Trial Outcomes & Findings for Anti-malaria MAb in Kenyan Children (NCT NCT05400655)
NCT ID: NCT05400655
Last Updated: 2025-10-16
Results Overview
Number of participants with at least one solicited local adverse events occurring within seven days of administration of intervention. Local reactogenicity included injection site pain, tenderness, bruising, swelling, redness, induration, pruritus, and other (e.g. injection site reaction). Adverse events were captured by Investigator examination and history from participants.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
912 participants
Primary outcome timeframe
Age De-escalation and Dose escalation: within 7 days of administration of intervention; Efficacy study: within 7 days after first intervention, and 7 days after second intervention (second intervention occurred 6 months post first intervention)
Results posted on
2025-10-16
Participant Flow
912 children were consented * 233 screen failure * 58 late screen failures * 92 withdrew consent * 58 non-compliant * 15 study group complete * 35 eligible but not enrolled * 4 excluded due to other reasons
Participant milestones
| Measure |
Age De-escalation and Dose-escalation Study: Arm 1a: Age 5-10 Years, 5 mg/kg of L9LS
Healthy children aged 5-10 years receive a single dose of 5 mg/kg L9LS via subcutaneous administration. Once subjects reach day 7 post-administration without safety concerns dosing begins for arm 2.
L9LS: Administered subcutaneously.
|
Age De-escalation and Dose-escalation Study: Arm 1b: Age 5-10 Years, Placebo
Healthy children aged 5-10 years receive a single dose of placebo via subcutaneous administration. Once subjects reach day 7 post-administration without safety concerns dosing begins for arm 2.
Placebo: Normal saline administered subcutaneously.
|
Age De-escalation and Dose-escalation Study: Arm 2a: Age 5-59 Months, 5 mg/kg of L9LS
Healthy children aged 5-59 months receive a single dose of 5 mg/kg L9LS via subcutaneous administration. Once subjects reach day 7 post-administration without safety concerns dosing begins for arm 3.
L9LS: Administered subcutaneously.
|
Age De-escalation and Dose-escalation Study: Arm 2b: Age 5-59 Months, Placebo
Healthy children aged 5-59 months receive a single dose of placebo via subcutaneous administration. Once subjects reach day 7 post-administration without safety concerns dosing begins for arm 3.
Placebo: Normal saline administered subcutaneously.
|
Age De-escalation and Dose-escalation Study: Arm 2c: Age 5-10 Years, 10 mg/kg of L9LS
Healthy children aged 5-10 years receive a single dose of 10 mg/kg L9LS via subcutaneous administration. Once subjects reach day 7 post-administration without safety concerns dosing begins for arm 3.
L9LS: Administered subcutaneously.
|
Age De-escalation and Dose-escalation Study: Arm 2d: Age 5-10 Years, Placebo
Healthy children aged 5-10 years receive a single dose placebo via subcutaneous administration. Once subjects reach day 7 post-administration without safety concerns dosing begins for arm 3.
Placebo: Normal saline administered subcutaneously.
|
Age De-escalation and Dose-escalation Study: Arm 3a: Age 5-10 Years, 20 mg/kg of L9LS
Healthy children aged 5-10 years receive a single dose of 20 mg/kg L9LS via subcutaneous administration. Once subjects reach day 7 post-administration without safety concerns dosing begins for arm 4.
L9LS: Administered subcutaneously.
|
Age De-escalation and Dose-escalation Study: Arm 3b: Age 5-10 Years, Placebo
Healthy children aged 5-10 years receive a single dose of placebo via subcutaneous administration. Once subjects reach day 7 post-administration without safety concerns dosing begins for arm 4.
Placebo: Normal saline administered subcutaneously.
|
Age De-escalation and Dose-escalation Study: Arm 3c: Age 5-59 Months, 10 mg/kg of L9LS
Healthy children aged 5-59 months receive a single dose of 10 mg/kg L9LS via subcutaneous administration. Once subjects reach day 7 post-administration without safety concerns dosing begins for arm 4.
L9LS: Administered subcutaneously.
|
Age De-escalation and Dose-escalation Study: Arm 3d: Age 5-59 Months, Placebo
Healthy children aged 5-59 months receive a single dose of placebo via subcutaneous administration. Once subjects reach day 7 post-administration without safety concerns dosing begins for arm 4.
Placebo: Normal saline administered subcutaneously.
|
Age De-escalation and Dose-escalation Study: Arm 4a: Age 5-59 Months, 20 mg/kg of L9LS
Healthy children aged 5-59 months receive a single dose of 20 mg/kg of L9LS one-time via subcutaneous administration.
L9LS: Administered subcutaneously.
|
Age De-escalation and Dose-escalation Study: Arm 4b: Age 5-59 Months, Placebo
Healthy children aged 5-59 months receive a single dose of placebo via subcutaneous administration.
Placebo: Normal saline administered subcutaneously.
|
Age De-escalation and Dose-escalation Study: Arm 5a: Age 5-71 Months, 30 mg/kg of L9LS
Healthy children aged 5-71 months receive a single dose of 30 mg/kg L9LS via subcutaneous administration. Once subjects reach day 7 post-administration without safety concerns dosing begins for arm 6.
L9LS: Administered subcutaneously.
|
Age De-escalation and Dose-escalation Study: Arm 5b: Age 5-71 Months, Placebo
Healthy children aged 5-71 months receive a single dose of placebo via subcutaneous administration. Once subjects reach day 7 post-administration without safety concerns dosing begins for arm 6.
Placebo: Normal saline administered subcutaneously.
|
Age De-escalation and Dose-escalation Study: Arm 6a: Age 5-71 Months, 40 mg/kg of L9LS
Healthy children aged 5-71 months receive a single dose of 40 mg/kg L9LS via subcutaneous administration.
L9LS: Administered subcutaneously.
|
Age De-escalation and Dose-escalation Study: Arm 6b: Age 5-71 Months, Placebo
Healthy children aged 5-71 months receive a single dose of placebo via subcutaneous administration.
Placebo: Normal saline administered subcutaneously.
|
Efficacy Study: Arm 1a: Age 5-17 Months, 10-20 mg/kg of L9LS/Placebo
Healthy children aged 5-17 months receive a single dose of 10-20 mg/kg L9LS via subcutaneous administration. Six months later, participants receive a single dose of placebo via subcutaneous administration.
L9LS: Administered subcutaneously.
Placebo: Normal saline administered subcutaneously.
|
Efficacy Study: Arm 1b: Age 5-17 Months, 10-20 mg/kg of L9LS/10-20 mg/kg of L9LS
Healthy children aged 5-17 months receive a single dose of 10-20 mg/kg L9LS via subcutaneous administration. Six months later, participants receive a second single dose of 10-20 mg/kg L9LS via subcutaneous administration.
L9LS: Administered subcutaneously.
|
Efficacy Study: Arm 1c: Age 5-17 Months, Placebo/Placebo
Healthy children aged 5-17 months receive a single dose of placebo via subcutaneous administration. Six months later, participants receive a second single dose of placebo via subcutaneous administration.
Placebo: Normal saline administered subcutaneously.
|
Efficacy Study: Arm 2a: Age 18-59 Months, 10-20 mg/kg of L9LS/Placebo
Healthy children aged 18-59 months receive a single dose of 10-20 mg/kg L9LS via subcutaneous administration. Six months later, participants receive a single dose of placebo via subcutaneous administration.
L9LS: Administered subcutaneously.
Placebo: Normal saline administered subcutaneously.
|
Efficacy Study: Arm 2b: Age 18-59 Months, 10-20 mg/kg of L9LS/10-20 mg/kg of L9LS
Healthy children aged 18-59 months receive a single dose of 10-20 mg/kg L9LS via subcutaneous administration. Six months later, participants receive a second single dose of 10-20 mg/kg L9LS via subcutaneous administration.
L9LS: Administered subcutaneously.
|
Efficacy Study: Arm 2c: Age 18-59 Months, Placebo/Placebo
Healthy children aged 18-59 months receive a single dose of placebo via subcutaneous administration. Six months later, participants receive a second single dose of placebo via subcutaneous administration.
Placebo: Normal saline administered subcutaneously.
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Part 1A: Period 1
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Part 1A: Period 1
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Part 1A: Period 1
Completed Three Month Study Follow up
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Part 1A: Period 1
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Part 1A: Period 2
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Part 1A: Period 2
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Part 1A: Period 2
Completed Three Month Study Follow up
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Part 1A: Period 2
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Part 1A: Period 2
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Part 1A: Period 3
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Part 1A: Period 3
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Part 1A: Period 3
Completed Three Month Study Follow up
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Part 1A: Period 3
COMPLETED
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Part 1A: Period 3
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Part 1A: Period 4
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Part 1A: Period 4
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Part 1A: Period 4
Completed Three Month Study Follow up
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Part 1A: Period 4
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Part 1B/Part 2 - Period 1
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Part 1B/Part 2 - Period 1
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Part 1B/Part 2 - Period 1
Completed Three Month Study Follow up (Part 1B Only)
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Part 1B/Part 2 - Period 1
Second Dose of Intervention (Efficacy Study Only)
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Part 1B/Part 2 - Period 1
COMPLETED
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Part 1B/Part 2 - Period 1
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Part 1B - Period 2
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Part 1B - Period 2
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Part 1B - Period 2
Completed Three Month Study Follow up
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Part 1B - Period 2
COMPLETED
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Part 1B - Period 2
NOT COMPLETED
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Reasons for withdrawal
| Measure |
Age De-escalation and Dose-escalation Study: Arm 1a: Age 5-10 Years, 5 mg/kg of L9LS
Healthy children aged 5-10 years receive a single dose of 5 mg/kg L9LS via subcutaneous administration. Once subjects reach day 7 post-administration without safety concerns dosing begins for arm 2.
L9LS: Administered subcutaneously.
|
Age De-escalation and Dose-escalation Study: Arm 1b: Age 5-10 Years, Placebo
Healthy children aged 5-10 years receive a single dose of placebo via subcutaneous administration. Once subjects reach day 7 post-administration without safety concerns dosing begins for arm 2.
Placebo: Normal saline administered subcutaneously.
|
Age De-escalation and Dose-escalation Study: Arm 2a: Age 5-59 Months, 5 mg/kg of L9LS
Healthy children aged 5-59 months receive a single dose of 5 mg/kg L9LS via subcutaneous administration. Once subjects reach day 7 post-administration without safety concerns dosing begins for arm 3.
L9LS: Administered subcutaneously.
|
Age De-escalation and Dose-escalation Study: Arm 2b: Age 5-59 Months, Placebo
Healthy children aged 5-59 months receive a single dose of placebo via subcutaneous administration. Once subjects reach day 7 post-administration without safety concerns dosing begins for arm 3.
Placebo: Normal saline administered subcutaneously.
|
Age De-escalation and Dose-escalation Study: Arm 2c: Age 5-10 Years, 10 mg/kg of L9LS
Healthy children aged 5-10 years receive a single dose of 10 mg/kg L9LS via subcutaneous administration. Once subjects reach day 7 post-administration without safety concerns dosing begins for arm 3.
L9LS: Administered subcutaneously.
|
Age De-escalation and Dose-escalation Study: Arm 2d: Age 5-10 Years, Placebo
Healthy children aged 5-10 years receive a single dose placebo via subcutaneous administration. Once subjects reach day 7 post-administration without safety concerns dosing begins for arm 3.
