Trial Outcomes & Findings for Long-term Safety and Efficacy of CSL312 (Garadacimab) in the Prophylactic Treatment of Hereditary Angioedema Attacks (NCT NCT04739059)
NCT ID: NCT04739059
Last Updated: 2026-06-02
Results Overview
The percentage of participants was rounded to one place of decimal.
COMPLETED
PHASE3
171 participants
Approximately up to 54 months
2026-06-02
Participant Flow
This study was conducted at 44 sites in 14 countries (Australia, Canada, Czechia, Germany, Hong Kong, Hungary, Israel, Japan, Netherlands, New Zealand, Russia, Spain, Taiwan, and United States of America).
Total of 171 participants provided informed consent, of which 92 were rolled over from prior studies (CSL312\_2001 and CSL312\_3001) and 79 were treatment-naive. Of 79 participants, 2 failed screening and 77 entered the run-in period. Only 69 participants completed the run-in period. Total of 8 participants discontinued during run-in period: 1 participated less than 1 month, 5 had insufficient HAE attacks, 1 discontinued due to a laboratory abnormality, and 1 discontinued for other reason.
Participant milestones
| Measure |
CSL312 (Garadacimab)
Participants who rolled over from previous CSL312 (garadacimab) studies into this study received CSL312 at 200 mg subcutaneously (SC) once monthly. The treatment-naive (newly enrolled) 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.
|
|---|---|
|
Overall Study
STARTED
|
161
|
|
Overall Study
COMPLETED
|
146
|
|
Overall Study
NOT COMPLETED
|
15
|
Reasons for withdrawal
| Measure |
CSL312 (Garadacimab)
Participants who rolled over from previous CSL312 (garadacimab) studies into this study received CSL312 at 200 mg subcutaneously (SC) once monthly. The treatment-naive (newly enrolled) 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.
|
|---|---|
|
Overall Study
Adverse Event
|
4
|
|
Overall Study
Pregnancy
|
1
|
|
Overall Study
Lack of Efficacy
|
1
|
|
Overall Study
Lost to Follow-up
|
1
|
|
Overall Study
Withdrawal by Subject
|
3
|
|
Overall Study
Physician Decision
|
2
|
|
Overall Study
Site Terminated by Sponsor due to war
|
3
|
Baseline Characteristics
Long-term Safety and Efficacy of CSL312 (Garadacimab) in the Prophylactic Treatment of Hereditary Angioedema Attacks
Baseline characteristics by cohort
| Measure |
CSL312 (Garadacimab)
n=161 Participants
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.
|
|---|---|
|
Age, Continuous
|
42.3 Years
STANDARD_DEVIATION 15.31 • n=9 Participants
|
|
Age, Customized
<=18 years
|
12 Participants
n=9 Participants
|
|
Age, Customized
Between 18 and 64 years
|
134 Participants
n=9 Participants
|
|
Age, Customized
>=65 years
|
15 Participants
n=9 Participants
|
|
Sex: Female, Male
Female
|
101 Participants
n=9 Participants
|
|
Sex: Female, Male
Male
|
60 Participants
n=9 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
9 Participants
n=9 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
150 Participants
n=9 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=9 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Asian
|
22 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=9 Participants
|
|
Race (NIH/OMB)
White
|
135 Participants
n=9 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=9 Participants
|
PRIMARY outcome
Timeframe: Approximately up to 54 monthsPopulation: 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.
Outcome measures
| Measure |
CSL312 (Garadacimab)
n=159 Participants
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.
|
|---|---|
|
Number of Participants With Treatment-emergent Adverse Events (TEAE)
|
146 Participants
|
PRIMARY outcome
Timeframe: Approximately up to 54 monthsPopulation: 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.
The percentage of participants was rounded to one place of decimal.
Outcome measures
| Measure |
CSL312 (Garadacimab)
n=159 Participants
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.
|
|---|---|
|
Percentage of Participants With TEAE
|
91.8 Percentage of participants
|
PRIMARY outcome
Timeframe: Approximately up to 54 monthsPopulation: 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.
Outcome measures
| Measure |
CSL312 (Garadacimab)
n=159 Participants
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.
|
|---|---|
|
Number of TEAE
|
1196 Events
|
PRIMARY outcome
Timeframe: Approximately up to 54 monthsPopulation: 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.
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.
