to these questions.
|
—
|
94.6 units on a scale
n=144 Participants • Baseline characteristics are reported separately for Cohort 1 and Cohort 2 participants. Questions used for School Functioning Dimension are only answered by participants who are attempting school at the time of the evaluation. One participant in Cohort 1R and 11 participants in Cohort 2 did not respond to these questions.
|
PRIMARY outcome
Timeframe: Cohort 1 Treatment Initiation through Week 4Population: Cohort 1 Evaluable: Cohort 1 participants who were treated exclusively on the dose being evaluated for a given cohort, and either (1) completed all treatment regimen through Cohort 1 Week 4 and completed the Week 4 visit or (2) experienced any of the following: death attributable to the study product; study product-related Grade 3 or higher event (excluding injection site adverse events); OR permanently discontinued from treatment due to study product-related toxicity (regardless of grade).
Based on the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Corrected Version 2.1, dated July 2017. The DAIDS grading table provides an AE severity grading scale ranging from grades 1 to 5 with descriptions for each AE based on the following general guidelines: grade 1 indicates a mild event, grade 2 indicates a moderate event, grade 3 indicates a severe event, grade 4 indicates a potentially life-threatening event, and grade 5 indicates death. We present the proportion of participants with at least one grade 3 or higher AE through 4 weeks post-treatment initiation, bounded by an exact 95% confidence interval (CI).
Outcome measures
| Measure |
Cohort 1C: CAB
n=30 Participants
Step 1: CAB administered orally as one 30 mg tablet once daily, beginning at the Entry visit, for 4-6 weeks.
Step 2 (Q4W dosing): CAB LA administered as three single intramuscular (IM) injections four weeks apart (600 mg injection at Week 4b, 400 mg injection at Week 8, and 400 mg injection at Week 12).
Step 2 (Q8W dosing): CAB LA administered as two single IM injections four weeks apart (600 mg injection at Week 4b and 600 mg injection at Week 8).
Oral Cabotegravir (CAB): 30 mg tablets administered orally
Long-Acting Injectable Cabotegravir (CAB LA): Administered by intramuscular (IM) injection
Combination Antiretroviral Therapy (cART): Participants continued their pre-study cART regimen. The antiretroviral drugs in participants' cART regimens were not provided through the study.
|
Cohort 1R: RPV
Step 1: RPV administered orally as one 25 mg tablet once daily, beginning at the Entry visit, for 4-6 weeks.
Step 2 (Q4W dosing): RPV LA administered as three single IM injections four weeks apart (900 mg injection at Week 4b, 600 mg injection at Week 8, 600 mg injection at and Week 12).
Step 2 (Q8W dosing): RPV LA administered as two single IM injections four weeks apart (900 mg injection at Week 4b and 900 mg injection at Week 8).
Oral Rilpivirine (RPV): 25 mg tablets administered orally
Long-Acting Injectable Rilpivirine (RPV LA): Administered by intramuscular (IM) injection
Combination Antiretroviral Therapy (cART): Participants continued their pre-study cART regimen. The antiretroviral drugs in participants' cART regimens were not provided through the study.
|
|---|---|---|
|
Proportion of Participants Who Had Grade 3 or Higher Adverse Event (Cohort 1)
|
0 proportion of participants
Interval 0.0 to 0.12
|
—
|
PRIMARY outcome
Timeframe: Cohort 1 Treatment Initiation through Week 4Population: Cohort 1 Evaluable: Cohort 1 participants who were treated exclusively on the dose being evaluated for a given cohort, and either (1) completed all treatment regimen through Cohort 1 Week 4 and completed the Week 4 visit or (2) experienced any of the following: death attributable to the study product; study product-related Grade 3 or higher event (excluding injection site adverse events); OR permanently discontinued from treatment due to study product-related toxicity (regardless of grade)
Based on the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Corrected Version 2.1, dated July 2017. The DAIDS grading table provides an AE severity grading scale ranging from grades 1 to 5 with descriptions for each AE based on the following general guidelines: grade 1 indicates a mild event, grade 2 indicates a moderate event, grade 3 indicates a severe event, grade 4 indicates a potentially life-threatening event, and grade 5 indicates death. We present the proportion of participants with at least one grade 3 or higher AE assessed as related by the site investigator of record to study product through 4 weeks post-treatment initiation, bounded by an exact 95% confidence interval (CI).
Outcome measures
| Measure |
Cohort 1C: CAB
n=30 Participants
Step 1: CAB administered orally as one 30 mg tablet once daily, beginning at the Entry visit, for 4-6 weeks.
Step 2 (Q4W dosing): CAB LA administered as three single intramuscular (IM) injections four weeks apart (600 mg injection at Week 4b, 400 mg injection at Week 8, and 400 mg injection at Week 12).
Step 2 (Q8W dosing): CAB LA administered as two single IM injections four weeks apart (600 mg injection at Week 4b and 600 mg injection at Week 8).
Oral Cabotegravir (CAB): 30 mg tablets administered orally
Long-Acting Injectable Cabotegravir (CAB LA): Administered by intramuscular (IM) injection
Combination Antiretroviral Therapy (cART): Participants continued their pre-study cART regimen. The antiretroviral drugs in participants' cART regimens were not provided through the study.
|
Cohort 1R: RPV
Step 1: RPV administered orally as one 25 mg tablet once daily, beginning at the Entry visit, for 4-6 weeks.
Step 2 (Q4W dosing): RPV LA administered as three single IM injections four weeks apart (900 mg injection at Week 4b, 600 mg injection at Week 8, 600 mg injection at and Week 12).
Step 2 (Q8W dosing): RPV LA administered as two single IM injections four weeks apart (900 mg injection at Week 4b and 900 mg injection at Week 8).
Oral Rilpivirine (RPV): 25 mg tablets administered orally
Long-Acting Injectable Rilpivirine (RPV LA): Administered by intramuscular (IM) injection
Combination Antiretroviral Therapy (cART): Participants continued their pre-study cART regimen. The antiretroviral drugs in participants' cART regimens were not provided through the study.
|
|---|---|---|
|
Proportion of Participants Who Had Grade 3 or Higher Adverse Events Assessed as Related to Study Product/s (Cohort 1)
|
0 proportion of participants
Interval 0.0 to 0.12
|
—
|
PRIMARY outcome
Timeframe: Cohort 1 Treatment Initiation through Week 4Population: Cohort 1 Evaluable: Cohort 1 participants who were treated exclusively on the dose being evaluated for a given cohort, and either (1) completed all treatment regimen through Cohort 1 Week 4 and completed the Week 4 visit or (2) experienced any of the following: death attributable to the study product; study product-related Grade 3 or higher event (excluding injection site adverse events); OR permanently discontinued from treatment due to study product-related toxicity (regardless of grade).
Adverse events (AE) were assessed as a Serious AE by ICH criteria. Per ICH, a serious AE is any untoward medical occurrence that results in death, is life-threatening, requires inpatient hospitalisation or prolongation of existing hospitalisation, results in persistent or significant disability/incapacity, or is a congenital anomaly/birth defect (see references for additional details). We present the proportion of participants with at least one serious AE assessed as related to study product by the site investigator of record through 4 weeks post-treatment initiation, bounded by an exact 95% confidence interval (CI).
Outcome measures
| Measure |
Cohort 1C: CAB
n=30 Participants
Step 1: CAB administered orally as one 30 mg tablet once daily, beginning at the Entry visit, for 4-6 weeks.
Step 2 (Q4W dosing): CAB LA administered as three single intramuscular (IM) injections four weeks apart (600 mg injection at Week 4b, 400 mg injection at Week 8, and 400 mg injection at Week 12).
Step 2 (Q8W dosing): CAB LA administered as two single IM injections four weeks apart (600 mg injection at Week 4b and 600 mg injection at Week 8).
Oral Cabotegravir (CAB): 30 mg tablets administered orally
Long-Acting Injectable Cabotegravir (CAB LA): Administered by intramuscular (IM) injection
Combination Antiretroviral Therapy (cART): Participants continued their pre-study cART regimen. The antiretroviral drugs in participants' cART regimens were not provided through the study.
|
Cohort 1R: RPV
Step 1: RPV administered orally as one 25 mg tablet once daily, beginning at the Entry visit, for 4-6 weeks.
Step 2 (Q4W dosing): RPV LA administered as three single IM injections four weeks apart (900 mg injection at Week 4b, 600 mg injection at Week 8, 600 mg injection at and Week 12).
Step 2 (Q8W dosing): RPV LA administered as two single IM injections four weeks apart (900 mg injection at Week 4b and 900 mg injection at Week 8).
Oral Rilpivirine (RPV): 25 mg tablets administered orally
Long-Acting Injectable Rilpivirine (RPV LA): Administered by intramuscular (IM) injection
Combination Antiretroviral Therapy (cART): Participants continued their pre-study cART regimen. The antiretroviral drugs in participants' cART regimens were not provided through the study.
|
|---|---|---|
|
Proportion of Participants Who Had Serious Adverse Events Meeting International Conference on Harmonisation (ICH) Criteria Assessed as Related to Study Product/s (Cohort 1)
|
0 proportion of participants
Interval 0.0 to 0.12
|
—
|
PRIMARY outcome
Timeframe: Cohort 1 Treatment Initiation through Week 4Population: Cohort 1 Evaluable: Cohort 1 participants who were treated exclusively on the dose being evaluated for a given cohort, and either (1) completed all treatment regimen through Cohort 1 Week 4 and completed the Week 4 visit or (2) experienced any of the following: death attributable to the study product; study product-related Grade 3 or higher event (excluding injection site adverse events); OR permanently discontinued from treatment due to study product-related toxicity (regardless of grade)
We present the proportion of participants who permanently discontinued study product due to adverse events (AEs) assessed as related to study product by the site investigator of record through 4 weeks post-treatment initiation, bounded by an exact 95% confidence interval (CI).
Outcome measures
| Measure |
Cohort 1C: CAB
n=30 Participants
Step 1: CAB administered orally as one 30 mg tablet once daily, beginning at the Entry visit, for 4-6 weeks.
Step 2 (Q4W dosing): CAB LA administered as three single intramuscular (IM) injections four weeks apart (600 mg injection at Week 4b, 400 mg injection at Week 8, and 400 mg injection at Week 12).
Step 2 (Q8W dosing): CAB LA administered as two single IM injections four weeks apart (600 mg injection at Week 4b and 600 mg injection at Week 8).
Oral Cabotegravir (CAB): 30 mg tablets administered orally
Long-Acting Injectable Cabotegravir (CAB LA): Administered by intramuscular (IM) injection
Combination Antiretroviral Therapy (cART): Participants continued their pre-study cART regimen. The antiretroviral drugs in participants' cART regimens were not provided through the study.
|
Cohort 1R: RPV
Step 1: RPV administered orally as one 25 mg tablet once daily, beginning at the Entry visit, for 4-6 weeks.
Step 2 (Q4W dosing): RPV LA administered as three single IM injections four weeks apart (900 mg injection at Week 4b, 600 mg injection at Week 8, 600 mg injection at and Week 12).
Step 2 (Q8W dosing): RPV LA administered as two single IM injections four weeks apart (900 mg injection at Week 4b and 900 mg injection at Week 8).
Oral Rilpivirine (RPV): 25 mg tablets administered orally
Long-Acting Injectable Rilpivirine (RPV LA): Administered by intramuscular (IM) injection
Combination Antiretroviral Therapy (cART): Participants continued their pre-study cART regimen. The antiretroviral drugs in participants' cART regimens were not provided through the study.
|
|---|---|---|
|
Proportion of Participants Who Permanently Discontinued Study Product Due to Adverse Events Assessed as Related to Study Product/s (Cohort 1)
|
0 proportion of participants
Interval 0.0 to 0.12
|
—
|
PRIMARY outcome
Timeframe: Cohort 1 Treatment Initiation through Week 4Population: Cohort 1 Evaluable: Cohort 1 participants who were treated exclusively on the dose being evaluated for a given cohort, and either (1) completed all treatment regimen through Cohort 1 Week 4 and completed the Week 4 visit or (2) experienced any of the following: death attributable to the study product; study product-related Grade 3 or higher event (excluding injection site adverse events); OR permanently discontinued from treatment due to study product-related toxicity (regardless of grade)
We present the proportion of participants who died due to adverse events assessed as related to study product by the site investigator of record through 4 weeks post-treatment initiation, bounded by an exact 95% confidence interval (CI).
Outcome measures
| Measure |
Cohort 1C: CAB
n=30 Participants
Step 1: CAB administered orally as one 30 mg tablet once daily, beginning at the Entry visit, for 4-6 weeks.
Step 2 (Q4W dosing): CAB LA administered as three single intramuscular (IM) injections four weeks apart (600 mg injection at Week 4b, 400 mg injection at Week 8, and 400 mg injection at Week 12).
Step 2 (Q8W dosing): CAB LA administered as two single IM injections four weeks apart (600 mg injection at Week 4b and 600 mg injection at Week 8).
Oral Cabotegravir (CAB): 30 mg tablets administered orally
Long-Acting Injectable Cabotegravir (CAB LA): Administered by intramuscular (IM) injection
Combination Antiretroviral Therapy (cART): Participants continued their pre-study cART regimen. The antiretroviral drugs in participants' cART regimens were not provided through the study.
|
Cohort 1R: RPV
Step 1: RPV administered orally as one 25 mg tablet once daily, beginning at the Entry visit, for 4-6 weeks.
Step 2 (Q4W dosing): RPV LA administered as three single IM injections four weeks apart (900 mg injection at Week 4b, 600 mg injection at Week 8, 600 mg injection at and Week 12).
Step 2 (Q8W dosing): RPV LA administered as two single IM injections four weeks apart (900 mg injection at Week 4b and 900 mg injection at Week 8).
Oral Rilpivirine (RPV): 25 mg tablets administered orally
Long-Acting Injectable Rilpivirine (RPV LA): Administered by intramuscular (IM) injection
Combination Antiretroviral Therapy (cART): Participants continued their pre-study cART regimen. The antiretroviral drugs in participants' cART regimens were not provided through the study.
|
|---|---|---|
|
Proportion of Participants Who Died Due to Adverse Events Assessed as Related to Study Product/s (Cohort 1)
|
0 proportion of participants
Interval 0.0 to 0.12
|
—
|
PRIMARY outcome
Timeframe: Cohort 1 Treatment Initiation through Week 16Population: Cohort 1 Evaluable: Cohort 1 participants who were treated exclusively on the dose being evaluated for a given cohort, and either (1) completed all treatment regimen through Cohort 1 Week 16 and completed the Week 16 visit or (2) experienced any of the following: death attributable to the study product; study product-related Grade 3 or higher event (excluding injection site adverse events); OR permanently discontinued from treatment due to study product-related toxicity (regardless of grade)
Based on the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Corrected Version 2.1, dated July 2017. The DAIDS grading table provides an adverse event (AE) severity grading scale ranging from grades 1 to 5 with descriptions for each AE based on the following general guidelines: grade 1 indicates a mild event, grade 2 indicates a moderate event, grade 3 indicates a severe event, grade 4 indicates a potentially life-threatening event, and grade 5 indicates death. We present the proportion of participants with at least one grade 3 or higher AE through 16 weeks post-treatment initiation, bounded by an exact 95% confidence interval (CI).
Outcome measures
| Measure |
Cohort 1C: CAB
n=29 Participants
Step 1: CAB administered orally as one 30 mg tablet once daily, beginning at the Entry visit, for 4-6 weeks.
Step 2 (Q4W dosing): CAB LA administered as three single intramuscular (IM) injections four weeks apart (600 mg injection at Week 4b, 400 mg injection at Week 8, and 400 mg injection at Week 12).
Step 2 (Q8W dosing): CAB LA administered as two single IM injections four weeks apart (600 mg injection at Week 4b and 600 mg injection at Week 8).
Oral Cabotegravir (CAB): 30 mg tablets administered orally
Long-Acting Injectable Cabotegravir (CAB LA): Administered by intramuscular (IM) injection
Combination Antiretroviral Therapy (cART): Participants continued their pre-study cART regimen. The antiretroviral drugs in participants' cART regimens were not provided through the study.
|
Cohort 1R: RPV
n=23 Participants
Step 1: RPV administered orally as one 25 mg tablet once daily, beginning at the Entry visit, for 4-6 weeks.
Step 2 (Q4W dosing): RPV LA administered as three single IM injections four weeks apart (900 mg injection at Week 4b, 600 mg injection at Week 8, 600 mg injection at and Week 12).
Step 2 (Q8W dosing): RPV LA administered as two single IM injections four weeks apart (900 mg injection at Week 4b and 900 mg injection at Week 8).
Oral Rilpivirine (RPV): 25 mg tablets administered orally
Long-Acting Injectable Rilpivirine (RPV LA): Administered by intramuscular (IM) injection
Combination Antiretroviral Therapy (cART): Participants continued their pre-study cART regimen. The antiretroviral drugs in participants' cART regimens were not provided through the study.
|
|---|---|---|
|
Proportion of Participants Who Had Grade 3 or Higher Adverse Events (Cohort 1)
|
0.24 proportion of participants
Interval 0.1 to 0.44
|
0.22 proportion of participants
Interval 0.07 to 0.44
|
PRIMARY outcome
Timeframe: Cohort 1 Treatment Initiation through Week 16Population: Cohort 1 Evaluable: Cohort 1 participants who were treated exclusively on the dose being evaluated for a given cohort, and either (1) completed all treatment regimen through Cohort 1 Week 16 and completed the Week 16 visit or (2) experienced any of the following: death attributable to the study product; study product-related Grade 3 or higher event (excluding injection site adverse events); OR permanently discontinued from treatment due to study product-related toxicity (regardless of grade)
Based on the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Corrected Version 2.1, dated July 2017. The DAIDS grading table provides an adverse event (AE) severity grading scale ranging from grades 1 to 5 with descriptions for each AE based on the following general guidelines: grade 1 indicates a mild event, grade 2 indicates a moderate event, grade 3 indicates a severe event, grade 4 indicates a potentially life-threatening event, and grade 5 indicates death. We present the proportion of participants with at least one grade 3 or higher AE assessed as related to study product by the site investigator of record through 16 weeks post-treatment initiation, bounded by an exact 95% confidence interval (CI).
Outcome measures
| Measure |
Cohort 1C: CAB
n=29 Participants
Step 1: CAB administered orally as one 30 mg tablet once daily, beginning at the Entry visit, for 4-6 weeks.
Step 2 (Q4W dosing): CAB LA administered as three single intramuscular (IM) injections four weeks apart (600 mg injection at Week 4b, 400 mg injection at Week 8, and 400 mg injection at Week 12).
Step 2 (Q8W dosing): CAB LA administered as two single IM injections four weeks apart (600 mg injection at Week 4b and 600 mg injection at Week 8).
Oral Cabotegravir (CAB): 30 mg tablets administered orally
Long-Acting Injectable Cabotegravir (CAB LA): Administered by intramuscular (IM) injection
Combination Antiretroviral Therapy (cART): Participants continued their pre-study cART regimen. The antiretroviral drugs in participants' cART regimens were not provided through the study.
|
Cohort 1R: RPV
n=23 Participants
Step 1: RPV administered orally as one 25 mg tablet once daily, beginning at the Entry visit, for 4-6 weeks.
Step 2 (Q4W dosing): RPV LA administered as three single IM injections four weeks apart (900 mg injection at Week 4b, 600 mg injection at Week 8, 600 mg injection at and Week 12).
Step 2 (Q8W dosing): RPV LA administered as two single IM injections four weeks apart (900 mg injection at Week 4b and 900 mg injection at Week 8).
Oral Rilpivirine (RPV): 25 mg tablets administered orally
Long-Acting Injectable Rilpivirine (RPV LA): Administered by intramuscular (IM) injection
Combination Antiretroviral Therapy (cART): Participants continued their pre-study cART regimen. The antiretroviral drugs in participants' cART regimens were not provided through the study.
|
|---|---|---|
|
Proportion of Participants Who Had Grade 3 or Higher Adverse Events Assessed as Related to Study Product/s (Cohort 1)
|
0.035 proportion of participants
Interval 0.001 to 0.18
|
0.04 proportion of participants
Interval 0.001 to 0.22
|
PRIMARY outcome
Timeframe: Cohort 1 Treatment Initiation through Week 16Population: Cohort 1 Evaluable: Cohort 1 participants who were treated exclusively on the dose being evaluated for a given cohort, and either (1) completed all treatment regimen through Cohort 1 Week 16 and completed the Week 16 visit or (2) experienced any of the following: death attributable to the study product; study product-related Grade 3 or higher event (excluding injection site adverse events); OR permanently discontinued from treatment due to study product-related toxicity (regardless of grade)
Adverse events (AE) were assessed as a Serious AE by ICH criteria. Per ICH, a serious AE is any untoward medical occurrence that results in death, is life-threatening, requires inpatient hospitalisation or prolongation of existing hospitalisation, results in persistent or significant disability/incapacity, or is a congenital anomaly/birth defect (see references for additional details). We present the proportion of participants with at least one serious AE assessed as related to study product by the site investigator of record through 16 weeks post-treatment initiation, bounded by an exact 95% confidence interval (CI).
