| Primary | Number of Participants With Treatment-emergent Adverse Events (TEAE) | | Analysis was performed on the Safety analysis set which consisted of all participants in the ATP analysis set who received at least one dose of investigational product (IP), and were analyzed using the actual treatment received. Here, 'overall number of participants analyzed' = participants with available data for this endpoint. | Posted | | Count of Participants | | Participants | | Approximately up to 54 months | | | | ID | Title | Description |
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| OG000 | Participants With c1-esterase Inhibitor (c1-INH) Hereditary Angioedema (HAE) | Participants with c1-INH HAE received CSL312 at 200 mg SC once monthly. |
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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 Safety analysis set which consisted of all participants in the ATP analysis set who received at least one dose of IP, and were analyzed using the actual treatment received. Here, 'overall number of participants analyzed' = participants with available data for this endpoint. | Posted | | Number | | Percentage of participants | | Approximately up to 54 months | | | | ID | Title | Description |
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| OG000 | Participants With c1-INH HAE | Participants with c1-INH HAE received CSL312 at 200 mg SC once monthly. |
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| Primary | Number of TEAE | | Analysis was performed on the Safety analysis set which consisted of all participants in the ATP analysis set who received at least one dose of IP, and were analyzed using the actual treatment received. Here, 'overall number of participants analyzed' = participants with available data for this endpoint. | Posted | | Number | | Events | | Approximately up to 54 months | | | | ID | Title | Description |
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| OG000 | Participants With c1-INH HAE | Participants with c1-INH HAE received CSL312 at 200 mg SC once monthly. |
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| Primary | TEAE Rates Per Injection | The TEAE rate per injection was calculated as the number of TEAE/ total number of injections. The number of injections was defined as the total injections received by participants during the respective safety evaluation period. | Analysis was performed on the Safety analysis set which consisted of all participants in the ATP analysis set who received at least one dose of IP, and were analyzed using the actual treatment received. Here, 'overall number of participants analyzed' = participants with available data for this endpoint. | Posted | | Number | | Number of TEAE per injection | | Approximately up to 54 months | | | | ID | Title | Description |
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| OG000 | Participants With c1-INH HAE | Participants with c1-INH HAE received CSL312 at 200 mg SC once monthly. |
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| Primary | TEAE Rates Per Participant Year | The TEAE rate per participant year was calculated as the total number of TEAE/ participant years. Participant years was defined as the sum of the time (in years) that participant were exposed to study treatment during the respective safety evaluation period. | Analysis was performed on the Safety analysis set which consisted of all participants in the ATP analysis set who received at least one dose of IP, and were analyzed using the actual treatment received. Here, 'overall number of participants analyzed' = participants with available data for this endpoint. | Posted | | Number | | Number of TEAE per participant year | | Approximately up to 54 months | | | | ID | Title | Description |
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| OG000 | Participants With c1-INH HAE | Participants with c1-INH HAE received CSL312 at 200 mg SC once monthly. |
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| Secondary | The Time-normalized Number (Per Month) of Hereditary Angioedema (HAE) Attacks During the Run-in Period and Treatment Period | 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 ATP analysis set which consisted of all participants in the Screened analysis set who were assigned to treatment. | Posted | | Median | 95% Confidence Interval | Number of HAE attacks per month | | Run-in Period: Up to Day 60 and Treatment Period: Approximately up to 52 months | | | | ID | Title | Description |
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| OG000 | CSL312 (Garadacimab) | Participants who rolled over from previous CSL312 (garadacimab) studies into this study received CSL312 at 200 mg SC once monthly. The treatment-naive participants received a loading dose of 400 mg (two 200 mg) CSL312 in the first month, followed by 200 mg CSL312 once monthly in subsequent months. |
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| Secondary | The Time-normalized Number (Per Year) of HAE Attacks During Treatment Period | 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 ATP analysis set which consisted of all participants in the Screened analysis set who were assigned to treatment. | Posted | | Median | 95% Confidence Interval | Number of HAE attacks per year | | Approximately up to 52 months | | | | ID | Title | Description |