Placebo: Normal saline administered subcutaneously.
|
Age De-escalation and Dose-escalation Study: Arm 3a: Age 5-10 Years, 20 mg/kg of L9LS
Healthy children aged 5-10 years receive a single dose of 20 mg/kg L9LS via subcutaneous administration. Once subjects reach day 7 post-administration without safety concerns dosing begins for arm 4.
L9LS: Administered subcutaneously.
|
Age De-escalation and Dose-escalation Study: Arm 3b: Age 5-10 Years, Placebo
Healthy children aged 5-10 years receive a single dose of placebo via subcutaneous administration. Once subjects reach day 7 post-administration without safety concerns dosing begins for arm 4.
Placebo: Normal saline administered subcutaneously.
|
Age De-escalation and Dose-escalation Study: Arm 3c: Age 5-59 Months, 10 mg/kg of L9LS
Healthy children aged 5-59 months receive a single dose of 10 mg/kg L9LS via subcutaneous administration. Once subjects reach day 7 post-administration without safety concerns dosing begins for arm 4.
L9LS: Administered subcutaneously.
|
Age De-escalation and Dose-escalation Study: Arm 3d: Age 5-59 Months, Placebo
Healthy children aged 5-59 months receive a single dose of placebo via subcutaneous administration. Once subjects reach day 7 post-administration without safety concerns dosing begins for arm 4.
Placebo: Normal saline administered subcutaneously.
|
Age De-escalation and Dose-escalation Study: Arm 4a: Age 5-59 Months, 20 mg/kg of L9LS
Healthy children aged 5-59 months receive a single dose of 20 mg/kg of L9LS one-time via subcutaneous administration.
L9LS: Administered subcutaneously.
|
Age De-escalation and Dose-escalation Study: Arm 4b: Age 5-59 Months, Placebo
Healthy children aged 5-59 months receive a single dose of placebo via subcutaneous administration.
Placebo: Normal saline administered subcutaneously.
|
Age De-escalation and Dose-escalation Study: Arm 5a: Age 5-71 Months, 30 mg/kg of L9LS
Healthy children aged 5-71 months receive a single dose of 30 mg/kg L9LS via subcutaneous administration. Once subjects reach day 7 post-administration without safety concerns dosing begins for arm 6.
L9LS: Administered subcutaneously.
|
Age De-escalation and Dose-escalation Study: Arm 5b: Age 5-71 Months, Placebo
Healthy children aged 5-71 months receive a single dose of placebo via subcutaneous administration. Once subjects reach day 7 post-administration without safety concerns dosing begins for arm 6.
Placebo: Normal saline administered subcutaneously.
|
Age De-escalation and Dose-escalation Study: Arm 6a: Age 5-71 Months, 40 mg/kg of L9LS
Healthy children aged 5-71 months receive a single dose of 40 mg/kg L9LS via subcutaneous administration.
L9LS: Administered subcutaneously.
|
Age De-escalation and Dose-escalation Study: Arm 6b: Age 5-71 Months, Placebo
Healthy children aged 5-71 months receive a single dose of placebo via subcutaneous administration.
Placebo: Normal saline administered subcutaneously.
|
Efficacy Study: Arm 1a: Age 5-17 Months, 10-20 mg/kg of L9LS/Placebo
Healthy children aged 5-17 months receive a single dose of 10-20 mg/kg L9LS via subcutaneous administration. Six months later, participants receive a single dose of placebo via subcutaneous administration.
L9LS: Administered subcutaneously.
Placebo: Normal saline administered subcutaneously.
|
Efficacy Study: Arm 1b: Age 5-17 Months, 10-20 mg/kg of L9LS/10-20 mg/kg of L9LS
Healthy children aged 5-17 months receive a single dose of 10-20 mg/kg L9LS via subcutaneous administration. Six months later, participants receive a second single dose of 10-20 mg/kg L9LS via subcutaneous administration.
L9LS: Administered subcutaneously.
|
Efficacy Study: Arm 1c: Age 5-17 Months, Placebo/Placebo
Healthy children aged 5-17 months receive a single dose of placebo via subcutaneous administration. Six months later, participants receive a second single dose of placebo via subcutaneous administration.
Placebo: Normal saline administered subcutaneously.
|
Efficacy Study: Arm 2a: Age 18-59 Months, 10-20 mg/kg of L9LS/Placebo
Healthy children aged 18-59 months receive a single dose of 10-20 mg/kg L9LS via subcutaneous administration. Six months later, participants receive a single dose of placebo via subcutaneous administration.
L9LS: Administered subcutaneously.
Placebo: Normal saline administered subcutaneously.
|
Efficacy Study: Arm 2b: Age 18-59 Months, 10-20 mg/kg of L9LS/10-20 mg/kg of L9LS
Healthy children aged 18-59 months receive a single dose of 10-20 mg/kg L9LS via subcutaneous administration. Six months later, participants receive a second single dose of 10-20 mg/kg L9LS via subcutaneous administration.
L9LS: Administered subcutaneously.
|
Efficacy Study: Arm 2c: Age 18-59 Months, Placebo/Placebo
Healthy children aged 18-59 months receive a single dose of placebo via subcutaneous administration. Six months later, participants receive a second single dose of placebo via subcutaneous administration.
Placebo: Normal saline administered subcutaneously.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Part 1A: Period 2
Withdrawal by Subject
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Part 1B/Part 2 - Period 1
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
1
|
0
|
1
|
2
|
0
|
0
|
|
Part 1B/Part 2 - Period 1
Adverse Event
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
2
|
0
|
1
|
0
|
0
|
0
|
|
Part 1B/Part 2 - Period 1
Lost to Follow-up
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
2
|
2
|
3
|
0
|
7
|
2
|
|
Part 1B/Part 2 - Period 1
Physician Decision
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
3
|
2
|
0
|
0
|
0
|
|
Part 1B/Part 2 - Period 1
Missed multiple clinic visits
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
1
|
3
|
1
|
3
|
Baseline Characteristics
Anti-malaria MAb in Kenyan Children
Baseline characteristics by cohort
| Measure |
Age De-escalation and Dose-escalation Study: Arm 1a: Age 5-10 Years, 5 mg/kg of L9LS
n=9 Participants
Healthy children aged 5-10 years receive a single dose of 5 mg/kg L9LS via subcutaneous administration. Once subjects reach day 7 post-administration without safety concerns dosing begins for arm 2.
L9LS: Administered subcutaneously.
|
Age De-escalation and Dose-escalation Study: Arm 1b: Age 5-10 Years, Placebo
n=3 Participants
Healthy children aged 5-10 years receive a single dose of placebo via subcutaneous administration. Once subjects reach day 7 post-administration without safety concerns dosing begins for arm 2.
|
Age De-escalation and Dose-escalation Study: Arm 2a: Age 5-59 Months, 5 mg/kg of L9LS
n=9 Participants
Healthy children aged 5-59 months receive a single dose of 5 mg/kg L9LS via subcutaneous administration. Once subjects reach day 7 post-administration without safety concerns dosing begins for arm 3.
L9LS: Administered subcutaneously.
|
Age De-escalation and Dose-escalation Study: Arm 2b: Age 5-59 Months, Placebo
n=3 Participants
Healthy children aged 5-59 months receive a single dose of placebo via subcutaneous administration. Once subjects reach day 7 post-administration without safety concerns dosing begins for arm 3
|
Age De-escalation and Dose-escalation Study: Arm 2c: Age 5-10 Years, 10 mg/kg of L9LS
n=9 Participants
Healthy children aged 5-10 years receive a single dose of 10 mg/kg L9LS via subcutaneous administration. Once subjects reach day 7 post-administration without safety concerns dosing begins for arm 3.
L9LS: Administered subcutaneously.
|
Age De-escalation and Dose-escalation Study: Arm 2d: Age 5-10 Years, Placebo
n=3 Participants
Healthy children aged 5-10 years receive a single dose placebo via subcutaneous administration. Once subjects reach day 7 post-administration without safety concerns dosing begins for arm 3.
|
Age De-escalation and Dose-escalation Study: Arm 3a: Age 5-10 Years, 20 mg/kg of L9LS
n=9 Participants
Healthy children aged 5-10 years receive a single dose of 20 mg/kg L9LS via subcutaneous administration. Once subjects reach day 7 post-administration without safety concerns dosing begins for arm 4.
L9LS: Administered subcutaneously.
|
Age De-escalation and Dose-escalation Study: Arm 3b: Age 5-10 Years, Placebo
n=3 Participants
Healthy children aged 5-10 years receive a single dose of placebo via subcutaneous administration. Once subjects reach day 7 post-administration without safety concerns dosing begins for arm 4.
|
Age De-escalation and Dose-escalation Study: Arm 3c: Age 5-59 Months, 10 mg/kg of L9LS
n=9 Participants
Healthy children aged 5-59 months receive a single dose of 10 mg/kg L9LS via subcutaneous administration. Once subjects reach day 7 post-administration without safety concerns dosing begins for arm 4.
L9LS: Administered subcutaneously.
|
Age De-escalation and Dose-escalation Study: Arm 3d: Age 5-59 Months, Placebo
n=3 Participants
Healthy children aged 5-59 months receive a single dose of placebo via subcutaneous administration. Once subjects reach day 7 post-administration without safety concerns dosing begins for arm 4
|
Age De-escalation and Dose-escalation Study: Arm 4a: Age 5-59 Months, 20 mg/kg of L9LS
n=9 Participants
Healthy children aged 5-59 months receive a single dose of 20 mg/kg of L9LS one-time via subcutaneous administration.
L9LS: Administered subcutaneously.
|
Age De-escalation and Dose-escalation Study: Arm 4b: Age 5-59 Months, Placebo
n=3 Participants
Healthy children aged 5-59 months receive a single dose of placebo via subcutaneous administration.
Placebo: Normal saline administered subcutaneously.
|
Age De-escalation and Dose-escalation Study: Arm 5a: Age 5-71 Months, 30 mg/kg of L9LS
n=9 Participants
Healthy children aged 5-71 months receive a single dose of 30 mg/kg L9LS via subcutaneous administration. Once subjects reach day 7 post-administration without safety concerns dosing begins for arm 6.
|
Age De-escalation and Dose-escalation Study: Arm 5b: Age 5-71 Months, Placebo
n=3 Participants
Healthy children aged 5-71 months receive a single dose of placebo via subcutaneous administration. Once subjects reach day 7 post-administration without safety concerns dosing begins for arm 6.
|
Age De-escalation and Dose-escalation Study: Arm 6a: Age 5-71 Months, 40 mg/kg of L9LS
n=9 Participants
Healthy children aged 5-71 months receive a single dose of 40 mg/kg L9LS via subcutaneous administration.
L9LS: Administered subcutaneously.
|
Age De-escalation and Dose-escalation Study: Arm 6b: Age 5-71 Months, Placebo
n=3 Participants
Healthy children aged 5-71 months receive a single dose of placebo via subcutaneous administration.
