| Primary | Number of Participants With Treatment Emergent Adverse Events (TEAE) | | Analysis was performed on the SAS, which consisted of all participants enrolled in the study who received at least 1 dose of the IP. | Posted | | Count of Participants | | Participants | | Up to Month 12 | | | | ID | Title | Description |
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| OG000 | CSL312 (Garadacimab) Q2M | Participants aged 2 to 5 years received SC injection of CSL312 (Garadacimab) 100 mg Q2M starting from Day 1 up to Month 12. | | OG001 | CSL312 (Garadacimab) Q1M | Participants aged 6 to 11 years received SC injection of CSL312 (Garadacimab) 100 mg Q1M starting from Day 1 up to Month 12. |
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| Primary | Percentage of Participants With TEAE | The percentage of participants was rounded to one place of decimal. | Analysis was performed on the SAS, which consisted of all participants enrolled in the study who received at least 1 dose of the IP. | Posted | | Number | | Percentage of participants | | Up to Month 12 | | | | ID | Title | Description |
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| OG000 | CSL312 (Garadacimab) Q2M | Participants aged 2 to 5 years received SC injection of CSL312 (Garadacimab) 100 mg Q2M starting from Day 1 up to Month 12. | | OG001 | CSL312 (Garadacimab) Q1M | Participants aged 6 to 11 years received SC injection of CSL312 (Garadacimab) 100 mg Q1M starting from Day 1 up to Month 12. |
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| Primary | Number of TEAE | | Analysis was performed on the SAS, which consisted of all participants enrolled in the study who received at least 1 dose of the IP. | Posted | | Number | | Events | | Up to Month 12 | | | | ID | Title | Description |
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| OG000 | CSL312 (Garadacimab) Q2M | Participants aged 2 to 5 years received SC injection of CSL312 (Garadacimab) 100 mg Q2M starting from Day 1 up to Month 12. | | OG001 | CSL312 (Garadacimab) Q1M | Participants aged 6 to 11 years received SC injection of CSL312 (Garadacimab) 100 mg Q1M starting from Day 1 up to Month 12. |
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| Primary | TEAE Rates Per Injection | The TEAE rate per injection was calculated as the number of TEAE/ number of injections. The number of injections was defined as the total injections a participant received during the Safety Evaluation Period under the dosing regimen to which the TEAE was assigned. | Analysis was performed on the SAS, which consisted of all participants enrolled in the study who received at least 1 dose of the IP. | Posted | | Number | | Number of TEAE per injection | | Up to Month 12 | | | | ID | Title | Description |
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| OG000 | CSL312 (Garadacimab) Q2M | Participants aged 2 to 5 years received SC injection of CSL312 (Garadacimab) 100 mg Q2M starting from Day 1 up to Month 12. | | OG001 | CSL312 (Garadacimab) Q1M | Participants aged 6 to 11 years received SC injection of CSL312 (Garadacimab) 100 mg Q1M starting from Day 1 up to Month 12. |
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| Primary | TEAE Rates Per Participant-Year | The TEAE rate per participant year was calculated as number of TEAEs/ participant years. Participant-years of exposure were calculated as the sum of each participant's exposure duration (in years) under the specified dosing regimen or overall. For the time assigned to a dosing regimen, each study day was counted under the corresponding regimen. | Analysis was performed on the SAS, which consisted of all participants enrolled in the study who received at least 1 dose of the IP. | Posted | | Number | | Number of TEAE per participant year | | Up to Month 12 | | | | ID | Title | Description |
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| OG000 | CSL312 (Garadacimab) Q2M | Participants aged 2 to 5 years received SC injection of CSL312 (Garadacimab) 100 mg Q2M starting from Day 1 up to Month 12. | | OG001 | CSL312 (Garadacimab) Q1M | Participants aged 6 to 11 years received SC injection of CSL312 (Garadacimab) 100 mg Q1M starting from Day 1 up to Month 12. |
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| Primary | Maximum Concentration (Cmax) of CSL312 at Steady-state | | Analysis was performed on the pharmacokinetic (PK) analysis set, which consisted of all participants in the SAS for whom there was at least one quantifiable PK concentration of CSL312 after administration. Here, 'overall number of participants analyzed' = participants with available data for this outcome measure. | Posted | | Mean | Standard Deviation | Nanograms per milliliter (ng/mL) | | Up to Month 12 | | | | ID | Title | Description |