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| OG000 | CSL312 (Garadacimab) | Participants who rolled over from previous CSL312 (garadacimab) studies into this study received CSL312 at 200 mg SC once monthly. The treatment-naive participants received a loading dose of 400 mg (two 200 mg) CSL312 in the first month, followed by 200 mg CSL312 once monthly in subsequent months. |
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| Secondary | Percentage Reduction in the Attack Rate During the Treatment Period Compared to the Run-in Period | The percentage reduction in the time-normalized number of HAE attacks was calculated within a participant as: 100*(1- time normalized number of HAE attacks per month during Treatment Period/time-normalized number of HAE attacks per month during Run-in Period). | Analysis was performed on the ATP analysis set which consisted of all participants in the Screened analysis set who were assigned to treatment. | Posted | | Mean | Standard Deviation | Percentage reduction in HAE attacks | | Run-in Period: Up to 60 days and Treatment Period: Approximately up to 52 months | | | | ID | Title | Description |
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| OG000 | CSL312 (Garadacimab) | Participants who rolled over from previous CSL312 (garadacimab) studies into this study received CSL312 at 200 mg SC once monthly. The treatment-naive participants received a loading dose of 400 mg (two 200 mg) CSL312 in the first month, followed by 200 mg CSL312 once monthly in subsequent months. |
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| Secondary | Number of Participants With Percentage Reduction (of >=50%, >=70%, >=90%, and 100%) in HAE Attacks | The number of participants who achieved a percentage reduction in HAE attacks of >=50% (also considered as responders), >=70%, >=90%, and 100% (attack free) during the Treatment Period compared with the Run-in Period. The percentage reduction in the time-normalized number of HAE attacks per month was calculated as 100*[1 - (time-normalized number of HAE attacks per month under CSL312 treatment / time-normalized number of HAE attacks per month during Run-in Period)]. | Analysis was performed on the ATP analysis set which consisted of all participants in the Screened analysis set who were assigned to treatment. | Posted | | Count of Participants | | Participants | | Run-in Period: Up to Day 60 and Treatment Period: Approximately up to 52 months | | | | ID | Title | Description |
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| OG000 | CSL312 (Garadacimab) | Participants who rolled over from previous CSL312 (garadacimab) studies into this study received CSL312 at 200 mg SC once monthly. The treatment-naive participants received a loading dose of 400 mg (two 200 mg) CSL312 in the first month, followed by 200 mg CSL312 once monthly in subsequent months. |
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| Secondary | The Time-normalized Number (Per Month) of HAE Attacks Requiring On-demand Treatment | Time-normalized number of HAE attacks per month requiring on demand treatment was calculated per participant as: [number of HAE attacks requiring on demand treatment during treatment period / length of participant treatment in days]*30.4375. | Analysis was performed on the ATP analysis set which consisted of all participants in the Screened analysis set who were assigned to treatment. | Posted | | Median | 95% Confidence Interval | Number of HAE attacks per month | | Approximately up to 52 months | | | | ID | Title | Description |
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| OG000 | CSL312 (Garadacimab) | Participants who rolled over from previous CSL312 (garadacimab) studies into this study received CSL312 at 200 mg SC once monthly. The treatment-naive participants received a loading dose of 400 mg (two 200 mg) CSL312 in the first month, followed by 200 mg CSL312 once monthly in subsequent months. |
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| Secondary | The Time-normalized Number (Per Year) of HAE Attacks Requiring On-demand Treatment | Time-normalized number of HAE attacks requiring on demand treatment per year was calculated per participant as: [number of HAE attacks requiring on demand treatment during treatment period / length of participant treatment in days]*365.25. | Analysis was performed on the ATP analysis set which consisted of all participants in the Screened analysis set who were assigned to treatment. | Posted | | Median | 95% Confidence Interval | Number of HAE attacks per year | | Approximately up to 52 months | | | | ID | Title | Description |
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| OG000 | CSL312 (Garadacimab) | Participants who rolled over from previous CSL312 (garadacimab) studies into this study received CSL312 at 200 mg SC once monthly. The treatment-naive participants received a loading dose of 400 mg (two 200 mg) CSL312 in the first month, followed by 200 mg CSL312 once monthly in subsequent months. |