Placebo: Normal saline administered subcutaneously.
|
Efficacy Study: Arm 1a: Age 5-17 Months, 10-20 mg/kg of L9LS/Placebo
n=54 Participants
Healthy children aged 5-17 months receive a single dose of 10-20 mg/kg L9LS via subcutaneous administration. Six months later, participants receive a single dose of placebo via subcutaneous administration.
L9LS: Administered subcutaneously.
Placebo: Normal saline administered subcutaneously.
|
Efficacy Study: Arm 1b: Age 5-17 Months, 10-20 mg/kg of L9LS/10-20 mg/kg of L9LS
n=54 Participants
Healthy children aged 5-17 months receive a single dose of 10-20 mg/kg L9LS via subcutaneous administration. Six months later, participants receive a second single dose of 10-20 mg/kg L9LS via subcutaneous administration.
L9LS: Administered subcutaneously.
|
Efficacy Study: Arm 1c: Age 5-17 Months, Placebo/Placebo
n=54 Participants
Healthy children aged 5-17 months receive a single dose of placebo via subcutaneous administration. Six months later, participants receive a second single dose of placebo via subcutaneous administration.
Placebo: Normal saline administered subcutaneously.
|
Efficacy Study: Arm 2a: Age 18-59 Months, 10-20 mg/kg of L9LS/Placebo
n=54 Participants
Healthy children aged 18-59 months receive a single dose of 10-20 mg/kg L9LS via subcutaneous administration. Six months later, participants receive a single dose of placebo via subcutaneous administration.
|
Efficacy Study: Arm 2b: Age 18-59 Months, 10-20 mg/kg of L9LS/10-20 mg/kg of L9LS
n=52 Participants
Healthy children aged 18-59 months receive a single dose of 10-20 mg/kg L9LS via subcutaneous administration. Six months later, participants receive a second single dose of 10-20 mg/kg L9LS via subcutaneous administration.
|
Efficacy Study: Arm 2c: Age 18-59 Months, Placebo/Placebo
n=56 Participants
Healthy children aged 18-59 months receive a single dose of placebo via subcutaneous administration. Six months later, participants receive a second single dose of placebo via subcutaneous administration.
|
Total
n=420 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Age, Customized
5-120 months
|
9 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
9 Participants
n=21 Participants
|
3 Participants
n=10 Participants
|
9 Participants
n=115 Participants
|
3 Participants
n=24 Participants
|
9 Participants
n=42 Participants
|
3 Participants
n=42 Participants
|
9 Participants
n=42 Participants
|
3 Participants
n=42 Participants
|
9 Participants
n=36 Participants
|
3 Participants
n=36 Participants
|
9 Participants
n=24 Participants
|
3 Participants
n=135 Participants
|
54 Participants
n=136 Participants
|
54 Participants
n=44 Participants
|
54 Participants
n=667 Participants
|
54 Participants
n=7 Participants
|
52 Participants
n=6 Participants
|
56 Participants
n=10 Participants
|
420 Participants
n=14 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
7 Participants
n=21 Participants
|
1 Participants
n=10 Participants
|
4 Participants
n=115 Participants
|
1 Participants
n=24 Participants
|
3 Participants
n=42 Participants
|
3 Participants
n=42 Participants
|
6 Participants
n=42 Participants
|
2 Participants
n=42 Participants
|
5 Participants
n=36 Participants
|
1 Participants
n=36 Participants
|
1 Participants
n=24 Participants
|
1 Participants
n=135 Participants
|
28 Participants
n=136 Participants
|
34 Participants
n=44 Participants
|
27 Participants
n=667 Participants
|
29 Participants
n=7 Participants
|
27 Participants
n=6 Participants
|
27 Participants
n=10 Participants
|
222 Participants
n=14 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
2 Participants
n=10 Participants
|
5 Participants
n=115 Participants
|
2 Participants
n=24 Participants
|
6 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
3 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
4 Participants
n=36 Participants
|
2 Participants
n=36 Participants
|
8 Participants
n=24 Participants
|
2 Participants
n=135 Participants
|
26 Participants
n=136 Participants
|
20 Participants
n=44 Participants
|
27 Participants
n=667 Participants
|
25 Participants
n=7 Participants
|
25 Participants
n=6 Participants
|
29 Participants
n=10 Participants
|
198 Participants
n=14 Participants
|
|
Race/Ethnicity, Customized
Black / Non-Hispanic
|
9 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
9 Participants
n=21 Participants
|
3 Participants
n=10 Participants
|
9 Participants
n=115 Participants
|
3 Participants
n=24 Participants
|
9 Participants
n=42 Participants
|
3 Participants
n=42 Participants
|
9 Participants
n=42 Participants
|
3 Participants
n=42 Participants
|
9 Participants
n=36 Participants
|
3 Participants
n=36 Participants
|
9 Participants
n=24 Participants
|
3 Participants
n=135 Participants
|
54 Participants
n=136 Participants
|
54 Participants
n=44 Participants
|
54 Participants
n=667 Participants
|
54 Participants
n=7 Participants
|
52 Participants
n=6 Participants
|
56 Participants
n=10 Participants
|
420 Participants
n=14 Participants
|
|
Region of Enrollment
Kenya
|
9 participants
n=5 Participants
|
3 participants
n=7 Participants
|
9 participants
n=5 Participants
|
3 participants
n=4 Participants
|
9 participants
n=21 Participants
|
3 participants
n=10 Participants
|
9 participants
n=115 Participants
|
3 participants
n=24 Participants
|
9 participants
n=42 Participants
|
3 participants
n=42 Participants
|
9 participants
n=42 Participants
|
3 participants
n=42 Participants
|
9 participants
n=36 Participants
|
3 participants
n=36 Participants
|
9 participants
n=24 Participants
|
3 participants
n=135 Participants
|
54 participants
n=136 Participants
|
54 participants
n=44 Participants
|
54 participants
n=667 Participants
|
54 participants
n=7 Participants
|
52 participants
n=6 Participants
|
56 participants
n=10 Participants
|
420 participants
n=14 Participants
|
PRIMARY outcome
Timeframe: Age De-escalation and Dose escalation: within 7 days of administration of intervention; Efficacy study: within 7 days after first intervention, and 7 days after second intervention (second intervention occurred 6 months post first intervention)Population: Modified intent to treat population
Number of participants with at least one solicited local adverse events occurring within seven days of administration of intervention. Local reactogenicity included injection site pain, tenderness, bruising, swelling, redness, induration, pruritus, and other (e.g. injection site reaction). Adverse events were captured by Investigator examination and history from participants.
Outcome measures
| Measure |
Age De-escalation and Dose-escalation Study: Arm 1a: Age 5-10 Years, 5 mg/kg of L9LS
n=9 Participants
Healthy children aged 5-10 years receive a single dose of 5 mg/kg L9LS via subcutaneous administration. Once subjects reach day 7 post-administration without safety concerns dosing begins for arm 2.
L9LS: Administered subcutaneously.
|
Age De-escalation and Dose-escalation Study: Arm 2a: Age 5-59 Months, 5 mg/kg of L9LS
n=9 Participants
Healthy children aged 5-59 months receive a single dose of 5 mg/kg L9LS via subcutaneous administration. Once subjects reach day 7 post-administration without safety concerns dosing begins for arm 3.
L9LS: Administered subcutaneously.
|
Age De-escalation and Dose-escalation Study: Arm 2c: Age 5-10 Years, 10 mg/kg of L9LS
n=9 Participants
Healthy children aged 5-10 years receive a single dose of 10 mg/kg L9LS via subcutaneous administration. Once subjects reach day 7 post-administration without safety concerns dosing begins for arm 3.
L9LS: Administered subcutaneously.
|
Age De-escalation and Dose-escalation Study: Arm 3a: Age 5-10 Years, 20 mg/kg of L9LS
n=9 Participants
Healthy children aged 5-10 years receive a single dose of 20 mg/kg L9LS via subcutaneous administration. Once subjects reach day 7 post-administration without safety concerns dosing begins for arm 4.
L9LS: Administered subcutaneously.
|
Age De-escalation and Dose-escalation Study: Age 5-10 Years, Placebo
n=9 Participants
Healthy children aged 5-10 years receive a single dose of placebo via subcutaneous administration.
|
Age De-escalation and Dose-escalation Study: Arm 3c: Age 5-59 Months, 10 mg/kg of L9LS
n=9 Participants
Healthy children aged 5-59 months receive a single dose of 10 mg/kg L9LS via subcutaneous administration. Once subjects reach day 7 post-administration without safety concerns dosing begins for arm 4.
L9LS: Administered subcutaneously.
|
Age De-escalation and Dose-escalation Study: Arm 4a: Age 5-59 Months, 20 mg/kg of L9LS
n=9 Participants
Healthy children aged 5-59 months receive a single dose of 20 mg/kg of L9LS one-time via subcutaneous administration.
L9LS: Administered subcutaneously.
|
Age De-escalation and Dose-escalation Study: Age 5-59 Months, Placebo
n=9 Participants
Healthy children aged 5-59 months receive a single dose of placebo via subcutaneous administration.
Placebo: Normal saline administered subcutaneously.
|
Age De-escalation and Dose-escalation Study: Arm 5a: Age 5-71 Months, 30 mg/kg of L9LS
n=9 Participants
Healthy children aged 5-71 months receive a single dose of 30 mg/kg L9LS via subcutaneous administration. Once subjects reach day 7 post-administration without safety concerns dosing begins for arm 6.
L9LS: Administered subcutaneously.
|
Age De-escalation and Dose-escalation Study: Arm 6a: Age 5-71 Months, 40 mg/kg of L9LS
n=9 Participants
Healthy children aged 5-71 months receive a single dose of 40 mg/kg L9LS via subcutaneous administration.
L9LS: Administered subcutaneously.
|
Age De-escalation and Dose-escalation Study: Age 5-71 Months, Placebo
n=6 Participants
Healthy children aged 5-71 months receive a single dose of placebo via subcutaneous administration.
Placebo: Normal saline administered subcutaneously.
|
Efficacy Study: Arm 1a: Age 5-17 Months, 10-20 mg/kg of L9LS/Placebo
n=54 Participants
Healthy children aged 5-17 months receive a single dose of 10-20 mg/kg L9LS via subcutaneous administration. Six months later, participants receive a single dose of placebo via subcutaneous administration.
L9LS: Administered subcutaneously.
Placebo: Normal saline administered subcutaneously.
|
Efficacy Study: Arm 1b: Age 5-17 Months, 10-20 mg/kg of L9L/10-20 mg/kg of L9LS
n=54 Participants
Healthy children aged 5-17 months receive a single dose of 10-20 mg/kg L9LS via subcutaneous administration. Six months later, participants receive a second single dose of 10-20 mg/kg L9LS via subcutaneous administration.
L9LS: Administered subcutaneously.
|
Efficacy Study: Arm 1c: Age 5-17 Months, Placebo/Placebo
n=54 Participants
Healthy children aged 5-17 months receive a single dose of placebo via subcutaneous administration. Six months later, participants receive a second single dose of placebo via subcutaneous administration.
Placebo: Normal saline administered subcutaneously.
|
Efficacy Study: Arm 2a: Age 18-59 Months, 10-20 mg/kg of L9LS/Placebo
n=54 Participants
Healthy children aged 18-59 months receive a single dose of 10-20 mg/kg L9LS via subcutaneous administration. Six months later, participants receive a single dose of placebo via subcutaneous administration.
