Trial Outcomes & Findings for Anti-malaria MAb in Malian Children (NCT NCT05304611)
NCT ID: NCT05304611
Last Updated: 2025-07-10
Results Overview
Number of participants with local adverse events occurring within 7 days after administration of L9LS. Local reactogenicity included pain/tenderness, swelling, redness, bruising, and pruritus at the site of infusion. Adverse events were captured by Investigator examination and history from participants.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
365 participants
Primary outcome timeframe
Within 7 days after administration of L9LS
Results posted on
2025-07-10
Participant Flow
365 participants were consented (341 pediatrics, 36 adults): * 62 participants were ineligible (57 pediatrics, five adults) * 23 participants served as backup (22 pediatrics, one adult) * One pediatric participant withdrew consent * 279 participants received intervention (261 pediatrics, 18 adults) in year one * 235 pediatric participants from year one participated in the extension study in year two
Participant milestones
| Measure |
Adult Dose-escalation Study: Arm 1: 300 mg of L9LS
Adult participants receive single dose of 300 mg of L9LS subcutaneously. Once subjects reach day 7 post-administration without safety concerns dosing begins for arm 2.
L9LS (VRC-MALMAB0114-00-AB): Administered one time via subcutaneous route.
|
Adult Dose-escalation Study: Arm 2: 600 mg of L9LS
Adult participants receive single dose of 600 mg of L9LS subcutaneously. Once subjects reach day 7 post-administration without safety concerns dosing begins for arm 3.
L9LS (VRC-MALMAB0114-00-AB): Administered one time via subcutaneous route.
|
Adult Dose-escalation Study: Arm 3: 20 mg/kg of L9LS
Adult participants receive highest single dose of 20 mg/kg IV of L9LS intravenously. Once subjects reach day 7 post-administration without safety concerns dosing begins for pediatric subjects dose escalation arm 1.
L9LS (VRC-MALMAB0114-00-AB): Administered one time via intravenous route.
|
Pediatric Dose-escalation Study: Arm 1: 150 mg of L9LS
Pediatric subjects ages 6-10 years receive 150 mg of L9LS subcutaneously. Once subjects reach day 7 post-administration without safety concerns, dosing begins for arm 2.
L9LS (VRC-MALMAB0114-00-AB): Administered one time via subcutaneous route.
|
Pediatric Dose-escalation Study: Arm 2: 300 mg of L9LS
Pediatric subjects ages 6-10 years receive 300 mg of L9LS subcutaneously. Once subjects reach day 7 post-administration without safety concerns, dosing begins for the pediatric efficacy study arms.
L9LS (VRC-MALMAB0114-00-AB): Administered one time via subcutaneous route.
|
Pediatric Dose-escalation Study: Arm 3: Placebo
Pediatric subjects ages 6-10 receive placebo of normal saline subcutaneously.
Normal saline: Administered one time via subcutaneous administration.
|
Pediatric Efficacy Study: Arm 1: 150 mg of L9LS
Pediatric subjects ages 6-10 receive 150 mg of L9LS subcutaneously.
L9LS (VRC-MALMAB0114-00-AB): Administered one time via subcutaneous route.
|
Pediatric Efficacy Study: Arm 2: 300 mg of L9LS
Pediatric subjects ages 6-10 receive 300 mg of L9LS subcutaneously.
L9LS (VRC-MALMAB0114-00-AB): Administered one time via subcutaneous route.
|
Pediatric Efficacy Study: Arm 3: Placebo
Pediatric subjects ages 6-10 receive placebo of normal saline subcutaneously.
Normal saline: Administered one time via subcutaneous administration.
|
Pediatric Extension Study: Arm 1: 150 mg of L9LS
Pediatric subjects ages 6-10 who completed year one of the study and agreed to continue with the extension were randomized to receive 150 mg of L9LS subcutaneously.
|
Pediatric Extension Study: Arm 2: 300 mg of L9LS
Pediatric subjects ages 6-10 who completed year one of the study and agreed to continue with the extension were randomized to receive 300 mg of L9LS subcutaneously.
|
Pediatric Extension Study: Arm 3: Placebo
Pediatric subjects ages 6-10 who completed year one of the study and agreed to continue with the extension were randomized to receive placebo of normal saline subcutaneously.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Adult Dose-escalation: 300 mg L9LS
STARTED
|
6
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Adult Dose-escalation: 300 mg L9LS
COMPLETED
|
6
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Adult Dose-escalation: 300 mg L9LS
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Adult Dose-escalation: 600 mg L9LS
STARTED
|
0
|
6
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Adult Dose-escalation: 600 mg L9LS
COMPLETED
|
0
|
6
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Adult Dose-escalation: 600 mg L9LS
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Adult Dose-escalation: 20 mg/kg L9LS
STARTED
|
0
|
0
|
6
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Adult Dose-escalation: 20 mg/kg L9LS
COMPLETED
|
0
|
0
|
6
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Adult Dose-escalation: 20 mg/kg L9LS
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Ped Dose-escalation: 150mg L9LS/ Placebo
STARTED
|
0
|
0
|
0
|
9
|
0
|
9
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Ped Dose-escalation: 150mg L9LS/ Placebo
COMPLETED
|
0
|
0
|
0
|
9
|
0
|
9
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Ped Dose-escalation: 150mg L9LS/ Placebo
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Ped Dose-escalation: 300mg L9LS/ Placebo
STARTED
|
0
|
0
|
0
|
0
|
9
|
9
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Ped Dose-escalation: 300mg L9LS/ Placebo
COMPLETED
|
0
|
0
|
0
|
0
|
9
|
9
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Ped Dose-escalation: 300mg L9LS/ Placebo
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Pediatric Efficacy Study
STARTED
|
0
|
0
|
0
|
0
|
0
|
0
|
75
|
75
|
75
|
0
|
0
|
0
|
|
Pediatric Efficacy Study
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
73
|
74
|
72
|
0
|
0
|
0
|
|
Pediatric Efficacy Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
2
|
1
|
3
|
0
|
0
|
0
|
|
Pediatric Extension Study
STARTED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
79
|
38
|
118
|
|
Pediatric Extension Study
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
79
|
37
|
116
|
|
Pediatric Extension Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
2
|
Reasons for withdrawal
| Measure |
Adult Dose-escalation Study: Arm 1: 300 mg of L9LS
Adult participants receive single dose of 300 mg of L9LS subcutaneously. Once subjects reach day 7 post-administration without safety concerns dosing begins for arm 2.
L9LS (VRC-MALMAB0114-00-AB): Administered one time via subcutaneous route.
|
Adult Dose-escalation Study: Arm 2: 600 mg of L9LS
Adult participants receive single dose of 600 mg of L9LS subcutaneously. Once subjects reach day 7 post-administration without safety concerns dosing begins for arm 3.
L9LS (VRC-MALMAB0114-00-AB): Administered one time via subcutaneous route.
|
Adult Dose-escalation Study: Arm 3: 20 mg/kg of L9LS
Adult participants receive highest single dose of 20 mg/kg IV of L9LS intravenously. Once subjects reach day 7 post-administration without safety concerns dosing begins for pediatric subjects dose escalation arm 1.
L9LS (VRC-MALMAB0114-00-AB): Administered one time via intravenous route.
|
Pediatric Dose-escalation Study: Arm 1: 150 mg of L9LS
Pediatric subjects ages 6-10 years receive 150 mg of L9LS subcutaneously. Once subjects reach day 7 post-administration without safety concerns, dosing begins for arm 2.
L9LS (VRC-MALMAB0114-00-AB): Administered one time via subcutaneous route.
|
Pediatric Dose-escalation Study: Arm 2: 300 mg of L9LS
Pediatric subjects ages 6-10 years receive 300 mg of L9LS subcutaneously. Once subjects reach day 7 post-administration without safety concerns, dosing begins for the pediatric efficacy study arms.
L9LS (VRC-MALMAB0114-00-AB): Administered one time via subcutaneous route.
|
Pediatric Dose-escalation Study: Arm 3: Placebo
Pediatric subjects ages 6-10 receive placebo of normal saline subcutaneously.
Normal saline: Administered one time via subcutaneous administration.
|
Pediatric Efficacy Study: Arm 1: 150 mg of L9LS
Pediatric subjects ages 6-10 receive 150 mg of L9LS subcutaneously.
L9LS (VRC-MALMAB0114-00-AB): Administered one time via subcutaneous route.
|
Pediatric Efficacy Study: Arm 2: 300 mg of L9LS
Pediatric subjects ages 6-10 receive 300 mg of L9LS subcutaneously.
L9LS (VRC-MALMAB0114-00-AB): Administered one time via subcutaneous route.
|
Pediatric Efficacy Study: Arm 3: Placebo
Pediatric subjects ages 6-10 receive placebo of normal saline subcutaneously.
Normal saline: Administered one time via subcutaneous administration.
|
Pediatric Extension Study: Arm 1: 150 mg of L9LS
Pediatric subjects ages 6-10 who completed year one of the study and agreed to continue with the extension were randomized to receive 150 mg of L9LS subcutaneously.
|
Pediatric Extension Study: Arm 2: 300 mg of L9LS
Pediatric subjects ages 6-10 who completed year one of the study and agreed to continue with the extension were randomized to receive 300 mg of L9LS subcutaneously.
|
Pediatric Extension Study: Arm 3: Placebo
Pediatric subjects ages 6-10 who completed year one of the study and agreed to continue with the extension were randomized to receive placebo of normal saline subcutaneously.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Pediatric Efficacy Study
Lost to Follow-up
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
1
|
0
|
0
|
0
|
|
Pediatric Efficacy Study
Withdrew consent
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
1
|
2
|
0
|
0
|
0
|
|
Pediatric Extension Study
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
2
|
Baseline Characteristics
Anti-malaria MAb in Malian Children
Baseline characteristics by cohort
| Measure |
Adult Dose-escalation Study: Arm 1: 300 mg of L9LS
n=6 Participants
Adult participants receive single dose of 300 mg of L9LS subcutaneously. Once subjects reach day 7 post-administration without safety concerns dosing begins for arm 2.
L9LS (VRC-MALMAB0114-00-AB): Administered one time via subcutaneous route.
|
Adult Dose-escalation Study: Arm 2: 600 mg of L9LS
n=6 Participants
Adult participants receive single dose of 600 mg of L9LS subcutaneously. Once subjects reach day 7 post-administration without safety concerns dosing begins for arm 3.
L9LS (VRC-MALMAB0114-00-AB): Administered one time via subcutaneous route.
|
Adult Dose-escalation Study: Arm 3: 20 mg/kg of L9LS
n=6 Participants
Adult participants receive highest single dose of 20 mg/kg IV of L9LS intravenously. Once subjects reach day 7 post-administration without safety concerns dosing begins for pediatric subjects dose escalation arm 1.
L9LS (VRC-MALMAB0114-00-AB): Administered one time via intravenous route.
|
Pediatric Dose-escalation Study: Arm 1: 150 mg of L9LS
n=9 Participants
Pediatric subjects ages 6-10 years receive 150 mg of L9LS subcutaneously. Once subjects reach day 7 post-administration without safety concerns, dosing begins for arm 2.
L9LS (VRC-MALMAB0114-00-AB): Administered one time via subcutaneous route.
|
Pediatric Dose-escalation Study: Arm 2: 300 mg of L9LS
n=9 Participants
Pediatric subjects ages 6-10 years receive 300 mg of L9LS subcutaneously. Once subjects reach day 7 post-administration without safety concerns, dosing begins for the pediatric efficacy study arms.
L9LS (VRC-MALMAB0114-00-AB): Administered one time via subcutaneous route.
|
Pediatric Dose-escalation Study: Arm 3: Placebo
n=18 Participants
Pediatric subjects ages 6-10 receive placebo of normal saline subcutaneously.
Normal saline: Administered one time via subcutaneous administration.
|
Pediatric Efficacy Study: Arm 1: 150 mg of L9LS
n=75 Participants
Pediatric subjects ages 6-10 receive 150 mg of L9LS subcutaneously.
L9LS (VRC-MALMAB0114-00-AB): Administered one time via subcutaneous route.
|
Pediatric Efficacy Study: Arm 2: 300 mg of L9LS
n=75 Participants
Pediatric subjects ages 6-10 receive 300 mg of L9LS subcutaneously.
L9LS (VRC-MALMAB0114-00-AB): Administered one time via subcutaneous route.
|
Pediatric Efficacy Study: Arm 3: Placebo
n=75 Participants
Pediatric subjects ages 6-10 receive placebo of normal saline subcutaneously.