Outcome measures
| Measure |
Cohort 1C: CAB
n=29 Participants
Step 1: CAB administered orally as one 30 mg tablet once daily, beginning at the Entry visit, for 4-6 weeks.
Step 2 (Q4W dosing): CAB LA administered as three single intramuscular (IM) injections four weeks apart (600 mg injection at Week 4b, 400 mg injection at Week 8, and 400 mg injection at Week 12).
Step 2 (Q8W dosing): CAB LA administered as two single IM injections four weeks apart (600 mg injection at Week 4b and 600 mg injection at Week 8).
Oral Cabotegravir (CAB): 30 mg tablets administered orally
Long-Acting Injectable Cabotegravir (CAB LA): Administered by intramuscular (IM) injection
Combination Antiretroviral Therapy (cART): Participants continued their pre-study cART regimen. The antiretroviral drugs in participants' cART regimens were not provided through the study.
|
Cohort 1R: RPV
n=23 Participants
Step 1: RPV administered orally as one 25 mg tablet once daily, beginning at the Entry visit, for 4-6 weeks.
Step 2 (Q4W dosing): RPV LA administered as three single IM injections four weeks apart (900 mg injection at Week 4b, 600 mg injection at Week 8, 600 mg injection at and Week 12).
Step 2 (Q8W dosing): RPV LA administered as two single IM injections four weeks apart (900 mg injection at Week 4b and 900 mg injection at Week 8).
Oral Rilpivirine (RPV): 25 mg tablets administered orally
Long-Acting Injectable Rilpivirine (RPV LA): Administered by intramuscular (IM) injection
Combination Antiretroviral Therapy (cART): Participants continued their pre-study cART regimen. The antiretroviral drugs in participants' cART regimens were not provided through the study.
|
|---|---|---|
|
Proportion of Participants Who Had Serious Adverse Events Meeting International Conference on Harmonisation (ICH) Criteria Assessed as Related to Study Product/s (Cohort 1)
|
0 proportion of participants
Interval 0.0 to 0.12
|
0 proportion of participants
Interval 0.0 to 0.15
|
PRIMARY outcome
Timeframe: Cohort 1 Treatment Initiation through Week 16Population: Cohort 1 Evaluable: Cohort 1 participants who were treated exclusively on the dose being evaluated for a given cohort, and either (1) completed all treatment regimen through Cohort 1 Week 16 and completed the Week 16 visit or (2) experienced any of the following: death attributable to the study product; study product-related Grade 3 or higher event (excluding injection site adverse events); OR permanently discontinued from treatment due to study product-related toxicity (regardless of grade)
We present the proportion of participants who permanently discontinued study product due to adverse events (AEs) assessed as related to study product by the site investigator of record through 16 weeks post-treatment initiation, bounded by an exact 95% confidence interval (CI).
Outcome measures
| Measure |
Cohort 1C: CAB
n=29 Participants
Step 1: CAB administered orally as one 30 mg tablet once daily, beginning at the Entry visit, for 4-6 weeks.
Step 2 (Q4W dosing): CAB LA administered as three single intramuscular (IM) injections four weeks apart (600 mg injection at Week 4b, 400 mg injection at Week 8, and 400 mg injection at Week 12).
Step 2 (Q8W dosing): CAB LA administered as two single IM injections four weeks apart (600 mg injection at Week 4b and 600 mg injection at Week 8).
Oral Cabotegravir (CAB): 30 mg tablets administered orally
Long-Acting Injectable Cabotegravir (CAB LA): Administered by intramuscular (IM) injection
Combination Antiretroviral Therapy (cART): Participants continued their pre-study cART regimen. The antiretroviral drugs in participants' cART regimens were not provided through the study.
|
Cohort 1R: RPV
n=23 Participants
Step 1: RPV administered orally as one 25 mg tablet once daily, beginning at the Entry visit, for 4-6 weeks.
Step 2 (Q4W dosing): RPV LA administered as three single IM injections four weeks apart (900 mg injection at Week 4b, 600 mg injection at Week 8, 600 mg injection at and Week 12).
Step 2 (Q8W dosing): RPV LA administered as two single IM injections four weeks apart (900 mg injection at Week 4b and 900 mg injection at Week 8).
Oral Rilpivirine (RPV): 25 mg tablets administered orally
Long-Acting Injectable Rilpivirine (RPV LA): Administered by intramuscular (IM) injection
Combination Antiretroviral Therapy (cART): Participants continued their pre-study cART regimen. The antiretroviral drugs in participants' cART regimens were not provided through the study.
|
|---|---|---|
|
Proportion of Participants Who Permanently Discontinued Study Product Due to Adverse Events Assessed as Related to Study Product/s (Cohort 1)
|
0 proportion of participants
Interval 0.0 to 0.12
|
0.044 proportion of participants
Interval 0.001 to 0.22
|
PRIMARY outcome
Timeframe: Cohort 1 Treatment Initiation through Week 16Population: Cohort 1 Evaluable: Cohort 1 participants who were treated exclusively on the dose being evaluated for a given cohort, and either (1) completed all treatment regimen through Cohort 1 Week 16 and completed the Week 16 visit or (2) experienced any of the following: death attributable to the study product; study product-related Grade 3 or higher event (excluding injection site adverse events); OR permanently discontinued from treatment due to study product-related toxicity (regardless of grade)
We present the proportion of participants who died due to adverse events assessed as related to study product by the site investigator of record through 16 weeks post-treatment initiation, bounded by an exact 95% confidence interval (CI).
Outcome measures
| Measure |
Cohort 1C: CAB
n=29 Participants
Step 1: CAB administered orally as one 30 mg tablet once daily, beginning at the Entry visit, for 4-6 weeks.
Step 2 (Q4W dosing): CAB LA administered as three single intramuscular (IM) injections four weeks apart (600 mg injection at Week 4b, 400 mg injection at Week 8, and 400 mg injection at Week 12).
Step 2 (Q8W dosing): CAB LA administered as two single IM injections four weeks apart (600 mg injection at Week 4b and 600 mg injection at Week 8).
Oral Cabotegravir (CAB): 30 mg tablets administered orally
Long-Acting Injectable Cabotegravir (CAB LA): Administered by intramuscular (IM) injection
Combination Antiretroviral Therapy (cART): Participants continued their pre-study cART regimen. The antiretroviral drugs in participants' cART regimens were not provided through the study.
|
Cohort 1R: RPV
n=23 Participants
Step 1: RPV administered orally as one 25 mg tablet once daily, beginning at the Entry visit, for 4-6 weeks.
Step 2 (Q4W dosing): RPV LA administered as three single IM injections four weeks apart (900 mg injection at Week 4b, 600 mg injection at Week 8, 600 mg injection at and Week 12).
Step 2 (Q8W dosing): RPV LA administered as two single IM injections four weeks apart (900 mg injection at Week 4b and 900 mg injection at Week 8).
Oral Rilpivirine (RPV): 25 mg tablets administered orally
Long-Acting Injectable Rilpivirine (RPV LA): Administered by intramuscular (IM) injection
Combination Antiretroviral Therapy (cART): Participants continued their pre-study cART regimen. The antiretroviral drugs in participants' cART regimens were not provided through the study.
|
|---|---|---|
|
Proportion of Participants Who Died Due to Adverse Events Assessed as Related to Study Product/s (Cohort 1)
|
0 proportion of participants
Interval 0.0 to 0.12
|
0 proportion of participants
Interval 0.0 to 0.15
|
PRIMARY outcome
Timeframe: Cohort 2 Treatment Initiation through Week 24Population: Cohort 2 Naive Evaluable: Cohort 2 participants who did not participate in Cohort 1, were treated exclusively on the final recommended dose for Cohort 2, and either (1) completed all treatment regimens through Week 24 visit or (2) experienced any of the following: death attributable to the study product(s); study product(s)-related Grade 3 or higher event (excluding ISR AEs); OR permanently discontinued from treatment due to study product(s)-related toxicity during the dose-finding period.
Based on the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Corrected Version 2.1, dated July 2017. The DAIDS grading table provides an adverse event (AE) severity grading scale ranging from grades 1 to 5 with descriptions for each AE based on the following general guidelines: grade 1 indicates a mild event, grade 2 indicates a moderate event, grade 3 indicates a severe event, grade 4 indicates a potentially life-threatening event, and grade 5 indicates death. We present the proportion of participants with at least one grade 3 or higher AE through 24 weeks post-Cohort 2 treatment initiation, bounded by an exact 95% confidence interval (CI).
Outcome measures
| Measure |
Cohort 1C: CAB
n=98 Participants
Step 1: CAB administered orally as one 30 mg tablet once daily, beginning at the Entry visit, for 4-6 weeks.
Step 2 (Q4W dosing): CAB LA administered as three single intramuscular (IM) injections four weeks apart (600 mg injection at Week 4b, 400 mg injection at Week 8, and 400 mg injection at Week 12).
Step 2 (Q8W dosing): CAB LA administered as two single IM injections four weeks apart (600 mg injection at Week 4b and 600 mg injection at Week 8).
Oral Cabotegravir (CAB): 30 mg tablets administered orally
Long-Acting Injectable Cabotegravir (CAB LA): Administered by intramuscular (IM) injection
Combination Antiretroviral Therapy (cART): Participants continued their pre-study cART regimen. The antiretroviral drugs in participants' cART regimens were not provided through the study.
|
Cohort 1R: RPV
Step 1: RPV administered orally as one 25 mg tablet once daily, beginning at the Entry visit, for 4-6 weeks.
Step 2 (Q4W dosing): RPV LA administered as three single IM injections four weeks apart (900 mg injection at Week 4b, 600 mg injection at Week 8, 600 mg injection at and Week 12).
Step 2 (Q8W dosing): RPV LA administered as two single IM injections four weeks apart (900 mg injection at Week 4b and 900 mg injection at Week 8).
Oral Rilpivirine (RPV): 25 mg tablets administered orally
Long-Acting Injectable Rilpivirine (RPV LA): Administered by intramuscular (IM) injection
Combination Antiretroviral Therapy (cART): Participants continued their pre-study cART regimen. The antiretroviral drugs in participants' cART regimens were not provided through the study.
|
|---|---|---|
|
Proportion of Participants Who Had Grade 3 or Higher Adverse Events (Cohort 2)
|
0.10 proportion of participants
Interval 0.05 to 0.18
|
—
|
PRIMARY outcome
Timeframe: Cohort 2 Treatment Initiation through Week 24Population: Cohort 2 Naive Evaluable: Cohort 2 participants who did not participate in Cohort 1, were treated exclusively on the final recommended dose for Cohort 2, and either (1) completed all treatment regimens through Week 24 visit or (2) experienced any of the following: death attributable to the study product(s); study product(s)-related Grade 3 or higher event (excluding ISR AEs); OR permanently discontinued from treatment due to study product(s)-related toxicity during the dose-finding period.
Based on the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Corrected Version 2.1, dated July 2017. The DAIDS grading table provides an adverse event (AE) severity grading scale ranging from grades 1 to 5 with descriptions for each AE based on the following general guidelines: grade 1 indicates a mild event, grade 2 indicates a moderate event, grade 3 indicates a severe event, grade 4 indicates a potentially life-threatening event, and grade 5 indicates death. We present the proportion of participants with at least one grade 3 or higher AE assessed as related to study product by the site investigator of record through 24 weeks post-Cohort 2 treatment initiation, bounded by an exact 95% confidence interval (CI).
Outcome measures
| Measure |
Cohort 1C: CAB
n=98 Participants
Step 1: CAB administered orally as one 30 mg tablet once daily, beginning at the Entry visit, for 4-6 weeks.
Step 2 (Q4W dosing): CAB LA administered as three single intramuscular (IM) injections four weeks apart (600 mg injection at Week 4b, 400 mg injection at Week 8, and 400 mg injection at Week 12).
Step 2 (Q8W dosing): CAB LA administered as two single IM injections four weeks apart (600 mg injection at Week 4b and 600 mg injection at Week 8).
Oral Cabotegravir (CAB): 30 mg tablets administered orally
Long-Acting Injectable Cabotegravir (CAB LA): Administered by intramuscular (IM) injection
Combination Antiretroviral Therapy (cART): Participants continued their pre-study cART regimen. The antiretroviral drugs in participants' cART regimens were not provided through the study.
|
Cohort 1R: RPV
Step 1: RPV administered orally as one 25 mg tablet once daily, beginning at the Entry visit, for 4-6 weeks.
Step 2 (Q4W dosing): RPV LA administered as three single IM injections four weeks apart (900 mg injection at Week 4b, 600 mg injection at Week 8, 600 mg injection at and Week 12).
Step 2 (Q8W dosing): RPV LA administered as two single IM injections four weeks apart (900 mg injection at Week 4b and 900 mg injection at Week 8).
Oral Rilpivirine (RPV): 25 mg tablets administered orally
Long-Acting Injectable Rilpivirine (RPV LA): Administered by intramuscular (IM) injection
Combination Antiretroviral Therapy (cART): Participants continued their pre-study cART regimen. The antiretroviral drugs in participants' cART regimens were not provided through the study.
|
|---|---|---|
|
Proportion of Participants Who Had Grade 3 or Higher Adverse Events Assessed as Related to Study Product/s (Cohort 2)
|
0 proportion of participants
Interval 0.0 to 0.04
|
—
|
PRIMARY outcome
Timeframe: Cohort 2 Treatment Initiation through Week 24Population: Cohort 2 Naive Evaluable: Cohort 2 participants who did not participate in Cohort 1, were treated exclusively on the final recommended dose for Cohort 2, and either (1) completed all treatment regimens through Week 24 visit or (2) experienced any of the following: death attributable to the study product(s); study product(s)-related Grade 3 or higher event (excluding ISR AEs); OR permanently discontinued from treatment due to study product(s)-related toxicity during the dose-finding period.
Adverse events (AE) were assessed as a Serious AE by ICH criteria. Per ICH, a serious AE is any untoward medical occurrence that results in death, is life-threatening, requires inpatient hospitalisation or prolongation of existing hospitalisation, results in persistent or significant disability/incapacity, or is a congenital anomaly/birth defect (see references for additional details). We present the proportion of participants with at least one serious AE assessed as related to study product by the site investigator of record through 24 weeks post-Cohort 2 treatment initiation, bounded by an exact 95% confidence interval (CI).
Outcome measures
| Measure |
Cohort 1C: CAB
n=98 Participants
Step 1: CAB administered orally as one 30 mg tablet once daily, beginning at the Entry visit, for 4-6 weeks.
Step 2 (Q4W dosing): CAB LA administered as three single intramuscular (IM) injections four weeks apart (600 mg injection at Week 4b, 400 mg injection at Week 8, and 400 mg injection at Week 12).
Step 2 (Q8W dosing): CAB LA administered as two single IM injections four weeks apart (600 mg injection at Week 4b and 600 mg injection at Week 8).
Oral Cabotegravir (CAB): 30 mg tablets administered orally
Long-Acting Injectable Cabotegravir (CAB LA): Administered by intramuscular (IM) injection
Combination Antiretroviral Therapy (cART): Participants continued their pre-study cART regimen. The antiretroviral drugs in participants' cART regimens were not provided through the study.
|
Cohort 1R: RPV
Step 1: RPV administered orally as one 25 mg tablet once daily, beginning at the Entry visit, for 4-6 weeks.
Step 2 (Q4W dosing): RPV LA administered as three single IM injections four weeks apart (900 mg injection at Week 4b, 600 mg injection at Week 8, 600 mg injection at and Week 12).
Step 2 (Q8W dosing): RPV LA administered as two single IM injections four weeks apart (900 mg injection at Week 4b and 900 mg injection at Week 8).
Oral Rilpivirine (RPV): 25 mg tablets administered orally
Long-Acting Injectable Rilpivirine (RPV LA): Administered by intramuscular (IM) injection
Combination Antiretroviral Therapy (cART): Participants continued their pre-study cART regimen. The antiretroviral drugs in participants' cART regimens were not provided through the study.
|
|---|---|---|
|
Proportion of Participants Who Had Serious Adverse Events Meeting ICH Criteria Assessed as Related to Study Product/s (Cohort 2)
|
0 proportion of participants
Interval 0.0 to 0.04
|
—
|
PRIMARY outcome
Timeframe: Cohort 2 Treatment Initiation through Week 24Population: Cohort 2 Naive Evaluable: Cohort 2 participants who did not participate in Cohort 1, were treated exclusively on the final recommended dose for Cohort 2, and either (1) completed all treatment regimens through Week 24 visit or (2) experienced any of the following: death attributable to the study product(s); study product(s)-related Grade 3 or higher event (excluding ISR AEs); OR permanently discontinued from treatment due to study product(s)-related toxicity during the dose-finding period.
We present the proportion of participants who permanently discontinued study product due to adverse events (AEs) assessed as related to study product by the site investigator of record through 24 weeks post-Cohort 2 treatment initiation, bounded by an exact 95% confidence interval (CI).
Outcome measures
| Measure |
Cohort 1C: CAB
n=98 Participants
Step 1: CAB administered orally as one 30 mg tablet once daily, beginning at the Entry visit, for 4-6 weeks.
Step 2 (Q4W dosing): CAB LA administered as three single intramuscular (IM) injections four weeks apart (600 mg injection at Week 4b, 400 mg injection at Week 8, and 400 mg injection at Week 12).
Step 2 (Q8W dosing): CAB LA administered as two single IM injections four weeks apart (600 mg injection at Week 4b and 600 mg injection at Week 8).
Oral Cabotegravir (CAB): 30 mg tablets administered orally
Long-Acting Injectable Cabotegravir (CAB LA): Administered by intramuscular (IM) injection
Combination Antiretroviral Therapy (cART): Participants continued their pre-study cART regimen. The antiretroviral drugs in participants' cART regimens were not provided through the study.
|
Cohort 1R: RPV
Step 1: RPV administered orally as one 25 mg tablet once daily, beginning at the Entry visit, for 4-6 weeks.
Step 2 (Q4W dosing): RPV LA administered as three single IM injections four weeks apart (900 mg injection at Week 4b, 600 mg injection at Week 8, 600 mg injection at and Week 12).
Step 2 (Q8W dosing): RPV LA administered as two single IM injections four weeks apart (900 mg injection at Week 4b and 900 mg injection at Week 8).
Oral Rilpivirine (RPV): 25 mg tablets administered orally
Long-Acting Injectable Rilpivirine (RPV LA): Administered by intramuscular (IM) injection
Combination Antiretroviral Therapy (cART): Participants continued their pre-study cART regimen. The antiretroviral drugs in participants' cART regimens were not provided through the study.
|
|---|---|---|
|
Proportion of Participants Who Permanently Discontinued Study Product Due to Adverse Events Assessed as Related to Study Product/s (Cohort 2)
|
0 proportion of participants
Interval 0.0 to 0.04
|
—
|
PRIMARY outcome
Timeframe: Cohort 2 Treatment Initiation through Week 24Population: Cohort 2 Naive Evaluable: Cohort 2 participants who did not participate in Cohort 1, were treated exclusively on the final recommended dose for Cohort 2, and either (1) completed all treatment regimens through Week 24 visit or (2) experienced any of the following: death attributable to the study product(s); study product(s)-related Grade 3 or higher event (excluding ISR AEs); OR permanently discontinued from treatment due to study product(s)-related toxicity during the dose-finding period.
We present the proportion of participants who died due to adverse events assessed as related to study product by the site investigator of record through 24 weeks post-Cohort 2 treatment initiation, bounded by an exact 95% confidence interval (CI).
Outcome measures
| Measure |
Cohort 1C: CAB
n=98 Participants
Step 1: CAB administered orally as one 30 mg tablet once daily, beginning at the Entry visit, for 4-6 weeks.
Step 2 (Q4W dosing): CAB LA administered as three single intramuscular (IM) injections four weeks apart (600 mg injection at Week 4b, 400 mg injection at Week 8, and 400 mg injection at Week 12).
Step 2 (Q8W dosing): CAB LA administered as two single IM injections four weeks apart (600 mg injection at Week 4b and 600 mg injection at Week 8).
Oral Cabotegravir (CAB): 30 mg tablets administered orally
Long-Acting Injectable Cabotegravir (CAB LA): Administered by intramuscular (IM) injection
Combination Antiretroviral Therapy (cART): Participants continued their pre-study cART regimen. The antiretroviral drugs in participants' cART regimens were not provided through the study.
|
Cohort 1R: RPV
Step 1: RPV administered orally as one 25 mg tablet once daily, beginning at the Entry visit, for 4-6 weeks.
Step 2 (Q4W dosing): RPV LA administered as three single IM injections four weeks apart (900 mg injection at Week 4b, 600 mg injection at Week 8, 600 mg injection at and Week 12).
Step 2 (Q8W dosing): RPV LA administered as two single IM injections four weeks apart (900 mg injection at Week 4b and 900 mg injection at Week 8).