L9LS: Administered subcutaneously.
Placebo: Normal saline administered subcutaneously.
|
Efficacy Study: Arm 2b: Age 18-59 Months, 10-20 mg/kg of L9L/10-20 mg/kg of L9LS
n=52 Participants
Healthy children aged 18-59 months receive a single dose of 10-20 mg/kg L9LS via subcutaneous administration. Six months later, participants receive a second single dose of 10-20 mg/kg L9LS via subcutaneous administration.
L9LS: Administered subcutaneously.
|
Efficacy Study: Arm 2c: Age 18-59 Months, Placebo/Placebo
n=56 Participants
Healthy children aged 18-59 months receive a single dose of placebo via subcutaneous administration. Six months later, participants receive a second single dose of placebo via subcutaneous administration.
Placebo: Normal saline administered subcutaneously.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Local Adverse Events (AEs)
Injection site redness
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Local Adverse Events (AEs)
Injection site pain
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Local Adverse Events (AEs)
Injection site swelling
|
0 Participants
|
2 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
3 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants With Local Adverse Events (AEs)
Injection site reaction
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Local Adverse Events (AEs)
Injection site induration
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Local Adverse Events (AEs)
Injection site pruritus
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Local Adverse Events (AEs)
Injection site bruising
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Age De-escalation and Dose escalation: within 7 days of administration of intervention; Efficacy study: within 7 days after first intervention, and 7 days after second intervention (second intervention occurred 6 months post first intervention)Population: Modified intent to treat population
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 |
Age De-escalation and Dose-escalation Study: Arm 1a: Age 5-10 Years, 5 mg/kg of L9LS
n=9 Participants
Healthy children aged 5-10 years receive a single dose of 5 mg/kg L9LS via subcutaneous administration. Once subjects reach day 7 post-administration without safety concerns dosing begins for arm 2.
L9LS: Administered subcutaneously.
|
Age De-escalation and Dose-escalation Study: Arm 2a: Age 5-59 Months, 5 mg/kg of L9LS
n=9 Participants
Healthy children aged 5-59 months receive a single dose of 5 mg/kg L9LS via subcutaneous administration. Once subjects reach day 7 post-administration without safety concerns dosing begins for arm 3.
L9LS: Administered subcutaneously.
|
Age De-escalation and Dose-escalation Study: Arm 2c: Age 5-10 Years, 10 mg/kg of L9LS
n=9 Participants
Healthy children aged 5-10 years receive a single dose of 10 mg/kg L9LS via subcutaneous administration. Once subjects reach day 7 post-administration without safety concerns dosing begins for arm 3.
L9LS: Administered subcutaneously.
|
Age De-escalation and Dose-escalation Study: Arm 3a: Age 5-10 Years, 20 mg/kg of L9LS
n=9 Participants
Healthy children aged 5-10 years receive a single dose of 20 mg/kg L9LS via subcutaneous administration. Once subjects reach day 7 post-administration without safety concerns dosing begins for arm 4.
L9LS: Administered subcutaneously.
|
Age De-escalation and Dose-escalation Study: Age 5-10 Years, Placebo
n=9 Participants
Healthy children aged 5-10 years receive a single dose of placebo via subcutaneous administration.
|
Age De-escalation and Dose-escalation Study: Arm 3c: Age 5-59 Months, 10 mg/kg of L9LS
n=9 Participants
Healthy children aged 5-59 months receive a single dose of 10 mg/kg L9LS via subcutaneous administration. Once subjects reach day 7 post-administration without safety concerns dosing begins for arm 4.
L9LS: Administered subcutaneously.
|
Age De-escalation and Dose-escalation Study: Arm 4a: Age 5-59 Months, 20 mg/kg of L9LS
n=9 Participants
Healthy children aged 5-59 months receive a single dose of 20 mg/kg of L9LS one-time via subcutaneous administration.
L9LS: Administered subcutaneously.
|
Age De-escalation and Dose-escalation Study: Age 5-59 Months, Placebo
n=9 Participants
Healthy children aged 5-59 months receive a single dose of placebo via subcutaneous administration.
Placebo: Normal saline administered subcutaneously.
|
Age De-escalation and Dose-escalation Study: Arm 5a: Age 5-71 Months, 30 mg/kg of L9LS
n=9 Participants
Healthy children aged 5-71 months receive a single dose of 30 mg/kg L9LS via subcutaneous administration. Once subjects reach day 7 post-administration without safety concerns dosing begins for arm 6.
L9LS: Administered subcutaneously.
|
Age De-escalation and Dose-escalation Study: Arm 6a: Age 5-71 Months, 40 mg/kg of L9LS
n=9 Participants
Healthy children aged 5-71 months receive a single dose of 40 mg/kg L9LS via subcutaneous administration.
L9LS: Administered subcutaneously.
|
Age De-escalation and Dose-escalation Study: Age 5-71 Months, Placebo
n=6 Participants
Healthy children aged 5-71 months receive a single dose of placebo via subcutaneous administration.
Placebo: Normal saline administered subcutaneously.
|
Efficacy Study: Arm 1a: Age 5-17 Months, 10-20 mg/kg of L9LS/Placebo
n=54 Participants
Healthy children aged 5-17 months receive a single dose of 10-20 mg/kg L9LS via subcutaneous administration. Six months later, participants receive a single dose of placebo via subcutaneous administration.
L9LS: Administered subcutaneously.
Placebo: Normal saline administered subcutaneously.
|
Efficacy Study: Arm 1b: Age 5-17 Months, 10-20 mg/kg of L9L/10-20 mg/kg of L9LS
n=54 Participants
Healthy children aged 5-17 months receive a single dose of 10-20 mg/kg L9LS via subcutaneous administration. Six months later, participants receive a second single dose of 10-20 mg/kg L9LS via subcutaneous administration.
L9LS: Administered subcutaneously.
|
Efficacy Study: Arm 1c: Age 5-17 Months, Placebo/Placebo
n=54 Participants
Healthy children aged 5-17 months receive a single dose of placebo via subcutaneous administration. Six months later, participants receive a second single dose of placebo via subcutaneous administration.
Placebo: Normal saline administered subcutaneously.
|
Efficacy Study: Arm 2a: Age 18-59 Months, 10-20 mg/kg of L9LS/Placebo
n=54 Participants
Healthy children aged 18-59 months receive a single dose of 10-20 mg/kg L9LS via subcutaneous administration. Six months later, participants receive a single dose of placebo via subcutaneous administration.
L9LS: Administered subcutaneously.
Placebo: Normal saline administered subcutaneously.
|
Efficacy Study: Arm 2b: Age 18-59 Months, 10-20 mg/kg of L9L/10-20 mg/kg of L9LS
n=52 Participants
Healthy children aged 18-59 months receive a single dose of 10-20 mg/kg L9LS via subcutaneous administration. Six months later, participants receive a second single dose of 10-20 mg/kg L9LS via subcutaneous administration.
L9LS: Administered subcutaneously.
|
Efficacy Study: Arm 2c: Age 18-59 Months, Placebo/Placebo
n=56 Participants
Healthy children aged 18-59 months receive a single dose of placebo via subcutaneous administration. Six months later, participants receive a second single dose of placebo via subcutaneous administration.
Placebo: Normal saline administered subcutaneously.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Local Adverse Events (AEs) (by Grade)
Grade 2
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Local Adverse Events (AEs) (by Grade)
Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Local Adverse Events (AEs) (by Grade)
Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Local Adverse Events (AEs) (by Grade)
Grade 5
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Local Adverse Events (AEs) (by Grade)
Grade 1
|
0 Participants
|
2 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
4 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
4 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Age De-escalation and Dose escalation: within 7 days of administration of intervention; Efficacy study: within 7 days after first intervention, and 7 days after second intervention (second intervention occurred 6 months post first intervention)Population: Modified intent to treat population
Number of participants with local adverse events occurring within seven days of administration of intervention. Systemic reactogenicity events included pyrexia (fever), malaise (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 |
Age De-escalation and Dose-escalation Study: Arm 1a: Age 5-10 Years, 5 mg/kg of L9LS
n=9 Participants
Healthy children aged 5-10 years receive a single dose of 5 mg/kg L9LS via subcutaneous administration. Once subjects reach day 7 post-administration without safety concerns dosing begins for arm 2.
L9LS: Administered subcutaneously.
|
Age De-escalation and Dose-escalation Study: Arm 2a: Age 5-59 Months, 5 mg/kg of L9LS
n=9 Participants
Healthy children aged 5-59 months receive a single dose of 5 mg/kg L9LS via subcutaneous administration. Once subjects reach day 7 post-administration without safety concerns dosing begins for arm 3.
L9LS: Administered subcutaneously.
|
Age De-escalation and Dose-escalation Study: Arm 2c: Age 5-10 Years, 10 mg/kg of L9LS
n=9 Participants
Healthy children aged 5-10 years receive a single dose of 10 mg/kg L9LS via subcutaneous administration. Once subjects reach day 7 post-administration without safety concerns dosing begins for arm 3.
L9LS: Administered subcutaneously.
|
Age De-escalation and Dose-escalation Study: Arm 3a: Age 5-10 Years, 20 mg/kg of L9LS
n=9 Participants
Healthy children aged 5-10 years receive a single dose of 20 mg/kg L9LS via subcutaneous administration. Once subjects reach day 7 post-administration without safety concerns dosing begins for arm 4.
L9LS: Administered subcutaneously.
|
Age De-escalation and Dose-escalation Study: Age 5-10 Years, Placebo
n=9 Participants
Healthy children aged 5-10 years receive a single dose of placebo via subcutaneous administration.
|
Age De-escalation and Dose-escalation Study: Arm 3c: Age 5-59 Months, 10 mg/kg of L9LS
n=9 Participants
Healthy children aged 5-59 months receive a single dose of 10 mg/kg L9LS via subcutaneous administration. Once subjects reach day 7 post-administration without safety concerns dosing begins for arm 4.
L9LS: Administered subcutaneously.
|
Age De-escalation and Dose-escalation Study: Arm 4a: Age 5-59 Months, 20 mg/kg of L9LS
n=9 Participants
Healthy children aged 5-59 months receive a single dose of 20 mg/kg of L9LS one-time via subcutaneous administration.
L9LS: Administered subcutaneously.
|
Age De-escalation and Dose-escalation Study: Age 5-59 Months, Placebo
n=9 Participants
Healthy children aged 5-59 months receive a single dose of placebo via subcutaneous administration.
Placebo: Normal saline administered subcutaneously.
|
Age De-escalation and Dose-escalation Study: Arm 5a: Age 5-71 Months, 30 mg/kg of L9LS
n=9 Participants
Healthy children aged 5-71 months receive a single dose of 30 mg/kg L9LS via subcutaneous administration. Once subjects reach day 7 post-administration without safety concerns dosing begins for arm 6.
L9LS: Administered subcutaneously.
|
Age De-escalation and Dose-escalation Study: Arm 6a: Age 5-71 Months, 40 mg/kg of L9LS
n=9 Participants
Healthy children aged 5-71 months receive a single dose of 40 mg/kg L9LS via subcutaneous administration.
L9LS: Administered subcutaneously.
|
Age De-escalation and Dose-escalation Study: Age 5-71 Months, Placebo
n=6 Participants
Healthy children aged 5-71 months receive a single dose of placebo via subcutaneous administration.