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| OG000 | CSL312 (Garadacimab) Q2M | Participants aged 2 to 5 years received SC injection of CSL312 (Garadacimab) 100 mg Q2M starting from Day 1 up to Month 12. | | OG001 | CSL312 (Garadacimab) Q1M | Participants aged 6 to 11 years received SC injection of CSL312 (Garadacimab) 100 mg Q1M starting from Day 1 up to Month 12. |
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| Primary | Trough Concentration (Ctrough) of CSL312 at Steady-state | | Analysis was performed on the PK analysis set, which consisted of all participants in the SAS for whom there was at least one quantifiable PK concentration of CSL312 after administration. Here, 'overall number of participants analyzed' = participants with available data for this outcome measure and 'number analyzed' = participants with available data at each specified timepoint. | Posted | | Mean | Standard Deviation | ng/mL | | At Months 3, 4, 6, 9, 10, and 12 | | | | ID | Title | Description |
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| OG000 | CSL312 (Garadacimab) Q2M | Participants aged 2 to 5 years received SC injection of CSL312 (Garadacimab) 100 mg Q2M starting from Day 1 up to Month 12. | | OG001 | CSL312 (Garadacimab) Q1M | Participants aged 6 to 11 years received SC injection of CSL312 (Garadacimab) 100 mg Q1M starting from Day 1 up to Month 12. |
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| Primary | Time to Maximum Concentration (Tmax) of CSL312 at Steady-State | | Analysis was performed on the PK analysis set, which consisted of all participants in the SAS for whom at least one quantifiable PK concentration of CSL312 after administration. Here, 'overall number of participants analyzed' = participants with available data for this outcome measure. | Posted | | Median | Full Range | Days | | Up to Month 12 | | | | ID | Title | Description |
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| OG000 | CSL312 (Garadacimab) Q2M | Participants aged 2 to 5 years received SC injection of CSL312 (Garadacimab) 100 mg Q2M starting from Day 1 up to Month 12. | | OG001 | CSL312 (Garadacimab) Q1M | Participants aged 6 to 11 years received SC injection of CSL312 (Garadacimab) 100 mg Q1M starting from Day 1 up to Month 12. |
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| Secondary | Time-normalized Number of HAE Attacks Per Month | Time-normalized number of HAE attacks per month during treatment was calculated per participant as: [Number of HAE attacks / Length of participant treatment in days] * 30.4375. | Analysis was performed on the enrolled analysis set, which consisted of all participants who enrolled in the study. | Posted | | Median | 95% Confidence Interval | Number of HAE attacks per month | | Up to Month 12 | | | | ID | Title | Description |
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| OG000 | CSL312 (Garadacimab) Q2M | Participants aged 2 to 5 years received SC injection of CSL312 (Garadacimab) 100 mg Q2M starting from Day 1 up to Month 12. | | OG001 | CSL312 (Garadacimab) Q1M | Participants aged 6 to 11 years received SC injection of CSL312 (Garadacimab) 100 mg Q1M starting from Day 1 up to Month 12. |
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| Secondary | Time-normalized Number of HAE Attacks Per Year | Time-normalized number of HAE attacks per year during treatment was calculated per participant as: [Number of HAE attacks / Length of participant treatment in days] * 365.25. | Analysis was performed on the enrolled analysis set, which consisted of all participants who enrolled in the study. | Posted | | Median | 95% Confidence Interval | Number of HAE attacks per year | | Up to Month 12 | | | | ID | Title | Description |
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| OG000 | CSL312 (Garadacimab) Q2M | Participants aged 2 to 5 years received SC injection of CSL312 (Garadacimab) 100 mg Q2M starting from Day 1 up to Month 12. | | OG001 | CSL312 (Garadacimab) Q1M | Participants aged 6 to 11 years received SC injection of CSL312 (Garadacimab) 100 mg Q1M starting from Day 1 up to Month 12. |