Normal saline: Administered one time via subcutaneous administration.
|
Total
n=279 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Age, Customized
6
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
5 Participants
n=10 Participants
|
20 Participants
n=115 Participants
|
23 Participants
n=6 Participants
|
31 Participants
n=6 Participants
|
80 Participants
n=64 Participants
|
|
Age, Customized
7
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
4 Participants
n=10 Participants
|
11 Participants
n=115 Participants
|
11 Participants
n=6 Participants
|
8 Participants
n=6 Participants
|
39 Participants
n=64 Participants
|
|
Age, Customized
8
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
4 Participants
n=10 Participants
|
23 Participants
n=115 Participants
|
13 Participants
n=6 Participants
|
19 Participants
n=6 Participants
|
64 Participants
n=64 Participants
|
|
Age, Customized
9
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
2 Participants
n=10 Participants
|
15 Participants
n=115 Participants
|
15 Participants
n=6 Participants
|
9 Participants
n=6 Participants
|
45 Participants
n=64 Participants
|
|
Age, Customized
10
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
3 Participants
n=10 Participants
|
6 Participants
n=115 Participants
|
13 Participants
n=6 Participants
|
8 Participants
n=6 Participants
|
33 Participants
n=64 Participants
|
|
Age, Customized
18-20
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
5 Participants
n=64 Participants
|
|
Age, Customized
21-30
|
0 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
5 Participants
n=64 Participants
|
|
Age, Customized
31-40
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
4 Participants
n=64 Participants
|
|
Age, Customized
41-50
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
4 Participants
n=64 Participants
|
|
Age, Customized
51-55
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=64 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
8 Participants
n=10 Participants
|
31 Participants
n=115 Participants
|
33 Participants
n=6 Participants
|
36 Participants
n=6 Participants
|
129 Participants
n=64 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
10 Participants
n=10 Participants
|
44 Participants
n=115 Participants
|
42 Participants
n=6 Participants
|
39 Participants
n=6 Participants
|
150 Participants
n=64 Participants
|
|
Race/Ethnicity, Customized
African
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
9 Participants
n=21 Participants
|
18 Participants
n=10 Participants
|
75 Participants
n=115 Participants
|
75 Participants
n=6 Participants
|
75 Participants
n=6 Participants
|
279 Participants
n=64 Participants
|
|
Region of Enrollment
Mali
|
6 participants
n=5 Participants
|
6 participants
n=7 Participants
|
6 participants
n=5 Participants
|
9 participants
n=4 Participants
|
9 participants
n=21 Participants
|
18 participants
n=10 Participants
|
75 participants
n=115 Participants
|
75 participants
n=6 Participants
|
75 participants
n=6 Participants
|
279 participants
n=64 Participants
|
PRIMARY outcome
Timeframe: Within 7 days after administration of L9LSPopulation: Modified intention-to-treat (MITT) - Analysis include all randomized subjects that received the study intervention.
Number of participants with local adverse events occurring within 7 days after administration of L9LS. Local reactogenicity included pain/tenderness, swelling, redness, bruising, and pruritus at the site of infusion. Adverse events were captured by Investigator examination and history from participants.
Outcome measures
| Measure |
Pediatric Efficacy Study: Arm 1: 150 mg of L9LS
n=6 Participants
Pediatric subjects age 6-10 receive 150 mg of L9LS subcutaneously.
L9LS (VRC-MALMAB0114-00-AB): Administered one time via subcutaneous route.
|
Pediatric Efficacy Study: Arm 2: 300 mg of L9LS
n=6 Participants
Pediatric subjects age 6-10 receive 300 mg of L9LS subcutaneously.
L9LS (VRC-MALMAB0114-00-AB): Administered one time via subcutaneous route.
|
Pediatric Efficacy Study: Arm 3: Placebo
n=6 Participants
Pediatric subjects age 6-10 receive placebo of normal saline subcutaneously.
Normal saline: Administered one time via subcutaneous administration.
|
Pediatric Dose-escalation Study: Arm 1: 150 mg of L9LS
n=9 Participants
Pediatric subjects age 6-10 years receive 150 mg of L9LS subcutaneously. Once subjects reach day 7 post-administration without safety concerns, dosing begins for arm 2.
L9LS (VRC-MALMAB0114-00-AB): Administered one time via subcutaneous route.
|
Pediatric Dose-escalation Study: Arm 2: 300 mg of L9LS
n=9 Participants
Pediatric subjects age 6-10 years receive 300 mg of L9LS subcutaneously. Once subjects reach day 7 post-administration without safety concerns, dosing begins for the pediatric efficacy study arms.
L9LS (VRC-MALMAB0114-00-AB): Administered one time via subcutaneous route.
|
Pediatric Dose-escalation Study: Arm 3: Placebo
n=18 Participants
Pediatric subjects age 6-10 receive placebo of normal saline subcutaneously.
Normal saline: Administered one time via subcutaneous administration.
|
Pediatric Efficacy Study: Arm 1: 150 mg of L9LS
n=75 Participants
Pediatric subjects age 6-10 receive 150 mg of L9LS subcutaneously.
L9LS (VRC-MALMAB0114-00-AB): Administered one time via subcutaneous route.
|
Pediatric Efficacy Study: Arm 2: 300 mg of L9LS
n=75 Participants
Pediatric subjects age 6-10 receive 300 mg of L9LS subcutaneously.
L9LS (VRC-MALMAB0114-00-AB): Administered one time via subcutaneous route.
|
Pediatric Efficacy Study: Arm 3: Placebo
n=75 Participants
Pediatric subjects age 6-10 receive placebo of normal saline subcutaneously.
Normal saline: Administered one time via subcutaneous administration.
|
|---|---|---|---|---|---|---|---|---|---|
|
Participants With Local Adverse Events (AEs) - Year One
Injection site swelling
|
3 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
3 Participants
|
0 Participants
|
|
Participants With Local Adverse Events (AEs) - Year One
Pain at Injection site
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Participants With Local Adverse Events (AEs) - Year One
Tenderness at injection site
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Participants With Local Adverse Events (AEs) - Year One
Redness at injection site
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Participants With Local Adverse Events (AEs) - Year One
Bruising at injection site
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Participants With Local Adverse Events (AEs) - Year One
Pruritus at injection site
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: Within 7 days after administration of L9LSPopulation: Modified intention-to-treat (MITT) - Analysis include all randomized subjects that received the study intervention.
The severity of local AEs was graded using the Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Clinical Trials. Grade 1: Pain = does not interfere with activity; Tenderness = mild discomfort to touch; Erythema/Redness = 2.5-5 cm; Induration/Swelling = 2.5-5 cm and does not interfere with activity. Grade 2: Pain = Repeated use of non-narcotic pain reliever \> 24 hours or interferes with daily activity; Tenderness= Discomfort with movement; Erythema/Redness = 5.1-10 cm; Induration/Swelling = 5.1-10 cm and interferes with activity. Grade 3: Pain = Any use of narcotic pain reliever or prevents daily activity; Tenderness = Significant discomfort at rest; Erythema/Redness = \> 10 cm; Induration/Swelling = \> 10 cm or prevents daily activity. Grade 4: Pain = Emergency room (ER) visit or hospitalization; Tenderness = ER visit or hospitalization; Erythema/Redness = Necrosis or exfoliative dermatitis; induration/Swelling = Necrosis Grade 5: Death
Outcome measures
| Measure |
Pediatric Efficacy Study: Arm 1: 150 mg of L9LS
n=6 Participants
Pediatric subjects age 6-10 receive 150 mg of L9LS subcutaneously.
L9LS (VRC-MALMAB0114-00-AB): Administered one time via subcutaneous route.
|
Pediatric Efficacy Study: Arm 2: 300 mg of L9LS
n=6 Participants
Pediatric subjects age 6-10 receive 300 mg of L9LS subcutaneously.
L9LS (VRC-MALMAB0114-00-AB): Administered one time via subcutaneous route.
|
Pediatric Efficacy Study: Arm 3: Placebo
n=6 Participants
Pediatric subjects age 6-10 receive placebo of normal saline subcutaneously.
Normal saline: Administered one time via subcutaneous administration.
|
Pediatric Dose-escalation Study: Arm 1: 150 mg of L9LS
n=9 Participants
Pediatric subjects age 6-10 years receive 150 mg of L9LS subcutaneously. Once subjects reach day 7 post-administration without safety concerns, dosing begins for arm 2.
L9LS (VRC-MALMAB0114-00-AB): Administered one time via subcutaneous route.
|
Pediatric Dose-escalation Study: Arm 2: 300 mg of L9LS
n=9 Participants
Pediatric subjects age 6-10 years receive 300 mg of L9LS subcutaneously. Once subjects reach day 7 post-administration without safety concerns, dosing begins for the pediatric efficacy study arms.
L9LS (VRC-MALMAB0114-00-AB): Administered one time via subcutaneous route.
|
Pediatric Dose-escalation Study: Arm 3: Placebo
n=18 Participants
Pediatric subjects age 6-10 receive placebo of normal saline subcutaneously.
Normal saline: Administered one time via subcutaneous administration.
|
Pediatric Efficacy Study: Arm 1: 150 mg of L9LS
n=75 Participants
Pediatric subjects age 6-10 receive 150 mg of L9LS subcutaneously.
L9LS (VRC-MALMAB0114-00-AB): Administered one time via subcutaneous route.
|
Pediatric Efficacy Study: Arm 2: 300 mg of L9LS
n=75 Participants
Pediatric subjects age 6-10 receive 300 mg of L9LS subcutaneously.
L9LS (VRC-MALMAB0114-00-AB): Administered one time via subcutaneous route.
|
Pediatric Efficacy Study: Arm 3: Placebo
n=75 Participants
Pediatric subjects age 6-10 receive placebo of normal saline subcutaneously.
Normal saline: Administered one time via subcutaneous administration.
|
|---|---|---|---|---|---|---|---|---|---|
|
Severity of Local Adverse Events (AEs) - Year One
Grade 5
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Severity of Local Adverse Events (AEs) - Year One
Grade 1
|
3 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
3 Participants
|
2 Participants
|
|
Severity of Local Adverse Events (AEs) - Year One
Grade 2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Severity of Local Adverse Events (AEs) - Year One
Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Severity of Local Adverse Events (AEs) - Year One
Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Within 7 days after the administration of L9LSPopulation: Modified intention-to-treat (MITT) - Analysis include all randomized subjects that received the study intervention.
Number of participants with local adverse events occurring within 7 days after administration of L9LS. Systemic reactogenicity events included fever, feeling unusually tired or unwell, muscle aches, headache, chills, nausea, and joint pain. Adverse events were captured by Investigator examination and history from participants.
Outcome measures
| Measure |
Pediatric Efficacy Study: Arm 1: 150 mg of L9LS
n=6 Participants
Pediatric subjects age 6-10 receive 150 mg of L9LS subcutaneously.
L9LS (VRC-MALMAB0114-00-AB): Administered one time via subcutaneous route.
|
Pediatric Efficacy Study: Arm 2: 300 mg of L9LS
n=6 Participants
Pediatric subjects age 6-10 receive 300 mg of L9LS subcutaneously.
L9LS (VRC-MALMAB0114-00-AB): Administered one time via subcutaneous route.
|
Pediatric Efficacy Study: Arm 3: Placebo
n=6 Participants
Pediatric subjects age 6-10 receive placebo of normal saline subcutaneously.
Normal saline: Administered one time via subcutaneous administration.
|
Pediatric Dose-escalation Study: Arm 1: 150 mg of L9LS
n=9 Participants
Pediatric subjects age 6-10 years receive 150 mg of L9LS subcutaneously. Once subjects reach day 7 post-administration without safety concerns, dosing begins for arm 2.
L9LS (VRC-MALMAB0114-00-AB): Administered one time via subcutaneous route.
|
Pediatric Dose-escalation Study: Arm 2: 300 mg of L9LS
n=9 Participants
Pediatric subjects age 6-10 years receive 300 mg of L9LS subcutaneously. Once subjects reach day 7 post-administration without safety concerns, dosing begins for the pediatric efficacy study arms.
L9LS (VRC-MALMAB0114-00-AB): Administered one time via subcutaneous route.
|
Pediatric Dose-escalation Study: Arm 3: Placebo
n=18 Participants
Pediatric subjects age 6-10 receive placebo of normal saline subcutaneously.
Normal saline: Administered one time via subcutaneous administration.
|
Pediatric Efficacy Study: Arm 1: 150 mg of L9LS
n=75 Participants
Pediatric subjects age 6-10 receive 150 mg of L9LS subcutaneously.
L9LS (VRC-MALMAB0114-00-AB): Administered one time via subcutaneous route.
|
Pediatric Efficacy Study: Arm 2: 300 mg of L9LS
n=75 Participants
Pediatric subjects age 6-10 receive 300 mg of L9LS subcutaneously.
L9LS (VRC-MALMAB0114-00-AB): Administered one time via subcutaneous route.
|
Pediatric Efficacy Study: Arm 3: Placebo
n=75 Participants
Pediatric subjects age 6-10 receive placebo of normal saline subcutaneously.
Normal saline: Administered one time via subcutaneous administration.
|
|---|---|---|---|---|---|---|---|---|---|
|
Participants With Systemic Adverse Events (AEs) - Year One
Muscle aches
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Participants With Systemic Adverse Events (AEs) - Year One
Chills
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Participants With Systemic Adverse Events (AEs) - Year One
Nausea
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Participants With Systemic Adverse Events (AEs) - Year One
Joint pain
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Participants With Systemic Adverse Events (AEs) - Year One
Fever
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
3 Participants
|
0 Participants
|
1 Participants
|
|
Participants With Systemic Adverse Events (AEs) - Year One
Feeling unusually tired or unwell
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Participants With Systemic Adverse Events (AEs) - Year One
Headache
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: Within 7 days after the administration of L9LSPopulation: Modified intention-to-treat (MITT) - Analysis include all randomized subjects that received the study intervention.