Placebo: Normal saline administered subcutaneously.
|
Efficacy Study: Arm 1a: Age 5-17 Months, 10-20 mg/kg of L9LS/Placebo
n=54 Participants
Healthy children aged 5-17 months receive a single dose of 10-20 mg/kg L9LS via subcutaneous administration. Six months later, participants receive a single dose of placebo via subcutaneous administration.
L9LS: Administered subcutaneously.
Placebo: Normal saline administered subcutaneously.
|
Efficacy Study: Arm 1b: Age 5-17 Months, 10-20 mg/kg of L9L/10-20 mg/kg of L9LS
n=54 Participants
Healthy children aged 5-17 months receive a single dose of 10-20 mg/kg L9LS via subcutaneous administration. Six months later, participants receive a second single dose of 10-20 mg/kg L9LS via subcutaneous administration.
L9LS: Administered subcutaneously.
|
Efficacy Study: Arm 1c: Age 5-17 Months, Placebo/Placebo
n=54 Participants
Healthy children aged 5-17 months receive a single dose of placebo via subcutaneous administration. Six months later, participants receive a second single dose of placebo via subcutaneous administration.
Placebo: Normal saline administered subcutaneously.
|
Efficacy Study: Arm 2a: Age 18-59 Months, 10-20 mg/kg of L9LS/Placebo
n=54 Participants
Healthy children aged 18-59 months receive a single dose of 10-20 mg/kg L9LS via subcutaneous administration. Six months later, participants receive a single dose of placebo via subcutaneous administration.
L9LS: Administered subcutaneously.
Placebo: Normal saline administered subcutaneously.
|
Efficacy Study: Arm 2b: Age 18-59 Months, 10-20 mg/kg of L9L/10-20 mg/kg of L9LS
n=52 Participants
Healthy children aged 18-59 months receive a single dose of 10-20 mg/kg L9LS via subcutaneous administration. Six months later, participants receive a second single dose of 10-20 mg/kg L9LS via subcutaneous administration.
L9LS: Administered subcutaneously.
|
Efficacy Study: Arm 2c: Age 18-59 Months, Placebo/Placebo
n=56 Participants
Healthy children aged 18-59 months receive a single dose of placebo via subcutaneous administration. Six months later, participants receive a second single dose of placebo via subcutaneous administration.
Placebo: Normal saline administered subcutaneously.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Systemic Adverse Events (AEs)
Chills
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Systemic Adverse Events (AEs)
Headache
|
0 Participants
|
0 Participants
|
1 Participants
|
3 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Systemic Adverse Events (AEs)
Pyrexia
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
3 Participants
|
0 Participants
|
4 Participants
|
12 Participants
|
13 Participants
|
7 Participants
|
|
Number of Participants With Systemic Adverse Events (AEs)
Malaise
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Systemic Adverse Events (AEs)
Muscle aches
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Systemic Adverse Events (AEs)
Nausea
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
5 Participants
|
6 Participants
|
4 Participants
|
3 Participants
|
6 Participants
|
5 Participants
|
|
Number of Participants With Systemic Adverse Events (AEs)
Joint pain
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Age De-escalation and Dose escalation: within 7 days of administration of intervention; Efficacy study: within 7 days after first intervention, and 7 days after second intervention (second intervention occurred 6 months post first intervention)Population: Modified intent to treat population
The severity of systemic adverse events 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 |
Age De-escalation and Dose-escalation Study: Arm 1a: Age 5-10 Years, 5 mg/kg of L9LS
n=9 Participants
Healthy children aged 5-10 years receive a single dose of 5 mg/kg L9LS via subcutaneous administration. Once subjects reach day 7 post-administration without safety concerns dosing begins for arm 2.
L9LS: Administered subcutaneously.
|
Age De-escalation and Dose-escalation Study: Arm 2a: Age 5-59 Months, 5 mg/kg of L9LS
n=9 Participants
Healthy children aged 5-59 months receive a single dose of 5 mg/kg L9LS via subcutaneous administration. Once subjects reach day 7 post-administration without safety concerns dosing begins for arm 3.
L9LS: Administered subcutaneously.
|
Age De-escalation and Dose-escalation Study: Arm 2c: Age 5-10 Years, 10 mg/kg of L9LS
n=9 Participants
Healthy children aged 5-10 years receive a single dose of 10 mg/kg L9LS via subcutaneous administration. Once subjects reach day 7 post-administration without safety concerns dosing begins for arm 3.
L9LS: Administered subcutaneously.
|
Age De-escalation and Dose-escalation Study: Arm 3a: Age 5-10 Years, 20 mg/kg of L9LS
n=9 Participants
Healthy children aged 5-10 years receive a single dose of 20 mg/kg L9LS via subcutaneous administration. Once subjects reach day 7 post-administration without safety concerns dosing begins for arm 4.
L9LS: Administered subcutaneously.
|
Age De-escalation and Dose-escalation Study: Age 5-10 Years, Placebo
n=9 Participants
Healthy children aged 5-10 years receive a single dose of placebo via subcutaneous administration.
|
Age De-escalation and Dose-escalation Study: Arm 3c: Age 5-59 Months, 10 mg/kg of L9LS
n=9 Participants
Healthy children aged 5-59 months receive a single dose of 10 mg/kg L9LS via subcutaneous administration. Once subjects reach day 7 post-administration without safety concerns dosing begins for arm 4.
L9LS: Administered subcutaneously.
|
Age De-escalation and Dose-escalation Study: Arm 4a: Age 5-59 Months, 20 mg/kg of L9LS
n=9 Participants
Healthy children aged 5-59 months receive a single dose of 20 mg/kg of L9LS one-time via subcutaneous administration.
L9LS: Administered subcutaneously.
|
Age De-escalation and Dose-escalation Study: Age 5-59 Months, Placebo
n=9 Participants
Healthy children aged 5-59 months receive a single dose of placebo via subcutaneous administration.
Placebo: Normal saline administered subcutaneously.
|
Age De-escalation and Dose-escalation Study: Arm 5a: Age 5-71 Months, 30 mg/kg of L9LS
n=9 Participants
Healthy children aged 5-71 months receive a single dose of 30 mg/kg L9LS via subcutaneous administration. Once subjects reach day 7 post-administration without safety concerns dosing begins for arm 6.
L9LS: Administered subcutaneously.
|
Age De-escalation and Dose-escalation Study: Arm 6a: Age 5-71 Months, 40 mg/kg of L9LS
n=9 Participants
Healthy children aged 5-71 months receive a single dose of 40 mg/kg L9LS via subcutaneous administration.
L9LS: Administered subcutaneously.
|
Age De-escalation and Dose-escalation Study: Age 5-71 Months, Placebo
n=6 Participants
Healthy children aged 5-71 months receive a single dose of placebo via subcutaneous administration.
Placebo: Normal saline administered subcutaneously.
|
Efficacy Study: Arm 1a: Age 5-17 Months, 10-20 mg/kg of L9LS/Placebo
n=54 Participants
Healthy children aged 5-17 months receive a single dose of 10-20 mg/kg L9LS via subcutaneous administration. Six months later, participants receive a single dose of placebo via subcutaneous administration.
L9LS: Administered subcutaneously.
Placebo: Normal saline administered subcutaneously.
|
Efficacy Study: Arm 1b: Age 5-17 Months, 10-20 mg/kg of L9L/10-20 mg/kg of L9LS
n=54 Participants
Healthy children aged 5-17 months receive a single dose of 10-20 mg/kg L9LS via subcutaneous administration. Six months later, participants receive a second single dose of 10-20 mg/kg L9LS via subcutaneous administration.
L9LS: Administered subcutaneously.
|
Efficacy Study: Arm 1c: Age 5-17 Months, Placebo/Placebo
n=54 Participants
Healthy children aged 5-17 months receive a single dose of placebo via subcutaneous administration. Six months later, participants receive a second single dose of placebo via subcutaneous administration.
Placebo: Normal saline administered subcutaneously.
|
Efficacy Study: Arm 2a: Age 18-59 Months, 10-20 mg/kg of L9LS/Placebo
n=54 Participants
Healthy children aged 18-59 months receive a single dose of 10-20 mg/kg L9LS via subcutaneous administration. Six months later, participants receive a single dose of placebo via subcutaneous administration.
L9LS: Administered subcutaneously.
Placebo: Normal saline administered subcutaneously.
|
Efficacy Study: Arm 2b: Age 18-59 Months, 10-20 mg/kg of L9L/10-20 mg/kg of L9LS
n=52 Participants
Healthy children aged 18-59 months receive a single dose of 10-20 mg/kg L9LS via subcutaneous administration. Six months later, participants receive a second single dose of 10-20 mg/kg L9LS via subcutaneous administration.
L9LS: Administered subcutaneously.
|
Efficacy Study: Arm 2c: Age 18-59 Months, Placebo/Placebo
n=56 Participants
Healthy children aged 18-59 months receive a single dose of placebo via subcutaneous administration. Six months later, participants receive a second single dose of placebo via subcutaneous administration.
Placebo: Normal saline administered subcutaneously.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Systemic Adverse Events (AEs) (by Grade)
Grade 1
|
1 Participants
|
0 Participants
|
1 Participants
|
3 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
10 Participants
|
11 Participants
|
7 Participants
|
6 Participants
|
3 Participants
|
5 Participants
|
|
Number of Participants With Systemic Adverse Events (AEs) (by Grade)
Grade 2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
3 Participants
|
4 Participants
|
3 Participants
|
3 Participants
|
4 Participants
|
3 Participants
|
|
Number of Participants With Systemic Adverse Events (AEs) (by Grade)
Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Systemic Adverse Events (AEs) (by Grade)
Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Systemic Adverse Events (AEs) (by Grade)
Grade 5
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
Adverse Events
Age De-escalation and Dose-escalation Study: Arm 1a: Age 5-10 Years, 5 mg/kg of L9LS
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Age De-escalation and Dose-escalation Study: Arm 2a: Age 5-59 Months, 5 mg/kg of L9LS
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Age De-escalation and Dose-escalation Study: Arm 2c: Age 5-10 Years, 10 mg/kg of L9LS
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Age De-escalation and Dose-escalation Study: Arm 3a: Age 5-10 Years, 20 mg/kg of L9LS
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Age De-escalation and Dose-escalation Study: Age 5-10 Years, Placebo
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Age De-escalation and Dose-escalation Study: Arm 3c: Age 5-59 Months, 10 mg/kg of L9LS
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Age De-escalation and Dose-escalation Study: Arm 4a: Age 5-59 Months, 20 mg/kg of L9LS
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Age De-escalation and Dose-escalation Study: Age 5-59 Months, Placebo
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Age De-escalation and Dose-escalation Study: Arm 5a: Age 5-71 Months, 30 mg/kg of L9LS
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Age De-escalation and Dose-escalation Study: Arm 6a: Age 5-71 Months, 40 mg/kg of L9LS
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Age De-escalation and Dose-escalation Study: Age 5-71 Months, Placebo
Serious events: 0 serious events
Other events: 6 other events
Deaths: 1 deaths
Efficacy Study: Arm 1a: Age 5-17 Months, 10-20 mg/kg of L9LS/Placebo
Serious events: 5 serious events
Other events: 54 other events
Deaths: 0 deaths
Efficacy Study: Arm 1b: Age 5-17 Months, 10-20 mg/kg of L9L/10-20 mg/kg of L9LS
Serious events: 4 serious events
Other events: 53 other events
Deaths: 0 deaths
Efficacy Study: Arm 1c: Age 5-17 Months, Placebo/Placebo
Serious events: 9 serious events
Other events: 53 other events
Deaths: 0 deaths
Efficacy Study: Arm 2a: Age 18-59 Months, 10-20 mg/kg of L9LS/Placebo
Serious events: 2 serious events
Other events: 53 other events
Deaths: 0 deaths
Efficacy Study: Arm 2b: Age 18-59 Months, 10-20 mg/kg of L9L/10-20 mg/kg of L9LS
Serious events: 0 serious events
Other events: 49 other events
Deaths: 0 deaths
Efficacy Study: Arm 2c: Age 18-59 Months, Placebo/Placebo
Serious events: 6 serious events
Other events: 55 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Age De-escalation and Dose-escalation Study: Arm 1a: Age 5-10 Years, 5 mg/kg of L9LS
n=9 participants at risk
Healthy children aged 5-10 years receive a single dose of 5 mg/kg L9LS via subcutaneous administration. Once subjects reach day 7 post-administration without safety concerns dosing begins for arm 2.