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| Secondary | The Time-normalized Number (Per Month) of Moderate and/or Severe HAE Attacks | 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 ATP analysis set which consisted of all participants in the Screened analysis set who were assigned to treatment. | Posted | | Median | 95% Confidence Interval | Number of HAE attacks per month | | Approximately up to 52 months | | | | ID | Title | Description |
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| OG000 | CSL312 (Garadacimab) | Participants who rolled over from previous CSL312 (garadacimab) studies into this study received CSL312 at 200 mg SC once monthly. The treatment-naive participants received a loading dose of 400 mg (two 200 mg) CSL312 in the first month, followed by 200 mg CSL312 once monthly in subsequent months. |
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| Secondary | The Time-normalized Number (Per Year) of Moderate and/or Severe HAE Attacks | Time-normalized number of moderate or severe HAE attacks per year 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 ATP analysis set which consisted of all participants in the Screened analysis set who were assigned to treatment. | Posted | | Median | 95% Confidence Interval | Number of HAE attacks per year | | Approximately up to 52 months | | | | ID | Title | Description |
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| OG000 | CSL312 (Garadacimab) | Participants who rolled over from previous CSL312 (garadacimab) studies into this study received CSL312 at 200 mg SC once monthly. The treatment-naive participants received a loading dose of 400 mg (two 200 mg) CSL312 in the first month, followed by 200 mg CSL312 once monthly in subsequent months. |
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| Secondary | Number of Participants Rating Their Response to Therapy as Good or Excellent | Number of participants rating their response to therapy as good or excellent was evaluated as per Subject's Global Assessment of Response to Therapy (SGART) questionnaire. SGART is a patient-reported outcome that represents the participant's overall response to treatment using the following ratings: (0) none: worse or no response at all, not acceptable, (1) poor: very little response, not acceptable, (2) fair: some response, acceptable but could be better, (3) good: good response, acceptable, and (4) excellent: excellent response, as good as can be imagined. Cumulative responses as "Good or Excellent" are reported for this outcome measure. | Analysis was performed on the ATP analysis set which consisted of all participants in the Screened analysis set who were assigned to treatment. The 'number analyzed' represents the participants with available data for each specified category. | Posted | | Count of Participants | | Participants | | At Months 12, 24, and 36 | | | | ID | Title | Description |
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| OG000 | CSL312 (Garadacimab) | Participants who rolled over from previous CSL312 (garadacimab) studies into this study received CSL312 at 200 mg SC once monthly. The treatment-naive participants received a loading dose of 400 mg (two 200 mg) CSL312 in the first month, followed by 200 mg CSL312 once monthly in subsequent months. |
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| Secondary | Percentage of Participants Rating Their Response to Therapy as Good or Excellent | Percentage of participants rating their response to therapy as good or excellent was evaluated as per SGART questionnaire. SGART is a patient-reported outcome that represents the participant's overall response to treatment using the following ratings: (0) none: worse or no response at all, not acceptable, (1) poor: very little response, not acceptable, (2) fair: some response, acceptable but could be better, (3) good: good response, acceptable, and (4) excellent: excellent response, as good as can be imagined. Cumulative responses as "Good or Excellent" are reported for this outcome measure. The percentage of participants was rounded to one place of decimal. | Analysis was performed on the ATP analysis set which consisted of all participants in the Screened analysis set who were assigned to treatment. The 'number analyzed' represents the participants with available data for each specified category. | Posted | | Number | | Percentage of Participants | | At Months 12, 24, and 36 | | | | ID | Title | Description |
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| OG000 | CSL312 (Garadacimab) | Participants who rolled over from previous CSL312 (garadacimab) studies into this study received CSL312 at 200 mg SC once monthly. The treatment-naive participants received a loading dose of 400 mg (two 200 mg) CSL312 in the first month, followed by 200 mg CSL312 once monthly in subsequent months. |
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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 Safety analysis set which consisted of all participants in the all treated participants analysis set who received at least 1 dose of IP, and were analyzed using the actual treatment received. | Posted | | Count of Participants | | Participants | | Approximately up to 54 months | | | | ID | Title | Description |
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| OG000 | CSL312 (Garadacimab) | Participants who rolled over from previous CSL312 (garadacimab) studies into this study received CSL312 at 200 mg SC once monthly. The treatment-naive participants received a loading dose of 400 mg (two 200 mg) CSL312 in the first month, followed by 200 mg CSL312 once monthly in subsequent months. |