Oral Rilpivirine (RPV): 25 mg tablets administered orally
Long-Acting Injectable Rilpivirine (RPV LA): Administered by intramuscular (IM) injection
Combination Antiretroviral Therapy (cART): Participants continued their pre-study cART regimen. The antiretroviral drugs in participants' cART regimens were not provided through the study.
|
|---|---|---|
|
Proportion of Participants Who Died Due to Adverse Events Assessed as Related to Study Product/s (Cohort 2)
|
0 proportion of participants
Interval 0.0 to 0.04
|
—
|
PRIMARY outcome
Timeframe: Week 2: Samples collected pre-dose and 1, 2, 3, 4, 8, and (for Q4W dosing) 24 hours post-dosePopulation: Cohort 1 All Treated: Cohort 1 participants who have taken at least 1 dose of any study product on Cohort 1 and had an available AUC measurement
AUC calculated using non-compartmental methods with linear up-log down trapezoidal rule (Phoenix WinNonlin v 8.3, Certara®). We present the geometric mean of the AUC with associated geometric coefficient of variation.
Outcome measures
| Measure |
Cohort 1C: CAB
n=29 Participants
Step 1: CAB administered orally as one 30 mg tablet once daily, beginning at the Entry visit, for 4-6 weeks.
Step 2 (Q4W dosing): CAB LA administered as three single intramuscular (IM) injections four weeks apart (600 mg injection at Week 4b, 400 mg injection at Week 8, and 400 mg injection at Week 12).
Step 2 (Q8W dosing): CAB LA administered as two single IM injections four weeks apart (600 mg injection at Week 4b and 600 mg injection at Week 8).
Oral Cabotegravir (CAB): 30 mg tablets administered orally
Long-Acting Injectable Cabotegravir (CAB LA): Administered by intramuscular (IM) injection
Combination Antiretroviral Therapy (cART): Participants continued their pre-study cART regimen. The antiretroviral drugs in participants' cART regimens were not provided through the study.
|
Cohort 1R: RPV
Step 1: RPV administered orally as one 25 mg tablet once daily, beginning at the Entry visit, for 4-6 weeks.
Step 2 (Q4W dosing): RPV LA administered as three single IM injections four weeks apart (900 mg injection at Week 4b, 600 mg injection at Week 8, 600 mg injection at and Week 12).
Step 2 (Q8W dosing): RPV LA administered as two single IM injections four weeks apart (900 mg injection at Week 4b and 900 mg injection at Week 8).
Oral Rilpivirine (RPV): 25 mg tablets administered orally
Long-Acting Injectable Rilpivirine (RPV LA): Administered by intramuscular (IM) injection
Combination Antiretroviral Therapy (cART): Participants continued their pre-study cART regimen. The antiretroviral drugs in participants' cART regimens were not provided through the study.
|
|---|---|---|
|
Geometric Mean Area Under the Plasma Concentration-time Curve (AUC) for Step 1 Oral CAB (Cohort 1C)
|
139 (h*ug)/mL
Geometric Coefficient of Variation 59.1
|
—
|
PRIMARY outcome
Timeframe: Week 2: Samples collected pre-dose and 1, 2, 3, 4, 8 and (for Q4W dosing) 24 hours post-dosePopulation: Cohort 1 All Treated: Cohort 1 participants who have taken at least 1 dose of any study product on Cohort 1 and have an available total body clearance measurement
We present the geometric mean of the total body clearance of CAB and associated geometric coefficient of variation, based on analysis of intensive pharmacokinetic (PK) samples.
Outcome measures
| Measure |
Cohort 1C: CAB
n=29 Participants
Step 1: CAB administered orally as one 30 mg tablet once daily, beginning at the Entry visit, for 4-6 weeks.
Step 2 (Q4W dosing): CAB LA administered as three single intramuscular (IM) injections four weeks apart (600 mg injection at Week 4b, 400 mg injection at Week 8, and 400 mg injection at Week 12).
Step 2 (Q8W dosing): CAB LA administered as two single IM injections four weeks apart (600 mg injection at Week 4b and 600 mg injection at Week 8).
Oral Cabotegravir (CAB): 30 mg tablets administered orally
Long-Acting Injectable Cabotegravir (CAB LA): Administered by intramuscular (IM) injection
Combination Antiretroviral Therapy (cART): Participants continued their pre-study cART regimen. The antiretroviral drugs in participants' cART regimens were not provided through the study.
|
Cohort 1R: RPV
Step 1: RPV administered orally as one 25 mg tablet once daily, beginning at the Entry visit, for 4-6 weeks.
Step 2 (Q4W dosing): RPV LA administered as three single IM injections four weeks apart (900 mg injection at Week 4b, 600 mg injection at Week 8, 600 mg injection at and Week 12).
Step 2 (Q8W dosing): RPV LA administered as two single IM injections four weeks apart (900 mg injection at Week 4b and 900 mg injection at Week 8).
Oral Rilpivirine (RPV): 25 mg tablets administered orally
Long-Acting Injectable Rilpivirine (RPV LA): Administered by intramuscular (IM) injection
Combination Antiretroviral Therapy (cART): Participants continued their pre-study cART regimen. The antiretroviral drugs in participants' cART regimens were not provided through the study.
|
|---|---|---|
|
Apparent Total Body Clearance (CL/F) of Step 1 Oral CAB (Cohort 1C)
|
216.0 mL/h
Geometric Coefficient of Variation 59.1
|
—
|
PRIMARY outcome
Timeframe: Week 2: Samples collected pre-dose and 1, 2, 3, 4, 8 and (for Q4W dosing) 24 hours post-dosePopulation: Cohort 1 All Treated: Cohort 1 participants who have taken at least 1 dose of any study product on Cohort 1 with an available Cmax measurement
We present the geometric mean of the maximum plasma concentration of CAB and associated geometric coefficient of variation, based on analysis of intensive PK samples
Outcome measures
| Measure |
Cohort 1C: CAB
n=29 Participants
Step 1: CAB administered orally as one 30 mg tablet once daily, beginning at the Entry visit, for 4-6 weeks.
Step 2 (Q4W dosing): CAB LA administered as three single intramuscular (IM) injections four weeks apart (600 mg injection at Week 4b, 400 mg injection at Week 8, and 400 mg injection at Week 12).
Step 2 (Q8W dosing): CAB LA administered as two single IM injections four weeks apart (600 mg injection at Week 4b and 600 mg injection at Week 8).
Oral Cabotegravir (CAB): 30 mg tablets administered orally
Long-Acting Injectable Cabotegravir (CAB LA): Administered by intramuscular (IM) injection
Combination Antiretroviral Therapy (cART): Participants continued their pre-study cART regimen. The antiretroviral drugs in participants' cART regimens were not provided through the study.
|
Cohort 1R: RPV
Step 1: RPV administered orally as one 25 mg tablet once daily, beginning at the Entry visit, for 4-6 weeks.
Step 2 (Q4W dosing): RPV LA administered as three single IM injections four weeks apart (900 mg injection at Week 4b, 600 mg injection at Week 8, 600 mg injection at and Week 12).
Step 2 (Q8W dosing): RPV LA administered as two single IM injections four weeks apart (900 mg injection at Week 4b and 900 mg injection at Week 8).
Oral Rilpivirine (RPV): 25 mg tablets administered orally
Long-Acting Injectable Rilpivirine (RPV LA): Administered by intramuscular (IM) injection
Combination Antiretroviral Therapy (cART): Participants continued their pre-study cART regimen. The antiretroviral drugs in participants' cART regimens were not provided through the study.
|
|---|---|---|
|
Geometric Mean Maximum Plasma Concentration (Cmax) of Oral CAB (Cohort 1C)
|
8.90 ug/mL
Geometric Coefficient of Variation 43.1
|
—
|
PRIMARY outcome
Timeframe: Week 2: Samples collected pre-dose and 1, 2, 3, 4, 8, and (for Q4W dosing) 24 hours post-dosePopulation: Cohort 1 All Treated: Cohort 1 participants who have taken at least 1 dose of any study product on Cohort 1 with an available Tmax measurement
We present the mean time of maximum concentration of CAB and associated standard deviation, based on analysis of intensive PK samples.
Outcome measures
| Measure |
Cohort 1C: CAB
n=29 Participants
Step 1: CAB administered orally as one 30 mg tablet once daily, beginning at the Entry visit, for 4-6 weeks.
Step 2 (Q4W dosing): CAB LA administered as three single intramuscular (IM) injections four weeks apart (600 mg injection at Week 4b, 400 mg injection at Week 8, and 400 mg injection at Week 12).
Step 2 (Q8W dosing): CAB LA administered as two single IM injections four weeks apart (600 mg injection at Week 4b and 600 mg injection at Week 8).
Oral Cabotegravir (CAB): 30 mg tablets administered orally
Long-Acting Injectable Cabotegravir (CAB LA): Administered by intramuscular (IM) injection
Combination Antiretroviral Therapy (cART): Participants continued their pre-study cART regimen. The antiretroviral drugs in participants' cART regimens were not provided through the study.
|
Cohort 1R: RPV
Step 1: RPV administered orally as one 25 mg tablet once daily, beginning at the Entry visit, for 4-6 weeks.
Step 2 (Q4W dosing): RPV LA administered as three single IM injections four weeks apart (900 mg injection at Week 4b, 600 mg injection at Week 8, 600 mg injection at and Week 12).
Step 2 (Q8W dosing): RPV LA administered as two single IM injections four weeks apart (900 mg injection at Week 4b and 900 mg injection at Week 8).
Oral Rilpivirine (RPV): 25 mg tablets administered orally
Long-Acting Injectable Rilpivirine (RPV LA): Administered by intramuscular (IM) injection
Combination Antiretroviral Therapy (cART): Participants continued their pre-study cART regimen. The antiretroviral drugs in participants' cART regimens were not provided through the study.
|
|---|---|---|
|
Time of Maximum Concentration (Tmax) of Oral CAB (Cohort 1C)
|
2.73 h
Standard Deviation 1.13
|
—
|
PRIMARY outcome
Timeframe: Week 2: Samples collected pre-dose and 1, 2, 3, 4, 8, and (for Q4W dosing) 24 hours post-dosePopulation: Cohort 1 All Treated: Cohort 1 participants who have taken at least 1 dose of any study product on Cohort 1 with an available pre-dose concentration measurement
We present the geometric mean pre-dose CAB concentration and associated geometric coefficient of variation, based on analysis of intensive PK samples.
Outcome measures
| Measure |
Cohort 1C: CAB
n=29 Participants
Step 1: CAB administered orally as one 30 mg tablet once daily, beginning at the Entry visit, for 4-6 weeks.
Step 2 (Q4W dosing): CAB LA administered as three single intramuscular (IM) injections four weeks apart (600 mg injection at Week 4b, 400 mg injection at Week 8, and 400 mg injection at Week 12).
Step 2 (Q8W dosing): CAB LA administered as two single IM injections four weeks apart (600 mg injection at Week 4b and 600 mg injection at Week 8).
Oral Cabotegravir (CAB): 30 mg tablets administered orally
Long-Acting Injectable Cabotegravir (CAB LA): Administered by intramuscular (IM) injection
Combination Antiretroviral Therapy (cART): Participants continued their pre-study cART regimen. The antiretroviral drugs in participants' cART regimens were not provided through the study.
|
Cohort 1R: RPV
Step 1: RPV administered orally as one 25 mg tablet once daily, beginning at the Entry visit, for 4-6 weeks.
Step 2 (Q4W dosing): RPV LA administered as three single IM injections four weeks apart (900 mg injection at Week 4b, 600 mg injection at Week 8, 600 mg injection at and Week 12).
Step 2 (Q8W dosing): RPV LA administered as two single IM injections four weeks apart (900 mg injection at Week 4b and 900 mg injection at Week 8).
Oral Rilpivirine (RPV): 25 mg tablets administered orally
Long-Acting Injectable Rilpivirine (RPV LA): Administered by intramuscular (IM) injection
Combination Antiretroviral Therapy (cART): Participants continued their pre-study cART regimen. The antiretroviral drugs in participants' cART regimens were not provided through the study.
|
|---|---|---|
|
Geometric Mean Pre-dose Concentration (C0) of Oral CAB (Cohort 1C)
|
4.09 ug/mL
Geometric Coefficient of Variation 96.1
|
—
|
PRIMARY outcome
Timeframe: Week 16Population: Cohort 1 Q4W: Cohort 1 participants who received the Q4W dosing regimen on Cohort 1
We present the geometric mean concentration of LA CAB/LA RPV and associated geometric coefficients of variation for participants on the Q4W dosing regimen, based on analysis of pre-dose PK sample.
Outcome measures
| Measure |
Cohort 1C: CAB
n=8 Participants
Step 1: CAB administered orally as one 30 mg tablet once daily, beginning at the Entry visit, for 4-6 weeks.
Step 2 (Q4W dosing): CAB LA administered as three single intramuscular (IM) injections four weeks apart (600 mg injection at Week 4b, 400 mg injection at Week 8, and 400 mg injection at Week 12).
Step 2 (Q8W dosing): CAB LA administered as two single IM injections four weeks apart (600 mg injection at Week 4b and 600 mg injection at Week 8).
Oral Cabotegravir (CAB): 30 mg tablets administered orally
Long-Acting Injectable Cabotegravir (CAB LA): Administered by intramuscular (IM) injection
Combination Antiretroviral Therapy (cART): Participants continued their pre-study cART regimen. The antiretroviral drugs in participants' cART regimens were not provided through the study.
|
Cohort 1R: RPV
n=12 Participants
Step 1: RPV administered orally as one 25 mg tablet once daily, beginning at the Entry visit, for 4-6 weeks.
Step 2 (Q4W dosing): RPV LA administered as three single IM injections four weeks apart (900 mg injection at Week 4b, 600 mg injection at Week 8, 600 mg injection at and Week 12).
Step 2 (Q8W dosing): RPV LA administered as two single IM injections four weeks apart (900 mg injection at Week 4b and 900 mg injection at Week 8).
Oral Rilpivirine (RPV): 25 mg tablets administered orally
Long-Acting Injectable Rilpivirine (RPV LA): Administered by intramuscular (IM) injection
Combination Antiretroviral Therapy (cART): Participants continued their pre-study cART regimen. The antiretroviral drugs in participants' cART regimens were not provided through the study.
|
|---|---|---|
|
Geometric Mean Concentration of LA CAB/LA RPV at Week 16 (Cohort 1 Q4W)
|
2.91 ug/mL
Geometric Coefficient of Variation 58.8
|
0.0644 ug/mL
Geometric Coefficient of Variation 59.9
|
PRIMARY outcome
Timeframe: Samples collected at Weeks 4b, 5, 6, and 8Population: Cohort 1 Q4W: Cohort 1 participants who received the Q4W dosing regimen on Cohort 1
We present the geometric mean of the maximum plasma concentration of LA CAB/LA RPV and associated geometric coefficient of variation for the first injection in participants on the Q4W dosing regimen, based on analysis of intensive PK samples.
Outcome measures
| Measure |
Cohort 1C: CAB
n=8 Participants
Step 1: CAB administered orally as one 30 mg tablet once daily, beginning at the Entry visit, for 4-6 weeks.
Step 2 (Q4W dosing): CAB LA administered as three single intramuscular (IM) injections four weeks apart (600 mg injection at Week 4b, 400 mg injection at Week 8, and 400 mg injection at Week 12).
Step 2 (Q8W dosing): CAB LA administered as two single IM injections four weeks apart (600 mg injection at Week 4b and 600 mg injection at Week 8).
Oral Cabotegravir (CAB): 30 mg tablets administered orally
Long-Acting Injectable Cabotegravir (CAB LA): Administered by intramuscular (IM) injection
Combination Antiretroviral Therapy (cART): Participants continued their pre-study cART regimen. The antiretroviral drugs in participants' cART regimens were not provided through the study.
|
Cohort 1R: RPV
n=13 Participants
Step 1: RPV administered orally as one 25 mg tablet once daily, beginning at the Entry visit, for 4-6 weeks.
Step 2 (Q4W dosing): RPV LA administered as three single IM injections four weeks apart (900 mg injection at Week 4b, 600 mg injection at Week 8, 600 mg injection at and Week 12).
Step 2 (Q8W dosing): RPV LA administered as two single IM injections four weeks apart (900 mg injection at Week 4b and 900 mg injection at Week 8).
Oral Rilpivirine (RPV): 25 mg tablets administered orally
Long-Acting Injectable Rilpivirine (RPV LA): Administered by intramuscular (IM) injection
Combination Antiretroviral Therapy (cART): Participants continued their pre-study cART regimen. The antiretroviral drugs in participants' cART regimens were not provided through the study.
|
|---|---|---|
|
Geometric Mean Maximum Plasma Concentration (Cmax) of LA CAB/LA RPV (Cohort 1 Q4W)
|
9.56 ug/mL
Geometric Coefficient of Variation 32.2
|
0.132 ug/mL
Geometric Coefficient of Variation 35.5
|
PRIMARY outcome
Timeframe: Samples collected at Weeks 4b, 5, 6, 8Population: Cohort 1 participants who received the Q4W dosing regimen on Cohort 1
We present the mean time of maximum concentration of LA CAB/LA RPV at the first injection and associated standard deviation for participants on the Q4W dosing regimen, based on analysis of intensive PK samples.
Outcome measures
| Measure |
Cohort 1C: CAB
n=8 Participants
Step 1: CAB administered orally as one 30 mg tablet once daily, beginning at the Entry visit, for 4-6 weeks.
Step 2 (Q4W dosing): CAB LA administered as three single intramuscular (IM) injections four weeks apart (600 mg injection at Week 4b, 400 mg injection at Week 8, and 400 mg injection at Week 12).
Step 2 (Q8W dosing): CAB LA administered as two single IM injections four weeks apart (600 mg injection at Week 4b and 600 mg injection at Week 8).
Oral Cabotegravir (CAB): 30 mg tablets administered orally
Long-Acting Injectable Cabotegravir (CAB LA): Administered by intramuscular (IM) injection
Combination Antiretroviral Therapy (cART): Participants continued their pre-study cART regimen. The antiretroviral drugs in participants' cART regimens were not provided through the study.
|
Cohort 1R: RPV
n=13 Participants
Step 1: RPV administered orally as one 25 mg tablet once daily, beginning at the Entry visit, for 4-6 weeks.
Step 2 (Q4W dosing): RPV LA administered as three single IM injections four weeks apart (900 mg injection at Week 4b, 600 mg injection at Week 8, 600 mg injection at and Week 12).
Step 2 (Q8W dosing): RPV LA administered as two single IM injections four weeks apart (900 mg injection at Week 4b and 900 mg injection at Week 8).
Oral Rilpivirine (RPV): 25 mg tablets administered orally
Long-Acting Injectable Rilpivirine (RPV LA): Administered by intramuscular (IM) injection
Combination Antiretroviral Therapy (cART): Participants continued their pre-study cART regimen. The antiretroviral drugs in participants' cART regimens were not provided through the study.
|
|---|---|---|
|
Time of Maximum Concentration (Tmax) of LA CAB/LA RPV (Cohort 1 Q4W)
|
1.50 h
Standard Deviation 0.551
|
89.6 h
Standard Deviation 162
|
PRIMARY outcome
Timeframe: Week 4b, Week 8, Week 12Population: Cohort 1 participants who received the Q4W dosing regimen on Cohort 1.
We present the geometric mean pre-dose concentrations of each injection and associated geometric coefficient of variation for participants on the Q4W dosing regimen, based on analysis of pre-dose PK samples.
Outcome measures
| Measure |
Cohort 1C: CAB
n=8 Participants
Step 1: CAB administered orally as one 30 mg tablet once daily, beginning at the Entry visit, for 4-6 weeks.
Step 2 (Q4W dosing): CAB LA administered as three single intramuscular (IM) injections four weeks apart (600 mg injection at Week 4b, 400 mg injection at Week 8, and 400 mg injection at Week 12).
Step 2 (Q8W dosing): CAB LA administered as two single IM injections four weeks apart (600 mg injection at Week 4b and 600 mg injection at Week 8).
Oral Cabotegravir (CAB): 30 mg tablets administered orally
Long-Acting Injectable Cabotegravir (CAB LA): Administered by intramuscular (IM) injection
Combination Antiretroviral Therapy (cART): Participants continued their pre-study cART regimen. The antiretroviral drugs in participants' cART regimens were not provided through the study.
|
Cohort 1R: RPV
n=13 Participants
Step 1: RPV administered orally as one 25 mg tablet once daily, beginning at the Entry visit, for 4-6 weeks.
Step 2 (Q4W dosing): RPV LA administered as three single IM injections four weeks apart (900 mg injection at Week 4b, 600 mg injection at Week 8, 600 mg injection at and Week 12).
Step 2 (Q8W dosing): RPV LA administered as two single IM injections four weeks apart (900 mg injection at Week 4b and 900 mg injection at Week 8).