L9LS: Administered subcutaneously.
|
Age De-escalation and Dose-escalation Study: Arm 2a: Age 5-59 Months, 5 mg/kg of L9LS
n=9 participants at risk
Healthy children aged 5-59 months receive a single dose of 5 mg/kg L9LS via subcutaneous administration. Once subjects reach day 7 post-administration without safety concerns dosing begins for arm 3.
L9LS: Administered subcutaneously.
|
Age De-escalation and Dose-escalation Study: Arm 2c: Age 5-10 Years, 10 mg/kg of L9LS
n=9 participants at risk
Healthy children aged 5-10 years receive a single dose of 10 mg/kg L9LS via subcutaneous administration. Once subjects reach day 7 post-administration without safety concerns dosing begins for arm 3.
L9LS: Administered subcutaneously.
|
Age De-escalation and Dose-escalation Study: Arm 3a: Age 5-10 Years, 20 mg/kg of L9LS
n=9 participants at risk
Healthy children aged 5-10 years receive a single dose of 20 mg/kg L9LS via subcutaneous administration. Once subjects reach day 7 post-administration without safety concerns dosing begins for arm 4.
L9LS: Administered subcutaneously.
|
Age De-escalation and Dose-escalation Study: Age 5-10 Years, Placebo
n=9 participants at risk
Healthy children aged 5-10 years receive a single dose of placebo via subcutaneous administration.
|
Age De-escalation and Dose-escalation Study: Arm 3c: Age 5-59 Months, 10 mg/kg of L9LS
n=9 participants at risk
Healthy children aged 5-59 months receive a single dose of 10 mg/kg L9LS via subcutaneous administration. Once subjects reach day 7 post-administration without safety concerns dosing begins for arm 4.
L9LS: Administered subcutaneously.
|
Age De-escalation and Dose-escalation Study: Arm 4a: Age 5-59 Months, 20 mg/kg of L9LS
n=9 participants at risk
Healthy children aged 5-59 months receive a single dose of 20 mg/kg of L9LS one-time via subcutaneous administration.
L9LS: Administered subcutaneously.
|
Age De-escalation and Dose-escalation Study: Age 5-59 Months, Placebo
n=9 participants at risk
Healthy children aged 5-59 months receive a single dose of placebo via subcutaneous administration.
Placebo: Normal saline administered subcutaneously.
|
Age De-escalation and Dose-escalation Study: Arm 5a: Age 5-71 Months, 30 mg/kg of L9LS
n=9 participants at risk
Healthy children aged 5-71 months receive a single dose of 30 mg/kg L9LS via subcutaneous administration. Once subjects reach day 7 post-administration without safety concerns dosing begins for arm 6.
L9LS: Administered subcutaneously.
|
Age De-escalation and Dose-escalation Study: Arm 6a: Age 5-71 Months, 40 mg/kg of L9LS
n=9 participants at risk
Healthy children aged 5-71 months receive a single dose of 40 mg/kg L9LS via subcutaneous administration.
L9LS: Administered subcutaneously.
|
Age De-escalation and Dose-escalation Study: Age 5-71 Months, Placebo
n=6 participants at risk
Healthy children aged 5-71 months receive a single dose of placebo via subcutaneous administration.
Placebo: Normal saline administered subcutaneously.
|
Efficacy Study: Arm 1a: Age 5-17 Months, 10-20 mg/kg of L9LS/Placebo
n=54 participants at risk
Healthy children aged 5-17 months receive a single dose of 10-20 mg/kg L9LS via subcutaneous administration. Six months later, participants receive a single dose of placebo via subcutaneous administration.
L9LS: Administered subcutaneously.
Placebo: Normal saline administered subcutaneously.
|
Efficacy Study: Arm 1b: Age 5-17 Months, 10-20 mg/kg of L9L/10-20 mg/kg of L9LS
n=54 participants at risk
Healthy children aged 5-17 months receive a single dose of 10-20 mg/kg L9LS via subcutaneous administration. Six months later, participants receive a second single dose of 10-20 mg/kg L9LS via subcutaneous administration.
L9LS: Administered subcutaneously.
|
Efficacy Study: Arm 1c: Age 5-17 Months, Placebo/Placebo
n=54 participants at risk
Healthy children aged 5-17 months receive a single dose of placebo via subcutaneous administration. Six months later, participants receive a second single dose of placebo via subcutaneous administration.
Placebo: Normal saline administered subcutaneously.
|
Efficacy Study: Arm 2a: Age 18-59 Months, 10-20 mg/kg of L9LS/Placebo
n=54 participants at risk
Healthy children aged 18-59 months receive a single dose of 10-20 mg/kg L9LS via subcutaneous administration. Six months later, participants receive a single dose of placebo via subcutaneous administration.
L9LS: Administered subcutaneously.
Placebo: Normal saline administered subcutaneously.
|
Efficacy Study: Arm 2b: Age 18-59 Months, 10-20 mg/kg of L9L/10-20 mg/kg of L9LS
n=52 participants at risk
Healthy children aged 18-59 months receive a single dose of 10-20 mg/kg L9LS via subcutaneous administration. Six months later, participants receive a second single dose of 10-20 mg/kg L9LS via subcutaneous administration.
L9LS: Administered subcutaneously.
|
Efficacy Study: Arm 2c: Age 18-59 Months, Placebo/Placebo
n=56 participants at risk
Healthy children aged 18-59 months receive a single dose of placebo via subcutaneous administration. Six months later, participants receive a second single dose of placebo via subcutaneous administration.
Placebo: Normal saline administered subcutaneously.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Congenital, familial and genetic disorders
Hydrocele
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/6 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
1.9%
1/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
1.9%
1/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/52 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
1.8%
1/56 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
|
Gastrointestinal disorders
Oesophageal Obstruction
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/6 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/52 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
1.8%
1/56 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
|
General disorders
Pyrexia
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/6 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
1.9%
1/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/52 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/56 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
|
Infections and infestations
Bronchiolitis
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/6 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/52 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
1.8%
1/56 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
|
Infections and infestations
Febrile Infection
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/6 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
1.9%
1/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/52 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/56 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/6 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
1.9%
1/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/52 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/56 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
|
Infections and infestations
Gastroenteritis Salmonella
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/6 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
1.9%
1/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/52 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/56 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
|
Infections and infestations
Malaria
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/6 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
5.6%
3/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
1.9%
1/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
5.6%
3/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/52 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
3.6%
2/56 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
|
Infections and infestations
Mumps
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/6 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
1.9%
1/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/52 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/56 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
|
Infections and infestations
Pneumonia
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/6 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
1.9%
1/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
1.9%
1/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
1.9%
1/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/52 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/56 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
|
Infections and infestations
Typhoid Fever
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/6 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/52 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
1.8%
1/56 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
|
Injury, poisoning and procedural complications
Burns Second Degree
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/6 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
1.9%
1/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/52 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/56 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
|
Investigations
False Positive Investigation Result
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/6 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
1.9%
1/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/52 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/56 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
|
Metabolism and nutrition disorders
Malnutrition
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/6 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
1.9%
1/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/52 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/56 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
|
Nervous system disorders
Epilepsy
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/6 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
1.9%
1/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
1.9%
1/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/52 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/56 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
Other adverse events
| Measure |
Age De-escalation and Dose-escalation Study: Arm 1a: Age 5-10 Years, 5 mg/kg of L9LS
n=9 participants at risk
Healthy children aged 5-10 years receive a single dose of 5 mg/kg L9LS via subcutaneous administration. Once subjects reach day 7 post-administration without safety concerns dosing begins for arm 2.
L9LS: Administered subcutaneously.
|
Age De-escalation and Dose-escalation Study: Arm 2a: Age 5-59 Months, 5 mg/kg of L9LS
n=9 participants at risk
Healthy children aged 5-59 months receive a single dose of 5 mg/kg L9LS via subcutaneous administration. Once subjects reach day 7 post-administration without safety concerns dosing begins for arm 3.
L9LS: Administered subcutaneously.
|
Age De-escalation and Dose-escalation Study: Arm 2c: Age 5-10 Years, 10 mg/kg of L9LS
n=9 participants at risk
Healthy children aged 5-10 years receive a single dose of 10 mg/kg L9LS via subcutaneous administration. Once subjects reach day 7 post-administration without safety concerns dosing begins for arm 3.
L9LS: Administered subcutaneously.
|
Age De-escalation and Dose-escalation Study: Arm 3a: Age 5-10 Years, 20 mg/kg of L9LS
n=9 participants at risk
Healthy children aged 5-10 years receive a single dose of 20 mg/kg L9LS via subcutaneous administration. Once subjects reach day 7 post-administration without safety concerns dosing begins for arm 4.
L9LS: Administered subcutaneously.
|
Age De-escalation and Dose-escalation Study: Age 5-10 Years, Placebo
n=9 participants at risk
Healthy children aged 5-10 years receive a single dose of placebo via subcutaneous administration.
|
Age De-escalation and Dose-escalation Study: Arm 3c: Age 5-59 Months, 10 mg/kg of L9LS
n=9 participants at risk
Healthy children aged 5-59 months receive a single dose of 10 mg/kg L9LS via subcutaneous administration. Once subjects reach day 7 post-administration without safety concerns dosing begins for arm 4.
L9LS: Administered subcutaneously.
|
Age De-escalation and Dose-escalation Study: Arm 4a: Age 5-59 Months, 20 mg/kg of L9LS
n=9 participants at risk
Healthy children aged 5-59 months receive a single dose of 20 mg/kg of L9LS one-time via subcutaneous administration.
L9LS: Administered subcutaneously.
|
Age De-escalation and Dose-escalation Study: Age 5-59 Months, Placebo
n=9 participants at risk
Healthy children aged 5-59 months receive a single dose of placebo via subcutaneous administration.