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| Secondary | Time-normalized Number of HAE Attacks Treated With On-demand Treatment Per Month | The time-normalized number of HAE attacks per month treated with on-demand treatment were calculated as follows: [(Number of HAE attacks treated with on - demand treatment during treatment period)/ Length of participant treatment in days] ∗ 30.4375. | Analysis was performed on the enrolled analysis set, which consisted of all participants who enrolled in the study. | Posted | | Median | 95% Confidence Interval | Number of HAE attacks per month | | Up to Month 12 | | | | ID | Title | Description |
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| OG000 | CSL312 (Garadacimab) Q2M | Participants aged 2 to 5 years received SC injection of CSL312 (Garadacimab) 100 mg Q2M starting from Day 1 up to Month 12. | | OG001 | CSL312 (Garadacimab) Q1M | Participants aged 6 to 11 years received SC injection of CSL312 (Garadacimab) 100 mg Q1M starting from Day 1 up to Month 12. |
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| Secondary | Time-normalized Number of HAE Attacks Treated With On-demand Treatment Per Year | The time-normalized number of HAE attacks per year treated with on-demand treatment were calculated as follows: [(Number of HAE attacks treated with on - demand treatment during treatment period)/ Length of participant treatment in days] ∗ 365.25. | Analysis was performed on the enrolled analysis set, which consisted of all participants who enrolled in the study. | Posted | | Median | 95% Confidence Interval | Number of HAE attacks per year | | Up to Month 12 | | | | ID | Title | Description |
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| OG000 | CSL312 (Garadacimab) Q2M | Participants aged 2 to 5 years received SC injection of CSL312 (Garadacimab) 100 mg Q2M starting from Day 1 up to Month 12. | | OG001 | CSL312 (Garadacimab) Q1M | Participants aged 6 to 11 years received SC injection of CSL312 (Garadacimab) 100 mg Q1M starting from Day 1 up to Month 12. |
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| Secondary | Time-normalized Number of Moderate and/or Severe HAE Attacks Per Month | Time-normalized number of moderate or severe HAE attacks per month during treatment period was calculated per participant as: [number of moderate or severe HAE attacks / length of participant treatment in days] * 30.4375. | Analysis was performed on the enrolled analysis set, which consisted of all participants who enrolled in the study. | Posted | | Median | 95% Confidence Interval | Number of HAE attacks per month | | Up to Month 12 | | | | ID | Title | Description |
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| OG000 | CSL312 (Garadacimab) Q2M | Participants aged 2 to 5 years received SC injection of CSL312 (Garadacimab) 100 mg Q2M starting from Day 1 up to Month 12. | | OG001 | CSL312 (Garadacimab) Q1M | Participants aged 6 to 11 years received SC injection of CSL312 (Garadacimab) 100 mg Q1M starting from Day 1 up to Month 12. |
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| Secondary | Time-normalized Number of Moderate and/or Severe HAE Attacks Per Year | Time-normalized number of moderate or severe HAE attacks per month during treatment period was calculated per participant as: [number of moderate or severe HAE attacks / length of participant treatment in days] * 365.25. | Analysis was performed on the enrolled analysis set, which consisted of all participants who enrolled in the study. | Posted | | Median | 95% Confidence Interval | Number of HAE attacks per year | | Up to Month 12 | | | | ID | Title | Description |
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| OG000 | CSL312 (Garadacimab) Q2M | Participants aged 2 to 5 years received SC injection of CSL312 (Garadacimab) 100 mg Q2M starting from Day 1 up to Month 12. | | OG001 | CSL312 (Garadacimab) Q1M | Participants aged 6 to 11 years received SC injection of CSL312 (Garadacimab) 100 mg Q1M starting from Day 1 up to Month 12. |
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| Secondary | Percentage Reduction in the Time-normalized Number of HAE Attacks | The percentage reduction in the time-normalized number of HAE attacks was calculated within a participant as follows: 100*[ 1 - (Time-normalized number of HAE attacks per month during treatment period/Time-normalized number of HAE attacks per month from historical data)]. | Analysis was performed on the enrolled analysis set, which consisted of all participants who enrolled in the study. | Posted | | Mean | Standard Deviation | Percentage reduction in HAE attacks | | Up to Month 12 | | | | ID | Title | Description |