The severity of systemic AEs occurring after the administration of L9LS was assessed using the grading scale below: Grade 1: Fever = 37.5\^oC-37.9\^oC; Fatigue, Headache, Myalgia = No interference with activity; Nausea = no interference with activity or 1-2 episodes/hour Grade 2: Fever = 38\^oC-38.4\^oC; Fatigue, Myalgia = Some interference with activity; Headache = Repeated use of non-narcotic pain reliever \> 24 hours or some interference with activity; Nausea = Some interference with activity or \> 2 episodes/24 hours Grade 3: Fever = 38.5\^oC-39.5\^oC; Fatigue = Prevents daily activity; Headache =Significant; any use of narcotic pain reliever or prevents daily activity; Myalgia =Significant; prevents daily activity; Nausea = Prevents daily activity, requires outpatient intravenous hydration Grade 4: Fever = \> 39.5\^oC; Fatigue, Headache, Myalgia = Emergency room (ER) visit or hospitalization; Nausea = ER visit or hospitalization for hypotensive shock Grade 5: Death
Outcome measures
| Measure |
Pediatric Efficacy Study: Arm 1: 150 mg of L9LS
n=6 Participants
Pediatric subjects age 6-10 receive 150 mg of L9LS subcutaneously.
L9LS (VRC-MALMAB0114-00-AB): Administered one time via subcutaneous route.
|
Pediatric Efficacy Study: Arm 2: 300 mg of L9LS
n=6 Participants
Pediatric subjects age 6-10 receive 300 mg of L9LS subcutaneously.
L9LS (VRC-MALMAB0114-00-AB): Administered one time via subcutaneous route.
|
Pediatric Efficacy Study: Arm 3: Placebo
n=6 Participants
Pediatric subjects age 6-10 receive placebo of normal saline subcutaneously.
Normal saline: Administered one time via subcutaneous administration.
|
Pediatric Dose-escalation Study: Arm 1: 150 mg of L9LS
n=9 Participants
Pediatric subjects age 6-10 years receive 150 mg of L9LS subcutaneously. Once subjects reach day 7 post-administration without safety concerns, dosing begins for arm 2.
L9LS (VRC-MALMAB0114-00-AB): Administered one time via subcutaneous route.
|
Pediatric Dose-escalation Study: Arm 2: 300 mg of L9LS
n=9 Participants
Pediatric subjects age 6-10 years receive 300 mg of L9LS subcutaneously. Once subjects reach day 7 post-administration without safety concerns, dosing begins for the pediatric efficacy study arms.
L9LS (VRC-MALMAB0114-00-AB): Administered one time via subcutaneous route.
|
Pediatric Dose-escalation Study: Arm 3: Placebo
n=18 Participants
Pediatric subjects age 6-10 receive placebo of normal saline subcutaneously.
Normal saline: Administered one time via subcutaneous administration.
|
Pediatric Efficacy Study: Arm 1: 150 mg of L9LS
n=75 Participants
Pediatric subjects age 6-10 receive 150 mg of L9LS subcutaneously.
L9LS (VRC-MALMAB0114-00-AB): Administered one time via subcutaneous route.
|
Pediatric Efficacy Study: Arm 2: 300 mg of L9LS
n=75 Participants
Pediatric subjects age 6-10 receive 300 mg of L9LS subcutaneously.
L9LS (VRC-MALMAB0114-00-AB): Administered one time via subcutaneous route.
|
Pediatric Efficacy Study: Arm 3: Placebo
n=75 Participants
Pediatric subjects age 6-10 receive placebo of normal saline subcutaneously.
Normal saline: Administered one time via subcutaneous administration.
|
|---|---|---|---|---|---|---|---|---|---|
|
Severity of Systemic Adverse Events (AEs) - Year One
Grade 1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
|
Severity of Systemic Adverse Events (AEs) - Year One
Grade 2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
4 Participants
|
1 Participants
|
0 Participants
|
|
Severity of Systemic Adverse Events (AEs) - Year One
Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Severity of Systemic Adverse Events (AEs) - Year One
Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Severity of Systemic Adverse Events (AEs) - Year One
Grade 5
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Day 7 through week 28Population: Modified intention-to-treat (MITT) - Analysis include all randomized subjects that received the study intervention during the efficacy study.
Number of participants with Plasmodium falciparum (Pf) blood stage infection defined as blood smear-positive for Pf was assessed by microscopic examination of thick blood smear collected from participants from day 14 through week 28 (196 days) after administration of L9LS or placebo. Analysis was done as number of participants who had at least one positive blood smear.
Outcome measures
| Measure |
Pediatric Efficacy Study: Arm 1: 150 mg of L9LS
n=75 Participants
Pediatric subjects age 6-10 receive 150 mg of L9LS subcutaneously.
L9LS (VRC-MALMAB0114-00-AB): Administered one time via subcutaneous route.
|
Pediatric Efficacy Study: Arm 2: 300 mg of L9LS
n=75 Participants
Pediatric subjects age 6-10 receive 300 mg of L9LS subcutaneously.
L9LS (VRC-MALMAB0114-00-AB): Administered one time via subcutaneous route.
|
Pediatric Efficacy Study: Arm 3: Placebo
n=75 Participants
Pediatric subjects age 6-10 receive placebo of normal saline subcutaneously.
Normal saline: Administered one time via subcutaneous administration.
|
Pediatric Dose-escalation Study: Arm 1: 150 mg of L9LS
Pediatric subjects age 6-10 years receive 150 mg of L9LS subcutaneously. Once subjects reach day 7 post-administration without safety concerns, dosing begins for arm 2.
L9LS (VRC-MALMAB0114-00-AB): Administered one time via subcutaneous route.
|
Pediatric Dose-escalation Study: Arm 2: 300 mg of L9LS
Pediatric subjects age 6-10 years receive 300 mg of L9LS subcutaneously. Once subjects reach day 7 post-administration without safety concerns, dosing begins for the pediatric efficacy study arms.
L9LS (VRC-MALMAB0114-00-AB): Administered one time via subcutaneous route.
|
Pediatric Dose-escalation Study: Arm 3: Placebo
Pediatric subjects age 6-10 receive placebo of normal saline subcutaneously.
Normal saline: Administered one time via subcutaneous administration.
|
Pediatric Efficacy Study: Arm 1: 150 mg of L9LS
Pediatric subjects age 6-10 receive 150 mg of L9LS subcutaneously.
L9LS (VRC-MALMAB0114-00-AB): Administered one time via subcutaneous route.
|
Pediatric Efficacy Study: Arm 2: 300 mg of L9LS
Pediatric subjects age 6-10 receive 300 mg of L9LS subcutaneously.
L9LS (VRC-MALMAB0114-00-AB): Administered one time via subcutaneous route.
|
Pediatric Efficacy Study: Arm 3: Placebo
Pediatric subjects age 6-10 receive placebo of normal saline subcutaneously.
Normal saline: Administered one time via subcutaneous administration.
|
|---|---|---|---|---|---|---|---|---|---|
|
Participants With Plasmodium Falciparum (Pf) Infection Detected by Microscopic Examination - Efficacy Study
|
36 Participants
|
30 Participants
|
61 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Measured through week 36Population: Modified intention-to-treat (MITT) - Analysis include all randomized subjects that received the study intervention in the extension study.
Number of participants with detectable anti-drug antibody (ADA) in sera after exposure to L9LS. Serum was collected from participants at specific timepoints throughout the study, on days 0, 7, 28, 84, 168, and 196. The tier 3 assay was used to directly measure ADA's ability to impair L9LS binding to Plasmodium falciparum circumsporozoite protein (PfCSP). Analysis was done to determine number of participants with positive or detectable ADA in sera.
Outcome measures
| Measure |
Pediatric Efficacy Study: Arm 1: 150 mg of L9LS
n=79 Participants
Pediatric subjects age 6-10 receive 150 mg of L9LS subcutaneously.
L9LS (VRC-MALMAB0114-00-AB): Administered one time via subcutaneous route.
|
Pediatric Efficacy Study: Arm 2: 300 mg of L9LS
n=38 Participants
Pediatric subjects age 6-10 receive 300 mg of L9LS subcutaneously.
L9LS (VRC-MALMAB0114-00-AB): Administered one time via subcutaneous route.
|
Pediatric Efficacy Study: Arm 3: Placebo
n=118 Participants
Pediatric subjects age 6-10 receive placebo of normal saline subcutaneously.
Normal saline: Administered one time via subcutaneous administration.
|
Pediatric Dose-escalation Study: Arm 1: 150 mg of L9LS
Pediatric subjects age 6-10 years receive 150 mg of L9LS subcutaneously. Once subjects reach day 7 post-administration without safety concerns, dosing begins for arm 2.
L9LS (VRC-MALMAB0114-00-AB): Administered one time via subcutaneous route.
|
Pediatric Dose-escalation Study: Arm 2: 300 mg of L9LS
Pediatric subjects age 6-10 years receive 300 mg of L9LS subcutaneously. Once subjects reach day 7 post-administration without safety concerns, dosing begins for the pediatric efficacy study arms.
L9LS (VRC-MALMAB0114-00-AB): Administered one time via subcutaneous route.
|
Pediatric Dose-escalation Study: Arm 3: Placebo
Pediatric subjects age 6-10 receive placebo of normal saline subcutaneously.
Normal saline: Administered one time via subcutaneous administration.
|
Pediatric Efficacy Study: Arm 1: 150 mg of L9LS
Pediatric subjects age 6-10 receive 150 mg of L9LS subcutaneously.
L9LS (VRC-MALMAB0114-00-AB): Administered one time via subcutaneous route.
|
Pediatric Efficacy Study: Arm 2: 300 mg of L9LS
Pediatric subjects age 6-10 receive 300 mg of L9LS subcutaneously.
L9LS (VRC-MALMAB0114-00-AB): Administered one time via subcutaneous route.
|
Pediatric Efficacy Study: Arm 3: Placebo
Pediatric subjects age 6-10 receive placebo of normal saline subcutaneously.
Normal saline: Administered one time via subcutaneous administration.
|
|---|---|---|---|---|---|---|---|---|---|
|
Participants With Detectable Anti-drug Antibody (ADA) in Sera - Extension Study
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Measured through Week 36Population: Modified intention-to-treat (MITT) - Analysis include all randomized subjects that received the L9LS intervention during the extension study.
Maximum total plasma concentration (Cmax) following a dose of 150 mg or 300 mg L9LS. Serum collected on days 0, 7, 28, 84, 140, 196, \& 252 after the administration of L9LS. Cmax for L9LS was obtained directly by visual inspection of the plasma concentration versus time profiles post dose. Analysis was done to determine each participant's observed maximum concentration based on all available timepoints and cumulative output was calculated as the central tendency and dispersion metric based on the observed maximum concentrations.
Outcome measures
| Measure |
Pediatric Efficacy Study: Arm 1: 150 mg of L9LS
n=79 Participants
Pediatric subjects age 6-10 receive 150 mg of L9LS subcutaneously.
L9LS (VRC-MALMAB0114-00-AB): Administered one time via subcutaneous route.
|
Pediatric Efficacy Study: Arm 2: 300 mg of L9LS
n=38 Participants
Pediatric subjects age 6-10 receive 300 mg of L9LS subcutaneously.
L9LS (VRC-MALMAB0114-00-AB): Administered one time via subcutaneous route.
|
Pediatric Efficacy Study: Arm 3: Placebo
Pediatric subjects age 6-10 receive placebo of normal saline subcutaneously.
Normal saline: Administered one time via subcutaneous administration.
|
Pediatric Dose-escalation Study: Arm 1: 150 mg of L9LS
Pediatric subjects age 6-10 years receive 150 mg of L9LS subcutaneously. Once subjects reach day 7 post-administration without safety concerns, dosing begins for arm 2.
L9LS (VRC-MALMAB0114-00-AB): Administered one time via subcutaneous route.
|
Pediatric Dose-escalation Study: Arm 2: 300 mg of L9LS
Pediatric subjects age 6-10 years receive 300 mg of L9LS subcutaneously. Once subjects reach day 7 post-administration without safety concerns, dosing begins for the pediatric efficacy study arms.
L9LS (VRC-MALMAB0114-00-AB): Administered one time via subcutaneous route.
|
Pediatric Dose-escalation Study: Arm 3: Placebo
Pediatric subjects age 6-10 receive placebo of normal saline subcutaneously.
Normal saline: Administered one time via subcutaneous administration.
|
Pediatric Efficacy Study: Arm 1: 150 mg of L9LS
Pediatric subjects age 6-10 receive 150 mg of L9LS subcutaneously.
L9LS (VRC-MALMAB0114-00-AB): Administered one time via subcutaneous route.
|
Pediatric Efficacy Study: Arm 2: 300 mg of L9LS
Pediatric subjects age 6-10 receive 300 mg of L9LS subcutaneously.
L9LS (VRC-MALMAB0114-00-AB): Administered one time via subcutaneous route.
|
Pediatric Efficacy Study: Arm 3: Placebo
Pediatric subjects age 6-10 receive placebo of normal saline subcutaneously.