Placebo: Normal saline administered subcutaneously.
|
Age De-escalation and Dose-escalation Study: Arm 5a: Age 5-71 Months, 30 mg/kg of L9LS
n=9 participants at risk
Healthy children aged 5-71 months receive a single dose of 30 mg/kg L9LS via subcutaneous administration. Once subjects reach day 7 post-administration without safety concerns dosing begins for arm 6.
L9LS: Administered subcutaneously.
|
Age De-escalation and Dose-escalation Study: Arm 6a: Age 5-71 Months, 40 mg/kg of L9LS
n=9 participants at risk
Healthy children aged 5-71 months receive a single dose of 40 mg/kg L9LS via subcutaneous administration.
L9LS: Administered subcutaneously.
|
Age De-escalation and Dose-escalation Study: Age 5-71 Months, Placebo
n=6 participants at risk
Healthy children aged 5-71 months receive a single dose of placebo via subcutaneous administration.
Placebo: Normal saline administered subcutaneously.
|
Efficacy Study: Arm 1a: Age 5-17 Months, 10-20 mg/kg of L9LS/Placebo
n=54 participants at risk
Healthy children aged 5-17 months receive a single dose of 10-20 mg/kg L9LS via subcutaneous administration. Six months later, participants receive a single dose of placebo via subcutaneous administration.
L9LS: Administered subcutaneously.
Placebo: Normal saline administered subcutaneously.
|
Efficacy Study: Arm 1b: Age 5-17 Months, 10-20 mg/kg of L9L/10-20 mg/kg of L9LS
n=54 participants at risk
Healthy children aged 5-17 months receive a single dose of 10-20 mg/kg L9LS via subcutaneous administration. Six months later, participants receive a second single dose of 10-20 mg/kg L9LS via subcutaneous administration.
L9LS: Administered subcutaneously.
|
Efficacy Study: Arm 1c: Age 5-17 Months, Placebo/Placebo
n=54 participants at risk
Healthy children aged 5-17 months receive a single dose of placebo via subcutaneous administration. Six months later, participants receive a second single dose of placebo via subcutaneous administration.
Placebo: Normal saline administered subcutaneously.
|
Efficacy Study: Arm 2a: Age 18-59 Months, 10-20 mg/kg of L9LS/Placebo
n=54 participants at risk
Healthy children aged 18-59 months receive a single dose of 10-20 mg/kg L9LS via subcutaneous administration. Six months later, participants receive a single dose of placebo via subcutaneous administration.
L9LS: Administered subcutaneously.
Placebo: Normal saline administered subcutaneously.
|
Efficacy Study: Arm 2b: Age 18-59 Months, 10-20 mg/kg of L9L/10-20 mg/kg of L9LS
n=52 participants at risk
Healthy children aged 18-59 months receive a single dose of 10-20 mg/kg L9LS via subcutaneous administration. Six months later, participants receive a second single dose of 10-20 mg/kg L9LS via subcutaneous administration.
L9LS: Administered subcutaneously.
|
Efficacy Study: Arm 2c: Age 18-59 Months, Placebo/Placebo
n=56 participants at risk
Healthy children aged 18-59 months receive a single dose of placebo via subcutaneous administration. Six months later, participants receive a second single dose of placebo via subcutaneous administration.
Placebo: Normal saline administered subcutaneously.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
11.1%
1/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
11.1%
1/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
11.1%
1/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
11.1%
1/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
22.2%
2/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
11.1%
1/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
22.2%
2/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/6 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
14.8%
8/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
14.8%
8/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
7.4%
4/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
7.4%
4/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
1.9%
1/52 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
5.4%
3/56 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
|
Gastrointestinal disorders
Faeces Hard
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/6 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/52 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
1.8%
1/56 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
|
Blood and lymphatic system disorders
Lymphadenitis
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
11.1%
1/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/6 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
1.9%
1/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/52 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/56 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/6 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
1.9%
1/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/52 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/56 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/6 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
3.7%
2/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/52 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
1.8%
1/56 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/6 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
1.9%
1/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
1.9%
1/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
1.9%
1/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/52 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
1.8%
1/56 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
|
Cardiac disorders
Palpitations
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/6 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
1.9%
1/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/52 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/56 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
|
Ear and labyrinth disorders
Cerumen Impaction
|
11.1%
1/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/6 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
1.9%
1/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
1.9%
1/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
3.8%
2/52 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
1.8%
1/56 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
|
Ear and labyrinth disorders
Ear Pain
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
22.2%
2/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/6 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/52 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/56 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
|
Ear and labyrinth disorders
Excessive Cerumen Production
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
11.1%
1/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/6 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/52 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/56 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
|
Eye disorders
Conjunctivitis Allergic
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
11.1%
1/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
11.1%
1/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
11.1%
1/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/6 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
1.9%
1/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/52 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/56 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
|
Gastrointestinal disorders
Abdominal Discomfort
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/6 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
1.9%
1/52 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/56 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
|
Gastrointestinal disorders
Abdominal Pain
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
22.2%
2/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
11.1%
1/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
22.2%
2/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
22.2%
2/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/6 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
3.7%
2/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/52 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/56 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
|
Gastrointestinal disorders
Aphthous Ulcer
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/6 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
1.9%
1/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
1.9%
1/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/52 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/56 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
11.1%
1/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/6 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/52 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/56 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
|
Gastrointestinal disorders
Dental Caries
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
11.1%
1/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
11.1%
1/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/6 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/52 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/56 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
|
Gastrointestinal disorders
Dental Discomfort
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
11.1%
1/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/6 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/52 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/56 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
11.1%
1/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
22.2%
2/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
22.2%
2/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
22.2%
2/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/6 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/52 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/56 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
|
Gastrointestinal disorders
Enteritis
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/6 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
1.9%
1/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/52 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/56 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
|
Gastrointestinal disorders
Gastritis
|
11.1%
1/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
11.1%
1/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
11.1%
1/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/6 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/52 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/56 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
|
Gastrointestinal disorders
Gingival Injury
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
11.1%
1/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/6 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/52 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/56 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
|
Gastrointestinal disorders
Gingivitis
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
11.1%
1/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
11.1%
1/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/6 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/52 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/56 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
|
Infections and infestations
Otitis Externa
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
11.1%
1/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/6 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/52 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/56 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
|
Gastrointestinal disorders
Haematochezia
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/6 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
1.9%
1/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/52 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/56 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
|
Gastrointestinal disorders
Lip Swelling
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/6 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/52 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
1.8%
1/56 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
11.1%
1/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
33.3%
3/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/6 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
7.4%
4/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
14.8%
8/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
9.3%
5/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
9.3%
5/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
11.5%
6/52 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
7.1%
4/56 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/6 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
7.4%
4/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/52 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/56 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
11.1%
1/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
11.1%
1/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/6 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/52 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/56 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
11.1%
1/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
11.1%
1/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
11.1%
1/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
11.1%
1/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/6 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
1.9%
1/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
1.9%
1/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/52 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/56 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
|
General disorders
Asthenia
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/6 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/52 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
1.8%
1/56 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
|
General disorders
Chills
|
11.1%
1/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/6 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/52 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/56 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
|
General disorders
Febrile Convulsion
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
11.1%
1/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/6 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/52 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/56 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
|
General disorders
Feeling Hot
|
22.2%
2/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
11.1%
1/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
33.3%
3/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
11.1%
1/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
11.1%
1/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
55.6%
5/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
22.2%
2/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
22.2%
2/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
22.2%
2/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
11.1%
1/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/6 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
11.1%
6/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
5.6%
3/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
11.1%
6/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
18.5%
10/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
15.4%
8/52 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
10.7%
6/56 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
|
General disorders
Injection Site Induration
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/6 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
1.9%
1/52 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/56 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
|
General disorders
Injection Site Pain
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
11.1%
1/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
11.1%
1/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
11.1%
1/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
11.1%
1/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
11.1%
1/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/6 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
1.9%
1/52 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/56 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
|
General disorders
Injection Site Reaction
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/6 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
1.9%
1/52 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/56 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
|
General disorders
Injection Site Swelling
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
22.2%
2/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
22.2%
2/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
11.1%
1/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
11.1%
1/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
11.1%
1/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
22.2%
2/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
33.3%
3/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/6 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
1.9%
1/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
1.9%
1/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
1.9%
1/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
3.8%
2/52 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/56 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
|
General disorders
Malaise
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/6 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
3.7%
2/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/52 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/56 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
|
General disorders
Pyrexia
|
11.1%
1/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
11.1%
1/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
11.1%
1/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
11.1%
1/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/6 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
24.1%
13/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
27.8%
15/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
9.3%
5/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
5.6%
3/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
5.8%
3/52 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
10.7%
6/56 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
|
Infections and infestations
Abscess
|
11.1%
1/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
11.1%
1/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
11.1%
1/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/6 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
1.9%
1/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
1.9%
1/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/52 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
1.8%
1/56 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
|
Infections and infestations
Acarodermatitis
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
11.1%
1/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/6 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
1.9%
1/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
5.6%
3/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
1.9%
1/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
3.8%
2/52 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
3.6%
2/56 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
|
General disorders
Bacterial Infection
|
11.1%
1/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
22.2%
2/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/6 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
1.9%
1/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
1.9%
1/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
3.7%
2/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
1.9%
1/52 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/56 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
|
General disorders
Body Tinea
|
11.1%
1/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
11.1%
1/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
11.1%
1/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
11.1%
1/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
22.2%
2/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
16.7%
1/6 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
5.6%
3/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
1.9%
1/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
3.7%
2/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
7.4%
4/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
3.8%
2/52 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/56 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
|
Infections and infestations
Bronchiolitis
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/6 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
7.4%
4/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/52 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/56 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
|
Infections and infestations
Bronchitis
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
11.1%
1/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/6 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/52 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/56 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
|
Infections and infestations
Cellulitis
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
11.1%
1/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/6 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
1.9%
1/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/52 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/56 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
|
Infections and infestations
Conjunctivitis
|
11.1%
1/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
22.2%
2/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
11.1%
1/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
55.6%
5/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
33.3%
3/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
33.3%
3/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
22.2%
2/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
16.7%
1/6 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
3.7%
2/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
14.8%
8/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
3.7%
2/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
7.4%
4/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
5.8%
3/52 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
8.9%
5/56 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
|
Infections and infestations
Conjunctivitis Bacterial
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
11.1%
1/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/6 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/52 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/56 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
|
Infections and infestations
Dysentery
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
11.1%
1/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/6 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/52 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/56 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
|
Infections and infestations
Ear Infection
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/6 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
1.9%
1/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/52 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/56 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
|
Infections and infestations
Ear Lobe Infection
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
11.1%
1/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/6 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/52 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/56 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
|
Infections and infestations
Furuncle
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/6 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
1.9%
1/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
3.8%
2/52 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
1.8%
1/56 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
|
Infections and infestations
Gastroenteritis
|
11.1%
1/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
22.2%
2/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
33.3%
3/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
77.8%
7/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
22.2%
2/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
33.3%
3/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
44.4%
4/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
55.6%
5/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
50.0%
3/6 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
31.5%
17/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
35.2%
19/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
38.9%
21/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
25.9%
14/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
30.8%
16/52 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
23.2%
13/56 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
|
Infections and infestations
Gastroenteritis Salmonella
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/6 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
1.9%
1/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/52 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/56 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
|
Infections and infestations
Helminthic Infection
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
11.1%
1/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
11.1%
1/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/6 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/52 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
1.8%
1/56 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
|
Infections and infestations
Hepatitis A
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
11.1%
1/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
11.1%
1/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
11.1%
1/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/6 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
1.9%
1/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
1.9%
1/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
1.9%
1/52 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
3.6%
2/56 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
|
Infections and infestations
Hordeolum
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/6 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
1.9%
1/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/52 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/56 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
|
Infections and infestations
Impetigo
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/6 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
1.9%
1/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/52 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/56 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
|
Infections and infestations
Malaria
|
44.4%
4/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
22.2%
2/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
22.2%
2/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
22.2%
2/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
33.3%
3/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
11.1%
1/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
11.1%
1/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
33.3%
3/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
11.1%
1/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
33.3%
2/6 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