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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 Safety analysis set which consisted of all participants in the all treated participants analysis set who received at least 1 dose of IP, and were analyzed using the actual treatment received. | Posted | | Number | | Percentage of participants | | Approximately up to 54 months | | | | ID | Title | Description |
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| OG000 | CSL312 (Garadacimab) | Participants who rolled over from previous CSL312 (garadacimab) studies into this study received CSL312 at 200 mg SC once monthly. The treatment-naive participants received a loading dose of 400 mg (two 200 mg) CSL312 in the first month, followed by 200 mg CSL312 once monthly in subsequent months. |
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| Secondary | Number of Participants Experiencing TEAE by Severity | Severity of AE was assessed by the investigator and categorized as mild, moderate and severe. A 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. A 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. A severe AE that interrupts usual activities of daily living, significantly affects clinical status, or may require intensive therapeutic intervention. | Analysis was performed on the Safety analysis set which consisted of all participants in the all treated participants analysis set who received at least 1 dose of IP, and were analyzed using the actual treatment received. | Posted | | Count of Participants | | Participants | | Approximately up to 54 months | | | | ID | Title | Description |
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| OG000 | CSL312 (Garadacimab) | Participants who rolled over from previous CSL312 (garadacimab) studies into this study received CSL312 at 200 mg SC once monthly. The treatment-naive participants received a loading dose of 400 mg (two 200 mg) CSL312 in the first month, followed by 200 mg CSL312 once monthly in subsequent months. |
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| Secondary | Percentage of Participants Experiencing TEAE by Severity | Severity of AE was assessed by the investigator and categorized as mild, moderate and severe. A 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. A 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. A 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 decimal place. | Analysis was performed on the Safety analysis set which included all participants in the all treated participants analysis set who received at least 1 dose of IP, and were analyzed using the actual treatment received. | Posted | | Number | | Percentage of participants | | Approximately up to 54 months | | | | ID | Title | Description |
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| OG000 | CSL312 (Garadacimab) | Participants who rolled over from previous CSL312 (garadacimab) studies into this study received CSL312 at 200 mg SC once monthly. The treatment-naive participants received a loading dose of 400 mg (two 200 mg) CSL312 in the first month, followed by 200 mg CSL312 once monthly in subsequent months. |
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| Secondary | Number of Participants Experiencing Adverse Events of Special Interest (AESI) | The AESI defined for this study were thromboembolic events, abnormal bleeding events, and severe hypersensitivity including anaphylaxis. The AESI reported have been identified by investigators. | Analysis was performed on the Safety analysis set which included all participants in the all treated participants analysis set who received at least 1 dose of IP, and were analyzed using the actual treatment received. | Posted | | Count of Participants | | Participants | | Approximately up to 54 months | | | | ID | Title | Description |
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| OG000 | CSL312 (Garadacimab) | Participants who rolled over from previous CSL312 (garadacimab) studies into this study received CSL312 at 200 mg SC once monthly. The treatment-naive participants received a loading dose of 400 mg (two 200 mg) CSL312 in the first month, followed by 200 mg CSL312 once monthly in subsequent months. |
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| Secondary | Percentage of Participants Experiencing AESI | The AESI defined for this study were thromboembolic events, abnormal bleeding events, and severe hypersensitivity including anaphylaxis. The AESI reported have been identified by investigators. | Analysis was performed on the Safety analysis set which included all participants in the all treated participants analysis set who received at least 1 dose of IP, and were analyzed using the actual treatment received. | Posted | | Number | | Percenatge of participants | | Approximately up to 54 months | | | | ID | Title | Description |
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| OG000 | CSL312 (Garadacimab) | Participants who rolled over from previous CSL312 (garadacimab) studies into this study received CSL312 at 200 mg SC once monthly. The treatment-naive participants received a loading dose of 400 mg (two 200 mg) CSL312 in the first month, followed by 200 mg CSL312 once monthly in subsequent months. |