Oral Rilpivirine (RPV): 25 mg tablets administered orally
Long-Acting Injectable Rilpivirine (RPV LA): Administered by intramuscular (IM) injection
Combination Antiretroviral Therapy (cART): Participants continued their pre-study cART regimen. The antiretroviral drugs in participants' cART regimens were not provided through the study.
|
|---|---|---|
|
Geometric Mean Pre-dose Concentration (C0) of LA CAB/LA RPV (Cohort 1 Q4W)
Week 4b
|
5.46 ug/mL
Geometric Coefficient of Variation 39.6
|
0.0704 ug/mL
Geometric Coefficient of Variation 227
|
|
Geometric Mean Pre-dose Concentration (C0) of LA CAB/LA RPV (Cohort 1 Q4W)
Week 8
|
2.10 ug/mL
Geometric Coefficient of Variation 37.0
|
0.0441 ug/mL
Geometric Coefficient of Variation 75.9
|
|
Geometric Mean Pre-dose Concentration (C0) of LA CAB/LA RPV (Cohort 1 Q4W)
Week 12
|
2.73 ug/mL
Geometric Coefficient of Variation 76.7
|
0.0555 ug/mL
Geometric Coefficient of Variation 56.7
|
PRIMARY outcome
Timeframe: Week 16Population: Cohort 1 participants who received the Q8W dosing regimen on Cohort 1
We present the geometric mean concentration of LA CAB/LA RPV and associated geometric coefficients of variation for participants on the Q4W dosing regimen, based on analysis of the pre-dose PK sample.
Outcome measures
| Measure |
Cohort 1C: CAB
n=21 Participants
Step 1: CAB administered orally as one 30 mg tablet once daily, beginning at the Entry visit, for 4-6 weeks.
Step 2 (Q4W dosing): CAB LA administered as three single intramuscular (IM) injections four weeks apart (600 mg injection at Week 4b, 400 mg injection at Week 8, and 400 mg injection at Week 12).
Step 2 (Q8W dosing): CAB LA administered as two single IM injections four weeks apart (600 mg injection at Week 4b and 600 mg injection at Week 8).
Oral Cabotegravir (CAB): 30 mg tablets administered orally
Long-Acting Injectable Cabotegravir (CAB LA): Administered by intramuscular (IM) injection
Combination Antiretroviral Therapy (cART): Participants continued their pre-study cART regimen. The antiretroviral drugs in participants' cART regimens were not provided through the study.
|
Cohort 1R: RPV
n=10 Participants
Step 1: RPV administered orally as one 25 mg tablet once daily, beginning at the Entry visit, for 4-6 weeks.
Step 2 (Q4W dosing): RPV LA administered as three single IM injections four weeks apart (900 mg injection at Week 4b, 600 mg injection at Week 8, 600 mg injection at and Week 12).
Step 2 (Q8W dosing): RPV LA administered as two single IM injections four weeks apart (900 mg injection at Week 4b and 900 mg injection at Week 8).
Oral Rilpivirine (RPV): 25 mg tablets administered orally
Long-Acting Injectable Rilpivirine (RPV LA): Administered by intramuscular (IM) injection
Combination Antiretroviral Therapy (cART): Participants continued their pre-study cART regimen. The antiretroviral drugs in participants' cART regimens were not provided through the study.
|
|---|---|---|
|
Geometric Mean Concentration of LA CAB/LA RPV at Week 16 (Cohort 1 Q8W)
|
1.01 ug/mL
Geometric Coefficient of Variation 237
|
0.0449 ug/mL
Geometric Coefficient of Variation 38.2
|
PRIMARY outcome
Timeframe: Samples collected at Weeks 4b, 5, and 8Population: Cohort 1 participants who received the Q8W dosing regimen on Cohort 1.
We present the geometric mean of the maximum plasma concentration of LA CAB/LA RPV and associated geometric coefficient of variation for the first injection in participants on the Q8W dosing regimen, based on analysis of intensive PK samples.
Outcome measures
| Measure |
Cohort 1C: CAB
n=21 Participants
Step 1: CAB administered orally as one 30 mg tablet once daily, beginning at the Entry visit, for 4-6 weeks.
Step 2 (Q4W dosing): CAB LA administered as three single intramuscular (IM) injections four weeks apart (600 mg injection at Week 4b, 400 mg injection at Week 8, and 400 mg injection at Week 12).
Step 2 (Q8W dosing): CAB LA administered as two single IM injections four weeks apart (600 mg injection at Week 4b and 600 mg injection at Week 8).
Oral Cabotegravir (CAB): 30 mg tablets administered orally
Long-Acting Injectable Cabotegravir (CAB LA): Administered by intramuscular (IM) injection
Combination Antiretroviral Therapy (cART): Participants continued their pre-study cART regimen. The antiretroviral drugs in participants' cART regimens were not provided through the study.
|
Cohort 1R: RPV
n=10 Participants
Step 1: RPV administered orally as one 25 mg tablet once daily, beginning at the Entry visit, for 4-6 weeks.
Step 2 (Q4W dosing): RPV LA administered as three single IM injections four weeks apart (900 mg injection at Week 4b, 600 mg injection at Week 8, 600 mg injection at and Week 12).
Step 2 (Q8W dosing): RPV LA administered as two single IM injections four weeks apart (900 mg injection at Week 4b and 900 mg injection at Week 8).
Oral Rilpivirine (RPV): 25 mg tablets administered orally
Long-Acting Injectable Rilpivirine (RPV LA): Administered by intramuscular (IM) injection
Combination Antiretroviral Therapy (cART): Participants continued their pre-study cART regimen. The antiretroviral drugs in participants' cART regimens were not provided through the study.
|
|---|---|---|
|
Geometric Mean Maximum Plasma Concentration (Cmax) of LA CAB/LA RPV (Cohort 1 Q8W)
|
6.42 ug/mL
Geometric Coefficient of Variation 42.2
|
0.129 ug/mL
Geometric Coefficient of Variation 39.4
|
PRIMARY outcome
Timeframe: Samples collected at Weeks 4b, 5, and 8Population: Cohort 1 participants who received the Q8W dosing regimen on Cohort 1
We present the mean time of maximum concentration of LA CAB/LA RPV at the first injection and associated standard deviation for participants on the Q8W dosing regimen, based on analysis of intensive PK samples.
Outcome measures
| Measure |
Cohort 1C: CAB
n=21 Participants
Step 1: CAB administered orally as one 30 mg tablet once daily, beginning at the Entry visit, for 4-6 weeks.
Step 2 (Q4W dosing): CAB LA administered as three single intramuscular (IM) injections four weeks apart (600 mg injection at Week 4b, 400 mg injection at Week 8, and 400 mg injection at Week 12).
Step 2 (Q8W dosing): CAB LA administered as two single IM injections four weeks apart (600 mg injection at Week 4b and 600 mg injection at Week 8).
Oral Cabotegravir (CAB): 30 mg tablets administered orally
Long-Acting Injectable Cabotegravir (CAB LA): Administered by intramuscular (IM) injection
Combination Antiretroviral Therapy (cART): Participants continued their pre-study cART regimen. The antiretroviral drugs in participants' cART regimens were not provided through the study.
|
Cohort 1R: RPV
n=10 Participants
Step 1: RPV administered orally as one 25 mg tablet once daily, beginning at the Entry visit, for 4-6 weeks.
Step 2 (Q4W dosing): RPV LA administered as three single IM injections four weeks apart (900 mg injection at Week 4b, 600 mg injection at Week 8, 600 mg injection at and Week 12).
Step 2 (Q8W dosing): RPV LA administered as two single IM injections four weeks apart (900 mg injection at Week 4b and 900 mg injection at Week 8).
Oral Rilpivirine (RPV): 25 mg tablets administered orally
Long-Acting Injectable Rilpivirine (RPV LA): Administered by intramuscular (IM) injection
Combination Antiretroviral Therapy (cART): Participants continued their pre-study cART regimen. The antiretroviral drugs in participants' cART regimens were not provided through the study.
|
|---|---|---|
|
Time of Maximum Concentration (Tmax) of LA CAB/LA RPV (Cohort 1 Q8W)
|
1.84 h
Standard Deviation 0.829
|
18.6 h
Standard Deviation 53.5
|
PRIMARY outcome
Timeframe: Week 4b, Week 8Population: We present the geometric mean pre-dose concentration of the first injection and associated coefficient of variation for participants on the Q4W dosing regimen, based on analysis of intensive PK samples.
We present the geometric mean pre-dose concentration of the first injection and associated geometric coefficient of variation for participants on the Q4W dosing regimen, based on analysis of pre-dose PK samples.
Outcome measures
| Measure |
Cohort 1C: CAB
n=21 Participants
Step 1: CAB administered orally as one 30 mg tablet once daily, beginning at the Entry visit, for 4-6 weeks.
Step 2 (Q4W dosing): CAB LA administered as three single intramuscular (IM) injections four weeks apart (600 mg injection at Week 4b, 400 mg injection at Week 8, and 400 mg injection at Week 12).
Step 2 (Q8W dosing): CAB LA administered as two single IM injections four weeks apart (600 mg injection at Week 4b and 600 mg injection at Week 8).
Oral Cabotegravir (CAB): 30 mg tablets administered orally
Long-Acting Injectable Cabotegravir (CAB LA): Administered by intramuscular (IM) injection
Combination Antiretroviral Therapy (cART): Participants continued their pre-study cART regimen. The antiretroviral drugs in participants' cART regimens were not provided through the study.
|
Cohort 1R: RPV
n=10 Participants
Step 1: RPV administered orally as one 25 mg tablet once daily, beginning at the Entry visit, for 4-6 weeks.
Step 2 (Q4W dosing): RPV LA administered as three single IM injections four weeks apart (900 mg injection at Week 4b, 600 mg injection at Week 8, 600 mg injection at and Week 12).
Step 2 (Q8W dosing): RPV LA administered as two single IM injections four weeks apart (900 mg injection at Week 4b and 900 mg injection at Week 8).
Oral Rilpivirine (RPV): 25 mg tablets administered orally
Long-Acting Injectable Rilpivirine (RPV LA): Administered by intramuscular (IM) injection
Combination Antiretroviral Therapy (cART): Participants continued their pre-study cART regimen. The antiretroviral drugs in participants' cART regimens were not provided through the study.
|
|---|---|---|
|
Geometric Mean Pre-dose Concentration (C0) of LA CAB/LA RPV (Cohort 1 Q8W)
Week 4b
|
2.89 ug/mL
Geometric Coefficient of Variation 194
|
0.0703 ug/mL
Geometric Coefficient of Variation 24.8
|
|
Geometric Mean Pre-dose Concentration (C0) of LA CAB/LA RPV (Cohort 1 Q8W)
Week 8
|
1.33 ug/mL
Geometric Coefficient of Variation 105
|
0.0327 ug/mL
Geometric Coefficient of Variation 28.8
|
SECONDARY outcome
Timeframe: Week 16Population: Cohort 1 All Treated: Cohort 1 participants who have taken at least 1 dose of any study product on Cohort 1
We present the proportion of participants with results of HIV-1 RNA \< 50 copies/mL at Week 16
Outcome measures
| Measure |
Cohort 1C: CAB
n=28 Participants
Step 1: CAB administered orally as one 30 mg tablet once daily, beginning at the Entry visit, for 4-6 weeks.
Step 2 (Q4W dosing): CAB LA administered as three single intramuscular (IM) injections four weeks apart (600 mg injection at Week 4b, 400 mg injection at Week 8, and 400 mg injection at Week 12).
Step 2 (Q8W dosing): CAB LA administered as two single IM injections four weeks apart (600 mg injection at Week 4b and 600 mg injection at Week 8).
Oral Cabotegravir (CAB): 30 mg tablets administered orally
Long-Acting Injectable Cabotegravir (CAB LA): Administered by intramuscular (IM) injection
Combination Antiretroviral Therapy (cART): Participants continued their pre-study cART regimen. The antiretroviral drugs in participants' cART regimens were not provided through the study.
|
Cohort 1R: RPV
n=22 Participants
Step 1: RPV administered orally as one 25 mg tablet once daily, beginning at the Entry visit, for 4-6 weeks.
Step 2 (Q4W dosing): RPV LA administered as three single IM injections four weeks apart (900 mg injection at Week 4b, 600 mg injection at Week 8, 600 mg injection at and Week 12).
Step 2 (Q8W dosing): RPV LA administered as two single IM injections four weeks apart (900 mg injection at Week 4b and 900 mg injection at Week 8).
Oral Rilpivirine (RPV): 25 mg tablets administered orally
Long-Acting Injectable Rilpivirine (RPV LA): Administered by intramuscular (IM) injection
Combination Antiretroviral Therapy (cART): Participants continued their pre-study cART regimen. The antiretroviral drugs in participants' cART regimens were not provided through the study.
|
|---|---|---|
|
Proportion of Participants With HIV-1 RNA < 50 Copies/mL (Cohort 1)
|
0.964 proportion of participants
|
1.00 proportion of participants
|
SECONDARY outcome
Timeframe: Week 8Population: Cohort 1 All Treated: Cohort 1 participants who have taken at least 1 dose of any study product on Cohort 1
Results collected via administration of Pain During Injection survey to participants after receiving injection. Pain during injections was assessed using the Faces Pain Scale-Revised which includes 6 visual and text options: "no hurt," "hurts little bit," "hurts little more," "hurts even more," "hurts whole lot" and "hurts worst".
Outcome measures
| Measure |
Cohort 1C: CAB
n=29 Participants
Step 1: CAB administered orally as one 30 mg tablet once daily, beginning at the Entry visit, for 4-6 weeks.
Step 2 (Q4W dosing): CAB LA administered as three single intramuscular (IM) injections four weeks apart (600 mg injection at Week 4b, 400 mg injection at Week 8, and 400 mg injection at Week 12).
Step 2 (Q8W dosing): CAB LA administered as two single IM injections four weeks apart (600 mg injection at Week 4b and 600 mg injection at Week 8).
Oral Cabotegravir (CAB): 30 mg tablets administered orally
Long-Acting Injectable Cabotegravir (CAB LA): Administered by intramuscular (IM) injection
Combination Antiretroviral Therapy (cART): Participants continued their pre-study cART regimen. The antiretroviral drugs in participants' cART regimens were not provided through the study.
|
Cohort 1R: RPV
n=23 Participants
Step 1: RPV administered orally as one 25 mg tablet once daily, beginning at the Entry visit, for 4-6 weeks.
Step 2 (Q4W dosing): RPV LA administered as three single IM injections four weeks apart (900 mg injection at Week 4b, 600 mg injection at Week 8, 600 mg injection at and Week 12).
Step 2 (Q8W dosing): RPV LA administered as two single IM injections four weeks apart (900 mg injection at Week 4b and 900 mg injection at Week 8).
Oral Rilpivirine (RPV): 25 mg tablets administered orally
Long-Acting Injectable Rilpivirine (RPV LA): Administered by intramuscular (IM) injection
Combination Antiretroviral Therapy (cART): Participants continued their pre-study cART regimen. The antiretroviral drugs in participants' cART regimens were not provided through the study.
|
|---|---|---|
|
Proportion of Participants Who Reported "Hurts Whole Lot" or "Hurts Worst" in Regards to Being Bothered by Pain During Injection of CAB LA or RPV LA (Cohort 1)
|
0 proportion of participants
|
0.043 proportion of participants
|
SECONDARY outcome
Timeframe: Week 16Population: Cohort 1 All Treated: Cohort 1 participants who have taken at least 1 dose of any study product on Cohort 1
A commonly used 23-item Pediatric Quality of Life Inventory, the PedsQLTM, was used to measure physical, emotional, and social dimensions of health as well as school functioning. Question responses were used to generate scores from 0-100 (100 being the best quality of life) based on the PedsQLTM guidelines. The number of participants drops slightly for the school functioning result as not all participants are eligible to answer these school-related questions.
Outcome measures
| Measure |
Cohort 1C: CAB
n=29 Participants
Step 1: CAB administered orally as one 30 mg tablet once daily, beginning at the Entry visit, for 4-6 weeks.
Step 2 (Q4W dosing): CAB LA administered as three single intramuscular (IM) injections four weeks apart (600 mg injection at Week 4b, 400 mg injection at Week 8, and 400 mg injection at Week 12).
Step 2 (Q8W dosing): CAB LA administered as two single IM injections four weeks apart (600 mg injection at Week 4b and 600 mg injection at Week 8).
Oral Cabotegravir (CAB): 30 mg tablets administered orally
Long-Acting Injectable Cabotegravir (CAB LA): Administered by intramuscular (IM) injection
Combination Antiretroviral Therapy (cART): Participants continued their pre-study cART regimen. The antiretroviral drugs in participants' cART regimens were not provided through the study.
|
Cohort 1R: RPV
n=23 Participants
Step 1: RPV administered orally as one 25 mg tablet once daily, beginning at the Entry visit, for 4-6 weeks.
Step 2 (Q4W dosing): RPV LA administered as three single IM injections four weeks apart (900 mg injection at Week 4b, 600 mg injection at Week 8, 600 mg injection at and Week 12).
Step 2 (Q8W dosing): RPV LA administered as two single IM injections four weeks apart (900 mg injection at Week 4b and 900 mg injection at Week 8).
Oral Rilpivirine (RPV): 25 mg tablets administered orally
Long-Acting Injectable Rilpivirine (RPV LA): Administered by intramuscular (IM) injection
Combination Antiretroviral Therapy (cART): Participants continued their pre-study cART regimen. The antiretroviral drugs in participants' cART regimens were not provided through the study.
|
|---|---|---|
|
Median Dimension of Quality of Life Scores
Physical Functioning
|
96.9 score on a scale
Interval 90.6 to 100.0
|
100 score on a scale
Interval 93.8 to 100.0
|
|
Median Dimension of Quality of Life Scores
Emotional Functioning
|
95 score on a scale
Interval 80.0 to 100.0
|
95 score on a scale
Interval 90.0 to 100.0
|
|
Median Dimension of Quality of Life Scores
Social Functioning
|
100 score on a scale
Interval 95.0 to 100.0
|
100 score on a scale
Interval 95.0 to 100.0
|
|
Median Dimension of Quality of Life Scores
School Functioning
|
80 score on a scale
Interval 65.0 to 90.0
|
85 score on a scale
Interval 80.0 to 95.0
|
|
Median Dimension of Quality of Life Scores
Psychosocial Functioning
|
91.7 score on a scale
Interval 76.7 to 96.7
|
91.7 score on a scale
Interval 86.7 to 96.7
|
|
Median Dimension of Quality of Life Scores
Total Functioning
|
93.5 score on a scale
Interval 82.6 to 96.7
|
94.6 score on a scale
Interval 90.2 to 97.8
|
SECONDARY outcome
Timeframe: Cohort 2 treatment initiation through Week 48Population: Cohort 2 Naive Evaluable: Cohort 2 participants who did not participate in Cohort 1, were treated exclusively on the final recommended dose for Cohort 2, and either (1) completed all treatment regimens through Week 48 visit or (2) experienced any of the following: death attributable to the study product(s); study product(s)-related Grade 3 or higher event (excluding ISR AEs); OR permanently discontinued from treatment due to study product(s)-related toxicity during the treatment period.
Based on the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Corrected Version 2.1, dated July 2017. The DAIDS grading table provides an adverse event (AE) severity grading scale ranging from grades 1 to 5 with descriptions for each AE based on the following general guidelines: grade 1 indicates a mild event, grade 2 indicates a moderate event, grade 3 indicates a severe event, grade 4 indicates a potentially life-threatening event, and grade 5 indicates death. We present the proportion of participants with at least one grade 3 or higher AE through 48 weeks post-Cohort 2 treatment initiation, bounded by an exact 95% confidence interval (CI).
Outcome measures
| Measure |
Cohort 1C: CAB
n=97 Participants
Step 1: CAB administered orally as one 30 mg tablet once daily, beginning at the Entry visit, for 4-6 weeks.
Step 2 (Q4W dosing): CAB LA administered as three single intramuscular (IM) injections four weeks apart (600 mg injection at Week 4b, 400 mg injection at Week 8, and 400 mg injection at Week 12).
Step 2 (Q8W dosing): CAB LA administered as two single IM injections four weeks apart (600 mg injection at Week 4b and 600 mg injection at Week 8).
Oral Cabotegravir (CAB): 30 mg tablets administered orally
Long-Acting Injectable Cabotegravir (CAB LA): Administered by intramuscular (IM) injection
Combination Antiretroviral Therapy (cART): Participants continued their pre-study cART regimen. The antiretroviral drugs in participants' cART regimens were not provided through the study.
|
Cohort 1R: RPV
Step 1: RPV administered orally as one 25 mg tablet once daily, beginning at the Entry visit, for 4-6 weeks.
Step 2 (Q4W dosing): RPV LA administered as three single IM injections four weeks apart (900 mg injection at Week 4b, 600 mg injection at Week 8, 600 mg injection at and Week 12).
Step 2 (Q8W dosing): RPV LA administered as two single IM injections four weeks apart (900 mg injection at Week 4b and 900 mg injection at Week 8).