81.5%
44/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
64.8%
35/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
77.8%
42/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
88.9%
48/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
73.1%
38/52 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
87.5%
49/56 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
|
Infections and infestations
Mumps
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/6 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
1.9%
1/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
3.8%
2/52 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/56 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
|
Infections and infestations
Oral Candidiasis
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/6 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
1.9%
1/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
1.9%
1/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/52 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/56 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
|
Infections and infestations
Oral Herpes
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/6 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/52 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
1.8%
1/56 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
|
Infections and infestations
Oral Pustule
|
11.1%
1/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/6 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/52 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/56 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
|
Infections and infestations
Otitis Media
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
11.1%
1/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
11.1%
1/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
11.1%
1/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
11.1%
1/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/6 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
1.9%
1/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
1.9%
1/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
3.7%
2/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
9.3%
5/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
1.9%
1/52 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
1.8%
1/56 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
|
Infections and infestations
Otitis Media Acute
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
11.1%
1/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
11.1%
1/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/6 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/52 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/56 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
|
Infections and infestations
Parotitis
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/6 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
1.9%
1/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
1.9%
1/52 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/56 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
|
Infections and infestations
Pertussis
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
11.1%
1/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/6 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
16.7%
9/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
16.7%
9/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
17.3%
9/52 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
1.8%
1/56 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/6 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
1.9%
1/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/52 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/56 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
|
Infections and infestations
Pneumonia
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
22.2%
2/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
22.2%
2/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
22.2%
2/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
11.1%
1/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
11.1%
1/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
16.7%
1/6 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
11.1%
6/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
14.8%
8/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
7.4%
4/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
5.6%
3/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
11.5%
6/52 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
3.6%
2/56 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
|
Infections and infestations
Rash Pustular
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
22.2%
2/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
11.1%
1/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
11.1%
1/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
11.1%
1/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/6 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
3.7%
2/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
5.6%
3/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
7.4%
4/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
7.4%
4/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
3.8%
2/52 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
1.8%
1/56 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
|
Infections and infestations
Rhinitis
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
11.1%
1/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
22.2%
2/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
11.1%
1/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
11.1%
1/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
22.2%
2/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/6 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
9.3%
5/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
7.4%
4/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
11.1%
6/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
7.4%
4/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
9.6%
5/52 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
3.6%
2/56 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
|
Infections and infestations
Septic Rash
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
11.1%
1/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
11.1%
1/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
11.1%
1/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
16.7%
1/6 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
7.4%
4/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
1.9%
1/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
5.8%
3/52 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/56 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
|
Infections and infestations
Tinea Capitis
|
11.1%
1/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
11.1%
1/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
33.3%
3/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
22.2%
2/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
11.1%
1/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/6 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
3.7%
2/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
15.4%
8/52 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
3.6%
2/56 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
|
Infections and infestations
Tonsillitis
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
11.1%
1/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
33.3%
3/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
11.1%
1/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
44.4%
4/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
22.2%
2/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
44.4%
4/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
22.2%
2/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/6 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
9.3%
5/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
5.6%
3/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
9.3%
5/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
7.4%
4/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
3.8%
2/52 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
5.4%
3/56 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
66.7%
6/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
100.0%
9/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
88.9%
8/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
77.8%
7/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
44.4%
4/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
100.0%
9/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
88.9%
8/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
88.9%
8/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
77.8%
7/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
77.8%
7/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
83.3%
5/6 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
66.7%
36/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
61.1%
33/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
63.0%
34/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
66.7%
36/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
73.1%
38/52 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
64.3%
36/56 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
|
Infections and infestations
Upper Respiratory Tract Infection Bacterial
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
11.1%
1/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
11.1%
1/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/6 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/52 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/56 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
|
Infections and infestations
Urinary Tract Infection
|
11.1%
1/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/6 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
1.9%
1/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
1.9%
1/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/52 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/56 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
|
Infections and infestations
Varicella
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
11.1%
1/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/6 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
1.9%
1/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
1.9%
1/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
1.9%
1/52 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/56 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
|
Infections and infestations
Viral Rash
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
11.1%
1/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/6 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/52 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/56 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
|
Infections and infestations
Wound Infection
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/6 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
1.9%
1/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
5.8%
3/52 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
1.8%
1/56 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
|
Infections and infestations
Wound Sepsis
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
22.2%
2/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/6 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/52 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/56 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
|
Injury, poisoning and procedural complications
Accidental Exposure To Product
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/6 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/52 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
1.8%
1/56 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
11.1%
1/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/6 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
1.9%
1/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
5.8%
3/52 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/56 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
|
Injury, poisoning and procedural complications
Greenstick Fracture
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
11.1%
1/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/6 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
1.9%
1/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/52 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/56 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
|
Injury, poisoning and procedural complications
Joint Dislocation
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/6 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/52 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
1.8%
1/56 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
|
Injury, poisoning and procedural complications
Limb Injury
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/6 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/52 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
1.8%
1/56 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
|
Injury, poisoning and procedural complications
Radius Fracture
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
11.1%
1/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/6 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/52 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/56 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
|
Injury, poisoning and procedural complications
Skin Laceration
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/6 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
1.9%
1/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/52 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/56 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
|
Injury, poisoning and procedural complications
Soft Tissue Injury
|
11.1%
1/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
11.1%
1/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/6 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
1.9%
1/52 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/56 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
|
Injury, poisoning and procedural complications
Thermal Burn
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
11.1%
1/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/6 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
5.6%
3/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
1.9%
1/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/52 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
1.8%
1/56 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
|
Injury, poisoning and procedural complications
Wound
|
11.1%
1/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
11.1%
1/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
11.1%
1/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/6 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
3.7%
2/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
1.9%
1/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
1.9%
1/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
1.9%
1/52 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
3.6%
2/56 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
|
Investigations
Alanine Aminotransferase Increased
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
11.1%
1/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/6 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/52 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/56 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
|
Investigations
Transaminases Increased
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
11.1%
1/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/6 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
1.9%
1/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
1.9%
1/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/52 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/56 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
|
Metabolism and nutrition disorders
Decreased Appetite
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
11.1%
1/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
11.1%
1/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/6 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
1.9%
1/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
1.9%
1/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
1.9%
1/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
1.9%
1/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/52 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/56 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
|
Metabolism and nutrition disorders
Malnutrition
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/6 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
1.9%
1/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/52 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/56 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
|
Musculoskeletal and connective tissue disorders
Neck Pain
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/6 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
1.9%
1/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/52 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/56 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
|
Nervous system disorders
Febrile Convulsion
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/6 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
5.6%
3/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
5.6%
3/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
7.4%
4/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
1.9%
1/52 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
7.1%
4/56 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
|
Nervous system disorders
Headache
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
11.1%
1/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
22.2%
2/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
44.4%
4/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
11.1%
1/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
11.1%
1/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/6 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
1.9%
1/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
1.9%
1/52 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
1.8%
1/56 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
|
Nervous system disorders
Seizure
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/6 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
1.9%
1/52 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
1.8%
1/56 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
|
Nervous system disorders
Tonic Convulsion
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/6 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
1.9%
1/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
1.9%
1/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/52 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/56 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
16.7%
1/6 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
1.9%
1/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
1.9%
1/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/52 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/56 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
|
Reproductive system and breast disorders
Breast Enlargement
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/6 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
1.9%
1/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/52 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/56 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
|
Reproductive system and breast disorders
Genital Pain
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/6 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/52 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
1.8%
1/56 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
|
Reproductive system and breast disorders
Pruritus Genital
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/6 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
1.9%
1/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/52 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/56 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
11.1%
1/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/6 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/52 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/56 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
11.1%
1/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
11.1%
1/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
11.1%
1/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
11.1%
1/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
11.1%
1/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
11.1%
1/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/6 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
1.9%
1/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/52 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
1.8%
1/56 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
11.1%
1/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/6 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/52 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/56 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/6 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/52 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
1.8%
1/56 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
|
Skin and subcutaneous tissue disorders
Dermatitis Allergic
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
11.1%
1/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/6 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
1.9%
1/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/52 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/56 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
|
Skin and subcutaneous tissue disorders
Dermatitis Bullous
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/6 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
1.9%
1/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/52 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/56 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
|
Skin and subcutaneous tissue disorders
Dermatitis Diaper
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/6 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
1.9%
1/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
1.9%
1/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/52 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/56 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
|
Skin and subcutaneous tissue disorders
Dermatitis Exfoliative
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/6 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
1.9%
1/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/52 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/56 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
11.1%
1/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/6 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
1.9%
1/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/52 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/56 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
|
Skin and subcutaneous tissue disorders
Exfoliative Rash
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
11.1%
1/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/6 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/52 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/56 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
|
Skin and subcutaneous tissue disorders
Miliaria
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/6 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
1.9%
1/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
1.9%
1/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/52 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/56 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
11.1%
1/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
11.1%
1/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/6 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/52 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/56 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
|
Skin and subcutaneous tissue disorders
Rash
|
11.1%
1/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
11.1%
1/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/6 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
1.9%
1/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
1.9%
1/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/52 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/56 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
|
Skin and subcutaneous tissue disorders
Rash Macular
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/6 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/52 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
1.8%
1/56 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
|
Skin and subcutaneous tissue disorders
Rash Maculo-Papular
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/6 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
1.9%
1/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/52 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/56 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
|
Skin and subcutaneous tissue disorders
Rash Papular
|
11.1%
1/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
11.1%
1/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
11.1%
1/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
11.1%
1/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
11.1%
1/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
33.3%
3/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
11.1%
1/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
55.6%
5/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
33.3%
2/6 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
25.9%
14/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
22.2%
12/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
22.2%
12/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
18.5%
10/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
15.4%
8/52 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
12.5%
7/56 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
|
Skin and subcutaneous tissue disorders
Rash Pruritic
|
11.1%
1/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
11.1%
1/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
11.1%
1/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/6 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
5.6%
3/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
1.9%
1/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
1.9%
1/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
5.6%
3/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
1.9%
1/52 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/56 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
|
Skin and subcutaneous tissue disorders
Rash Vesicular
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
33.3%
3/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
11.1%
1/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/6 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
7.4%
4/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
1.9%
1/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
1.9%
1/52 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/56 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/9 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/6 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
1.9%
1/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/54 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/52 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
0.00%
0/56 • Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing
|
Additional Information
Dr. Laura Steinhardt, PhD, MPH
Centers for Disease Control and Prevention
Phone: 1 6467641472
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place