Normal saline: Administered one time via subcutaneous administration.
|
|---|---|---|---|---|---|---|---|---|---|
|
Maximum Total Plasma Concentration (Cmax) for L9LS - Extension Study
|
64.63 ug/mL
Standard Deviation 17.36
|
116.93 ug/mL
Standard Deviation 24.78
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Measured through Week 36Population: Modified intention-to-treat (MITT) - Analysis include all randomized subjects that received the L9LS intervention during the extension study.
Time to maximum total plasma concentration (Cmax) following a dose of 150 mg or 300 mg L9LS. Serum collected on days 0, 7, 28, 84, 140, 196, \& 252 after the administration of L9LS. Tmax for L9LS was obtained directly by visual inspection of the plasma concentration versus time profiles. Analysis was done to determine the time (in days) at which the maximum observed concentration was achieved for each participant and cumulative output was calculated as the central tendency and dispersion metric based on the observed time of maximum concentration.
Outcome measures
| Measure |
Pediatric Efficacy Study: Arm 1: 150 mg of L9LS
n=79 Participants
Pediatric subjects age 6-10 receive 150 mg of L9LS subcutaneously.
L9LS (VRC-MALMAB0114-00-AB): Administered one time via subcutaneous route.
|
Pediatric Efficacy Study: Arm 2: 300 mg of L9LS
n=38 Participants
Pediatric subjects age 6-10 receive 300 mg of L9LS subcutaneously.
L9LS (VRC-MALMAB0114-00-AB): Administered one time via subcutaneous route.
|
Pediatric Efficacy Study: Arm 3: Placebo
Pediatric subjects age 6-10 receive placebo of normal saline subcutaneously.
Normal saline: Administered one time via subcutaneous administration.
|
Pediatric Dose-escalation Study: Arm 1: 150 mg of L9LS
Pediatric subjects age 6-10 years receive 150 mg of L9LS subcutaneously. Once subjects reach day 7 post-administration without safety concerns, dosing begins for arm 2.
L9LS (VRC-MALMAB0114-00-AB): Administered one time via subcutaneous route.
|
Pediatric Dose-escalation Study: Arm 2: 300 mg of L9LS
Pediatric subjects age 6-10 years receive 300 mg of L9LS subcutaneously. Once subjects reach day 7 post-administration without safety concerns, dosing begins for the pediatric efficacy study arms.
L9LS (VRC-MALMAB0114-00-AB): Administered one time via subcutaneous route.
|
Pediatric Dose-escalation Study: Arm 3: Placebo
Pediatric subjects age 6-10 receive placebo of normal saline subcutaneously.
Normal saline: Administered one time via subcutaneous administration.
|
Pediatric Efficacy Study: Arm 1: 150 mg of L9LS
Pediatric subjects age 6-10 receive 150 mg of L9LS subcutaneously.
L9LS (VRC-MALMAB0114-00-AB): Administered one time via subcutaneous route.
|
Pediatric Efficacy Study: Arm 2: 300 mg of L9LS
Pediatric subjects age 6-10 receive 300 mg of L9LS subcutaneously.
L9LS (VRC-MALMAB0114-00-AB): Administered one time via subcutaneous route.
|
Pediatric Efficacy Study: Arm 3: Placebo
Pediatric subjects age 6-10 receive placebo of normal saline subcutaneously.
Normal saline: Administered one time via subcutaneous administration.
|
|---|---|---|---|---|---|---|---|---|---|
|
Time to Maximum Plasma Concentration (TMax) for L9LS - Extension Study
|
7.00 Days
Standard Deviation 0.16
|
7.58 Days
Standard Deviation 3.41
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Within 7 days after administration of L9LSPopulation: Modified intention-to-treat (MITT) - Analysis include all randomized subjects that received the study intervention.
Number of participants with local adverse events occurring within 7 days after administration of L9LS. Local reactogenicity included pain/tenderness, swelling, redness, bruising, and pruritus at the site of infusion. Adverse events were captured by Investigator examination and history from participants.
Outcome measures
| Measure |
Pediatric Efficacy Study: Arm 1: 150 mg of L9LS
n=79 Participants
Pediatric subjects age 6-10 receive 150 mg of L9LS subcutaneously.
L9LS (VRC-MALMAB0114-00-AB): Administered one time via subcutaneous route.
|
Pediatric Efficacy Study: Arm 2: 300 mg of L9LS
n=38 Participants
Pediatric subjects age 6-10 receive 300 mg of L9LS subcutaneously.
L9LS (VRC-MALMAB0114-00-AB): Administered one time via subcutaneous route.
|
Pediatric Efficacy Study: Arm 3: Placebo
n=118 Participants
Pediatric subjects age 6-10 receive placebo of normal saline subcutaneously.
Normal saline: Administered one time via subcutaneous administration.
|
Pediatric Dose-escalation Study: Arm 1: 150 mg of L9LS
Pediatric subjects age 6-10 years receive 150 mg of L9LS subcutaneously. Once subjects reach day 7 post-administration without safety concerns, dosing begins for arm 2.
L9LS (VRC-MALMAB0114-00-AB): Administered one time via subcutaneous route.
|
Pediatric Dose-escalation Study: Arm 2: 300 mg of L9LS
Pediatric subjects age 6-10 years receive 300 mg of L9LS subcutaneously. Once subjects reach day 7 post-administration without safety concerns, dosing begins for the pediatric efficacy study arms.
L9LS (VRC-MALMAB0114-00-AB): Administered one time via subcutaneous route.
|
Pediatric Dose-escalation Study: Arm 3: Placebo
Pediatric subjects age 6-10 receive placebo of normal saline subcutaneously.
Normal saline: Administered one time via subcutaneous administration.
|
Pediatric Efficacy Study: Arm 1: 150 mg of L9LS
Pediatric subjects age 6-10 receive 150 mg of L9LS subcutaneously.
L9LS (VRC-MALMAB0114-00-AB): Administered one time via subcutaneous route.
|
Pediatric Efficacy Study: Arm 2: 300 mg of L9LS
Pediatric subjects age 6-10 receive 300 mg of L9LS subcutaneously.
L9LS (VRC-MALMAB0114-00-AB): Administered one time via subcutaneous route.
|
Pediatric Efficacy Study: Arm 3: Placebo
Pediatric subjects age 6-10 receive placebo of normal saline subcutaneously.
Normal saline: Administered one time via subcutaneous administration.
|
|---|---|---|---|---|---|---|---|---|---|
|
Participants With Local Adverse Events (AEs) - Extension Study
Redness at injection site
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Participants With Local Adverse Events (AEs) - Extension Study
Bruising at injection site
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Participants With Local Adverse Events (AEs) - Extension Study
Pruritus at injection site
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Participants With Local Adverse Events (AEs) - Extension Study
Injection site swelling
|
1 Participants
|
2 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Participants With Local Adverse Events (AEs) - Extension Study
Pain at Injection site
|
0 Participants
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Participants With Local Adverse Events (AEs) - Extension Study
Tenderness at injection site
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Within 7 days after administration of L9LSPopulation: Modified intention-to-treat (MITT) - Analysis include all randomized subjects that received the study intervention.
The severity of local AEs was graded using the Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Clinical Trials. Grade 1: Pain = does not interfere with activity; Tenderness = mild discomfort to touch; Erythema/Redness = 2.5-5 cm; Induration/Swelling = 2.5-5 cm and does not interfere with activity. Grade 2: Pain = Repeated use of non-narcotic pain reliever \> 24 hours or interferes with daily activity; Tenderness= Discomfort with movement; Erythema/Redness = 5.1-10 cm; Induration/Swelling = 5.1-10 cm and interferes with activity. Grade 3: Pain = Any use of narcotic pain reliever or prevents daily activity; Tenderness = Significant discomfort at rest; Erythema/Redness = \> 10 cm; Induration/Swelling = \> 10 cm or prevents daily activity. Grade 4: Pain = Emergency room (ER) visit or hospitalization; Tenderness = ER visit or hospitalization; Erythema/Redness = Necrosis or exfoliative dermatitis; induration/Swelling = Necrosis Grade 5: Death
Outcome measures
| Measure |
Pediatric Efficacy Study: Arm 1: 150 mg of L9LS
n=79 Participants
Pediatric subjects age 6-10 receive 150 mg of L9LS subcutaneously.
L9LS (VRC-MALMAB0114-00-AB): Administered one time via subcutaneous route.
|
Pediatric Efficacy Study: Arm 2: 300 mg of L9LS
n=38 Participants
Pediatric subjects age 6-10 receive 300 mg of L9LS subcutaneously.
L9LS (VRC-MALMAB0114-00-AB): Administered one time via subcutaneous route.
|
Pediatric Efficacy Study: Arm 3: Placebo
n=118 Participants
Pediatric subjects age 6-10 receive placebo of normal saline subcutaneously.
Normal saline: Administered one time via subcutaneous administration.
|
Pediatric Dose-escalation Study: Arm 1: 150 mg of L9LS
Pediatric subjects age 6-10 years receive 150 mg of L9LS subcutaneously. Once subjects reach day 7 post-administration without safety concerns, dosing begins for arm 2.
L9LS (VRC-MALMAB0114-00-AB): Administered one time via subcutaneous route.
|
Pediatric Dose-escalation Study: Arm 2: 300 mg of L9LS
Pediatric subjects age 6-10 years receive 300 mg of L9LS subcutaneously. Once subjects reach day 7 post-administration without safety concerns, dosing begins for the pediatric efficacy study arms.
L9LS (VRC-MALMAB0114-00-AB): Administered one time via subcutaneous route.
|
Pediatric Dose-escalation Study: Arm 3: Placebo
Pediatric subjects age 6-10 receive placebo of normal saline subcutaneously.
Normal saline: Administered one time via subcutaneous administration.
|
Pediatric Efficacy Study: Arm 1: 150 mg of L9LS
Pediatric subjects age 6-10 receive 150 mg of L9LS subcutaneously.
L9LS (VRC-MALMAB0114-00-AB): Administered one time via subcutaneous route.
|
Pediatric Efficacy Study: Arm 2: 300 mg of L9LS
Pediatric subjects age 6-10 receive 300 mg of L9LS subcutaneously.
L9LS (VRC-MALMAB0114-00-AB): Administered one time via subcutaneous route.
|
Pediatric Efficacy Study: Arm 3: Placebo
Pediatric subjects age 6-10 receive placebo of normal saline subcutaneously.
Normal saline: Administered one time via subcutaneous administration.
|
|---|---|---|---|---|---|---|---|---|---|
|
Severity of Local Adverse Events (AEs) - Extension Study
Grade 1
|
1 Participants
|
2 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Severity of Local Adverse Events (AEs) - Extension Study
Grade 2
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Severity of Local Adverse Events (AEs) - Extension Study
Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Severity of Local Adverse Events (AEs) - Extension Study
Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Severity of Local Adverse Events (AEs) - Extension Study
Grade 5
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Within 7 days after the administration of L9LSPopulation: Modified intention-to-treat (MITT) - Analysis include all randomized subjects that received the study intervention.
Number of participants with local adverse events occurring within 7 days after administration of L9LS. Systemic reactogenicity events included fever, feeling unusually tired or unwell, muscle aches, headache, chills, nausea, and joint pain. Adverse events were captured by Investigator examination and history from participants.
Outcome measures
| Measure |
Pediatric Efficacy Study: Arm 1: 150 mg of L9LS
n=79 Participants
Pediatric subjects age 6-10 receive 150 mg of L9LS subcutaneously.
L9LS (VRC-MALMAB0114-00-AB): Administered one time via subcutaneous route.
|
Pediatric Efficacy Study: Arm 2: 300 mg of L9LS
n=38 Participants
Pediatric subjects age 6-10 receive 300 mg of L9LS subcutaneously.
L9LS (VRC-MALMAB0114-00-AB): Administered one time via subcutaneous route.
|
Pediatric Efficacy Study: Arm 3: Placebo
n=118 Participants
Pediatric subjects age 6-10 receive placebo of normal saline subcutaneously.
Normal saline: Administered one time via subcutaneous administration.
|
Pediatric Dose-escalation Study: Arm 1: 150 mg of L9LS
Pediatric subjects age 6-10 years receive 150 mg of L9LS subcutaneously. Once subjects reach day 7 post-administration without safety concerns, dosing begins for arm 2.
L9LS (VRC-MALMAB0114-00-AB): Administered one time via subcutaneous route.
|
Pediatric Dose-escalation Study: Arm 2: 300 mg of L9LS
Pediatric subjects age 6-10 years receive 300 mg of L9LS subcutaneously. Once subjects reach day 7 post-administration without safety concerns, dosing begins for the pediatric efficacy study arms.
L9LS (VRC-MALMAB0114-00-AB): Administered one time via subcutaneous route.
|
Pediatric Dose-escalation Study: Arm 3: Placebo
Pediatric subjects age 6-10 receive placebo of normal saline subcutaneously.
Normal saline: Administered one time via subcutaneous administration.
|
Pediatric Efficacy Study: Arm 1: 150 mg of L9LS
Pediatric subjects age 6-10 receive 150 mg of L9LS subcutaneously.
L9LS (VRC-MALMAB0114-00-AB): Administered one time via subcutaneous route.
|
Pediatric Efficacy Study: Arm 2: 300 mg of L9LS
Pediatric subjects age 6-10 receive 300 mg of L9LS subcutaneously.