Oral Rilpivirine (RPV): 25 mg tablets administered orally
Long-Acting Injectable Rilpivirine (RPV LA): Administered by intramuscular (IM) injection
Combination Antiretroviral Therapy (cART): Participants continued their pre-study cART regimen. The antiretroviral drugs in participants' cART regimens were not provided through the study.
|
|---|---|---|
|
Proportion of Participants Who Had Grade 3 or Higher Adverse Events (Cohort 2)
|
0.14 proportion of participants
Interval 0.08 to 0.23
|
—
|
SECONDARY outcome
Timeframe: Cohort 2 treatment initiation through Week 48Population: Cohort 2 Naive Evaluable: Cohort 2 participants who did not participate in Cohort 1, were treated exclusively on the final recommended dose for Cohort 2, and either (1) completed all treatment regimens through Week 48 visit or (2) experienced any of the following: death attributable to the study product(s); study product(s)-related Grade 3 or higher event (excluding ISR AEs); OR permanently discontinued from treatment due to study product(s)-related toxicity during the treatment period.
Based on the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Corrected Version 2.1, dated July 2017. The DAIDS grading table provides an adverse event (AE) severity grading scale ranging from grades 1 to 5 with descriptions for each AE based on the following general guidelines: grade 1 indicates a mild event, grade 2 indicates a moderate event, grade 3 indicates a severe event, grade 4 indicates a potentially life-threatening event, and grade 5 indicates death. We present the proportion of participants with at least one grade 3 or higher AE assessed as related to study product by the site investigator of record through 48 weeks post-Cohort 2 treatment initiation, bounded by an exact 95% confidence interval (CI).
Outcome measures
| Measure |
Cohort 1C: CAB
n=97 Participants
Step 1: CAB administered orally as one 30 mg tablet once daily, beginning at the Entry visit, for 4-6 weeks.
Step 2 (Q4W dosing): CAB LA administered as three single intramuscular (IM) injections four weeks apart (600 mg injection at Week 4b, 400 mg injection at Week 8, and 400 mg injection at Week 12).
Step 2 (Q8W dosing): CAB LA administered as two single IM injections four weeks apart (600 mg injection at Week 4b and 600 mg injection at Week 8).
Oral Cabotegravir (CAB): 30 mg tablets administered orally
Long-Acting Injectable Cabotegravir (CAB LA): Administered by intramuscular (IM) injection
Combination Antiretroviral Therapy (cART): Participants continued their pre-study cART regimen. The antiretroviral drugs in participants' cART regimens were not provided through the study.
|
Cohort 1R: RPV
Step 1: RPV administered orally as one 25 mg tablet once daily, beginning at the Entry visit, for 4-6 weeks.
Step 2 (Q4W dosing): RPV LA administered as three single IM injections four weeks apart (900 mg injection at Week 4b, 600 mg injection at Week 8, 600 mg injection at and Week 12).
Step 2 (Q8W dosing): RPV LA administered as two single IM injections four weeks apart (900 mg injection at Week 4b and 900 mg injection at Week 8).
Oral Rilpivirine (RPV): 25 mg tablets administered orally
Long-Acting Injectable Rilpivirine (RPV LA): Administered by intramuscular (IM) injection
Combination Antiretroviral Therapy (cART): Participants continued their pre-study cART regimen. The antiretroviral drugs in participants' cART regimens were not provided through the study.
|
|---|---|---|
|
Proportion of Participants Who Had Grade 3 or Higher Adverse Events Assessed as Related to Study Product/s (Cohort 2)
|
0.02 proportion of participants
Interval 0.003 to 0.07
|
—
|
SECONDARY outcome
Timeframe: Cohort 2 treatment initiation through Week 48Population: Cohort 2 Naive Evaluable: Cohort 2 participants who did not participate in Cohort 1, were treated exclusively on the final recommended dose for Cohort 2, and either (1) completed all treatment regimens through Week 48 visit or (2) experienced any of the following: death attributable to the study product(s); study product(s)-related Grade 3 or higher event (excluding ISR AEs); OR permanently discontinued from treatment due to study product(s)-related toxicity during the treatment period.
Adverse events (AE) were assessed as a Serious AE by ICH criteria. Per ICH, a serious AE is any untoward medical occurrence that results in death, is life-threatening, requires inpatient hospitalisation or prolongation of existing hospitalisation, results in persistent or significant disability/incapacity, or is a congenital anomaly/birth defect (see references for additional details). We present the proportion of participants with at least one serious AE assessed as related to study product by the site investigator of record through 48 weeks post-Cohort 2 treatment initiation, bounded by an exact 95% confidence interval (CI).
Outcome measures
| Measure |
Cohort 1C: CAB
n=97 Participants
Step 1: CAB administered orally as one 30 mg tablet once daily, beginning at the Entry visit, for 4-6 weeks.
Step 2 (Q4W dosing): CAB LA administered as three single intramuscular (IM) injections four weeks apart (600 mg injection at Week 4b, 400 mg injection at Week 8, and 400 mg injection at Week 12).
Step 2 (Q8W dosing): CAB LA administered as two single IM injections four weeks apart (600 mg injection at Week 4b and 600 mg injection at Week 8).
Oral Cabotegravir (CAB): 30 mg tablets administered orally
Long-Acting Injectable Cabotegravir (CAB LA): Administered by intramuscular (IM) injection
Combination Antiretroviral Therapy (cART): Participants continued their pre-study cART regimen. The antiretroviral drugs in participants' cART regimens were not provided through the study.
|
Cohort 1R: RPV
Step 1: RPV administered orally as one 25 mg tablet once daily, beginning at the Entry visit, for 4-6 weeks.
Step 2 (Q4W dosing): RPV LA administered as three single IM injections four weeks apart (900 mg injection at Week 4b, 600 mg injection at Week 8, 600 mg injection at and Week 12).
Step 2 (Q8W dosing): RPV LA administered as two single IM injections four weeks apart (900 mg injection at Week 4b and 900 mg injection at Week 8).
Oral Rilpivirine (RPV): 25 mg tablets administered orally
Long-Acting Injectable Rilpivirine (RPV LA): Administered by intramuscular (IM) injection
Combination Antiretroviral Therapy (cART): Participants continued their pre-study cART regimen. The antiretroviral drugs in participants' cART regimens were not provided through the study.
|
|---|---|---|
|
Proportion of Participants Who Had Serious Adverse Events Meeting ICH Criteria, as Cited in References, Assessed as Related to Study Product/s (Cohort 2)
|
0 proportion of participants
Interval 0.0 to 0.04
|
—
|
SECONDARY outcome
Timeframe: Cohort 2 treatment initiation through Week 48Population: Cohort 2 Naive Evaluable: Cohort 2 participants who did not participate in Cohort 1, were treated exclusively on the final recommended dose for Cohort 2, and either (1) completed all treatment regimens through Week 48 visit or (2) experienced any of the following: death attributable to the study product(s); study product(s)-related Grade 3 or higher event (excluding ISR AEs); OR permanently discontinued from treatment due to study product(s)-related toxicity during the treatment period.
We present the proportion of participants who permanently discontinued study product due to adverse events (AEs) assessed as related to study product by the site investigator of record through 48 weeks post-Cohort 2 treatment initiation, bounded by an exact 95% confidence interval (CI).
Outcome measures
| Measure |
Cohort 1C: CAB
n=97 Participants
Step 1: CAB administered orally as one 30 mg tablet once daily, beginning at the Entry visit, for 4-6 weeks.
Step 2 (Q4W dosing): CAB LA administered as three single intramuscular (IM) injections four weeks apart (600 mg injection at Week 4b, 400 mg injection at Week 8, and 400 mg injection at Week 12).
Step 2 (Q8W dosing): CAB LA administered as two single IM injections four weeks apart (600 mg injection at Week 4b and 600 mg injection at Week 8).
Oral Cabotegravir (CAB): 30 mg tablets administered orally
Long-Acting Injectable Cabotegravir (CAB LA): Administered by intramuscular (IM) injection
Combination Antiretroviral Therapy (cART): Participants continued their pre-study cART regimen. The antiretroviral drugs in participants' cART regimens were not provided through the study.
|
Cohort 1R: RPV
Step 1: RPV administered orally as one 25 mg tablet once daily, beginning at the Entry visit, for 4-6 weeks.
Step 2 (Q4W dosing): RPV LA administered as three single IM injections four weeks apart (900 mg injection at Week 4b, 600 mg injection at Week 8, 600 mg injection at and Week 12).
Step 2 (Q8W dosing): RPV LA administered as two single IM injections four weeks apart (900 mg injection at Week 4b and 900 mg injection at Week 8).
Oral Rilpivirine (RPV): 25 mg tablets administered orally
Long-Acting Injectable Rilpivirine (RPV LA): Administered by intramuscular (IM) injection
Combination Antiretroviral Therapy (cART): Participants continued their pre-study cART regimen. The antiretroviral drugs in participants' cART regimens were not provided through the study.
|
|---|---|---|
|
Proportion of Participants Who Permanently Discontinued Study Product Due to Adverse Events Assessed as Related to Study Product/s (Cohort 2)
|
0 proportion of participants
Interval 0.0 to 0.04
|
—
|
SECONDARY outcome
Timeframe: Cohort 2 treatment initiation through Week 48Population: Cohort 2 Naive Evaluable: Cohort 2 participants who did not participate in Cohort 1, were treated exclusively on the final recommended dose for Cohort 2, and either (1) completed all treatment regimens through Week 48 visit or (2) experienced any of the following: death attributable to the study product(s); study product(s)-related Grade 3 or higher event (excluding ISR AEs); OR permanently discontinued from treatment due to study product(s)-related toxicity during the treatment period.
We present the proportion of participants who died due to adverse events assessed as related to study product by the site investigator of record through 48 weeks post-Cohort 2 treatment initiation, bounded by an exact 95% confidence interval (CI).
Outcome measures
| Measure |
Cohort 1C: CAB
n=97 Participants
Step 1: CAB administered orally as one 30 mg tablet once daily, beginning at the Entry visit, for 4-6 weeks.
Step 2 (Q4W dosing): CAB LA administered as three single intramuscular (IM) injections four weeks apart (600 mg injection at Week 4b, 400 mg injection at Week 8, and 400 mg injection at Week 12).
Step 2 (Q8W dosing): CAB LA administered as two single IM injections four weeks apart (600 mg injection at Week 4b and 600 mg injection at Week 8).
Oral Cabotegravir (CAB): 30 mg tablets administered orally
Long-Acting Injectable Cabotegravir (CAB LA): Administered by intramuscular (IM) injection
Combination Antiretroviral Therapy (cART): Participants continued their pre-study cART regimen. The antiretroviral drugs in participants' cART regimens were not provided through the study.
|
Cohort 1R: RPV
Step 1: RPV administered orally as one 25 mg tablet once daily, beginning at the Entry visit, for 4-6 weeks.
Step 2 (Q4W dosing): RPV LA administered as three single IM injections four weeks apart (900 mg injection at Week 4b, 600 mg injection at Week 8, 600 mg injection at and Week 12).
Step 2 (Q8W dosing): RPV LA administered as two single IM injections four weeks apart (900 mg injection at Week 4b and 900 mg injection at Week 8).
Oral Rilpivirine (RPV): 25 mg tablets administered orally
Long-Acting Injectable Rilpivirine (RPV LA): Administered by intramuscular (IM) injection
Combination Antiretroviral Therapy (cART): Participants continued their pre-study cART regimen. The antiretroviral drugs in participants' cART regimens were not provided through the study.
|
|---|---|---|
|
Proportion of Participants Who Died Due to Adverse Events Assessed as Related to Study Product/s (Cohort 2)
|
0 proportion of participants
Interval 0.0 to 0.04
|
—
|
SECONDARY outcome
Timeframe: Week 24Population: Cohort 2 Naive Evaluable: Cohort 2 participants who did not participate in Cohort 1, were treated exclusively on the final recommended dose for Cohort 2, and either (1) completed all treatment regimens through Week 24 visit or (2) experienced any of the following: death attributable to the study product(s); study product(s)-related Grade 3 or higher event (excluding ISR AEs); OR permanently discontinued from treatment due to study product(s)-related toxicity during the treatment period
We present the proportion of participants with HIV-1 RNA \>= 50 copies/mL and associated exact 95% CI (Clopper-Pearson) per the FDA snapshot, based on laboratory evaluations.
Outcome measures
| Measure |
Cohort 1C: CAB
n=98 Participants
Step 1: CAB administered orally as one 30 mg tablet once daily, beginning at the Entry visit, for 4-6 weeks.
Step 2 (Q4W dosing): CAB LA administered as three single intramuscular (IM) injections four weeks apart (600 mg injection at Week 4b, 400 mg injection at Week 8, and 400 mg injection at Week 12).
Step 2 (Q8W dosing): CAB LA administered as two single IM injections four weeks apart (600 mg injection at Week 4b and 600 mg injection at Week 8).
Oral Cabotegravir (CAB): 30 mg tablets administered orally
Long-Acting Injectable Cabotegravir (CAB LA): Administered by intramuscular (IM) injection
Combination Antiretroviral Therapy (cART): Participants continued their pre-study cART regimen. The antiretroviral drugs in participants' cART regimens were not provided through the study.
|
Cohort 1R: RPV
Step 1: RPV administered orally as one 25 mg tablet once daily, beginning at the Entry visit, for 4-6 weeks.
Step 2 (Q4W dosing): RPV LA administered as three single IM injections four weeks apart (900 mg injection at Week 4b, 600 mg injection at Week 8, 600 mg injection at and Week 12).
Step 2 (Q8W dosing): RPV LA administered as two single IM injections four weeks apart (900 mg injection at Week 4b and 900 mg injection at Week 8).
Oral Rilpivirine (RPV): 25 mg tablets administered orally
Long-Acting Injectable Rilpivirine (RPV LA): Administered by intramuscular (IM) injection
Combination Antiretroviral Therapy (cART): Participants continued their pre-study cART regimen. The antiretroviral drugs in participants' cART regimens were not provided through the study.
|
|---|---|---|
|
Proportion of Participants With Plasma HIV-1 RNA >= 50 Copies/mL Per the FDA Snapshot (Cohort 2)
|
0.02 proportion of participants
Interval 0.002 to 0.07
|
—
|
SECONDARY outcome
Timeframe: Week 24Population: Cohort 2 Naive Evaluable: Cohort 2 participants who did not participate in Cohort 1, were treated exclusively on the final recommended dose for Cohort 2, and either (1) completed all treatment regimens through Week 24 visit or (2) experienced any of the following: death attributable to the study product(s); study product(s)-related Grade 3 or higher event (excluding ISR AEs); OR permanently discontinued from treatment due to study product(s)-related toxicity during the treatment period
We present the proportion of participants with HIV-1 RNA \>= 200 copies/mL and associated exact 95% CI (Clopper-Pearson) per the FDA snapshot, based on laboratory evaluations.
Outcome measures
| Measure |
Cohort 1C: CAB
n=98 Participants
Step 1: CAB administered orally as one 30 mg tablet once daily, beginning at the Entry visit, for 4-6 weeks.
Step 2 (Q4W dosing): CAB LA administered as three single intramuscular (IM) injections four weeks apart (600 mg injection at Week 4b, 400 mg injection at Week 8, and 400 mg injection at Week 12).
Step 2 (Q8W dosing): CAB LA administered as two single IM injections four weeks apart (600 mg injection at Week 4b and 600 mg injection at Week 8).
Oral Cabotegravir (CAB): 30 mg tablets administered orally
Long-Acting Injectable Cabotegravir (CAB LA): Administered by intramuscular (IM) injection
Combination Antiretroviral Therapy (cART): Participants continued their pre-study cART regimen. The antiretroviral drugs in participants' cART regimens were not provided through the study.
|
Cohort 1R: RPV
Step 1: RPV administered orally as one 25 mg tablet once daily, beginning at the Entry visit, for 4-6 weeks.
Step 2 (Q4W dosing): RPV LA administered as three single IM injections four weeks apart (900 mg injection at Week 4b, 600 mg injection at Week 8, 600 mg injection at and Week 12).
Step 2 (Q8W dosing): RPV LA administered as two single IM injections four weeks apart (900 mg injection at Week 4b and 900 mg injection at Week 8).
Oral Rilpivirine (RPV): 25 mg tablets administered orally
Long-Acting Injectable Rilpivirine (RPV LA): Administered by intramuscular (IM) injection
Combination Antiretroviral Therapy (cART): Participants continued their pre-study cART regimen. The antiretroviral drugs in participants' cART regimens were not provided through the study.
|
|---|---|---|
|
Proportion of Participants With Plasma HIV-1 RNA >= 200 Copies/mL Per the FDA Snapshot (Cohort 2)
|
0 proportion of participants
Interval 0.0 to 0.037
|
—
|
SECONDARY outcome
Timeframe: Week 48Population: Cohort 2 Naive Evaluable: Cohort 2 participants who did not participate in Cohort 1, were treated exclusively on the final recommended dose for Cohort 2, and either (1) completed all treatment regimens through Week 48 visit or (2) experienced any of the following: death attributable to the study product(s); study product(s)-related Grade 3 or higher event (excluding ISR AEs); OR permanently discontinued from treatment due to study product(s)-related toxicity during the treatment period
We present the proportion of participants with HIV-1 RNA \>= 50 copies/mL and associated exact 95% CI (Clopper-Pearson) per the FDA snapshot, based on laboratory evaluations.
Outcome measures
| Measure |
Cohort 1C: CAB
n=97 Participants
Step 1: CAB administered orally as one 30 mg tablet once daily, beginning at the Entry visit, for 4-6 weeks.
Step 2 (Q4W dosing): CAB LA administered as three single intramuscular (IM) injections four weeks apart (600 mg injection at Week 4b, 400 mg injection at Week 8, and 400 mg injection at Week 12).
Step 2 (Q8W dosing): CAB LA administered as two single IM injections four weeks apart (600 mg injection at Week 4b and 600 mg injection at Week 8).
Oral Cabotegravir (CAB): 30 mg tablets administered orally
Long-Acting Injectable Cabotegravir (CAB LA): Administered by intramuscular (IM) injection
Combination Antiretroviral Therapy (cART): Participants continued their pre-study cART regimen. The antiretroviral drugs in participants' cART regimens were not provided through the study.
|
Cohort 1R: RPV
Step 1: RPV administered orally as one 25 mg tablet once daily, beginning at the Entry visit, for 4-6 weeks.
Step 2 (Q4W dosing): RPV LA administered as three single IM injections four weeks apart (900 mg injection at Week 4b, 600 mg injection at Week 8, 600 mg injection at and Week 12).
Step 2 (Q8W dosing): RPV LA administered as two single IM injections four weeks apart (900 mg injection at Week 4b and 900 mg injection at Week 8).
Oral Rilpivirine (RPV): 25 mg tablets administered orally
Long-Acting Injectable Rilpivirine (RPV LA): Administered by intramuscular (IM) injection
Combination Antiretroviral Therapy (cART): Participants continued their pre-study cART regimen. The antiretroviral drugs in participants' cART regimens were not provided through the study.
|
|---|---|---|
|
Proportion of Participants With Plasma HIV-1 RNA >= 50 Copies/mL Per the FDA Snapshot (Cohort 2)
|
0 proportion of participants
Interval 0.0 to 0.04
|
—
|
SECONDARY outcome
Timeframe: Week 48Population: Cohort 2 Naive Evaluable: Cohort 2 participants who did not participate in Cohort 1, were treated exclusively on the final recommended dose for Cohort 2, and either (1) completed all treatment regimens through Week 48 visit or (2) experienced any of the following: death attributable to the study product(s); study product(s)-related Grade 3 or higher event (excluding ISR AEs); OR permanently discontinued from treatment due to study product(s)-related toxicity during the treatment period
We present the proportion of participants with HIV-1 RNA \>= 200 copies/mL and associated exact 95% CI (Clopper-Pearson) per the FDA snapshot, based on laboratory evaluations.
Outcome measures
| Measure |
Cohort 1C: CAB
n=97 Participants
Step 1: CAB administered orally as one 30 mg tablet once daily, beginning at the Entry visit, for 4-6 weeks.
Step 2 (Q4W dosing): CAB LA administered as three single intramuscular (IM) injections four weeks apart (600 mg injection at Week 4b, 400 mg injection at Week 8, and 400 mg injection at Week 12).
Step 2 (Q8W dosing): CAB LA administered as two single IM injections four weeks apart (600 mg injection at Week 4b and 600 mg injection at Week 8).
Oral Cabotegravir (CAB): 30 mg tablets administered orally
Long-Acting Injectable Cabotegravir (CAB LA): Administered by intramuscular (IM) injection
Combination Antiretroviral Therapy (cART): Participants continued their pre-study cART regimen. The antiretroviral drugs in participants' cART regimens were not provided through the study.
|
Cohort 1R: RPV
Step 1: RPV administered orally as one 25 mg tablet once daily, beginning at the Entry visit, for 4-6 weeks.
Step 2 (Q4W dosing): RPV LA administered as three single IM injections four weeks apart (900 mg injection at Week 4b, 600 mg injection at Week 8, 600 mg injection at and Week 12).