Outcome measures
| Measure |
CSL312 (Garadacimab)
n=159 Participants
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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|---|---|
|
TEAE Rates Per Injection
|
0.20 Number of TEAE per injection
|
PRIMARY outcome
Timeframe: Approximately up to 54 monthsPopulation: 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.
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.
Outcome measures
| Measure |
CSL312 (Garadacimab)
n=159 Participants
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.
|
|---|---|
|
TEAE Rates Per Participant Year
|
2.26 Number of TEAE per participant year
|
SECONDARY outcome
Timeframe: Run-in Period: Up to Day 60 and Treatment Period: Approximately up to 52 monthsPopulation: Analysis was performed on the ATP analysis set which consisted of all participants in the Screened analysis set who were assigned to treatment.
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.
Outcome measures
| Measure |
CSL312 (Garadacimab)
n=161 Participants
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.
|
|---|---|
|
The Time-normalized Number (Per Month) of Hereditary Angioedema (HAE) Attacks During the Run-in Period and Treatment Period
Per month (Run-in Period)
|
2.85 Number of HAE attacks per month
Interval 2.61 to 3.17
|
|
The Time-normalized Number (Per Month) of Hereditary Angioedema (HAE) Attacks During the Run-in Period and Treatment Period
Per month (Treatment Period)
|
0.02 Number of HAE attacks per month
Interval 0.0 to 0.02
|
SECONDARY outcome
Timeframe: Approximately up to 52 monthsPopulation: Analysis was performed on the ATP analysis set which consisted of all participants in the Screened analysis set who were assigned to treatment.
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.
Outcome measures
| Measure |
CSL312 (Garadacimab)
n=161 Participants
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.
|
|---|---|
|
The Time-normalized Number (Per Year) of HAE Attacks During Treatment Period
|
0.25 Number of HAE attacks per year
Interval 0.0 to 0.28
|
SECONDARY outcome
Timeframe: Run-in Period: Up to 60 days and Treatment Period: Approximately up to 52 monthsPopulation: Analysis was performed on the ATP analysis set which consisted of all participants in the Screened analysis set who were assigned to treatment.
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).
Outcome measures
| Measure |
CSL312 (Garadacimab)
n=161 Participants
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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|---|---|
|
Percentage Reduction in the Attack Rate During the Treatment Period Compared to the Run-in Period
|
95.41 Percentage reduction in HAE attacks
Standard Deviation 11.073
|
SECONDARY outcome
Timeframe: Run-in Period: Up to Day 60 and Treatment Period: Approximately up to 52 monthsPopulation: 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 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\*\[1 - (time-normalized number of HAE attacks per month under CSL312 treatment / time-normalized number of HAE attacks per month during Run-in Period)\].
Outcome measures
| Measure |
CSL312 (Garadacimab)
n=161 Participants
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.
|
|---|---|
|
Number of Participants With Percentage Reduction (of >=50%, >=70%, >=90%, and 100%) in HAE Attacks
>= 50%
|
158 Participants
|
|
Number of Participants With Percentage Reduction (of >=50%, >=70%, >=90%, and 100%) in HAE Attacks
>= 70%
|
155 Participants
|
|
Number of Participants With Percentage Reduction (of >=50%, >=70%, >=90%, and 100%) in HAE Attacks
>= 90%
|
139 Participants
|
|
Number of Participants With Percentage Reduction (of >=50%, >=70%, >=90%, and 100%) in HAE Attacks
Attack free (Reduction of 100%)
|
76 Participants
|
SECONDARY outcome
Timeframe: Approximately up to 52 monthsPopulation: Analysis was performed on the ATP analysis set which consisted of all participants in the Screened analysis set who were assigned to 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.
Outcome measures
| Measure |
CSL312 (Garadacimab)
n=161 Participants
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.
|
|---|---|
|
The Time-normalized Number (Per Month) of HAE Attacks Requiring On-demand Treatment
|
0.00 Number of HAE attacks per month
Interval 0.0 to 0.02
|
SECONDARY outcome
Timeframe: Approximately up to 52 monthsPopulation: Analysis was performed on the ATP analysis set which consisted of all participants in the Screened analysis set who were assigned to 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.