L9LS (VRC-MALMAB0114-00-AB): Administered one time via subcutaneous route.
|
Pediatric Efficacy Study: Arm 3: Placebo
Pediatric subjects age 6-10 receive placebo of normal saline subcutaneously.
Normal saline: Administered one time via subcutaneous administration.
|
|---|---|---|---|---|---|---|---|---|---|
|
Participants With Systemic Adverse Events (AEs) - Extension Study
Fever
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Participants With Systemic Adverse Events (AEs) - Extension Study
Feeling unusually tired or unwell
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Participants With Systemic Adverse Events (AEs) - Extension Study
Muscle aches
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Participants With Systemic Adverse Events (AEs) - Extension Study
Headache
|
1 Participants
|
1 Participants
|
4 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Participants With Systemic Adverse Events (AEs) - Extension Study
Chills
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Participants With Systemic Adverse Events (AEs) - Extension Study
Nausea
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Participants With Systemic Adverse Events (AEs) - Extension Study
Joint pain
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Within 7 days after the administration of L9LSPopulation: Modified intention-to-treat (MITT) - Analysis include all randomized subjects that received the study intervention.
The severity of systemic AEs occurring after the administration of L9LS was assessed using the grading scale below: Grade 1: Fever = 37.5\^oC-37.9\^oC; Fatigue, Headache, Myalgia = No interference with activity; Nausea = no interference with activity or 1-2 episodes/hour Grade 2: Fever = 38\^oC-38.4\^oC; Fatigue, Myalgia = Some interference with activity; Headache = Repeated use of non-narcotic pain reliever \> 24 hours or some interference with activity; Nausea = Some interference with activity or \> 2 episodes/24 hours Grade 3: Fever = 38.5\^oC-39.5\^oC; Fatigue = Prevents daily activity; Headache =Significant; any use of narcotic pain reliever or prevents daily activity; Myalgia =Significant; prevents daily activity; Nausea = Prevents daily activity, requires outpatient intravenous hydration Grade 4: Fever = \> 39.5\^oC; Fatigue, Headache, Myalgia = Emergency room (ER) visit or hospitalization; Nausea = ER visit or hospitalization for hypotensive shock Grade 5: Death
Outcome measures
| Measure |
Pediatric Efficacy Study: Arm 1: 150 mg of L9LS
n=79 Participants
Pediatric subjects age 6-10 receive 150 mg of L9LS subcutaneously.
L9LS (VRC-MALMAB0114-00-AB): Administered one time via subcutaneous route.
|
Pediatric Efficacy Study: Arm 2: 300 mg of L9LS
n=38 Participants
Pediatric subjects age 6-10 receive 300 mg of L9LS subcutaneously.
L9LS (VRC-MALMAB0114-00-AB): Administered one time via subcutaneous route.
|
Pediatric Efficacy Study: Arm 3: Placebo
n=118 Participants
Pediatric subjects age 6-10 receive placebo of normal saline subcutaneously.
Normal saline: Administered one time via subcutaneous administration.
|
Pediatric Dose-escalation Study: Arm 1: 150 mg of L9LS
Pediatric subjects age 6-10 years receive 150 mg of L9LS subcutaneously. Once subjects reach day 7 post-administration without safety concerns, dosing begins for arm 2.
L9LS (VRC-MALMAB0114-00-AB): Administered one time via subcutaneous route.
|
Pediatric Dose-escalation Study: Arm 2: 300 mg of L9LS
Pediatric subjects age 6-10 years receive 300 mg of L9LS subcutaneously. Once subjects reach day 7 post-administration without safety concerns, dosing begins for the pediatric efficacy study arms.
L9LS (VRC-MALMAB0114-00-AB): Administered one time via subcutaneous route.
|
Pediatric Dose-escalation Study: Arm 3: Placebo
Pediatric subjects age 6-10 receive placebo of normal saline subcutaneously.
Normal saline: Administered one time via subcutaneous administration.
|
Pediatric Efficacy Study: Arm 1: 150 mg of L9LS
Pediatric subjects age 6-10 receive 150 mg of L9LS subcutaneously.
L9LS (VRC-MALMAB0114-00-AB): Administered one time via subcutaneous route.
|
Pediatric Efficacy Study: Arm 2: 300 mg of L9LS
Pediatric subjects age 6-10 receive 300 mg of L9LS subcutaneously.
L9LS (VRC-MALMAB0114-00-AB): Administered one time via subcutaneous route.
|
Pediatric Efficacy Study: Arm 3: Placebo
Pediatric subjects age 6-10 receive placebo of normal saline subcutaneously.
Normal saline: Administered one time via subcutaneous administration.
|
|---|---|---|---|---|---|---|---|---|---|
|
Severity of Systemic Adverse Events (AEs) - Extension Study
Grade 1
|
0 Participants
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Severity of Systemic Adverse Events (AEs) - Extension Study
Grade 2
|
1 Participants
|
1 Participants
|
3 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Severity of Systemic Adverse Events (AEs) - Extension Study
Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Severity of Systemic Adverse Events (AEs) - Extension Study
Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Severity of Systemic Adverse Events (AEs) - Extension Study
Grade 5
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Measured through week 24 (dose escalation study) and week 28 (efficacy study)Population: Modified intention-to-treat (MITT) - Analysis include all randomized pediatric subjects that received intervention during year one of the study.
Number of participants with Plasmodium falciparum (Pf) blood stage infection defined as blood sample positive for Pf was assessed by real-time polymerase chain reaction (RT-PCR) of blood sample collected from participants from day 0 through week 28 (196 days) after administration of L9LS or placebo. Analysis was done as number of participants who had at least one positive blood sample.
Outcome measures
| Measure |
Pediatric Efficacy Study: Arm 1: 150 mg of L9LS
n=9 Participants
Pediatric subjects age 6-10 receive 150 mg of L9LS subcutaneously.
L9LS (VRC-MALMAB0114-00-AB): Administered one time via subcutaneous route.
|
Pediatric Efficacy Study: Arm 2: 300 mg of L9LS
n=9 Participants
Pediatric subjects age 6-10 receive 300 mg of L9LS subcutaneously.
L9LS (VRC-MALMAB0114-00-AB): Administered one time via subcutaneous route.
|
Pediatric Efficacy Study: Arm 3: Placebo
n=18 Participants
Pediatric subjects age 6-10 receive placebo of normal saline subcutaneously.
Normal saline: Administered one time via subcutaneous administration.
|
Pediatric Dose-escalation Study: Arm 1: 150 mg of L9LS
n=75 Participants
Pediatric subjects age 6-10 years receive 150 mg of L9LS subcutaneously. Once subjects reach day 7 post-administration without safety concerns, dosing begins for arm 2.
L9LS (VRC-MALMAB0114-00-AB): Administered one time via subcutaneous route.
|
Pediatric Dose-escalation Study: Arm 2: 300 mg of L9LS
n=75 Participants
Pediatric subjects age 6-10 years receive 300 mg of L9LS subcutaneously. Once subjects reach day 7 post-administration without safety concerns, dosing begins for the pediatric efficacy study arms.
L9LS (VRC-MALMAB0114-00-AB): Administered one time via subcutaneous route.
|
Pediatric Dose-escalation Study: Arm 3: Placebo
n=75 Participants
Pediatric subjects age 6-10 receive placebo of normal saline subcutaneously.
Normal saline: Administered one time via subcutaneous administration.
|
Pediatric Efficacy Study: Arm 1: 150 mg of L9LS
Pediatric subjects age 6-10 receive 150 mg of L9LS subcutaneously.
L9LS (VRC-MALMAB0114-00-AB): Administered one time via subcutaneous route.
|
Pediatric Efficacy Study: Arm 2: 300 mg of L9LS
Pediatric subjects age 6-10 receive 300 mg of L9LS subcutaneously.
L9LS (VRC-MALMAB0114-00-AB): Administered one time via subcutaneous route.
|
Pediatric Efficacy Study: Arm 3: Placebo
Pediatric subjects age 6-10 receive placebo of normal saline subcutaneously.
Normal saline: Administered one time via subcutaneous administration.
|
|---|---|---|---|---|---|---|---|---|---|
|
Participants With Plasmodium Falciparum (Pf) Infection Detected by Real-Time Polymerase Chain Reaction (RT-PCR)
|
7 Participants
|
8 Participants
|
13 Participants
|
33 Participants
|
32 Participants
|
62 Participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Measured through Week 28Population: Modified intention-to-treat (MITT) - Analysis include all randomized subjects that received intervention during the pediatric dose escalation study.
Number of pediatric participants with clinical malaria during a single malaria season, defined by an illness accompanied by measured axillary fever ≥37.5°C, or history of fever (subjective or objective) in the previous 24 hours, and Plasmodium falciparum (Pf) asexual parasitemia \>5,000 parasites/μL as detected from microscopic examination of thick blood smear. Assessment was done from day 0 through week 28 (196 days) after administration of L9LS or placebo. Subjective data, objective data and blood sample were collected from administration of intervention through week 28. Analysis was done as number of participants who had at least one symptom and positive blood sample.
Outcome measures
| Measure |
Pediatric Efficacy Study: Arm 1: 150 mg of L9LS
n=9 Participants
Pediatric subjects age 6-10 receive 150 mg of L9LS subcutaneously.
L9LS (VRC-MALMAB0114-00-AB): Administered one time via subcutaneous route.
|
Pediatric Efficacy Study: Arm 2: 300 mg of L9LS
n=9 Participants
Pediatric subjects age 6-10 receive 300 mg of L9LS subcutaneously.
L9LS (VRC-MALMAB0114-00-AB): Administered one time via subcutaneous route.
|
Pediatric Efficacy Study: Arm 3: Placebo
n=18 Participants
Pediatric subjects age 6-10 receive placebo of normal saline subcutaneously.
Normal saline: Administered one time via subcutaneous administration.
|
Pediatric Dose-escalation Study: Arm 1: 150 mg of L9LS
Pediatric subjects age 6-10 years receive 150 mg of L9LS subcutaneously. Once subjects reach day 7 post-administration without safety concerns, dosing begins for arm 2.
L9LS (VRC-MALMAB0114-00-AB): Administered one time via subcutaneous route.
|
Pediatric Dose-escalation Study: Arm 2: 300 mg of L9LS
Pediatric subjects age 6-10 years receive 300 mg of L9LS subcutaneously. Once subjects reach day 7 post-administration without safety concerns, dosing begins for the pediatric efficacy study arms.
L9LS (VRC-MALMAB0114-00-AB): Administered one time via subcutaneous route.
|
Pediatric Dose-escalation Study: Arm 3: Placebo
Pediatric subjects age 6-10 receive placebo of normal saline subcutaneously.
Normal saline: Administered one time via subcutaneous administration.
|
Pediatric Efficacy Study: Arm 1: 150 mg of L9LS
Pediatric subjects age 6-10 receive 150 mg of L9LS subcutaneously.
L9LS (VRC-MALMAB0114-00-AB): Administered one time via subcutaneous route.
|
Pediatric Efficacy Study: Arm 2: 300 mg of L9LS
Pediatric subjects age 6-10 receive 300 mg of L9LS subcutaneously.
L9LS (VRC-MALMAB0114-00-AB): Administered one time via subcutaneous route.
|
Pediatric Efficacy Study: Arm 3: Placebo
Pediatric subjects age 6-10 receive placebo of normal saline subcutaneously.
Normal saline: Administered one time via subcutaneous administration.
|
|---|---|---|---|---|---|---|---|---|---|
|
Participants With Clinical Malaria - Pediatric Dose Escalation Study
|
6 Participants
|
4 Participants
|
11 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Measured through Week 28Population: Modified intention-to-treat (MITT) - Analysis include all randomized subjects that received the study intervention.
Number of pediatric participants with clinical malaria during a single malaria season, defined by an illness accompanied by measured axillary fever ≥37.5°C, or history of fever (subjective or objective) in the previous 24 hours, and Plasmodium falciparum (Pf) asexual parasitemia \>5,000 parasites/μL as detected from microscopic examination of thick blood smear. Assessment was done from day 0 through week 28 (196 days) after administration of L9LS or placebo. Subjective data, objective data and blood sample were collected from administration of intervention through week 28. Analysis was done as number of participants who had at least one symptom and positive blood sample.
Outcome measures
| Measure |
Pediatric Efficacy Study: Arm 1: 150 mg of L9LS
n=75 Participants
Pediatric subjects age 6-10 receive 150 mg of L9LS subcutaneously.
L9LS (VRC-MALMAB0114-00-AB): Administered one time via subcutaneous route.
|
Pediatric Efficacy Study: Arm 2: 300 mg of L9LS
n=75 Participants
Pediatric subjects age 6-10 receive 300 mg of L9LS subcutaneously.
L9LS (VRC-MALMAB0114-00-AB): Administered one time via subcutaneous route.
|
Pediatric Efficacy Study: Arm 3: Placebo
n=75 Participants
Pediatric subjects age 6-10 receive placebo of normal saline subcutaneously.
Normal saline: Administered one time via subcutaneous administration.
|
Pediatric Dose-escalation Study: Arm 1: 150 mg of L9LS
Pediatric subjects age 6-10 years receive 150 mg of L9LS subcutaneously. Once subjects reach day 7 post-administration without safety concerns, dosing begins for arm 2.