Step 2 (Q8W dosing): RPV LA administered as two single IM injections four weeks apart (900 mg injection at Week 4b and 900 mg injection at Week 8).
Oral Rilpivirine (RPV): 25 mg tablets administered orally
Long-Acting Injectable Rilpivirine (RPV LA): Administered by intramuscular (IM) injection
Combination Antiretroviral Therapy (cART): Participants continued their pre-study cART regimen. The antiretroviral drugs in participants' cART regimens were not provided through the study.
|
|---|---|---|
|
Proportion of Participants With Plasma HIV-1 RNA >= 200 Copies/mL Per the FDA Snapshot (Cohort 2)
|
0 proportion of participants
Interval 0.0 to 0.04
|
—
|
SECONDARY outcome
Timeframe: Week 2Population: Cohort 2 All Treated: Cohort 2 participants who have taken at least 1 dose of any study product on Cohort 2
We present the geometric mean of the pre-dose concentration of oral CAB and oral RPV and associated coefficient of variation, based on analysis of pre-dose PK sample.
Outcome measures
| Measure |
Cohort 1C: CAB
n=144 Participants
Step 1: CAB administered orally as one 30 mg tablet once daily, beginning at the Entry visit, for 4-6 weeks.
Step 2 (Q4W dosing): CAB LA administered as three single intramuscular (IM) injections four weeks apart (600 mg injection at Week 4b, 400 mg injection at Week 8, and 400 mg injection at Week 12).
Step 2 (Q8W dosing): CAB LA administered as two single IM injections four weeks apart (600 mg injection at Week 4b and 600 mg injection at Week 8).
Oral Cabotegravir (CAB): 30 mg tablets administered orally
Long-Acting Injectable Cabotegravir (CAB LA): Administered by intramuscular (IM) injection
Combination Antiretroviral Therapy (cART): Participants continued their pre-study cART regimen. The antiretroviral drugs in participants' cART regimens were not provided through the study.
|
Cohort 1R: RPV
Step 1: RPV administered orally as one 25 mg tablet once daily, beginning at the Entry visit, for 4-6 weeks.
Step 2 (Q4W dosing): RPV LA administered as three single IM injections four weeks apart (900 mg injection at Week 4b, 600 mg injection at Week 8, 600 mg injection at and Week 12).
Step 2 (Q8W dosing): RPV LA administered as two single IM injections four weeks apart (900 mg injection at Week 4b and 900 mg injection at Week 8).
Oral Rilpivirine (RPV): 25 mg tablets administered orally
Long-Acting Injectable Rilpivirine (RPV LA): Administered by intramuscular (IM) injection
Combination Antiretroviral Therapy (cART): Participants continued their pre-study cART regimen. The antiretroviral drugs in participants' cART regimens were not provided through the study.
|
|---|---|---|
|
Geometric Mean Pre-dose Concentration (C0) of Oral CAB and Oral RPV (Cohort 2)
CAB concentration
|
6.65 ug/mL
Geometric Coefficient of Variation 42.3
|
—
|
|
Geometric Mean Pre-dose Concentration (C0) of Oral CAB and Oral RPV (Cohort 2)
RPV concentration
|
0.0708 ug/mL
Geometric Coefficient of Variation 59.0
|
—
|
SECONDARY outcome
Timeframe: Week 8 and Week 24Population: Cohort 2 All Treated: Cohort 2 participants who have taken at least 1 dose of any study product on Cohort 2
We present the geometric mean of the ratios of pre-dose CAB and RPV concentrations at Week 24:Week 8 and associated coefficient of variation, based on analysis of pre-dose PK samples.
Outcome measures
| Measure |
Cohort 1C: CAB
n=139 Participants
Step 1: CAB administered orally as one 30 mg tablet once daily, beginning at the Entry visit, for 4-6 weeks.
Step 2 (Q4W dosing): CAB LA administered as three single intramuscular (IM) injections four weeks apart (600 mg injection at Week 4b, 400 mg injection at Week 8, and 400 mg injection at Week 12).
Step 2 (Q8W dosing): CAB LA administered as two single IM injections four weeks apart (600 mg injection at Week 4b and 600 mg injection at Week 8).
Oral Cabotegravir (CAB): 30 mg tablets administered orally
Long-Acting Injectable Cabotegravir (CAB LA): Administered by intramuscular (IM) injection
Combination Antiretroviral Therapy (cART): Participants continued their pre-study cART regimen. The antiretroviral drugs in participants' cART regimens were not provided through the study.
|
Cohort 1R: RPV
Step 1: RPV administered orally as one 25 mg tablet once daily, beginning at the Entry visit, for 4-6 weeks.
Step 2 (Q4W dosing): RPV LA administered as three single IM injections four weeks apart (900 mg injection at Week 4b, 600 mg injection at Week 8, 600 mg injection at and Week 12).
Step 2 (Q8W dosing): RPV LA administered as two single IM injections four weeks apart (900 mg injection at Week 4b and 900 mg injection at Week 8).
Oral Rilpivirine (RPV): 25 mg tablets administered orally
Long-Acting Injectable Rilpivirine (RPV LA): Administered by intramuscular (IM) injection
Combination Antiretroviral Therapy (cART): Participants continued their pre-study cART regimen. The antiretroviral drugs in participants' cART regimens were not provided through the study.
|
|---|---|---|
|
Geometric Mean Ratio of Pre-dose CAB and RPV Concentrations at Week 24: Pre-dose CAB and RPV Concentrations at Week 8 (Cohort 2)
CAB Ratio
|
1.14 ratio
Geometric Coefficient of Variation 107
|
—
|
|
Geometric Mean Ratio of Pre-dose CAB and RPV Concentrations at Week 24: Pre-dose CAB and RPV Concentrations at Week 8 (Cohort 2)
RPV Ratio
|
1.35 ratio
Geometric Coefficient of Variation 47.1
|
—
|
SECONDARY outcome
Timeframe: Week 16 and Week 24Population: Cohort 2 All Treated: Cohort 2 participants who have taken at least 1 dose of any study product on Cohort 2
We present the geometric mean of the ratios of pre-dose CAB and RPV concentrations at Week 24:Week 16 and associated coefficient of variation, based on analysis of pre-dose PK samples.
Outcome measures
| Measure |
Cohort 1C: CAB
n=139 Participants
Step 1: CAB administered orally as one 30 mg tablet once daily, beginning at the Entry visit, for 4-6 weeks.
Step 2 (Q4W dosing): CAB LA administered as three single intramuscular (IM) injections four weeks apart (600 mg injection at Week 4b, 400 mg injection at Week 8, and 400 mg injection at Week 12).
Step 2 (Q8W dosing): CAB LA administered as two single IM injections four weeks apart (600 mg injection at Week 4b and 600 mg injection at Week 8).
Oral Cabotegravir (CAB): 30 mg tablets administered orally
Long-Acting Injectable Cabotegravir (CAB LA): Administered by intramuscular (IM) injection
Combination Antiretroviral Therapy (cART): Participants continued their pre-study cART regimen. The antiretroviral drugs in participants' cART regimens were not provided through the study.
|
Cohort 1R: RPV
Step 1: RPV administered orally as one 25 mg tablet once daily, beginning at the Entry visit, for 4-6 weeks.
Step 2 (Q4W dosing): RPV LA administered as three single IM injections four weeks apart (900 mg injection at Week 4b, 600 mg injection at Week 8, 600 mg injection at and Week 12).
Step 2 (Q8W dosing): RPV LA administered as two single IM injections four weeks apart (900 mg injection at Week 4b and 900 mg injection at Week 8).
Oral Rilpivirine (RPV): 25 mg tablets administered orally
Long-Acting Injectable Rilpivirine (RPV LA): Administered by intramuscular (IM) injection
Combination Antiretroviral Therapy (cART): Participants continued their pre-study cART regimen. The antiretroviral drugs in participants' cART regimens were not provided through the study.
|
|---|---|---|
|
Geometric Mean Ratio of Pre-dose CAB and RPV Concentrations at Week 24: Pre-dose CAB and RPV Concentrations at Week 16 (Cohort 2)
CAB Ratio
|
0.974 ratio
Geometric Coefficient of Variation 47.0
|
—
|
|
Geometric Mean Ratio of Pre-dose CAB and RPV Concentrations at Week 24: Pre-dose CAB and RPV Concentrations at Week 16 (Cohort 2)
RPV Ratio
|
1.22 ratio
Geometric Coefficient of Variation 32.7
|
—
|
SECONDARY outcome
Timeframe: Week 8 and Week 48Population: Cohort 2 All Treated: Cohort 2 participants who have taken at least 1 dose of any study product on Cohort 2
We present the geometric mean of the ratios of pre-dose CAB and RPV concentrations at Week 48:Week 8 and associated coefficient of variation, based on analysis of pre-dose PK samples.
Outcome measures
| Measure |
Cohort 1C: CAB
n=138 Participants
Step 1: CAB administered orally as one 30 mg tablet once daily, beginning at the Entry visit, for 4-6 weeks.
Step 2 (Q4W dosing): CAB LA administered as three single intramuscular (IM) injections four weeks apart (600 mg injection at Week 4b, 400 mg injection at Week 8, and 400 mg injection at Week 12).
Step 2 (Q8W dosing): CAB LA administered as two single IM injections four weeks apart (600 mg injection at Week 4b and 600 mg injection at Week 8).
Oral Cabotegravir (CAB): 30 mg tablets administered orally
Long-Acting Injectable Cabotegravir (CAB LA): Administered by intramuscular (IM) injection
Combination Antiretroviral Therapy (cART): Participants continued their pre-study cART regimen. The antiretroviral drugs in participants' cART regimens were not provided through the study.
|
Cohort 1R: RPV
Step 1: RPV administered orally as one 25 mg tablet once daily, beginning at the Entry visit, for 4-6 weeks.
Step 2 (Q4W dosing): RPV LA administered as three single IM injections four weeks apart (900 mg injection at Week 4b, 600 mg injection at Week 8, 600 mg injection at and Week 12).
Step 2 (Q8W dosing): RPV LA administered as two single IM injections four weeks apart (900 mg injection at Week 4b and 900 mg injection at Week 8).
Oral Rilpivirine (RPV): 25 mg tablets administered orally
Long-Acting Injectable Rilpivirine (RPV LA): Administered by intramuscular (IM) injection
Combination Antiretroviral Therapy (cART): Participants continued their pre-study cART regimen. The antiretroviral drugs in participants' cART regimens were not provided through the study.
|
|---|---|---|
|
Geometric Mean Ratio of Pre-dose CAB and RPV Concentrations at Week 48: Pre-dose CAB and RPV Concentrations at Week 8 (Cohort 2)
CAB Ratio
|
1.31 ratio
Geometric Coefficient of Variation 97.6
|
—
|
|
Geometric Mean Ratio of Pre-dose CAB and RPV Concentrations at Week 48: Pre-dose CAB and RPV Concentrations at Week 8 (Cohort 2)
RPV Ratio
|
1.84 ratio
Geometric Coefficient of Variation 47.1
|
—
|
SECONDARY outcome
Timeframe: Week 16 and Week 48Population: Cohort 2 All Treated: Cohort 2 participants who have taken at least 1 dose of any study product on Cohort 2
We present the geometric mean of the ratios of pre-dose CAB and RPV concentrations at Week 48:Week 16 and associated coefficient of variation, based on analysis of pre-dose PK samples.
Outcome measures
| Measure |
Cohort 1C: CAB
n=138 Participants
Step 1: CAB administered orally as one 30 mg tablet once daily, beginning at the Entry visit, for 4-6 weeks.
Step 2 (Q4W dosing): CAB LA administered as three single intramuscular (IM) injections four weeks apart (600 mg injection at Week 4b, 400 mg injection at Week 8, and 400 mg injection at Week 12).
Step 2 (Q8W dosing): CAB LA administered as two single IM injections four weeks apart (600 mg injection at Week 4b and 600 mg injection at Week 8).
Oral Cabotegravir (CAB): 30 mg tablets administered orally
Long-Acting Injectable Cabotegravir (CAB LA): Administered by intramuscular (IM) injection
Combination Antiretroviral Therapy (cART): Participants continued their pre-study cART regimen. The antiretroviral drugs in participants' cART regimens were not provided through the study.
|
Cohort 1R: RPV
Step 1: RPV administered orally as one 25 mg tablet once daily, beginning at the Entry visit, for 4-6 weeks.
Step 2 (Q4W dosing): RPV LA administered as three single IM injections four weeks apart (900 mg injection at Week 4b, 600 mg injection at Week 8, 600 mg injection at and Week 12).
Step 2 (Q8W dosing): RPV LA administered as two single IM injections four weeks apart (900 mg injection at Week 4b and 900 mg injection at Week 8).
Oral Rilpivirine (RPV): 25 mg tablets administered orally
Long-Acting Injectable Rilpivirine (RPV LA): Administered by intramuscular (IM) injection
Combination Antiretroviral Therapy (cART): Participants continued their pre-study cART regimen. The antiretroviral drugs in participants' cART regimens were not provided through the study.
|
|---|---|---|
|
Geometric Mean Ratio of Pre-dose CAB and RPV Concentrations at Week 48: Pre-dose CAB and RPV Concentrations at Week 16 (Cohort 2)
CAB Ratio
|
1.12 ratio
Geometric Coefficient of Variation 50.9
|
—
|
|
Geometric Mean Ratio of Pre-dose CAB and RPV Concentrations at Week 48: Pre-dose CAB and RPV Concentrations at Week 16 (Cohort 2)
RPV Ratio
|
1.68 ratio
Geometric Coefficient of Variation 37.9
|
—
|
Adverse Events
Cohort 1C: CAB
Serious events: 1 serious events
Other events: 28 other events
Deaths: 0 deaths
Cohort 1R: RPV
Serious events: 0 serious events
Other events: 23 other events
Deaths: 0 deaths
Cohort 2A: Oral CAB + Oral RPV and CAB LA + RPV LA
Serious events: 9 serious events
Other events: 136 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Cohort 1C: CAB
n=30 participants at risk
Step 1: CAB administered orally as one 30 mg tablet once daily, beginning at the Entry visit, for 4-6 weeks.
Step 2 (Q4W dosing): CAB LA administered as three single intramuscular (IM) injections four weeks apart (600 mg injection at Week 4b, 400 mg injection at Week 8, and 400 mg injection at Week 12).
Step 2 (Q8W dosing): CAB LA administered as two single IM injections four weeks apart (600 mg injection at Week 4b and 600 mg injection at Week 8).
Oral Cabotegravir (CAB): 30 mg tablets administered orally
Long-Acting Injectable Cabotegravir (CAB LA): Administered by intramuscular (IM) injection
Combination Antiretroviral Therapy (cART): Participants continued their pre-study cART regimen. The antiretroviral drugs in participants' cART regimens were not provided through the study.
|
Cohort 1R: RPV
n=25 participants at risk
Step 1: RPV administered orally as one 25 mg tablet once daily, beginning at the Entry visit, for 4-6 weeks.
Step 2 (Q4W dosing): RPV LA administered as three single IM injections four weeks apart (900 mg injection at Week 4b, 600 mg injection at Week 8, 600 mg injection at and Week 12).
Step 2 (Q8W dosing): RPV LA administered as two single IM injections four weeks apart (900 mg injection at Week 4b and 900 mg injection at Week 8).
Oral Rilpivirine (RPV): 25 mg tablets administered orally
Long-Acting Injectable Rilpivirine (RPV LA): Administered by intramuscular (IM) injection
Combination Antiretroviral Therapy (cART): Participants continued their pre-study cART regimen. The antiretroviral drugs in participants' cART regimens were not provided through the study.
|
Cohort 2A: Oral CAB + Oral RPV and CAB LA + RPV LA
n=144 participants at risk
Step 3: CAB administered orally as one 30 mg tablet once daily and RPV administered orally as one 25 mg tablet once daily, beginning at the Entry visit for 4-6 weeks.
Step 4: First and second injections: CAB LA administered as a 600 mg IM injection and RPV LA administered as a 900 mg IM injection at Week 4b and at Week 8. Subsequent injections: starting at Week 16, CAB LA administered as a 600 mg IM injection and RPV LA administered as a 900 mg IM injection every eight weeks through Week 96 or final safety extension visit.
Oral Cabotegravir (CAB): 30 mg tablets administered orally
Oral Rilpivirine (RPV): 25 mg tablets administered orally
Long-Acting Injectable Cabotegravir (CAB LA): Administered by intramuscular (IM) injection
Long-Acting Injectable Rilpivirine (RPV LA): Administered by intramuscular (IM) injection
|
|---|---|---|---|
|
Eye disorders
Cataract
|
0.00%
0/30 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
0.00%
0/25 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
0.69%
1/144 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
|
Gastrointestinal disorders
Gastritis alcoholic haemorrhagic
|
3.3%
1/30 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
0.00%
0/25 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
0.69%
1/144 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
|
Immune system disorders
Anaphylactic reaction
|
0.00%
0/30 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
0.00%
0/25 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
0.69%
1/144 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
|
Infections and infestations
Dengue fever
|
0.00%
0/30 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
0.00%
0/25 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
0.69%
1/144 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
|
Infections and infestations
Malaria
|
0.00%
0/30 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
0.00%
0/25 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
1.4%
2/144 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
|
Infections and infestations
Respiratory tract infection
|
0.00%
0/30 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
0.00%
0/25 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
0.69%
1/144 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
|
Infections and infestations
Typhoid fever
|
0.00%
0/30 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
0.00%
0/25 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
0.69%
1/144 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
|
Injury, poisoning and procedural complications
Radius fracture
|
0.00%
0/30 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
0.00%
0/25 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
0.69%
1/144 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/30 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
0.00%
0/25 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
0.69%
1/144 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
|
Investigations
Blood creatine phosphokinase increased
|
0.00%
0/30 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
0.00%
0/25 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
0.69%
1/144 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
|
Musculoskeletal and connective tissue disorders
Rhabdomyolysis
|
0.00%
0/30 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
0.00%
0/25 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
0.69%
1/144 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
|
Pregnancy, puerperium and perinatal conditions
Cephalo-pelvic disproportion
|
0.00%
0/30 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
0.00%
0/25 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
0.69%
1/144 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
|
Pregnancy, puerperium and perinatal conditions
Prolonged labour
|
0.00%
0/30 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
0.00%
0/25 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
0.69%
1/144 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
|
Pregnancy, puerperium and perinatal conditions
Umbilical cord around neck
|
0.00%
0/30 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
0.00%
0/25 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
0.69%
1/144 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
Other adverse events
| Measure |
Cohort 1C: CAB
n=30 participants at risk
Step 1: CAB administered orally as one 30 mg tablet once daily, beginning at the Entry visit, for 4-6 weeks.
Step 2 (Q4W dosing): CAB LA administered as three single intramuscular (IM) injections four weeks apart (600 mg injection at Week 4b, 400 mg injection at Week 8, and 400 mg injection at Week 12).
Step 2 (Q8W dosing): CAB LA administered as two single IM injections four weeks apart (600 mg injection at Week 4b and 600 mg injection at Week 8).
Oral Cabotegravir (CAB): 30 mg tablets administered orally
Long-Acting Injectable Cabotegravir (CAB LA): Administered by intramuscular (IM) injection
Combination Antiretroviral Therapy (cART): Participants continued their pre-study cART regimen. The antiretroviral drugs in participants' cART regimens were not provided through the study.
|
Cohort 1R: RPV
n=25 participants at risk
Step 1: RPV administered orally as one 25 mg tablet once daily, beginning at the Entry visit, for 4-6 weeks.
Step 2 (Q4W dosing): RPV LA administered as three single IM injections four weeks apart (900 mg injection at Week 4b, 600 mg injection at Week 8, 600 mg injection at and Week 12).
Step 2 (Q8W dosing): RPV LA administered as two single IM injections four weeks apart (900 mg injection at Week 4b and 900 mg injection at Week 8).
Oral Rilpivirine (RPV): 25 mg tablets administered orally
Long-Acting Injectable Rilpivirine (RPV LA): Administered by intramuscular (IM) injection
Combination Antiretroviral Therapy (cART): Participants continued their pre-study cART regimen. The antiretroviral drugs in participants' cART regimens were not provided through the study.
|
Cohort 2A: Oral CAB + Oral RPV and CAB LA + RPV LA
n=144 participants at risk
Step 3: CAB administered orally as one 30 mg tablet once daily and RPV administered orally as one 25 mg tablet once daily, beginning at the Entry visit for 4-6 weeks.
Step 4: First and second injections: CAB LA administered as a 600 mg IM injection and RPV LA administered as a 900 mg IM injection at Week 4b and at Week 8. Subsequent injections: starting at Week 16, CAB LA administered as a 600 mg IM injection and RPV LA administered as a 900 mg IM injection every eight weeks through Week 96 or final safety extension visit.