Outcome measures
| Measure |
CSL312 (Garadacimab)
n=161 Participants
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.
|
|---|---|
|
The Time-normalized Number (Per Year) of HAE Attacks Requiring On-demand Treatment
|
0.00 Number of HAE attacks per year
Interval 0.0 to 0.25
|
SECONDARY outcome
Timeframe: Approximately up to 52 monthsPopulation: Analysis was performed on the ATP analysis set which consisted of all participants in the Screened analysis set who were assigned to treatment.
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.
Outcome measures
| Measure |
CSL312 (Garadacimab)
n=161 Participants
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.
|
|---|---|
|
The Time-normalized Number (Per Month) of Moderate and/or Severe HAE Attacks
|
0.00 Number of HAE attacks per month
Interval 0.0 to 0.02
|
SECONDARY outcome
Timeframe: Approximately up to 52 monthsPopulation: Analysis was performed on the ATP analysis set which consisted of all participants in the Screened analysis set who were assigned to treatment.
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.
Outcome measures
| Measure |
CSL312 (Garadacimab)
n=161 Participants
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.
|
|---|---|
|
The Time-normalized Number (Per Year) of Moderate and/or Severe HAE Attacks
|
0.00 Number of HAE attacks per year
Interval 0.0 to 0.23
|
SECONDARY outcome
Timeframe: At Months 12, 24, and 36Population: 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.
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.
Outcome measures
| Measure |
CSL312 (Garadacimab)
n=161 Participants
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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|---|---|
|
Number of Participants Rating Their Response to Therapy as Good or Excellent
At Month 12
|
136 Participants
|
|
Number of Participants Rating Their Response to Therapy as Good or Excellent
At Month 24
|
130 Participants
|
|
Number of Participants Rating Their Response to Therapy as Good or Excellent
At Month 36
|
108 Participants
|
SECONDARY outcome
Timeframe: At Months 12, 24, and 36Population: 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.
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.
Outcome measures
| Measure |
CSL312 (Garadacimab)
n=161 Participants
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.
|
|---|---|
|
Percentage of Participants Rating Their Response to Therapy as Good or Excellent
At Month 12
|
93.8 Percentage of Participants
|
|
Percentage of Participants Rating Their Response to Therapy as Good or Excellent
At Month 24
|
97.7 Percentage of Participants
|
|
Percentage of Participants Rating Their Response to Therapy as Good or Excellent
At Month 36
|
94.7 Percentage of Participants
|
SECONDARY outcome
Timeframe: Approximately up to 54 monthsPopulation: 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.
Outcome measures
| Measure |
CSL312 (Garadacimab)
n=161 Participants
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.
|
|---|---|
|
Number of Participants Experiencing Serious Adverse Events (SAE), Experiencing Death, Related TEAE, TEAE Leading to Study Discontinuation
SAE
|
14 Participants
|
|
Number of Participants Experiencing Serious Adverse Events (SAE), Experiencing Death, Related TEAE, TEAE Leading to Study Discontinuation
Experiencing Death
|
0 Participants
|
|
Number of Participants Experiencing Serious Adverse Events (SAE), Experiencing Death, Related TEAE, TEAE Leading to Study Discontinuation
Related TEAE
|
24 Participants
|
|
Number of Participants Experiencing Serious Adverse Events (SAE), Experiencing Death, Related TEAE, TEAE Leading to Study Discontinuation
TEAE leading to study discontinuation
|
4 Participants
|
SECONDARY outcome
Timeframe: Approximately up to 54 monthsPopulation: 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.
The percentage of participants was rounded to one decimal place.
Outcome measures
| Measure |
CSL312 (Garadacimab)
n=161 Participants
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.
|
|---|---|
|
Percentage of Participants Experiencing SAE, Experiencing Death, Related TEAE, TEAE Leading to Study Discontinuation
SAE
|
8.7 Percentage of participants
|
|
Percentage of Participants Experiencing SAE, Experiencing Death, Related TEAE, TEAE Leading to Study Discontinuation
Experiencing Death
|
0 Percentage of participants
|
|
Percentage of Participants Experiencing SAE, Experiencing Death, Related TEAE, TEAE Leading to Study Discontinuation
Related TEAE
|
14.9 Percentage of participants
|
|
Percentage of Participants Experiencing SAE, Experiencing Death, Related TEAE, TEAE Leading to Study Discontinuation
TEAE leading to study discontinuation
|
2.5 Percentage of participants
|
SECONDARY outcome
Timeframe: Approximately up to 54 monthsPopulation: 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.