L9LS (VRC-MALMAB0114-00-AB): Administered one time via subcutaneous route.
|
Pediatric Dose-escalation Study: Arm 2: 300 mg of L9LS
Pediatric subjects age 6-10 years receive 300 mg of L9LS subcutaneously. Once subjects reach day 7 post-administration without safety concerns, dosing begins for the pediatric efficacy study arms.
L9LS (VRC-MALMAB0114-00-AB): Administered one time via subcutaneous route.
|
Pediatric Dose-escalation Study: Arm 3: Placebo
Pediatric subjects age 6-10 receive placebo of normal saline subcutaneously.
Normal saline: Administered one time via subcutaneous administration.
|
Pediatric Efficacy Study: Arm 1: 150 mg of L9LS
Pediatric subjects age 6-10 receive 150 mg of L9LS subcutaneously.
L9LS (VRC-MALMAB0114-00-AB): Administered one time via subcutaneous route.
|
Pediatric Efficacy Study: Arm 2: 300 mg of L9LS
Pediatric subjects age 6-10 receive 300 mg of L9LS subcutaneously.
L9LS (VRC-MALMAB0114-00-AB): Administered one time via subcutaneous route.
|
Pediatric Efficacy Study: Arm 3: Placebo
Pediatric subjects age 6-10 receive placebo of normal saline subcutaneously.
Normal saline: Administered one time via subcutaneous administration.
|
|---|---|---|---|---|---|---|---|---|---|
|
Participants With Clinical Malaria - Pediatric Efficacy Study
|
21 Participants
|
14 Participants
|
44 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Measured through Week 28Population: Modified intention-to-treat (MITT) - Analysis include all randomized subjects that received the intervention during the pediatric dose escalation study.
Number of participants with clinical malaria during a single malaria season, defined by an illness accompanied by any level of Plasmodium Falciparum (Pf) asexual parasitemia as detected from microscopic examination of thick blood smear that results in the administration of anti-malarial treatment.
Outcome measures
| Measure |
Pediatric Efficacy Study: Arm 1: 150 mg of L9LS
n=9 Participants
Pediatric subjects age 6-10 receive 150 mg of L9LS subcutaneously.
L9LS (VRC-MALMAB0114-00-AB): Administered one time via subcutaneous route.
|
Pediatric Efficacy Study: Arm 2: 300 mg of L9LS
n=9 Participants
Pediatric subjects age 6-10 receive 300 mg of L9LS subcutaneously.
L9LS (VRC-MALMAB0114-00-AB): Administered one time via subcutaneous route.
|
Pediatric Efficacy Study: Arm 3: Placebo
n=18 Participants
Pediatric subjects age 6-10 receive placebo of normal saline subcutaneously.
Normal saline: Administered one time via subcutaneous administration.
|
Pediatric Dose-escalation Study: Arm 1: 150 mg of L9LS
Pediatric subjects age 6-10 years receive 150 mg of L9LS subcutaneously. Once subjects reach day 7 post-administration without safety concerns, dosing begins for arm 2.
L9LS (VRC-MALMAB0114-00-AB): Administered one time via subcutaneous route.
|
Pediatric Dose-escalation Study: Arm 2: 300 mg of L9LS
Pediatric subjects age 6-10 years receive 300 mg of L9LS subcutaneously. Once subjects reach day 7 post-administration without safety concerns, dosing begins for the pediatric efficacy study arms.
L9LS (VRC-MALMAB0114-00-AB): Administered one time via subcutaneous route.
|
Pediatric Dose-escalation Study: Arm 3: Placebo
Pediatric subjects age 6-10 receive placebo of normal saline subcutaneously.
Normal saline: Administered one time via subcutaneous administration.
|
Pediatric Efficacy Study: Arm 1: 150 mg of L9LS
Pediatric subjects age 6-10 receive 150 mg of L9LS subcutaneously.
L9LS (VRC-MALMAB0114-00-AB): Administered one time via subcutaneous route.
|
Pediatric Efficacy Study: Arm 2: 300 mg of L9LS
Pediatric subjects age 6-10 receive 300 mg of L9LS subcutaneously.
L9LS (VRC-MALMAB0114-00-AB): Administered one time via subcutaneous route.
|
Pediatric Efficacy Study: Arm 3: Placebo
Pediatric subjects age 6-10 receive placebo of normal saline subcutaneously.
Normal saline: Administered one time via subcutaneous administration.
|
|---|---|---|---|---|---|---|---|---|---|
|
Participants With Clinical Malaria Detected by Microscopic Examination of Thick Blood Smear - Pediatric Dose Escalation Study
|
7 Participants
|
7 Participants
|
13 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Measured through Week 24Population: Modified intention-to-treat (MITT) - Analysis include all randomized subjects that received intervention during the pediatric efficacy study.
Number of participants with clinical malaria during a single malaria season, defined by an illness accompanied by any level of Plasmodium Falciparum (Pf) asexual parasitemia as detected from microscopic examination of thick blood smear that results in the administration of anti-malarial treatment.
Outcome measures
| Measure |
Pediatric Efficacy Study: Arm 1: 150 mg of L9LS
n=75 Participants
Pediatric subjects age 6-10 receive 150 mg of L9LS subcutaneously.
L9LS (VRC-MALMAB0114-00-AB): Administered one time via subcutaneous route.
|
Pediatric Efficacy Study: Arm 2: 300 mg of L9LS
n=75 Participants
Pediatric subjects age 6-10 receive 300 mg of L9LS subcutaneously.
L9LS (VRC-MALMAB0114-00-AB): Administered one time via subcutaneous route.
|
Pediatric Efficacy Study: Arm 3: Placebo
n=75 Participants
Pediatric subjects age 6-10 receive placebo of normal saline subcutaneously.
Normal saline: Administered one time via subcutaneous administration.
|
Pediatric Dose-escalation Study: Arm 1: 150 mg of L9LS
Pediatric subjects age 6-10 years receive 150 mg of L9LS subcutaneously. Once subjects reach day 7 post-administration without safety concerns, dosing begins for arm 2.
L9LS (VRC-MALMAB0114-00-AB): Administered one time via subcutaneous route.
|
Pediatric Dose-escalation Study: Arm 2: 300 mg of L9LS
Pediatric subjects age 6-10 years receive 300 mg of L9LS subcutaneously. Once subjects reach day 7 post-administration without safety concerns, dosing begins for the pediatric efficacy study arms.
L9LS (VRC-MALMAB0114-00-AB): Administered one time via subcutaneous route.
|
Pediatric Dose-escalation Study: Arm 3: Placebo
Pediatric subjects age 6-10 receive placebo of normal saline subcutaneously.
Normal saline: Administered one time via subcutaneous administration.
|
Pediatric Efficacy Study: Arm 1: 150 mg of L9LS
Pediatric subjects age 6-10 receive 150 mg of L9LS subcutaneously.
L9LS (VRC-MALMAB0114-00-AB): Administered one time via subcutaneous route.
|
Pediatric Efficacy Study: Arm 2: 300 mg of L9LS
Pediatric subjects age 6-10 receive 300 mg of L9LS subcutaneously.
L9LS (VRC-MALMAB0114-00-AB): Administered one time via subcutaneous route.
|
Pediatric Efficacy Study: Arm 3: Placebo
Pediatric subjects age 6-10 receive placebo of normal saline subcutaneously.
Normal saline: Administered one time via subcutaneous administration.
|
|---|---|---|---|---|---|---|---|---|---|
|
Participants With Clinical Malaria Detected by Microscopic Examination of Thick Blood Smear - Pediatric Efficacy Study
|
33 Participants
|
25 Participants
|
57 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Measured through Week 36Population: Modified intention-to-treat (MITT) - Analysis include all randomized subjects that received L9LS in year one study.
Maximum total plasma concentration (Cmax) following a dose of 150 mg or 300 mg L9LS. Serum collected on days 0, 7, 28, 56, 84, 112, 140, 168, 196, 224, \& 252 after the administration of L9LS. Cmax for L9LS was obtained directly by visual inspection of the plasma concentration versus time profiles post dose. Analysis was done to determine each participant's observed maximum concentration based on all available timepoints and cumulative output was calculated as the central tendency and dispersion metric based on the observed maximum concentrations.
Outcome measures
| Measure |
Pediatric Efficacy Study: Arm 1: 150 mg of L9LS
n=9 Participants
Pediatric subjects age 6-10 receive 150 mg of L9LS subcutaneously.
L9LS (VRC-MALMAB0114-00-AB): Administered one time via subcutaneous route.
|
Pediatric Efficacy Study: Arm 2: 300 mg of L9LS
n=9 Participants
Pediatric subjects age 6-10 receive 300 mg of L9LS subcutaneously.
L9LS (VRC-MALMAB0114-00-AB): Administered one time via subcutaneous route.
|
Pediatric Efficacy Study: Arm 3: Placebo
n=75 Participants
Pediatric subjects age 6-10 receive placebo of normal saline subcutaneously.
Normal saline: Administered one time via subcutaneous administration.
|
Pediatric Dose-escalation Study: Arm 1: 150 mg of L9LS
n=75 Participants
Pediatric subjects age 6-10 years receive 150 mg of L9LS subcutaneously. Once subjects reach day 7 post-administration without safety concerns, dosing begins for arm 2.
L9LS (VRC-MALMAB0114-00-AB): Administered one time via subcutaneous route.
|
Pediatric Dose-escalation Study: Arm 2: 300 mg of L9LS
Pediatric subjects age 6-10 years receive 300 mg of L9LS subcutaneously. Once subjects reach day 7 post-administration without safety concerns, dosing begins for the pediatric efficacy study arms.
L9LS (VRC-MALMAB0114-00-AB): Administered one time via subcutaneous route.
|
Pediatric Dose-escalation Study: Arm 3: Placebo
Pediatric subjects age 6-10 receive placebo of normal saline subcutaneously.
Normal saline: Administered one time via subcutaneous administration.
|
Pediatric Efficacy Study: Arm 1: 150 mg of L9LS
Pediatric subjects age 6-10 receive 150 mg of L9LS subcutaneously.
L9LS (VRC-MALMAB0114-00-AB): Administered one time via subcutaneous route.
|
Pediatric Efficacy Study: Arm 2: 300 mg of L9LS
Pediatric subjects age 6-10 receive 300 mg of L9LS subcutaneously.
L9LS (VRC-MALMAB0114-00-AB): Administered one time via subcutaneous route.
|
Pediatric Efficacy Study: Arm 3: Placebo
Pediatric subjects age 6-10 receive placebo of normal saline subcutaneously.
Normal saline: Administered one time via subcutaneous administration.
|
|---|---|---|---|---|---|---|---|---|---|
|
Maximum Total Plasma Concentration (Cmax) for L9LS - Study Year One
|
76.97 ug/mL
Standard Deviation 18.88
|
142.79 ug/mL
Standard Deviation 30.36
|
76.19 ug/mL
Standard Deviation 22.04
|
142.70 ug/mL
Standard Deviation 29.56
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Measured through Week 36Population: Modified intention-to-treat (MITT) - Analysis include all randomized subjects that received L9LS in year one study.
Time to maximum total plasma concentration (Cmax) following a dose of 150 mg or 300 mg L9LS. Serum was collected on days 0, 7, 28, 56, 84, 112, 140, 168, 196, 224, \& 252 after administration of L9LS. Tmax for L9LS was obtained directly by visual inspection of the plasma concentration versus time profiles. Analysis was done to determine the time (in days) at which the maximum observed concentration was achieved for each participant and cumulative output was calculated as the central tendency and dispersion metric based on the observed time of maximum concentration.
Outcome measures
| Measure |
Pediatric Efficacy Study: Arm 1: 150 mg of L9LS
n=9 Participants
Pediatric subjects age 6-10 receive 150 mg of L9LS subcutaneously.
L9LS (VRC-MALMAB0114-00-AB): Administered one time via subcutaneous route.
|
Pediatric Efficacy Study: Arm 2: 300 mg of L9LS
n=9 Participants
Pediatric subjects age 6-10 receive 300 mg of L9LS subcutaneously.
L9LS (VRC-MALMAB0114-00-AB): Administered one time via subcutaneous route.
|
Pediatric Efficacy Study: Arm 3: Placebo
n=75 Participants
Pediatric subjects age 6-10 receive placebo of normal saline subcutaneously.
Normal saline: Administered one time via subcutaneous administration.
|
Pediatric Dose-escalation Study: Arm 1: 150 mg of L9LS
n=75 Participants
Pediatric subjects age 6-10 years receive 150 mg of L9LS subcutaneously. Once subjects reach day 7 post-administration without safety concerns, dosing begins for arm 2.
L9LS (VRC-MALMAB0114-00-AB): Administered one time via subcutaneous route.
|
Pediatric Dose-escalation Study: Arm 2: 300 mg of L9LS
Pediatric subjects age 6-10 years receive 300 mg of L9LS subcutaneously. Once subjects reach day 7 post-administration without safety concerns, dosing begins for the pediatric efficacy study arms.
L9LS (VRC-MALMAB0114-00-AB): Administered one time via subcutaneous route.
|
Pediatric Dose-escalation Study: Arm 3: Placebo
Pediatric subjects age 6-10 receive placebo of normal saline subcutaneously.