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| OG000 | CSL312 (Garadacimab) Q2M | Participants aged 2 to 5 years received SC injection of CSL312 (Garadacimab) 100 mg Q2M starting from Day 1 up to Month 12. | | OG001 | CSL312 (Garadacimab) Q1M | Participants aged 6 to 11 years received SC injection of CSL312 (Garadacimab) 100 mg Q1M starting from Day 1 up to Month 12. |
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| Secondary | Number of Participants Experiencing at Least Greater Than or Equal to (>=) 50 Percent (%), >= 70%, >= 90%, or Equal to 100% (Attack-free) Reduction in the Time-normalized Number of HAE Attacks | A participant was classified as a responder if the percentage reduction in the time-normalized number of HAE attacks under treatment compared to the time-normalized number of HAE attacks documented in the medical records was >= 50%. Percent Reduction = 100 * [1 - (time-normalized number of HAE attacks during corresponding time window / time-normalized number of HAE attacks based on historical data)]. Here number of participants experiencing at least >= 50%, >= 70%, >= 90%, or equal to 100% (Attack-free) reduction in the time-normalized number of HAE attacks are reported. The number of responders at each reduction category have been reported. | Analysis was performed on the enrolled analysis set, which consisted of all participants who enrolled in the study. | Posted | | Count of Participants | | Participants | | Up to Month 12 | | | | ID | Title | Description |
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| OG000 | CSL312 (Garadacimab) Q2M | Participants aged 2 to 5 years received SC injection of CSL312 (Garadacimab) 100 mg Q2M starting from Day 1 up to Month 12. | | OG001 | CSL312 (Garadacimab) Q1M | Participants aged 6 to 11 years received SC injection of CSL312 (Garadacimab) 100 mg Q1M starting from Day 1 up to Month 12. |
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| Secondary | Number of Participants Experiencing Serious Adverse Events (SAE), Experiencing Death, Related TEAE, TEAE Leading to Study Discontinuation | | Analysis was performed on the SAS, which consisted of all participants enrolled in the study who received at least 1 dose of the IP. | Posted | | Count of Participants | | Participants | | Up to Month 12 | | | | ID | Title | Description |
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| OG000 | CSL312 (Garadacimab) Q2M | Participants aged 2 to 5 years received SC injection of CSL312 (Garadacimab) 100 mg Q2M starting from Day 1 up to Month 12. | | OG001 | CSL312 (Garadacimab) Q1M | Participants aged 6 to 11 years received SC injection of CSL312 (Garadacimab) 100 mg Q1M starting from Day 1 up to Month 12. |
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| Secondary | Percentage of Participants Experiencing SAE, Experiencing Death, Related TEAE, TEAE Leading to Study Discontinuation | The percentage of participants was rounded to one decimal place. | Analysis was performed on the SAS, which consisted of all participants enrolled in the study who received at least 1 dose of the IP. | Posted | | Number | | Percentage of participants | | Up to Month 12 | | | | ID | Title | Description |
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| OG000 | CSL312 (Garadacimab) Q2M | Participants aged 2 to 5 years received SC injection of CSL312 (Garadacimab) 100 mg Q2M starting from Day 1 up to Month 12. | | OG001 | CSL312 (Garadacimab) Q1M | Participants aged 6 to 11 years received SC injection of CSL312 (Garadacimab) 100 mg Q1M starting from Day 1 up to Month 12. |
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| Secondary | Number of Participants With TEAE by Severity | Severity of AE was assessed by the investigator and categorized as mild, moderate and severe where: Mild: AE that is usually transient and may require only minimal treatment or therapeutic intervention. The event does not generally interfere with usual activities of daily living. Moderate: AE that is usually alleviated with additional specific therapeutic intervention. The event interferes with usual activities of daily living, causing discomfort but poses no significant or permanent risk of harm to the research participant. Severe: AE that interrupts usual activities of daily living, significantly affects clinical status, or may require intensive therapeutic intervention. | Analysis was performed on the SAS, which consisted of all participants enrolled in the study who received at least 1 dose of the IP. | Posted | | Count of Participants | | Participants | | Up to Month 12 | | | | ID | Title | Description |