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.
Outcome measures
| Measure |
CSL312 (Garadacimab)
n=161 Participants
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.
|
|---|---|
|
Number of Participants Experiencing TEAE by Severity
Mild
|
121 Participants
|
|
Number of Participants Experiencing TEAE by Severity
Moderate
|
111 Participants
|
|
Number of Participants Experiencing TEAE by Severity
Severe
|
20 Participants
|
|
Number of Participants Experiencing TEAE by Severity
Missing
|
1 Participants
|
SECONDARY outcome
Timeframe: Approximately up to 54 monthsPopulation: 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.
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.
Outcome measures
| Measure |
CSL312 (Garadacimab)
n=161 Participants
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.
|
|---|---|
|
Percentage of Participants Experiencing TEAE by Severity
Mild
|
75.2 Percentage of participants
|
|
Percentage of Participants Experiencing TEAE by Severity
Moderate
|
68.9 Percentage of participants
|
|
Percentage of Participants Experiencing TEAE by Severity
Severe
|
12.4 Percentage of participants
|
|
Percentage of Participants Experiencing TEAE by Severity
Missing
|
0.6 Percentage of participants
|
SECONDARY outcome
Timeframe: Approximately up to 54 monthsPopulation: 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.
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.
Outcome measures
| Measure |
CSL312 (Garadacimab)
n=161 Participants
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.
|
|---|---|
|
Number of Participants Experiencing Adverse Events of Special Interest (AESI)
Thromboembolic events (Investigator)
|
0 Participants
|
|
Number of Participants Experiencing Adverse Events of Special Interest (AESI)
Abnormal bleeding events (Investigator)
|
0 Participants
|
|
Number of Participants Experiencing Adverse Events of Special Interest (AESI)
Hypersensitivity including anaphylaxis (Investigator)
|
0 Participants
|
SECONDARY outcome
Timeframe: Approximately up to 54 monthsPopulation: 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.
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.
Outcome measures
| Measure |
CSL312 (Garadacimab)
n=161 Participants
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.
|
|---|---|
|
Percentage of Participants Experiencing AESI
Thromboembolic events (Investigator)
|
0 Percenatge of participants
|
|
Percentage of Participants Experiencing AESI
Abnormal bleeding events (Investigator)
|
0 Percenatge of participants
|
|
Percentage of Participants Experiencing AESI
Hypersensitivity including anaphylaxis (Investigator)
|
0 Percenatge of participants
|
SECONDARY outcome
Timeframe: Approximately up to 54 monthsPopulation: 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.
Outcome measures
| Measure |
CSL312 (Garadacimab)
n=161 Participants
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.
|
|---|---|
|
Number of Participants With Laboratory Findings Reported as TEAE
Urinary occult blood positive
|
1 Participants
|
|
Number of Participants With Laboratory Findings Reported as TEAE
Urinary sediment present
|
1 Participants
|
|
Number of Participants With Laboratory Findings Reported as TEAE
Urinary tract infection
|
1 Participants
|
|
Number of Participants With Laboratory Findings Reported as TEAE
Urine analysis abnormal
|
1 Participants
|
|
Number of Participants With Laboratory Findings Reported as TEAE
Hyperbilirubinaemia
|
1 Participants
|
|
Number of Participants With Laboratory Findings Reported as TEAE
Urine ketone body present
|
1 Participants
|
|
Number of Participants With Laboratory Findings Reported as TEAE
Lymphocyte count decreased
|
1 Participants
|
|
Number of Participants With Laboratory Findings Reported as TEAE
Neutrophil count decreased
|
1 Participants
|
|
Number of Participants With Laboratory Findings Reported as TEAE
Nitrite urine present
|
1 Participants
|
|
Number of Participants With Laboratory Findings Reported as TEAE
Platelet count increased
|
1 Participants
|
|
Number of Participants With Laboratory Findings Reported as TEAE
Protein urine present
|
1 Participants
|
|
Number of Participants With Laboratory Findings Reported as TEAE
Specific gravity urine increased