Normal saline: Administered one time via subcutaneous administration.
|
Pediatric Efficacy Study: Arm 1: 150 mg of L9LS
Pediatric subjects age 6-10 receive 150 mg of L9LS subcutaneously.
L9LS (VRC-MALMAB0114-00-AB): Administered one time via subcutaneous route.
|
Pediatric Efficacy Study: Arm 2: 300 mg of L9LS
Pediatric subjects age 6-10 receive 300 mg of L9LS subcutaneously.
L9LS (VRC-MALMAB0114-00-AB): Administered one time via subcutaneous route.
|
Pediatric Efficacy Study: Arm 3: Placebo
Pediatric subjects age 6-10 receive placebo of normal saline subcutaneously.
Normal saline: Administered one time via subcutaneous administration.
|
|---|---|---|---|---|---|---|---|---|---|
|
Time to Maximum Plasma Concentration (TMax) for L9LS - Study Year One
|
7.00 Days
Standard Deviation 0.00
|
7.00 Days
Standard Deviation 0.00
|
7.17 Days
Standard Deviation 2.46
|
7.36 Days
Standard Deviation 2.45
|
—
|
—
|
—
|
—
|
—
|
Adverse Events
Adult Dose-escalation Study: Arm 1: 300 mg of L9LS
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Adult Dose-escalation Study: Arm 2: 600 mg of L9LS
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Adult Dose-escalation Study: Arm 3: 20 mg/kg of L9LS
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Pediatric Dose-escalation Study: Arm 1: 150 mg of L9LS
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Pediatric Dose-escalation Study: Arm 2: 300 mg of L9LS
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Pediatric Dose-escalation Study: Arm 3: Placebo
Serious events: 0 serious events
Other events: 18 other events
Deaths: 0 deaths
Pediatric Efficacy Study: Arm 1: 150 mg of L9LS
Serious events: 0 serious events
Other events: 67 other events
Deaths: 0 deaths
Pediatric Efficacy Study: Arm 2: 300 mg of L9LS
Serious events: 0 serious events
Other events: 71 other events
Deaths: 0 deaths
Pediatric Efficacy Study: Arm 3: Placebo
Serious events: 0 serious events
Other events: 72 other events
Deaths: 0 deaths
Pediatric Extension Study: Arm 1: 150 mg of L9LS
Serious events: 0 serious events
Other events: 74 other events
Deaths: 0 deaths
Pediatric Extension Study: Arm 2: 300 mg of L9LS
Serious events: 0 serious events
Other events: 33 other events
Deaths: 0 deaths
Pediatric Extension Study: Arm 3: Placebo
Serious events: 0 serious events
Other events: 111 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Adult Dose-escalation Study: Arm 1: 300 mg of L9LS
n=6 participants at risk
Adult participants receive single dose of 300 mg of L9LS subcutaneously. Once subjects reach day 7 post-administration without safety concerns dosing begins for arm 2.
L9LS (VRC-MALMAB0114-00-AB): Administered one time via subcutaneous route.
|
Adult Dose-escalation Study: Arm 2: 600 mg of L9LS
n=6 participants at risk
Adult participants receive single dose of 600 mg of L9LS subcutaneously. Once subjects reach day 7 post-administration without safety concerns dosing begins for arm 3.
L9LS (VRC-MALMAB0114-00-AB): Administered one time via subcutaneous route.
|
Adult Dose-escalation Study: Arm 3: 20 mg/kg of L9LS
n=6 participants at risk
Adult participants receive highest single dose of 20 mg/kg IV of L9LS intravenously. Once subjects reach day 7 post-administration without safety concerns dosing begins for pediatric subjects dose escalation arm 1.
L9LS (VRC-MALMAB0114-00-AB): Administered one time via intravenous route.
|
Pediatric Dose-escalation Study: Arm 1: 150 mg of L9LS
n=9 participants at risk
Pediatric subjects age 6-10 years receive 150 mg of L9LS subcutaneously. Once subjects reach day 7 post-administration without safety concerns, dosing begins for arm 2.
L9LS (VRC-MALMAB0114-00-AB): Administered one time via subcutaneous route.
|
Pediatric Dose-escalation Study: Arm 2: 300 mg of L9LS
n=9 participants at risk
Pediatric subjects age 6-10 years receive 300 mg of L9LS subcutaneously. Once subjects reach day 7 post-administration without safety concerns, dosing begins for the pediatric efficacy study arms.
L9LS (VRC-MALMAB0114-00-AB): Administered one time via subcutaneous route.
|
Pediatric Dose-escalation Study: Arm 3: Placebo
n=18 participants at risk
Pediatric subjects age 6-10 receive placebo of normal saline subcutaneously.
Normal saline: Administered one time via subcutaneous administration.
|
Pediatric Efficacy Study: Arm 1: 150 mg of L9LS
n=75 participants at risk
Pediatric subjects age 6-10 receive 150 mg of L9LS subcutaneously.
L9LS (VRC-MALMAB0114-00-AB): Administered one time via subcutaneous route.
|
Pediatric Efficacy Study: Arm 2: 300 mg of L9LS
n=75 participants at risk
Pediatric subjects age 6-10 receive 300 mg of L9LS subcutaneously.
L9LS (VRC-MALMAB0114-00-AB): Administered one time via subcutaneous route.
|
Pediatric Efficacy Study: Arm 3: Placebo
n=75 participants at risk
Pediatric subjects age 6-10 receive placebo of normal saline subcutaneously.
Normal saline: Administered one time via subcutaneous administration.
|
Pediatric Extension Study: Arm 1: 150 mg of L9LS
n=79 participants at risk
Pediatric subjects ages 6-10 who completed year one of the study and agreed to continue with the extension were randomized to receive 150 mg of L9LS subcutaneously.
|
Pediatric Extension Study: Arm 2: 300 mg of L9LS
n=38 participants at risk
Pediatric subjects ages 6-10 who completed year one of the study and agreed to continue with the extension were randomized to receive 300 mg of L9LS subcutaneously.
|
Pediatric Extension Study: Arm 3: Placebo
n=118 participants at risk
Pediatric subjects ages 6-10 who completed year one of the study and agreed to continue with the extension were randomized to receive placebo of normal saline subcutaneously.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.00%
0/6 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
0.00%
0/6 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
0.00%
0/6 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
11.1%
1/9 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
0.00%
0/9 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
0.00%
0/18 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
0.00%
0/75 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
1.3%
1/75 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
1.3%
1/75 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
0.00%
0/79 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
0.00%
0/38 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
1.7%
2/118 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/6 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
16.7%
1/6 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
0.00%
0/6 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
11.1%
1/9 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
0.00%
0/9 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
16.7%
3/18 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
0.00%
0/75 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
2.7%
2/75 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
0.00%
0/75 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
3.8%
3/79 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
0.00%
0/38 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
0.85%
1/118 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
|
Blood and lymphatic system disorders
Neutropenia
|
16.7%
1/6 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
16.7%
1/6 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
16.7%
1/6 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
22.2%
2/9 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
0.00%
0/9 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
22.2%
4/18 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
1.3%
1/75 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
4.0%
3/75 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
4.0%
3/75 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
2.5%
2/79 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
0.00%
0/38 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
4.2%
5/118 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
|
Cardiac disorders
Bradycardia
|
0.00%
0/6 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
0.00%
0/6 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
0.00%
0/6 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
0.00%
0/9 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
0.00%
0/9 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
5.6%
1/18 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
0.00%
0/75 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
2.7%
2/75 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
1.3%
1/75 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
0.00%
0/79 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
0.00%
0/38 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
0.00%
0/118 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
|
Cardiac disorders
Dizziness
|
0.00%
0/6 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
0.00%
0/6 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
0.00%
0/6 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
0.00%
0/9 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
0.00%
0/9 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
5.6%
1/18 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
0.00%
0/75 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
0.00%
0/75 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
0.00%
0/75 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
0.00%
0/79 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
2.6%
1/38 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
0.85%
1/118 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
|
Cardiac disorders
Tachycardia
|
16.7%
1/6 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
33.3%
2/6 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
16.7%
1/6 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
22.2%
2/9 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
0.00%
0/9 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
0.00%
0/18 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
1.3%
1/75 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
5.3%
4/75 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
8.0%
6/75 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
1.3%
1/79 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
2.6%
1/38 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
2.5%
3/118 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
|
Ear and labyrinth disorders
Ear pain
|
0.00%
0/6 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
0.00%
0/6 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
0.00%
0/6 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
0.00%
0/9 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
0.00%
0/9 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
0.00%
0/18 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
0.00%
0/75 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
1.3%
1/75 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
0.00%
0/75 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
2.5%
2/79 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
0.00%
0/38 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
0.00%
0/118 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/6 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
16.7%
1/6 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
16.7%
1/6 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
11.1%
1/9 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
11.1%
1/9 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
38.9%
7/18 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
25.3%
19/75 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
17.3%
13/75 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
21.3%
16/75 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
32.9%
26/79 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
23.7%
9/38 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
28.0%
33/118 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/6 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
0.00%
0/6 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
0.00%
0/6 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
11.1%
1/9 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
0.00%
0/9 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
5.6%
1/18 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
0.00%
0/75 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
1.3%
1/75 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
0.00%
0/75 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
1.3%
1/79 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
0.00%
0/38 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
0.00%
0/118 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/6 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
0.00%
0/6 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
16.7%
1/6 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
0.00%
0/9 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
0.00%
0/9 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
0.00%
0/18 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
0.00%
0/75 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
0.00%
0/75 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
0.00%
0/75 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
0.00%
0/79 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
0.00%
0/38 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
0.00%
0/118 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
|
Gastrointestinal disorders
Food poisoning
|
0.00%
0/6 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
0.00%
0/6 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
0.00%
0/6 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
0.00%
0/9 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
0.00%
0/9 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
5.6%
1/18 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
1.3%
1/75 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
4.0%
3/75 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
1.3%
1/75 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
1.3%
1/79 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
2.6%
1/38 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
0.00%
0/118 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
|
Gastrointestinal disorders
Gastritis
|
16.7%
1/6 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
16.7%
1/6 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
33.3%
2/6 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
0.00%
0/9 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
0.00%
0/9 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
0.00%
0/18 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
0.00%
0/75 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
0.00%
0/75 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
0.00%
0/75 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
0.00%
0/79 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
0.00%
0/38 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
0.00%
0/118 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/6 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
0.00%
0/6 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
0.00%
0/6 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
11.1%
1/9 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
0.00%
0/9 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
0.00%
0/18 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
0.00%
0/75 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
0.00%
0/75 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
0.00%
0/75 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
0.00%
0/79 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
0.00%
0/38 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
0.00%
0/118 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/6 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
0.00%
0/6 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
0.00%
0/6 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
0.00%
0/9 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
0.00%
0/9 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
0.00%
0/18 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
1.3%
1/75 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
0.00%
0/75 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
1.3%
1/75 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
2.5%
2/79 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
2.6%
1/38 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
1.7%
2/118 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/6 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
0.00%
0/6 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
0.00%
0/6 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
0.00%
0/9 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
0.00%
0/9 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
11.1%
2/18 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
1.3%
1/75 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
2.7%
2/75 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
5.3%
4/75 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
2.5%
2/79 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
0.00%
0/38 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
1.7%
2/118 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
|
General disorders
Chills
|
0.00%
0/6 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
0.00%
0/6 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
0.00%
0/6 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
0.00%
0/9 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
0.00%
0/9 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
0.00%
0/18 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
0.00%
0/75 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
5.3%
4/75 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
1.3%
1/75 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
7.6%
6/79 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
2.6%
1/38 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
1.7%
2/118 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
|
General disorders
Injection site pain
|
0.00%
0/6 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
0.00%
0/6 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
0.00%
0/6 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
0.00%
0/9 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
0.00%
0/9 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
0.00%
0/18 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
1.3%
1/75 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
0.00%
0/75 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
1.3%
1/75 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
0.00%
0/79 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
0.00%
0/38 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
0.85%
1/118 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
|
General disorders
Injection site pruritus
|
0.00%
0/6 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
0.00%
0/6 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
0.00%
0/6 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
0.00%
0/9 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
0.00%
0/9 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
0.00%
0/18 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
0.00%
0/75 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
0.00%
0/75 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
1.3%
1/75 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
0.00%
0/79 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
0.00%
0/38 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
0.00%
0/118 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
|
General disorders
Injection site swelling
|
50.0%
3/6 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
16.7%
1/6 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
0.00%
0/6 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
0.00%
0/9 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
0.00%
0/9 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
0.00%
0/18 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
2.7%
2/75 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
5.3%
4/75 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
0.00%
0/75 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
1.3%
1/79 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
5.3%
2/38 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
0.00%
0/118 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
|
General disorders
Pyrexia
|
0.00%
0/6 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
16.7%
1/6 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
0.00%
0/6 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
22.2%
2/9 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
11.1%
1/9 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
5.6%
1/18 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
16.0%
12/75 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
17.3%
13/75 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
9.3%
7/75 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
7.6%
6/79 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
2.6%
1/38 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
9.3%
11/118 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
|
Infections and infestations
Bacterial infection
|
0.00%
0/6 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
0.00%
0/6 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
0.00%
0/6 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
11.1%
1/9 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
0.00%
0/9 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
0.00%
0/18 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
0.00%
0/75 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
0.00%
0/75 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
0.00%
0/75 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
0.00%
0/79 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
0.00%
0/38 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
0.00%
0/118 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
|
Infections and infestations
Conjunctivitis
|
0.00%
0/6 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
0.00%
0/6 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
0.00%
0/6 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
11.1%
1/9 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
0.00%
0/9 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
0.00%
0/18 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
0.00%
0/75 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
0.00%
0/75 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
0.00%
0/75 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
15.2%
12/79 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
7.9%
3/38 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
16.9%
20/118 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
|
Infections and infestations
Ear infection
|
0.00%
0/6 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
0.00%
0/6 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
0.00%
0/6 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
0.00%
0/9 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
0.00%
0/9 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
5.6%
1/18 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
0.00%
0/75 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
0.00%
0/75 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
0.00%
0/75 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
2.5%
2/79 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
0.00%
0/38 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
1.7%
2/118 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
|
Infections and infestations
Malaria
|
16.7%
1/6 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
33.3%
2/6 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
16.7%
1/6 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
77.8%
7/9 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
77.8%
7/9 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
72.2%
13/18 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
48.0%
36/75 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
44.0%
33/75 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
78.7%
59/75 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
40.5%
32/79 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
39.5%
15/38 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
70.3%
83/118 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/6 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
0.00%
0/6 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
0.00%
0/6 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
0.00%
0/9 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
0.00%
0/9 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
16.7%
3/18 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
1.3%
1/75 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
0.00%
0/75 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
1.3%
1/75 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
2.5%
2/79 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
0.00%