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| Secondary | Number of Participants With Laboratory Findings Reported as TEAE | | Analysis was performed on the safety analysis set which included all participants in the all treated participants analysis set who received at least 1 dose of IP, and were analyzed using the actual treatment received. | Posted | | Count of Participants | | Participants | | Approximately up to 54 months | | | | ID | Title | Description |
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| OG000 | CSL312 (Garadacimab) | Participants who rolled over from previous CSL312 (garadacimab) studies into this study received CSL312 at 200 mg SC once monthly. The treatment-naive participants received a loading dose of 400 mg (two 200 mg) CSL312 in the first month, followed by 200 mg CSL312 once monthly in subsequent months. |
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| Secondary | Percentage of Participants With Laboratory Findings Reported as TEAE | The percentage of participant was rounded to one place of decimal. | Analysis was performed on the safety analysis set which included all participants in the all treated participants analysis set who received at least 1 dose of IP, and were analyzed using the actual treatment received. | Posted | | Number | | Percentage of Participants | | Approximately up to 54 months | | | | ID | Title | Description |
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| OG000 | CSL312 (Garadacimab) | Participants who rolled over from previous CSL312 (garadacimab) studies into this study received CSL312 at 200 mg SC once monthly. The treatment-naive participants received a loading dose of 400 mg (two 200 mg) CSL312 in the first month, followed by 200 mg CSL312 once monthly in subsequent months. |
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| Secondary | Number of Participants With Normal C1-esterase Inhibitor (nC1-INH) Experiencing TEAE | | Analysis was performed on the Safety analysis set which consisted of all participants in the all treated participants analysis set who received at least 1 dose of IP, and were analyzed using the actual treatment received. Here, 'overall number of participants analyzed' = participants with available data for this endpoint. | Posted | | Count of Participants | | Participants | | Approximately up to 54 months | | | | ID | Title | Description |
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| OG000 | Participants With nC1-INH HAE | Participants with nC1-INH HAE received CSL312 at 200 mg SC once monthly |
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| Secondary | Percentage of Participants With nC1-INH Experiencing TEAE | | Analysis was performed on the Safety analysis set which consisted of all participants in the all treated participants analysis set who received at least 1 dose of IP, and were analyzed using the actual treatment received. Here, 'overall number of participants analyzed' = participants with available data for this endpoint. | Posted | | Number | | Percenatge of participants | | Approximately up to 54 months | | | | ID | Title | Description |
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| OG000 | Participants With nC1-INH HAE | Participants with nC1-INH HAE received CSL312 at 200 mg SC once monthly |
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| Secondary | Number of Participants With Anti-CSL312 Antibodies | | Analysis was performed on the Safety analysis set which included all participants in the all treated participants analysis set who received at least 1 dose of IP, and were analyzed using the actual treatment received. | Posted | | Count of Participants | | Participants | | At Day 1, Months 6, 12, 36 and 43 (end of treatment [EOT]) | | | | ID | Title | Description |
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| OG000 | CSL312 (Garadacimab) | Participants who rolled over from previous CSL312 (garadacimab) studies into this study received CSL312 at 200 mg SC once monthly. The treatment-naive participants received a loading dose of 400 mg (two 200 mg) CSL312 in the first month, followed by 200 mg CSL312 once monthly in subsequent months. |
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| Secondary | Percentage of Participants With Anti-CSL312 Antibodies | The percentage of participants was rounded to one decimal place. | Analysis was performed on the Safety analysis set which included all participants in the all treated participants analysis set who received at least 1 dose of IP, and were analyzed using the actual treatment received. | Posted | | Number | | Percentage of participants | | At Day 1, Months 6, 12, 36 and 43 (EOT) | | | | ID | Title | Description |
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| OG000 | CSL312 (Garadacimab) | Participants who rolled over from previous CSL312 (garadacimab) studies into this study received CSL312 at 200 mg SC once monthly. The treatment-naive participants received a loading dose of 400 mg (two 200 mg) CSL312 in the first month, followed by 200 mg CSL312 once monthly in subsequent months. |
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