|
1 Participants
|
|
Number of Participants With Laboratory Findings Reported as TEAE
Thrombocytopenia
|
1 Participants
|
|
Number of Participants With Laboratory Findings Reported as TEAE
Bacterial test positive
|
6 Participants
|
|
Number of Participants With Laboratory Findings Reported as TEAE
Urinary squamous epithelial cells increased
|
4 Participants
|
|
Number of Participants With Laboratory Findings Reported as TEAE
White blood cells urine positive
|
2 Participants
|
|
Number of Participants With Laboratory Findings Reported as TEAE
Crystal urine present
|
2 Participants
|
|
Number of Participants With Laboratory Findings Reported as TEAE
Red blood cells urine positive
|
2 Participants
|
|
Number of Participants With Laboratory Findings Reported as TEAE
White blood cell count increased
|
2 Participants
|
|
Number of Participants With Laboratory Findings Reported as TEAE
Neutrophil count increased
|
1 Participants
|
|
Number of Participants With Laboratory Findings Reported as TEAE
Bilirubin conjugated increased
|
1 Participants
|
|
Number of Participants With Laboratory Findings Reported as TEAE
Blood bilirubin increased
|
1 Participants
|
|
Number of Participants With Laboratory Findings Reported as TEAE
Blood calcium decreased
|
1 Participants
|
|
Number of Participants With Laboratory Findings Reported as TEAE
Blood creatinine increased
|
1 Participants
|
|
Number of Participants With Laboratory Findings Reported as TEAE
Crystalluria
|
1 Participants
|
|
Number of Participants With Laboratory Findings Reported as TEAE
Cystitis
|
1 Participants
|
|
Number of Participants With Laboratory Findings Reported as TEAE
Fibrin D dimer increased
|
1 Participants
|
|
Number of Participants With Laboratory Findings Reported as TEAE
Gastroenteritis
|
1 Participants
|
SECONDARY outcome
Timeframe: Approximately up to 54 monthsPopulation: 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.
The percentage of participant was rounded to one place of decimal.
Outcome measures
| Measure |
CSL312 (Garadacimab)
n=161 Participants
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.
|
|---|---|
|
Percentage of Participants With Laboratory Findings Reported as TEAE
Blood creatinine increased
|
0.6 Percentage of Participants
|
|
Percentage of Participants With Laboratory Findings Reported as TEAE
Crystalluria
|
0.6 Percentage of Participants
|
|
Percentage of Participants With Laboratory Findings Reported as TEAE
Cystitis
|
0.6 Percentage of Participants
|
|
Percentage of Participants With Laboratory Findings Reported as TEAE
Fibrin D dimer increased
|
0.6 Percentage of Participants
|
|
Percentage of Participants With Laboratory Findings Reported as TEAE
Gastroenteritis
|
0.6 Percentage of Participants
|
|
Percentage of Participants With Laboratory Findings Reported as TEAE
Hyperbilirubinaemia
|
0.6 Percentage of Participants
|
|
Percentage of Participants With Laboratory Findings Reported as TEAE
Lymphocyte count decreased
|
0.6 Percentage of Participants
|
|
Percentage of Participants With Laboratory Findings Reported as TEAE
Neutrophil count decreased
|
0.6 Percentage of Participants
|
|
Percentage of Participants With Laboratory Findings Reported as TEAE
Nitrite urine present
|
0.6 Percentage of Participants
|
|
Percentage of Participants With Laboratory Findings Reported as TEAE
Platelet count increased
|
0.6 Percentage of Participants
|
|
Percentage of Participants With Laboratory Findings Reported as TEAE
Protein urine present
|
0.6 Percentage of Participants
|
|
Percentage of Participants With Laboratory Findings Reported as TEAE
Specific gravity urine increased
|
0.6 Percentage of Participants
|
|
Percentage of Participants With Laboratory Findings Reported as TEAE
Thrombocytopenia
|
0.6 Percentage of Participants
|
|
Percentage of Participants With Laboratory Findings Reported as TEAE
Urinary occult blood positive
|
0.6 Percentage of Participants
|
|
Percentage of Participants With Laboratory Findings Reported as TEAE
Urinary sediment present
|
0.6 Percentage of Participants
|
|
Percentage of Participants With Laboratory Findings Reported as TEAE
Urinary tract infection
|
0.6 Percentage of Participants
|
|
Percentage of Participants With Laboratory Findings Reported as TEAE