0/38 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
5.1%
6/118 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
|
Injury, poisoning and procedural complications
Wound
|
0.00%
0/6 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
0.00%
0/6 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
0.00%
0/6 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
0.00%
0/9 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
0.00%
0/9 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
0.00%
0/18 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
0.00%
0/75 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
0.00%
0/75 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
1.3%
1/75 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
8.9%
7/79 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
2.6%
1/38 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
4.2%
5/118 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/6 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
0.00%
0/6 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
0.00%
0/6 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
0.00%
0/9 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
0.00%
0/9 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
0.00%
0/18 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
0.00%
0/75 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
0.00%
0/75 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
2.7%
2/75 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
0.00%
0/79 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
0.00%
0/38 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
0.85%
1/118 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
|
Investigations
Blood Pressure Diastolic Increased
|
0.00%
0/6 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
0.00%
0/6 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
0.00%
0/6 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
0.00%
0/9 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
0.00%
0/9 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
0.00%
0/18 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
1.3%
1/75 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
0.00%
0/75 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
0.00%
0/75 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
1.3%
1/79 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
0.00%
0/38 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
4.2%
5/118 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
|
Investigations
Blood pressure systolic decreased
|
0.00%
0/6 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
0.00%
0/6 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
0.00%
0/6 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
11.1%
1/9 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
0.00%
0/9 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
11.1%
2/18 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
6.7%
5/75 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
5.3%
4/75 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
6.7%
5/75 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
2.5%
2/79 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
2.6%
1/38 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
1.7%
2/118 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
|
Investigations
Haemoglobin decreased
|
0.00%
0/6 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
16.7%
1/6 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
0.00%
0/6 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
11.1%
1/9 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
0.00%
0/9 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
0.00%
0/18 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
0.00%
0/75 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
0.00%
0/75 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
0.00%
0/75 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
1.3%
1/79 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
0.00%
0/38 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
0.00%
0/118 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
|
Investigations
Platelet count decreased
|
0.00%
0/6 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
0.00%
0/6 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
0.00%
0/6 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
0.00%
0/9 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
0.00%
0/9 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
0.00%
0/18 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
0.00%
0/75 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
2.7%
2/75 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
1.3%
1/75 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
3.8%
3/79 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
2.6%
1/38 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
0.85%
1/118 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/6 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
0.00%
0/6 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
0.00%
0/6 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
11.1%
1/9 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
0.00%
0/9 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
0.00%
0/18 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
1.3%
1/75 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
0.00%
0/75 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
0.00%
0/75 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
0.00%
0/79 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
0.00%
0/38 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
0.00%
0/118 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
|
Nervous system disorders
Headache
|
50.0%
3/6 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
33.3%
2/6 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
16.7%
1/6 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
55.6%
5/9 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
33.3%
3/9 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
44.4%
8/18 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
36.0%
27/75 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
36.0%
27/75 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
28.0%
21/75 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
43.0%
34/79 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
26.3%
10/38 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
44.1%
52/118 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
|
Renal and urinary disorders
Urinary tract infection
|
0.00%
0/6 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
0.00%
0/6 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
0.00%
0/6 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
0.00%
0/9 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
0.00%
0/9 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
0.00%
0/18 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
1.3%
1/75 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
1.3%
1/75 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
0.00%
0/75 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
0.00%
0/79 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
0.00%
0/38 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
0.00%
0/118 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/6 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
16.7%
1/6 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
16.7%
1/6 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
22.2%
2/9 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
22.2%
2/9 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
16.7%
3/18 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
17.3%
13/75 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
24.0%
18/75 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
29.3%
22/75 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
21.5%
17/79 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
28.9%
11/38 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
18.6%
22/118 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis
|
16.7%
1/6 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
33.3%
2/6 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
16.7%
1/6 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
44.4%
4/9 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
33.3%
3/9 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
16.7%
3/18 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
25.3%
19/75 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
34.7%
26/75 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
36.0%
27/75 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
21.5%
17/79 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
23.7%
9/38 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
20.3%
24/118 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
|
Respiratory, thoracic and mediastinal disorders
Tonsillitis
|
0.00%
0/6 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
0.00%
0/6 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
0.00%
0/6 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
11.1%
1/9 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
0.00%
0/9 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
0.00%
0/18 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
4.0%
3/75 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
0.00%
0/75 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
0.00%
0/75 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
8.9%
7/79 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
2.6%
1/38 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
8.5%
10/118 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory tract infection
|
66.7%
4/6 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
16.7%
1/6 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
66.7%
4/6 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
44.4%
4/9 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
44.4%
4/9 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
33.3%
6/18 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
46.7%
35/75 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
48.0%
36/75 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
44.0%
33/75 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
16.5%
13/79 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
26.3%
10/38 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
20.3%
24/118 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
|
Skin and subcutaneous tissue disorders
Paronychia
|
0.00%
0/6 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
16.7%
1/6 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
0.00%
0/6 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
0.00%
0/9 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
0.00%
0/9 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
0.00%
0/18 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
0.00%
0/75 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
0.00%
0/75 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
0.00%
0/75 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
0.00%
0/79 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
0.00%
0/38 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
0.85%
1/118 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
|
Skin and subcutaneous tissue disorders
Tinea capitis
|
0.00%
0/6 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
0.00%
0/6 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
0.00%
0/6 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
0.00%
0/9 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
0.00%
0/9 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
0.00%
0/18 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
1.3%
1/75 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
0.00%
0/75 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
0.00%
0/75 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
1.3%
1/79 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
0.00%
0/38 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
0.00%
0/118 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
|
Vascular disorders
Diastolic hypertension
|
0.00%
0/6 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
0.00%
0/6 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
0.00%
0/6 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
0.00%
0/9 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
0.00%
0/9 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
0.00%
0/18 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
0.00%
0/75 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
1.3%
1/75 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
0.00%
0/75 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
0.00%
0/79 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
0.00%
0/38 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
0.00%
0/118 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
|
Blood and lymphatic system disorders
Lymphadenitis
|
0.00%
0/6 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
0.00%
0/6 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
0.00%
0/6 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
0.00%
0/9 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
0.00%
0/9 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
0.00%
0/18 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
0.00%
0/75 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
0.00%
0/75 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
0.00%
0/75 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
0.00%
0/79 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
0.00%
0/38 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
0.85%
1/118 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
|
Ear and labyrinth disorders
Otorrhoea
|
0.00%
0/6 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
0.00%
0/6 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
0.00%
0/6 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
0.00%
0/9 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
0.00%
0/9 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
0.00%
0/18 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
0.00%
0/75 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
0.00%
0/75 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
0.00%
0/75 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
1.3%
1/79 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
0.00%
0/38 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
0.85%
1/118 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
|
Eye disorders
Conjunctival haemorrhage
|
0.00%
0/6 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
0.00%
0/6 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
0.00%
0/6 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
0.00%
0/9 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
0.00%
0/9 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
0.00%
0/18 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
0.00%
0/75 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
0.00%
0/75 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
0.00%
0/75 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
0.00%
0/79 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
2.6%
1/38 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
0.00%
0/118 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
|
Gastrointestinal disorders
Dental caries
|
0.00%
0/6 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
0.00%
0/6 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
0.00%
0/6 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
0.00%
0/9 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
0.00%
0/9 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
0.00%
0/18 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
0.00%
0/75 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
0.00%
0/75 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
0.00%
0/75 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
2.5%
2/79 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
2.6%
1/38 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
0.00%
0/118 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
|
Gastrointestinal disorders
Dysentery
|
0.00%
0/6 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
0.00%
0/6 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
0.00%
0/6 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
0.00%
0/9 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
0.00%
0/9 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
0.00%
0/18 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
0.00%
0/75 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
0.00%
0/75 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
0.00%
0/75 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
1.3%
1/79 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
0.00%
0/38 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
1.7%
2/118 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
|
Gastrointestinal disorders
Gastroenteritis
|
0.00%
0/6 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
0.00%
0/6 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
0.00%
0/6 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
0.00%
0/9 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
0.00%
0/9 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
0.00%
0/18 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
0.00%
0/75 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
0.00%
0/75 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
0.00%
0/75 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
0.00%
0/79 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
2.6%
1/38 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
0.85%
1/118 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
|
Gastrointestinal disorders
Parotitis
|
0.00%
0/6 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
0.00%
0/6 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
0.00%
0/6 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
0.00%
0/9 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
0.00%
0/9 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
0.00%
0/18 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
0.00%
0/75 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
0.00%
0/75 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
0.00%
0/75 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
0.00%
0/79 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
0.00%
0/38 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
0.85%
1/118 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
|
General disorders
Inflammation
|
0.00%
0/6 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
0.00%
0/6 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
0.00%
0/6 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
0.00%
0/9 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
0.00%
0/9 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
0.00%
0/18 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
0.00%
0/75 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
0.00%
0/75 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
0.00%
0/75 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
0.00%
0/79 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
0.00%
0/38 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
1.7%
2/118 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
|
Infections and infestations
Salmonellosis
|
0.00%
0/6 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
0.00%
0/6 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
0.00%
0/6 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
0.00%
0/9 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
0.00%
0/9 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
0.00%
0/18 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
0.00%
0/75 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
0.00%
0/75 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
0.00%
0/75 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
1.3%
1/79 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
2.6%
1/38 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
4.2%
5/118 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
|
Infections and infestations
Schistosomiasis
|
0.00%
0/6 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
0.00%
0/6 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
0.00%
0/6 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
0.00%
0/9 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
0.00%
0/9 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
0.00%
0/18 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
0.00%
0/75 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
0.00%
0/75 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
0.00%
0/75 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
0.00%
0/79 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
2.6%
1/38 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
0.00%
0/118 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
|
Injury, poisoning and procedural complications
Limb injury
|
0.00%
0/6 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
0.00%
0/6 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
0.00%
0/6 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
0.00%
0/9 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
0.00%
0/9 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
0.00%
0/18 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
0.00%
0/75 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
0.00%
0/75 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
0.00%
0/75 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
1.3%
1/79 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
0.00%
0/38 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
0.85%
1/118 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
|
Musculoskeletal and connective tissue disorders
Forearm fracture
|
0.00%
0/6 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
0.00%
0/6 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
0.00%
0/6 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
0.00%
0/9 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
0.00%
0/9 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
0.00%
0/18 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
0.00%
0/75 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
0.00%
0/75 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
0.00%
0/75 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
1.3%
1/79 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
2.6%
1/38 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
0.85%
1/118 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
|
Skin and subcutaneous tissue disorders
Dermatosis
|
0.00%
0/6 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
0.00%
0/6 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
0.00%
0/6 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
0.00%
0/9 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
0.00%
0/9 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
0.00%
0/18 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
0.00%
0/75 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
0.00%
0/75 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
0.00%
0/75 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
2.5%
2/79 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
0.00%
0/38 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
3.4%
4/118 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
|
Skin and subcutaneous tissue disorders
Furuncle
|
0.00%
0/6 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
0.00%
0/6 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
0.00%
0/6 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
0.00%
0/9 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
0.00%
0/9 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
0.00%
0/18 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
0.00%
0/75 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
0.00%
0/75 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
0.00%
0/75 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
2.5%
2/79 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
2.6%
1/38 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
2.5%
3/118 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/6 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
0.00%
0/6 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
0.00%
0/6 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
0.00%
0/9 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
0.00%
0/9 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
0.00%
0/18 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
0.00%
0/75 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
0.00%
0/75 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
0.00%
0/75 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
0.00%
0/79 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
5.3%
2/38 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
0.00%
0/118 • Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two)
|
Additional Information
Dr. Peter Crompton
National Institute of Allergy and Infectious Diseases (NIAID)
Phone: 301-761-5042
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place