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| OG000 | CSL312 (Garadacimab) Q2M | Participants aged 2 to 5 years received SC injection of CSL312 (Garadacimab) 100 mg Q2M starting from Day 1 up to Month 12. | | OG001 | CSL312 (Garadacimab) Q1M | Participants aged 6 to 11 years received SC injection of CSL312 (Garadacimab) 100 mg Q1M starting from Day 1 up to Month 12. |
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| Secondary | Percentage of Participants With TEAE by Severity | Severity of AE was assessed by the investigator and categorized as mild, moderate and severe where: Mild: AE that is usually transient and may require only minimal treatment or therapeutic intervention. The event does not generally interfere with usual activities of daily living. Moderate: AE that is usually alleviated with additional specific therapeutic intervention. The event interferes with usual activities of daily living, causing discomfort but poses no significant or permanent risk of harm to the research participant. Severe: AE that interrupts usual activities of daily living, significantly affects clinical status, or may require intensive therapeutic intervention. The percentage of participants was rounded to one place of decimal. | Analysis was performed on the SAS, which consisted of all participants enrolled in the study who received at least 1 dose of the IP. | Posted | | Number | | Percentage of participants | | Up to Month 12 | | | | ID | Title | Description |
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| OG000 | CSL312 (Garadacimab) Q2M | Participants aged 2 to 5 years received SC injection of CSL312 (Garadacimab) 100 mg Q2M starting from Day 1 up to Month 12. | | OG001 | CSL312 (Garadacimab) Q1M | Participants aged 6 to 11 years received SC injection of CSL312 (Garadacimab) 100 mg Q1M starting from Day 1 up to Month 12. |
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| Secondary | Number of Participants With Anti-CSL312 Antibodies | | Analysis was performed on the SAS, which consisted of all participants enrolled in the study who received at least 1 dose of the IP. Here, 'number analyzed' = participants with available data at each specified timepoint. | Posted | | Count of Participants | | Participants | | At Day 1, Months 6 and 12 | | | | ID | Title | Description |
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| OG000 | CSL312 (Garadacimab) Q2M | Participants aged 2 to 5 years received SC injection of CSL312 (Garadacimab) 100 mg Q2M starting from Day 1 up to Month 12. | | OG001 | CSL312 (Garadacimab) Q1M | Participants aged 6 to 11 years received SC injection of CSL312 (Garadacimab) 100 mg Q1M starting from Day 1 up to Month 12. |
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| Secondary | Percentage of Participants With Anti-CSL312 Antibodies | The percentage of participants was rounded to one place of decimal. | Analysis was performed on the SAS, which consisted of all participants enrolled in the study who received at least 1 dose of the IP. Here, 'number analyzed' = participants with available data at each specified timepoint. | Posted | | Number | | Percentage of participants | | At Day 1, Months 6 and 12 | | | | ID | Title | Description |
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| OG000 | CSL312 (Garadacimab) Q2M | Participants aged 2 to 5 years received SC injection of CSL312 (Garadacimab) 100 mg Q2M starting from Day 1 up to Month 12. | | OG001 | CSL312 (Garadacimab) Q1M | Participants aged 6 to 11 years received SC injection of CSL312 (Garadacimab) 100 mg Q1M starting from Day 1 up to Month 12. |
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| Secondary | Number of Participants With Adverse Events of Special Interest (AESI) | AESI included severe hypersensitivity including anaphylaxis. The AESI reported have been identified by investigators and suggestive events were independently identified for further review with a Standardized MedDRA Query (SMQ). | Analysis was performed on the SAS, which consisted of all participants enrolled in the study who received at least 1 dose of the IP. | Posted | | Count of Participants | | Participants | | Up to Month 12 | | | | ID | Title | Description |
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| OG000 | CSL312 (Garadacimab) Q2M | Participants aged 2 to 5 years received SC injection of CSL312 (Garadacimab) 100 mg Q2M starting from Day 1 up to Month 12. | | OG001 | CSL312 (Garadacimab) Q1M | Participants aged 6 to 11 years received SC injection of CSL312 (Garadacimab) 100 mg Q1M starting from Day 1 up to Month 12. |