Urine ketone body present
|
0.6 Percentage of Participants
|
|
Percentage of Participants With Laboratory Findings Reported as TEAE
Bacterial test positive
|
3.7 Percentage of Participants
|
|
Percentage of Participants With Laboratory Findings Reported as TEAE
Urinary squamous epithelial cells increased
|
2.5 Percentage of Participants
|
|
Percentage of Participants With Laboratory Findings Reported as TEAE
White blood cells urine positive
|
1.2 Percentage of Participants
|
|
Percentage of Participants With Laboratory Findings Reported as TEAE
Crystal urine present
|
1.2 Percentage of Participants
|
|
Percentage of Participants With Laboratory Findings Reported as TEAE
Red blood cells urine positive
|
1.2 Percentage of Participants
|
|
Percentage of Participants With Laboratory Findings Reported as TEAE
White blood cell count increased
|
1.2 Percentage of Participants
|
|
Percentage of Participants With Laboratory Findings Reported as TEAE
Neutrophil count increased
|
0.6 Percentage of Participants
|
|
Percentage of Participants With Laboratory Findings Reported as TEAE
Bilirubin conjugated increased
|
0.6 Percentage of Participants
|
|
Percentage of Participants With Laboratory Findings Reported as TEAE
Blood bilirubin increased
|
0.6 Percentage of Participants
|
|
Percentage of Participants With Laboratory Findings Reported as TEAE
Blood calcium decreased
|
0.6 Percentage of Participants
|
|
Percentage of Participants With Laboratory Findings Reported as TEAE
Urine analysis abnormal
|
0.6 Percentage of Participants
|
SECONDARY outcome
Timeframe: Approximately up to 54 monthsPopulation: 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.
Outcome measures
| Measure |
CSL312 (Garadacimab)
n=2 Participants
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.
|
|---|---|
|
Number of Participants With Normal C1-esterase Inhibitor (nC1-INH) Experiencing TEAE
|
2 Participants
|
SECONDARY outcome
Timeframe: Approximately up to 54 monthsPopulation: 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.
Outcome measures
| Measure |
CSL312 (Garadacimab)
n=2 Participants
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.
|
|---|---|
|
Percentage of Participants With nC1-INH Experiencing TEAE
|
100 Percenatge of participants
|
SECONDARY outcome
Timeframe: At Day 1, Months 6, 12, 36 and 43 (end of treatment [EOT])Population: 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.
Outcome measures
| Measure |
CSL312 (Garadacimab)
n=161 Participants
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.
|
|---|---|
|
Number of Participants With Anti-CSL312 Antibodies
Day 1: Positive
|
1 Participants
|
|
Number of Participants With Anti-CSL312 Antibodies
Month 6: Positive
|
1 Participants
|
|
Number of Participants With Anti-CSL312 Antibodies
Month 12: Positive
|
4 Participants
|
|
Number of Participants With Anti-CSL312 Antibodies
Month 24: Positive
|
0 Participants
|
|
Number of Participants With Anti-CSL312 Antibodies
Month 36: Positive
|
0 Participants
|
|
Number of Participants With Anti-CSL312 Antibodies
EOT: Positive
|
2 Participants
|
SECONDARY outcome
Timeframe: At Day 1, Months 6, 12, 36 and 43 (EOT)Population: 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.
The percentage of participants was rounded to one decimal place.
Outcome measures
| Measure |
CSL312 (Garadacimab)
n=161 Participants
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.
|
|---|---|
|
Percentage of Participants With Anti-CSL312 Antibodies
Day 1: Positive
|
0.6 Percentage of participants
|
|
Percentage of Participants With Anti-CSL312 Antibodies
Month 6: Positive
|
0.6 Percentage of participants
|
|
Percentage of Participants With Anti-CSL312 Antibodies
Month 12: Positive
|
2.5 Percentage of participants
|
|
Percentage of Participants With Anti-CSL312 Antibodies
Month 24: Positive
|
0 Percentage of participants
|
|
Percentage of Participants With Anti-CSL312 Antibodies
Month 36: Positive
|
0 Percentage of participants
|
|
Percentage of Participants With Anti-CSL312 Antibodies
EOT: Positive
|
1.2 Percentage of participants
|
Adverse Events
CSL312 (Garadacimab)
Serious adverse events
| Measure |
CSL312 (Garadacimab)
n=161 participants at risk
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.