Oral Cabotegravir (CAB): 30 mg tablets administered orally
Oral Rilpivirine (RPV): 25 mg tablets administered orally
Long-Acting Injectable Cabotegravir (CAB LA): Administered by intramuscular (IM) injection
Long-Acting Injectable Rilpivirine (RPV LA): Administered by intramuscular (IM) injection
|
|---|---|---|---|
|
Infections and infestations
Viral upper respiratory tract infection
|
3.3%
1/30 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
12.0%
3/25 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
6.9%
10/144 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
|
Infections and infestations
Vulvovaginal candidiasis
|
0.00%
0/30 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
0.00%
0/25 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
2.1%
3/144 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
|
Injury, poisoning and procedural complications
Adverse event following immunisation
|
3.3%
1/30 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
0.00%
0/25 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
0.69%
1/144 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
|
Injury, poisoning and procedural complications
Animal bite
|
0.00%
0/30 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
0.00%
0/25 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
0.69%
1/144 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
0.00%
0/30 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
0.00%
0/25 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
0.69%
1/144 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/30 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
0.00%
0/25 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
0.69%
1/144 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
|
Injury, poisoning and procedural complications
Incision site pain
|
0.00%
0/30 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
0.00%
0/25 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
0.69%
1/144 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
|
Injury, poisoning and procedural complications
Injection related reaction
|
0.00%
0/30 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
0.00%
0/25 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
2.1%
3/144 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
|
Injury, poisoning and procedural complications
Limb injury
|
0.00%
0/30 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
4.0%
1/25 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
1.4%
2/144 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
|
Injury, poisoning and procedural complications
Perineal injury
|
3.3%
1/30 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
0.00%
0/25 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
0.00%
0/144 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
|
Injury, poisoning and procedural complications
Post procedural inflammation
|
0.00%
0/30 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
4.0%
1/25 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
0.69%
1/144 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
|
Injury, poisoning and procedural complications
Postoperative wound complication
|
0.00%
0/30 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
4.0%
1/25 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
0.69%
1/144 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.00%
0/30 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
8.0%
2/25 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
2.8%
4/144 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
|
Injury, poisoning and procedural complications
Product administration error
|
0.00%
0/30 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
0.00%
0/25 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
1.4%
2/144 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
|
Injury, poisoning and procedural complications
Scar
|
3.3%
1/30 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
0.00%
0/25 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
0.69%
1/144 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
|
Injury, poisoning and procedural complications
Skin abrasion
|
0.00%
0/30 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
0.00%
0/25 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
1.4%
2/144 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
|
Injury, poisoning and procedural complications
Skin laceration
|
0.00%
0/30 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
4.0%
1/25 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
2.8%
4/144 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
|
Injury, poisoning and procedural complications
Stab wound
|
0.00%
0/30 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
0.00%
0/25 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
0.69%
1/144 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
|
Injury, poisoning and procedural complications
Thermal burn
|
3.3%
1/30 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
0.00%
0/25 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
1.4%
2/144 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
|
Injury, poisoning and procedural complications
Traumatic pain
|
0.00%
0/30 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
0.00%
0/25 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
1.4%
2/144 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
|
Injury, poisoning and procedural complications
Upper limb fracture
|
0.00%
0/30 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
0.00%
0/25 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
0.69%
1/144 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
|
Injury, poisoning and procedural complications
Wound
|
3.3%
1/30 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
0.00%
0/25 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
0.69%
1/144 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
|
Injury, poisoning and procedural complications
Wound complication
|
0.00%
0/30 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
0.00%
0/25 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
0.69%
1/144 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
|
Injury, poisoning and procedural complications
Wound secretion
|
0.00%
0/30 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
0.00%
0/25 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
0.69%
1/144 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/30 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
0.00%
0/25 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
2.8%
4/144 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/30 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
0.00%
0/25 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
1.4%
2/144 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
|
Investigations
Blood bilirubin increased
|
3.3%
1/30 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
0.00%
0/25 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
0.69%
1/144 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
|
Investigations
Blood creatine phosphokinase increased
|
3.3%
1/30 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
12.0%
3/25 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
13.2%
19/144 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
|
Investigations
Blood creatinine increased
|
3.3%
1/30 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
0.00%
0/25 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
1.4%
2/144 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
|
Investigations
Blood glucose increased
|
0.00%
0/30 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
0.00%
0/25 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
0.69%
1/144 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
|
Investigations
Blood pressure diastolic increased
|
3.3%
1/30 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
0.00%
0/25 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
2.1%
3/144 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
|
Investigations
Blood pressure increased
|
20.0%
6/30 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
0.00%
0/25 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
16.0%
23/144 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
|
Investigations
Blood pressure systolic increased
|
3.3%
1/30 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
0.00%
0/25 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
10.4%
15/144 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
|
Investigations
Breath sounds abnormal
|
0.00%
0/30 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
0.00%
0/25 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
0.69%
1/144 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
|
Investigations
Creatinine renal clearance decreased
|
6.7%
2/30 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
4.0%
1/25 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
4.9%
7/144 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
|
Investigations
Electrocardiogram PR prolongation
|
3.3%
1/30 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
0.00%
0/25 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
0.69%
1/144 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
|
Investigations
Glomerular filtration rate decreased
|
0.00%
0/30 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
0.00%
0/25 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
1.4%
2/144 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
|
Investigations
Haemoglobin decreased
|
6.7%
2/30 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
0.00%
0/25 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
6.2%
9/144 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
|
Investigations
Lipase increased
|
0.00%
0/30 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
4.0%
1/25 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
0.00%
0/144 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
|
Investigations
Low density lipoprotein increased
|
0.00%
0/30 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
0.00%
0/25 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
0.69%
1/144 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/30 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
8.0%
2/25 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
3.5%
5/144 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
|
Investigations
Platelet count decreased
|
0.00%
0/30 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
0.00%
0/25 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
0.69%
1/144 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
|
Investigations
SARS-CoV-2 test positive
|
0.00%
0/30 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
0.00%
0/25 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
0.69%
1/144 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
|
Investigations
Weight decreased
|
0.00%
0/30 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
0.00%
0/25 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
3.5%
5/144 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
|
Investigations
Weight increased
|
0.00%
0/30 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
4.0%
1/25 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
0.69%
1/144 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
|
Metabolism and nutrition disorders
Abnormal loss of weight
|
0.00%
0/30 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
0.00%
0/25 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
1.4%
2/144 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
3.3%
1/30 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
4.0%
1/25 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
2.8%
4/144 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
|
Metabolism and nutrition disorders
Dehydration
|
3.3%
1/30 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
0.00%
0/25 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
2.1%
3/144 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
0.00%
0/30 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
0.00%
0/25 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
0.69%
1/144 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/30 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
0.00%
0/25 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
0.69%
1/144 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/30 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
0.00%
0/25 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
0.69%
1/144 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
|
Metabolism and nutrition disorders
Obesity
|
0.00%
0/30 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
0.00%
0/25 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
0.69%
1/144 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
|
Metabolism and nutrition disorders
Overweight
|
0.00%
0/30 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
0.00%
0/25 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
1.4%
2/144 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
|
Metabolism and nutrition disorders
Underweight
|
6.7%
2/30 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
0.00%
0/25 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
3.5%
5/144 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
|
Metabolism and nutrition disorders
Vitamin D deficiency
|
0.00%
0/30 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
4.0%
1/25 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
1.4%
2/144 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/30 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
4.0%
1/25 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
4.2%
6/144 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
3.3%
1/30 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
12.0%
3/25 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
6.2%
9/144 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
|
Musculoskeletal and connective tissue disorders
Coccydynia
|
0.00%
0/30 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
0.00%
0/25 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
0.69%
1/144 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.00%
0/30 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
0.00%
0/25 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
1.4%
2/144 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
|
Musculoskeletal and connective tissue disorders
Joint stiffness
|
0.00%
0/30 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
0.00%
0/25 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
0.69%
1/144 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
0.00%
0/30 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
0.00%
0/25 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
1.4%
2/144 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/30 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
0.00%
0/25 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
1.4%
2/144 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
3.3%
1/30 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
8.0%
2/25 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
8.3%
12/144 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/30 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
0.00%
0/25 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
0.69%
1/144 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
3.3%
1/30 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
12.0%
3/25 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
5.6%
8/144 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
|
Musculoskeletal and connective tissue disorders
Pain in jaw
|
0.00%
0/30 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
0.00%
0/25 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
1.4%
2/144 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
|
Musculoskeletal and connective tissue disorders
Tendon pain
|
0.00%
0/30 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
0.00%
0/25 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
0.69%
1/144 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
|
Musculoskeletal and connective tissue disorders
Torticollis
|
0.00%
0/30 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
4.0%
1/25 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
0.69%
1/144 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Fibroadenoma of breast
|
0.00%
0/30 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
0.00%
0/25 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
1.4%
2/144 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pyogenic granuloma
|
0.00%
0/30 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
0.00%
0/25 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
0.69%
1/144 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
|
Nervous system disorders
Delayed sleep phase
|
0.00%
0/30 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
4.0%
1/25 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
0.69%
1/144 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
|
Nervous system disorders
Dizziness
|
3.3%
1/30 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
12.0%
3/25 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
6.9%
10/144 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/30 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
0.00%
0/25 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
0.69%
1/144 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
|
Nervous system disorders
Headache
|
10.0%
3/30 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
32.0%
8/25 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
29.2%
42/144 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
|
Nervous system disorders
Migraine
|
0.00%
0/30 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
0.00%
0/25 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
0.69%
1/144 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
|
Nervous system disorders
Presyncope
|
0.00%
0/30 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
0.00%
0/25 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
1.4%
2/144 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
|
Nervous system disorders
Restless legs syndrome
|
0.00%
0/30 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
4.0%
1/25 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
0.69%
1/144 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
|
Nervous system disorders
Sciatica
|
0.00%
0/30 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
0.00%
0/25 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
0.69%
1/144 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
|
Nervous system disorders
Seizure
|
0.00%
0/30 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
0.00%
0/25 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
0.69%
1/144 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
|
Nervous system disorders
Sleep paralysis
|
3.3%
1/30 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
0.00%
0/25 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
0.00%
0/144 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
|
Nervous system disorders
Somnolence
|
0.00%
0/30 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
4.0%
1/25 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
1.4%
2/144 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
|
Nervous system disorders
Speech disorder
|
0.00%
0/30 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
0.00%
0/25 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
0.69%
1/144 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
|
Nervous system disorders
Syncope
|
0.00%
0/30 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
4.0%
1/25 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
1.4%
2/144 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
|
Psychiatric disorders
Agitation
|
0.00%
0/30 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
0.00%
0/25 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
0.69%
1/144 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
|
Psychiatric disorders
Anxiety
|
3.3%
1/30 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
0.00%
0/25 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
1.4%
2/144 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
|
Psychiatric disorders
Attention deficit hyperactivity disorder
|
0.00%
0/30 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
0.00%
0/25 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
0.69%
1/144 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
|
Psychiatric disorders
Depression
|
3.3%
1/30 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
0.00%
0/25 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
0.69%
1/144 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
|
Psychiatric disorders
Insomnia
|
6.7%
2/30 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
8.0%
2/25 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
2.8%
4/144 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
|
Psychiatric disorders
Major depression
|
0.00%
0/30 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
0.00%
0/25 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
0.69%
1/144 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
|
Psychiatric disorders
Post-traumatic stress disorder
|
3.3%
1/30 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
0.00%
0/25 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
0.69%
1/144 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
|
Psychiatric disorders
Stress
|
3.3%
1/30 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
0.00%
0/25 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
0.00%
0/144 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
|
Renal and urinary disorders
Chronic kidney disease
|
0.00%
0/30 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
0.00%
0/25 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
0.69%
1/144 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
|
Renal and urinary disorders
Glycosuria
|
0.00%
0/30 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
0.00%
0/25 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
0.69%
1/144 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
|
Renal and urinary disorders
Proteinuria
|
0.00%
0/30 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
0.00%
0/25 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
0.69%
1/144 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
|
Reproductive system and breast disorders
Abnormal uterine bleeding
|
0.00%
0/30 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
0.00%
0/25 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
2.1%
3/144 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
|
Reproductive system and breast disorders
Adnexa uteri mass
|
0.00%
0/30 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
0.00%
0/25 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
0.69%
1/144 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
|
Reproductive system and breast disorders
Amenorrhoea
|
0.00%
0/30 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
0.00%
0/25 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
0.69%
1/144 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
|
Reproductive system and breast disorders
Breast discharge
|
0.00%
0/30 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
0.00%
0/25 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
0.69%
1/144 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
|
Reproductive system and breast disorders
Breast mass
|
0.00%
0/30 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
0.00%
0/25 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
0.69%
1/144 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
|
Reproductive system and breast disorders
Breast pain
|
0.00%
0/30 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
0.00%
0/25 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
0.69%
1/144 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
|
Reproductive system and breast disorders
Breast swelling
|
0.00%
0/30 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
0.00%
0/25 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
0.69%
1/144 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
|
Reproductive system and breast disorders
Breast tenderness
|
0.00%
0/30 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
0.00%
0/25 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
0.69%
1/144 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
|
Reproductive system and breast disorders
Dysmenorrhoea
|
3.3%
1/30 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
8.0%
2/25 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
3.5%
5/144 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
|
Reproductive system and breast disorders
Heavy menstrual bleeding
|
3.3%
1/30 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
0.00%
0/25 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
1.4%
2/144 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
|
Reproductive system and breast disorders
Menstruation irregular
|
0.00%
0/30 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
8.0%
2/25 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
0.69%
1/144 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
|
Reproductive system and breast disorders
Ovarian cyst
|
0.00%
0/30 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
0.00%
0/25 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
0.69%
1/144 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
|
Reproductive system and breast disorders
Penile pain
|
0.00%
0/30 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
0.00%
0/25 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
0.69%
1/144 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
|
Reproductive system and breast disorders
Perineal pain
|
3.3%
1/30 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
0.00%
0/25 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
0.00%
0/144 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
|
Reproductive system and breast disorders
Vaginal discharge
|
0.00%
0/30 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
0.00%
0/25 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
0.69%
1/144 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
|
Reproductive system and breast disorders
Vaginal haemorrhage
|
0.00%
0/30 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
0.00%
0/25 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
2.1%
3/144 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
30.0%
9/30 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
24.0%
6/25 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
36.1%
52/144 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
|
Respiratory, thoracic and mediastinal disorders
Dry throat
|
0.00%
0/30 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
4.0%
1/25 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
0.69%
1/144 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
0.00%
0/30 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
0.00%
0/25 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
1.4%
2/144 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/30 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
8.0%
2/25 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
3.5%
5/144 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
3.3%
1/30 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
0.00%
0/25 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
1.4%
2/144 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
|
Respiratory, thoracic and mediastinal disorders
Increased upper airway secretion
|
0.00%
0/30 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
0.00%
0/25 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
0.69%
1/144 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
|
Respiratory, thoracic and mediastinal disorders
Lung hypoinflation
|
0.00%
0/30 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
4.0%
1/25 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
0.69%
1/144 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
13.3%
4/30 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
20.0%
5/25 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
19.4%
28/144 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal inflammation
|
0.00%
0/30 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
4.0%
1/25 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
0.69%
1/144 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal mucosal discolouration
|
3.3%
1/30 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
12.0%
3/25 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
1.4%
2/144 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal mucosal disorder
|
3.3%
1/30 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
16.0%
4/25 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
1.4%
2/144 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal mucosal hypertrophy
|
0.00%
0/30 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
4.0%
1/25 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
0.69%
1/144 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal pruritus
|
0.00%
0/30 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
0.00%
0/25 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
0.69%
1/144 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal discomfort
|
0.00%
0/30 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
0.00%
0/25 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
0.69%
1/144 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
20.0%
6/30 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
20.0%
5/25 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
20.1%
29/144 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal erythema
|
0.00%
0/30 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
8.0%
2/25 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
2.1%
3/144 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
3.3%
1/30 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
0.00%
0/25 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
9.7%
14/144 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
0.00%
0/30 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
0.00%
0/25 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
2.8%
4/144 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
6.7%
2/30 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
20.0%
5/25 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
18.1%
26/144 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
0.00%
0/30 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
0.00%
0/25 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
0.69%
1/144 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
|
Respiratory, thoracic and mediastinal disorders
Sinus pain
|
0.00%
0/30 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
4.0%
1/25 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
0.69%
1/144 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
|
Respiratory, thoracic and mediastinal disorders
Sneezing
|
3.3%
1/30 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
8.0%
2/25 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
4.2%
6/144 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
|
Respiratory, thoracic and mediastinal disorders
Snoring
|
0.00%
0/30 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
4.0%
1/25 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
0.69%
1/144 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
|
Respiratory, thoracic and mediastinal disorders
Throat irritation
|
3.3%
1/30 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
12.0%
3/25 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
2.1%
3/144 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
|
Respiratory, thoracic and mediastinal disorders
Tonsillar erythema
|
0.00%
0/30 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
0.00%
0/25 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
2.1%
3/144 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
|
Respiratory, thoracic and mediastinal disorders
Tonsillar hypertrophy
|
0.00%
0/30 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
0.00%
0/25 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
1.4%
2/144 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
|
Respiratory, thoracic and mediastinal disorders
Tonsillar inflammation
|
0.00%
0/30 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
4.0%
1/25 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
0.69%
1/144 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
|
Respiratory, thoracic and mediastinal disorders
Upper-airway cough syndrome
|
0.00%
0/30 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
0.00%
0/25 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
0.69%
1/144 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.00%
0/30 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
4.0%
1/25 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
2.1%
3/144 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
|
Skin and subcutaneous tissue disorders
Acne
|
0.00%
0/30 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
8.0%
2/25 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
2.8%
4/144 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
|
Skin and subcutaneous tissue disorders
Blister
|
0.00%
0/30 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
0.00%
0/25 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
0.69%
1/144 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
3.3%
1/30 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
0.00%
0/25 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
0.69%
1/144 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
|
Skin and subcutaneous tissue disorders
Dermatitis allergic
|
0.00%
0/30 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
0.00%
0/25 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
0.69%
1/144 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
|
Skin and subcutaneous tissue disorders
Dermatitis atopic
|
0.00%
0/30 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
0.00%
0/25 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
0.69%
1/144 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
|
Skin and subcutaneous tissue disorders
Dilated pores
|
3.3%
1/30 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
0.00%
0/25 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
0.00%
0/144 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/30 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
4.0%
1/25 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
2.1%
3/144 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/30 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
4.0%
1/25 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
0.69%
1/144 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/30 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
0.00%
0/25 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
0.69%
1/144 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
|
Skin and subcutaneous tissue disorders
Ingrowing nail
|
0.00%
0/30 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
0.00%
0/25 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
0.69%
1/144 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
|
Skin and subcutaneous tissue disorders
Rash
|
6.7%
2/30 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
8.0%
2/25 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
4.9%
7/144 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
0.00%
0/30 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
4.0%
1/25 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
0.69%
1/144 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
|
Skin and subcutaneous tissue disorders
Papule
|
0.00%
0/30 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
4.0%
1/25 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
4.2%
6/144 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
|
Skin and subcutaneous tissue disorders
Photosensitivity reaction
|
0.00%
0/30 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
0.00%
0/25 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
0.69%
1/144 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
3.3%
1/30 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
4.0%
1/25 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
3.5%
5/144 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
|
Skin and subcutaneous tissue disorders
Psoriasis
|
0.00%
0/30 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
0.00%
0/25 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
0.69%
1/144 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/30 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
4.0%
1/25 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
2.1%
3/144 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
|
Skin and subcutaneous tissue disorders
Rash papular
|
0.00%
0/30 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
4.0%
1/25 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
2.1%
3/144 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
|
Skin and subcutaneous tissue disorders
Rash pruritic
|
3.3%
1/30 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
0.00%
0/25 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
2.8%
4/144 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
|
Skin and subcutaneous tissue disorders
Skin discolouration
|
0.00%
0/30 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
4.0%
1/25 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
0.69%
1/144 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
|
Skin and subcutaneous tissue disorders
Skin fissures
|
0.00%
0/30 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
0.00%
0/25 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
0.69%
1/144 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
|
0.00%
0/30 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
4.0%
1/25 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
0.69%
1/144 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
0.00%
0/30 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
0.00%
0/25 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
0.69%
1/144 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/30 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
4.0%
1/25 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
2.8%
4/144 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
|
Social circumstances
Physical assault
|
0.00%
0/30 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
0.00%
0/25 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
0.69%
1/144 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
|
Social circumstances
Sexual abuse
|
0.00%
0/30 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
4.0%
1/25 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
0.69%
1/144 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
|
Social circumstances
Substance use
|
0.00%
0/30 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
0.00%
0/25 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
0.69%
1/144 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
|
Vascular disorders
Hot flush
|
0.00%
0/30 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
0.00%
0/25 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
0.69%
1/144 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
|