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| Secondary | Percentage of Participants With AESI | AESI included severe hypersensitivity including anaphylaxis. The AESI reported have been identified by investigators and suggestive events were independently identified for further review with an SMQ. The percentage of participants was rounded to one place of decimal. | Analysis was performed on the SAS, which consisted of all participants enrolled in the study who received at least 1 dose of the IP. | Posted | | Number | | Percentage of participants | | Up to Month 12 | | | | ID | Title | Description |
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| OG000 | CSL312 (Garadacimab) Q2M | Participants aged 2 to 5 years received SC injection of CSL312 (Garadacimab) 100 mg Q2M starting from Day 1 up to Month 12. | | OG001 | CSL312 (Garadacimab) Q1M | Participants aged 6 to 11 years received SC injection of CSL312 (Garadacimab) 100 mg Q1M starting from Day 1 up to Month 12. |
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| Secondary | FXIIa-mediated Kallikrein Activity | | Analysis was performed on the Pharmacodynamic (PD) analysis set, which consisted of all participants in the SAS for whom at least one PD measurement was obtained. Here, 'number analyzed' = participants with available data at each specified timepoint. | Posted | | Mean | Standard Deviation | DeltaA405 nanometer per minute | | At Months 3, 4, and 12 and pre-dose and post dose at Months 6, 9, and 10 | | | | ID | Title | Description |
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| OG000 | CSL312 (Garadacimab) Q2M | Participants aged 2 to 5 years received SC injection of CSL312 (Garadacimab) 100 mg Q2M starting from Day 1 up to Month 12. | | OG001 | CSL312 (Garadacimab) Q1M | Participants aged 6 to 11 years received SC injection of CSL312 (Garadacimab) 100 mg Q1M starting from Day 1 up to Month 12. |
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| Secondary | Percent of Baseline FXIIa-mediated Kallikrein Activity | Percent of Baseline at Visit [i] = 100 * (actual value at Visit [i] / Baseline value), where Baseline is defined as the most recent, non-missing value before the first IP administration (including unscheduled visits). Here unit of measure is Percent (%) of FXIIa-mediated Kallikrein Activity. | Analysis was performed on the PD analysis set, which consisted of all participants in the SAS for whom at least one PD measurement was obtained. Here, 'number analyzed' = participants with available data at each specified timepoint. | Posted | | Mean | Standard Deviation | % FXIIa-mediated Kallikrein Activity | | At Months 3, 4, and 12 and pre-dose and post dose at Months 6, 9, and 10 | | | | ID | Title | Description |
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| OG000 | CSL312 (Garadacimab) Q2M | Participants aged 2 to 5 years received SC injection of CSL312 (Garadacimab) 100 mg Q2M starting from Day 1 up to Month 12. | | OG001 | CSL312 (Garadacimab) Q1M | Participants aged 6 to 11 years received SC injection of CSL312 (Garadacimab) 100 mg Q1M starting from Day 1 up to Month 12. |
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| Secondary | Number of Participants With Laboratory Findings Reported as AE | | Analysis was performed on the SAS, which consisted of all participants enrolled in the study who received at least 1 dose of the IP. | Posted | | Count of Participants | | Participants | | Up to Month 12 | | | | ID | Title | Description |
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| OG000 | CSL312 (Garadacimab) Q2M | Participants aged 2 to 5 years received SC injection of CSL312 (Garadacimab) 100 mg Q2M starting from Day 1 up to Month 12. | | OG001 | CSL312 (Garadacimab) Q1M | Participants aged 6 to 11 years received SC injection of CSL312 (Garadacimab) 100 mg Q1M starting from Day 1 up to Month 12. |
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| Secondary | Percentage of Participants With Laboratory Findings Reported as AE | The participant data were rounded to one decimal place. | Analysis was performed on the SAS, which consisted of all participants enrolled in the study who received at least 1 dose of the IP. | Posted | | Number | | Percentage of participants | | Up to Month 12 | | | | ID | Title | Description |
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| OG000 | CSL312 (Garadacimab) Q2M | Participants aged 2 to 5 years received SC injection of CSL312 (Garadacimab) 100 mg Q2M starting from Day 1 up to Month 12. | | OG001 | CSL312 (Garadacimab) Q1M | Participants aged 6 to 11 years received SC injection of CSL312 (Garadacimab) 100 mg Q1M starting from Day 1 up to Month 12. |
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