|
|---|---|
|
Infections and infestations
COVID-19
|
1.2%
2/161 • Number of events 2 • Approximately up to 54 months
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.
|
|
Infections and infestations
Appendicitis perforated
|
0.62%
1/161 • Number of events 1 • Approximately up to 54 months
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.
|
|
Infections and infestations
Gastroenteritis
|
0.62%
1/161 • Number of events 1 • Approximately up to 54 months
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.
|
|
Infections and infestations
Gastroenteritis viral
|
0.62%
1/161 • Number of events 1 • Approximately up to 54 months
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.
|
|
Infections and infestations
Sinusitis
|
0.62%
1/161 • Number of events 1 • Approximately up to 54 months
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.
|
|
Injury, poisoning and procedural complications
Craniofacial injury
|
0.62%
1/161 • Number of events 1 • Approximately up to 54 months
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.
|
|
Injury, poisoning and procedural complications
Hand fracture
|
0.62%
1/161 • Number of events 1 • Approximately up to 54 months
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.
|
|
Congenital, familial and genetic disorders
Hereditary angioedema
|
0.62%
1/161 • Number of events 1 • Approximately up to 54 months
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.
|
|
Gastrointestinal disorders
Abdominal incarcerated hernia
|
0.62%
1/161 • Number of events 1 • Approximately up to 54 months
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.
|
|
Immune system disorders
Food allergy
|
0.62%
1/161 • Number of events 1 • Approximately up to 54 months
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.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.62%
1/161 • Number of events 1 • Approximately up to 54 months
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.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.62%
1/161 • Number of events 1 • Approximately up to 54 months
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.
|
|
Nervous system disorders
Radiculopathy
|
0.62%
1/161 • Number of events 1 • Approximately up to 54 months
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.
|
|
Skin and subcutaneous tissue disorders
Drug eruption
|
0.62%
1/161 • Number of events 1 • Approximately up to 54 months
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.
|
|
Vascular disorders
Hypotension
|
0.62%
1/161 • Number of events 1 • Approximately up to 54 months
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.
|
Other adverse events
| Measure |
CSL312 (Garadacimab)
n=161 participants at risk
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.
|
|---|---|
|
Infections and infestations
COVID-19
|
41.6%
67/161 • Number of events 86 • Approximately up to 54 months
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.
|
|
Infections and infestations
Nasopharyngitis
|
28.0%
45/161 • Number of events 102 • Approximately up to 54 months
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.
|
|
Infections and infestations
Influenza
|
10.6%
17/161 • Number of events 20 • Approximately up to 54 months
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.
|
|
Infections and infestations
Upper respiratory tract infection
|
8.7%
14/161 • Number of events 17 • Approximately up to 54 months
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.
|
|
Infections and infestations
Sinusitis
|
6.2%
10/161 • Number of events 13 • Approximately up to 54 months
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.
|
|
Gastrointestinal disorders
Abdominal pain
|
6.8%
11/161 • Number of events 24 • Approximately up to 54 months
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.
|
|
General disorders
Injection site erythema
|
8.1%
13/161 • Number of events 18 • Approximately up to 54 months
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.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
8.1%
13/161 • Number of events 20 • Approximately up to 54 months
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.
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
6.2%
10/161 • Number of events 12 • Approximately up to 54 months
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.
|
|
Injury, poisoning and procedural complications
Fall
|
5.6%
9/161 • Number of events 10 • Approximately up to 54 months
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.
|
|
Nervous system disorders
Headache
|
9.3%
15/161 • Number of events 25 • Approximately up to 54 months
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.
|
|
Infections and infestations
Gastroenteritis
|
5.0%
8/161 • Number of events 8 • Approximately up to 54 months
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.
|
|
Infections and infestations
Urinary tract infection
|
5.0%
8/161 • Number of events 9 • Approximately up to 54 months
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.
|
|
Gastrointestinal disorders
Toothache
|
6.8%
11/161 • Number of events 19 • Approximately up to 54 months
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.
|
|
Gastrointestinal disorders
Diarrhoea
|
5.6%
9/161 • Number of events 9 • Approximately up to 54 months
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.
|
|
Injury, poisoning and procedural complications
Contusion
|
5.0%
8/161 • Number of events 10 • Approximately up to 54 months
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.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
6.2%
10/161 • Number of events 12 • Approximately up to 54 months
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.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place