Vascular disorders
Hypertension
|
20.0%
6/30 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
0.00%
0/25 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
4.2%
6/144 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
|
Vascular disorders
Hypotension
|
0.00%
0/30 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
0.00%
0/25 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
1.4%
2/144 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
|
Vascular disorders
Pallor
|
0.00%
0/30 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
0.00%
0/25 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
0.69%
1/144 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
|
Vascular disorders
Systolic hypertension
|
0.00%
0/30 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
0.00%
0/25 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
0.69%
1/144 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
|
Blood and lymphatic system disorders
Anaemia
|
6.7%
2/30 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
0.00%
0/25 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
1.4%
2/144 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
6.7%
2/30 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
0.00%
0/25 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
5.6%
8/144 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.00%
0/30 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
8.0%
2/25 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
3.5%
5/144 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
|
Blood and lymphatic system disorders
Microcytic anaemia
|
0.00%
0/30 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
0.00%
0/25 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
1.4%
2/144 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
|
Blood and lymphatic system disorders
Neutropenia
|
3.3%
1/30 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
0.00%
0/25 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
1.4%
2/144 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
|
Blood and lymphatic system disorders
Normocytic anaemia
|
0.00%
0/30 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
0.00%
0/25 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
1.4%
2/144 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/30 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
0.00%
0/25 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
0.69%
1/144 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
|
Cardiac disorders
Bradycardia
|
6.7%
2/30 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
0.00%
0/25 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
2.1%
3/144 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
|
Cardiac disorders
Palpitations
|
0.00%
0/30 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
0.00%
0/25 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
0.69%
1/144 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
|
Cardiac disorders
Sinus bradycardia
|
3.3%
1/30 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
0.00%
0/25 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
1.4%
2/144 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/30 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
4.0%
1/25 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
4.9%
7/144 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
|
Congenital, familial and genetic disorders
Sickle cell trait
|
0.00%
0/30 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
4.0%
1/25 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
0.69%
1/144 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
|
Ear and labyrinth disorders
Ear canal erythema
|
3.3%
1/30 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
4.0%
1/25 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
0.69%
1/144 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
|
Ear and labyrinth disorders
Ear discomfort
|
0.00%
0/30 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
0.00%
0/25 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
0.69%
1/144 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
|
Ear and labyrinth disorders
Ear pain
|
3.3%
1/30 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
0.00%
0/25 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
1.4%
2/144 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
|
Ear and labyrinth disorders
Ear pruritus
|
0.00%
0/30 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
8.0%
2/25 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
0.69%
1/144 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
|
Ear and labyrinth disorders
Middle ear effusion
|
0.00%
0/30 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
8.0%
2/25 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
0.69%
1/144 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
|
Ear and labyrinth disorders
Motion sickness
|
0.00%
0/30 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
0.00%
0/25 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
0.69%
1/144 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
|
Ear and labyrinth disorders
Noninfective myringitis
|
0.00%
0/30 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
0.00%
0/25 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
0.69%
1/144 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
|
Ear and labyrinth disorders
Otorrhoea
|
0.00%
0/30 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
4.0%
1/25 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
1.4%
2/144 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
|
Ear and labyrinth disorders
Tympanic membrane disorder
|
0.00%
0/30 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
0.00%
0/25 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
0.69%
1/144 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
|
Ear and labyrinth disorders
Vertigo positional
|
0.00%
0/30 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
0.00%
0/25 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
0.69%
1/144 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
|
Endocrine disorders
Autoimmune thyroiditis
|
0.00%
0/30 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
0.00%
0/25 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
0.69%
1/144 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
|
Endocrine disorders
Hypothyroidism
|
0.00%
0/30 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
0.00%
0/25 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
0.69%
1/144 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
|
Eye disorders
Conjunctival pallor
|
3.3%
1/30 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
0.00%
0/25 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
2.8%
4/144 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
|
Eye disorders
Conjunctivitis allergic
|
0.00%
0/30 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
0.00%
0/25 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
1.4%
2/144 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
|
Eye disorders
Dry eye
|
0.00%
0/30 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
0.00%
0/25 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
0.69%
1/144 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
|
Eye disorders
Eye discharge
|
0.00%
0/30 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
0.00%
0/25 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
0.69%
1/144 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
|
Eye disorders
Eye pain
|
0.00%
0/30 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
4.0%
1/25 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
0.00%
0/144 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
|
Eye disorders
Eye pruritus
|
0.00%
0/30 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
4.0%
1/25 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
2.8%
4/144 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
|
Eye disorders
Eyelid oedema
|
0.00%
0/30 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
0.00%
0/25 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
0.69%
1/144 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
|
Eye disorders
Lacrimation increased
|
0.00%
0/30 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
4.0%
1/25 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
2.8%
4/144 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
|
Eye disorders
Ocular discomfort
|
0.00%
0/30 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
0.00%
0/25 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
0.69%
1/144 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
|
Eye disorders
Ocular hyperaemia
|
0.00%
0/30 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
0.00%
0/25 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
0.69%
1/144 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
|
Eye disorders
Photophobia
|
0.00%
0/30 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
0.00%
0/25 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
1.4%
2/144 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
|
Eye disorders
Visual impairment
|
0.00%
0/30 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
0.00%
0/25 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
1.4%
2/144 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/30 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
8.0%
2/25 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
0.00%
0/144 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/30 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
8.0%
2/25 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
6.2%
9/144 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.00%
0/30 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
4.0%
1/25 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
1.4%
2/144 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
3.3%
1/30 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
8.0%
2/25 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
4.2%
6/144 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
|
Gastrointestinal disorders
Abdominal tenderness
|
0.00%
0/30 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
0.00%
0/25 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
0.69%
1/144 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
|
Gastrointestinal disorders
Aphthous ulcer
|
0.00%
0/30 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
4.0%
1/25 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
1.4%
2/144 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
|
Gastrointestinal disorders
Breath odour
|
0.00%
0/30 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
4.0%
1/25 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
0.69%
1/144 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/30 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
12.0%
3/25 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
2.8%
4/144 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
|
Gastrointestinal disorders
Dental caries
|
0.00%
0/30 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
0.00%
0/25 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
0.69%
1/144 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
|
Gastrointestinal disorders
Diarrhoea
|
6.7%
2/30 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
12.0%
3/25 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
6.2%
9/144 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
|
Gastrointestinal disorders
Duodenal ulcer
|
0.00%
0/30 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
0.00%
0/25 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
0.69%
1/144 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
|
Gastrointestinal disorders
Dyspepsia
|
3.3%
1/30 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
8.0%
2/25 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
1.4%
2/144 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
|
Gastrointestinal disorders
Enlarged uvula
|
3.3%
1/30 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
0.00%
0/25 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
0.69%
1/144 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/30 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
0.00%
0/25 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
1.4%
2/144 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/30 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
0.00%
0/25 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
2.1%
3/144 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
|
Gastrointestinal disorders
Gingival pain
|
0.00%
0/30 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
0.00%
0/25 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
0.69%
1/144 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
|
Gastrointestinal disorders
Haematochezia
|
0.00%
0/30 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
0.00%
0/25 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
0.69%
1/144 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
|
Gastrointestinal disorders
Hypoaesthesia oral
|
0.00%
0/30 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
0.00%
0/25 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
0.69%
1/144 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
|
Gastrointestinal disorders
Lip dry
|
0.00%
0/30 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
0.00%
0/25 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
0.69%
1/144 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
|
Gastrointestinal disorders
Malpositioned teeth
|
0.00%
0/30 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
0.00%
0/25 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
0.69%
1/144 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
|
Gastrointestinal disorders
Melaena
|
3.3%
1/30 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
0.00%
0/25 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
0.69%
1/144 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
|
Gastrointestinal disorders
Nausea
|
3.3%
1/30 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
20.0%
5/25 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
7.6%
11/144 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
|
Gastrointestinal disorders
Oral mucosal erythema
|
3.3%
1/30 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
0.00%
0/25 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
0.69%
1/144 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/30 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
0.00%
0/25 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
1.4%
2/144 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
|
Gastrointestinal disorders
Tongue ulceration
|
0.00%
0/30 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
4.0%
1/25 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
1.4%
2/144 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
|
Gastrointestinal disorders
Tooth impacted
|
0.00%
0/30 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
4.0%
1/25 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
0.69%
1/144 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/30 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
4.0%
1/25 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
4.2%
6/144 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
|
Gastrointestinal disorders
Vomiting
|
3.3%
1/30 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
16.0%
4/25 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
8.3%
12/144 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
|
General disorders
Asthenia
|
0.00%
0/30 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
4.0%
1/25 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
4.2%
6/144 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
|
General disorders
Chest discomfort
|
6.7%
2/30 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
8.0%
2/25 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
2.8%
4/144 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
|
General disorders
Chills
|
3.3%
1/30 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
0.00%
0/25 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
4.2%
6/144 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
|
General disorders
Complication of device insertion
|
0.00%
0/30 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
0.00%
0/25 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
0.69%
1/144 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
|
General disorders
Fatigue
|
3.3%
1/30 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
0.00%
0/25 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
5.6%
8/144 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
|
General disorders
Immediate post-injection reaction
|
0.00%
0/30 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
0.00%
0/25 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
0.69%
1/144 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
|
General disorders
Influenza like illness
|
0.00%
0/30 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
0.00%
0/25 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
0.69%
1/144 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
|
General disorders
Injection site bruising
|
0.00%
0/30 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
0.00%
0/25 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
0.69%
1/144 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
|
General disorders
Injection site erythema
|
0.00%
0/30 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
0.00%
0/25 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
0.69%
1/144 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
|
General disorders
Injection site hypoaesthesia
|
0.00%
0/30 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
4.0%
1/25 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
0.69%
1/144 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
|
General disorders
Injection site induration
|
0.00%
0/30 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
0.00%
0/25 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
2.1%
3/144 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
|
General disorders
Injection site joint pain
|
0.00%
0/30 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
0.00%
0/25 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
0.69%
1/144 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
|
General disorders
Injection site nodule
|
0.00%
0/30 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
4.0%
1/25 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
4.2%
6/144 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
|
General disorders
Injection site pain
|
30.0%
9/30 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
36.0%
9/25 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
39.6%
57/144 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
|
General disorders
Injection site pruritus
|
0.00%
0/30 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
0.00%
0/25 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
1.4%
2/144 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
|
General disorders
Injection site swelling
|
3.3%
1/30 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
4.0%
1/25 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
5.6%
8/144 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
|
General disorders
Malaise
|
0.00%
0/30 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
0.00%
0/25 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
2.1%
3/144 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
|
General disorders
Medical device pain
|
0.00%
0/30 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
0.00%
0/25 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
0.69%
1/144 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
|
General disorders
Mucosal discolouration
|
0.00%
0/30 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
0.00%
0/25 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
0.69%
1/144 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
|
General disorders
Mucosal disorder
|
0.00%
0/30 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
4.0%
1/25 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
0.69%
1/144 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
|
General disorders
Mucosal hyperaemia
|
0.00%
0/30 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
4.0%
1/25 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
0.00%
0/144 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
|
General disorders
Nodule
|
0.00%
0/30 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
0.00%
0/25 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
0.69%
1/144 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
|
General disorders
Non-cardiac chest pain
|
3.3%
1/30 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
0.00%
0/25 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
6.9%
10/144 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
|
General disorders
Pain
|
3.3%
1/30 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
0.00%
0/25 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
2.8%
4/144 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
|
General disorders
Peripheral swelling
|
0.00%
0/30 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
0.00%
0/25 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
0.69%
1/144 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
|
General disorders
Pyrexia
|
6.7%
2/30 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
4.0%
1/25 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
18.1%
26/144 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
|
General disorders
Suprapubic pain
|
0.00%
0/30 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
0.00%
0/25 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
0.69%
1/144 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
|
General disorders
Swelling face
|
0.00%
0/30 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
4.0%
1/25 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
0.69%
1/144 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
|
General disorders
Vaccination site pain
|
3.3%
1/30 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
0.00%
0/25 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
0.69%
1/144 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
|
General disorders
Vessel puncture site pain
|
0.00%
0/30 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
0.00%
0/25 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
0.69%
1/144 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
|
Hepatobiliary disorders
Hepatic steatosis
|
0.00%
0/30 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
0.00%
0/25 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
0.69%
1/144 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
|
Hepatobiliary disorders
Ocular icterus
|
0.00%
0/30 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
4.0%
1/25 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
0.69%
1/144 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
|
Immune system disorders
Food allergy
|
0.00%
0/30 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
0.00%
0/25 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
0.69%
1/144 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
|
Immune system disorders
Hypersensitivity
|
0.00%
0/30 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
8.0%
2/25 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
1.4%
2/144 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
|
Immune system disorders
Seasonal allergy
|
0.00%
0/30 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
8.0%
2/25 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
0.69%
1/144 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
|
Infections and infestations
Abscess limb
|
0.00%
0/30 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
0.00%
0/25 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
1.4%
2/144 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
|
Infections and infestations
Acute sinusitis
|
0.00%
0/30 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
4.0%
1/25 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
1.4%
2/144 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
|
Infections and infestations
Bacteraemia
|
0.00%
0/30 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
0.00%
0/25 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
0.69%
1/144 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
|
Infections and infestations
Body tinea
|
0.00%
0/30 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
0.00%
0/25 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
0.69%
1/144 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/30 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
0.00%
0/25 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
0.69%
1/144 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
|
Infections and infestations
COVID-19
|
6.7%
2/30 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
0.00%
0/25 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
7.6%
11/144 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
|
Infections and infestations
Conjunctivitis
|
0.00%
0/30 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
0.00%
0/25 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
2.1%
3/144 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
|
Infections and infestations
Cystitis
|
0.00%
0/30 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
0.00%
0/25 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
0.69%
1/144 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
|
Infections and infestations
Dermatophytosis
|
0.00%
0/30 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
0.00%
0/25 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
0.69%
1/144 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
|
Infections and infestations
Diarrhoea infectious
|
0.00%
0/30 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
0.00%
0/25 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
0.69%
1/144 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
|
Infections and infestations
Enterocolitis viral
|
0.00%
0/30 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
4.0%
1/25 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
0.69%
1/144 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
|
Infections and infestations
Folliculitis
|
0.00%
0/30 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
0.00%
0/25 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
0.69%
1/144 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
|
Infections and infestations
Furuncle
|
0.00%
0/30 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
0.00%
0/25 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
1.4%
2/144 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/30 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
0.00%
0/25 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
2.8%
4/144 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
|
Infections and infestations
Gastroenteritis viral
|
0.00%
0/30 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
4.0%
1/25 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
0.69%
1/144 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
|
Infections and infestations
Genital herpes
|
0.00%
0/30 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
0.00%
0/25 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
0.69%
1/144 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
|
Infections and infestations
Herpes simplex pharyngitis
|
0.00%
0/30 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
0.00%
0/25 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
0.69%
1/144 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/30 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
0.00%
0/25 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
0.69%
1/144 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
|
Infections and infestations
Hordeolum
|
0.00%
0/30 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
0.00%
0/25 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
0.69%
1/144 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
|
Infections and infestations
Impetigo
|
0.00%
0/30 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
0.00%
0/25 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
1.4%
2/144 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
|
Infections and infestations
Influenza
|
0.00%
0/30 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
4.0%
1/25 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
2.1%
3/144 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
|
Infections and infestations
Injection site abscess
|
0.00%
0/30 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
0.00%
0/25 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
1.4%
2/144 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
|
Infections and infestations
Laryngitis
|
0.00%
0/30 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
0.00%
0/25 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
0.69%
1/144 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
|
Infections and infestations
Latent syphilis
|
0.00%
0/30 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
0.00%
0/25 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
0.69%
1/144 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
|
Infections and infestations
Lower respiratory tract infection
|
0.00%
0/30 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
0.00%
0/25 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
1.4%
2/144 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
|
Infections and infestations
Malaria
|
0.00%
0/30 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
0.00%
0/25 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
4.9%
7/144 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
|
Infections and infestations
Mumps
|
0.00%
0/30 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
0.00%
0/25 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
0.69%
1/144 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
|
Infections and infestations
Nasopharyngitis
|
3.3%
1/30 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
0.00%
0/25 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
9.7%
14/144 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
|
Infections and infestations
Onychomycosis
|
0.00%
0/30 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
0.00%
0/25 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
0.69%
1/144 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
|
Infections and infestations
Oral herpes
|
3.3%
1/30 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
0.00%
0/25 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
4.2%
6/144 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
|
Infections and infestations
Otitis media
|
0.00%
0/30 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
0.00%
0/25 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
1.4%
2/144 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
|
Infections and infestations
Otitis media acute
|
0.00%
0/30 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
0.00%
0/25 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
1.4%
2/144 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
|
Infections and infestations
Paronychia
|
0.00%
0/30 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
4.0%
1/25 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
0.69%
1/144 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
|
Infections and infestations
Pelvic inflammatory disease
|
0.00%
0/30 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
0.00%
0/25 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
0.69%
1/144 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
|
Infections and infestations
Pharyngitis
|
3.3%
1/30 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
0.00%
0/25 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
1.4%
2/144 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
|
Infections and infestations
Pharyngitis streptococcal
|
0.00%
0/30 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
0.00%
0/25 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
2.1%
3/144 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
|
Infections and infestations
Plasmodium falciparum infection
|
0.00%
0/30 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
0.00%
0/25 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
1.4%
2/144 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/30 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
0.00%
0/25 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
0.69%
1/144 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
|
Infections and infestations
Proctitis gonococcal
|
0.00%
0/30 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
0.00%
0/25 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
0.69%
1/144 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
|
Infections and infestations
Respiratory tract infection
|
0.00%
0/30 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
0.00%
0/25 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
2.1%
3/144 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
|
Infections and infestations
Respiratory tract infection viral
|
0.00%
0/30 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
0.00%
0/25 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
1.4%
2/144 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
|
Infections and infestations
Rhinitis
|
0.00%
0/30 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
0.00%
0/25 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
0.69%
1/144 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
|
Infections and infestations
Scabies
|
0.00%
0/30 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
0.00%
0/25 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
0.69%
1/144 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
|
Infections and infestations
Secondary syphilis
|
0.00%
0/30 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
4.0%
1/25 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
0.69%
1/144 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
|
Infections and infestations
Sinusitis
|
3.3%
1/30 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
0.00%
0/25 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
2.1%
3/144 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
|
Infections and infestations
Skin bacterial infection
|
0.00%
0/30 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
0.00%
0/25 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
0.69%
1/144 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
|
Infections and infestations
Skin candida
|
0.00%
0/30 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
0.00%
0/25 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
0.69%
1/144 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
|
Infections and infestations
Subcutaneous abscess
|
0.00%
0/30 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
0.00%
0/25 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
0.69%
1/144 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
|
Infections and infestations
Syphilis genital
|
0.00%
0/30 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
4.0%
1/25 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
0.69%
1/144 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
|
Infections and infestations
Tinea infection
|
0.00%
0/30 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
0.00%
0/25 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
0.69%
1/144 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
|
Infections and infestations
Tinea pedis
|
0.00%
0/30 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
0.00%
0/25 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
0.69%
1/144 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
|
Infections and infestations
Tinea versicolour
|
0.00%
0/30 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
0.00%
0/25 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
0.69%
1/144 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
|
Infections and infestations
Tonsillitis
|
0.00%
0/30 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
0.00%
0/25 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
1.4%
2/144 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
|
Infections and infestations
Tooth infection
|
0.00%
0/30 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
0.00%
0/25 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
1.4%
2/144 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
|
Infections and infestations
Typhoid fever
|
0.00%
0/30 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
0.00%
0/25 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
0.69%
1/144 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
|
Infections and infestations
Upper respiratory tract infection
|
13.3%
4/30 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
8.0%
2/25 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
20.8%
30/144 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
|
Infections and infestations
Urethritis
|
0.00%
0/30 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
0.00%
0/25 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
0.69%
1/144 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
|
Infections and infestations
Urethritis gonococcal
|
0.00%
0/30 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
0.00%
0/25 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
0.69%
1/144 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/30 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
0.00%
0/25 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
4.9%
7/144 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
|
Infections and infestations
Viral infection
|
0.00%
0/30 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
4.0%
1/25 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
0.69%
1/144 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
|
Infections and infestations
Viral pharyngitis
|
0.00%
0/30 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
4.0%
1/25 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
1.4%
2/144 • Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit)
According to the study protocol, safety outcome measures are summarized for Cohort 1C and Cohort 1R without respect to the dosing regimen. These adverse events are also presented by Cohort, and not by dosing regimen. Dosing regimen is only reported for PK related outcome measures and results. Adverse events were not collected for enrolled parent/caregivers in either Cohort 1 or Cohort 2.
|
Additional Information
IMPAACT ClinicalTrials.gov Coordinator
Family Health International (FHI 360)
Phone: (919) 405-1429
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee In accordance with the Clinical Trials Agreement between NIAID (DAIDS) and company collaborators, NIAID (DAIDS) provides companies with a copy of any abstract, press release, or manuscript prior to submission for publication with sufficient time for company review and comment. The publication/other disclosure can be delayed for up to 30 additional business days for manuscripts and five (5) business days for abstracts, to preserve U.S. or foreign patent or other intellectual property rights.
- Publication restrictions are in place
Restriction type: OTHER