Trial Outcomes & Findings for A Study to Evaluate the Clinical Pharmacology and Safety of C1-esterase Inhibitor Administered by the Subcutaneous Route (NCT NCT01576523)

NCT ID: NCT01576523

Last Updated: 2021-02-01

Results Overview

Mean trough C1-esterase inhibitor functional activity of the low, medium and high subcutaneous dose regimens, based on modeling and simulation

• Recruitment status: COMPLETED
• Study phase: PHASE1/PHASE2
• Target enrollment: 18 participants
• Primary outcome timeframe: at the fourth week of each dosing regimen
• Results posted on: 2021-02-01

Participant Flow

Participant milestones

Measure	Low, Then Medium, CSL830 Dose C1-esterase inhibitor - single intravenous dose(Berinert): A single intravenous dose of C1-esterase inhibitor at 20 units per kg body weight will be administered to all subjects prior to receiving the first dose of subcutaneous C1-esterase inhibitor (CSL830). C1-esterase inhibitor - subcutaneous low dose (CSL830): A low dose of C1-esterase inhibitor (1500 IU) will be administered subcutaneously twice a week for four weeks, then C1-esterase inhibitor - subcutaneous medium dose (CSL830): A medium dose of C1-esterase inhibitor (3000 IU) will be administered subcutaneously twice a week for four weeks.	Medium, Then Low, CSL830 Dose C1-esterase inhibitor - single intravenous dose(Berinert): A single intravenous dose of C1-esterase inhibitor at 20 units per kg body weight will be administered to all subjects prior to receiving the first dose of subcutaneous C1-esterase inhibitor (CSL830). C1-esterase inhibitor - subcutaneous medium dose (CSL830): A medium dose of C1-esterase inhibitor (3000 IU) will be administered subcutaneously twice a week for four weeks, then C1-esterase inhibitor - subcutaneous low dose (CSL830): A low dose of C1-esterase inhibitor (1500 IU) will be administered subcutaneously twice a week for four weeks.	Medium, Then High, CSL830 Dose C1-esterase inhibitor - single intravenous dose(Berinert): A single intravenous dose of C1-esterase inhibitor at 20 units per kg body weight will be administered to all subjects prior to receiving the first dose of subcutaneous C1-esterase inhibitor (CSL830). C1-esterase inhibitor - subcutaneous medium dose (CSL830): A medium dose of C1-esterase inhibitor (3000 IU) will be administered subcutaneously twice a week for four weeks, then C1-esterase inhibitor - subcutaneous high dose (CSL830): A high dose of C1-esterase inhibitor (6000 IU) will administered subcutaneously twice a week for four weeks.	Low, Then High, CSL830 Dose C1-esterase inhibitor - single intravenous dose(Berinert): A single intravenous dose of C1-esterase inhibitor at 20 units per kg body weight will be administered to all subjects prior to receiving the first dose of subcutaneous C1-esterase inhibitor (CSL830). C1-esterase inhibitor - subcutaneous low dose (CSL830): A low dose of C1-esterase inhibitor (1500 IU) will be administered subcutaneously twice a week for four weeks, then C1-esterase inhibitor - subcutaneous high dose (CSL830): A high dose of C1-esterase inhibitor (6000 IU) will administered subcutaneously twice a week for four weeks.	High, Then Low, CSL830 Dose C1-esterase inhibitor - single intravenous dose:(Berinert): A single intravenous dose of C1-esterase inhibitor at 20 units per kg body weight will be administered to all subjects prior to receiving the first dose of subcutaneous C1-esterase inhibitor (CSL830). C1-esterase inhibitor - subcutaneous high dose (CSL830): A high dose of C1-esterase inhibitor (6000 IU) will be administered subcutaneously twice a week for four weeks, then C1-esterase inhibitor - subcutaneous low dose (CSL830): A low dose of C1-esterase inhibitor (1500 IU) will administered subcutaneously twice a week for four weeks.	High, Then Medium, CSL830 Dose C1-esterase inhibitor - single intravenous dose(Berinert): A single intravenous dose of C1-esterase inhibitor at 20 units per kg body weight will be administered to all subjects prior to receiving the first dose of subcutaneous C1-esterase inhibitor (CSL830). C1-esterase inhibitor - subcutaneous high dose (CSL830): A high dose of C1-esterase inhibitor (6000 IU) will be administered subcutaneously twice a week for four weeks, then C1-esterase inhibitor - subcutaneous medium dose (CSL830): A medium dose of C1-esterase inhibitor (3000 IU) will be administered subcutaneously twice a week for four weeks.
Dosing Period 1 STARTED	3	3	3	3	3	3
Dosing Period 1 COMPLETED	3	3	3	3	3	3
Dosing Period 1 NOT COMPLETED	0	0	0	0	0	0
Dosing Period 2 STARTED	3	3	3	3	3	3
Dosing Period 2 COMPLETED	3	3	3	3	3	3
Dosing Period 2 NOT COMPLETED	0	0	0	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Study to Evaluate the Clinical Pharmacology and Safety of C1-esterase Inhibitor Administered by the Subcutaneous Route

Baseline characteristics by cohort

Measure	Low, Then Medium, CSL830 Dose n=3 Participants C1-esterase inhibitor - single intravenous dose(Berinert): A single intravenous dose of C1- esterase inhibitor at 20 units per kg body weight will be administered to all subjects prior to receiving the first dose of subcutaneous C1-esterase inhibitor (CSL830). C1-esterase inhibitor - subcutaneous low dose (CSL830): A low dose of C1- esterase inhibitor (1500 IU) will be administered subcutaneously twice a week for four weeks, then C1-esterase inhibitor - subcutaneous medium dose (CSL830): A medium dose of C1-esterase inhibitor (3000 IU) will be administered subcutaneously twice a week for four weeks.	Medium, Then Low, CSL830 Dose n=3 Participants C1-esterase inhibitor - single intravenous dose(Berinert): A single intravenous dose of C1- esterase inhibitor at 20 units per kg body weight will be administered to all subjects prior to receiving the first dose of subcutaneous C1-esterase inhibitor (CSL830). C1-esterase inhibitor - subcutaneous medium dose (CSL830): A medium dose of C1-esterase inhibitor (3000 IU) will be administered subcutaneously twice a week for four weeks, then C1-esterase inhibitor - subcutaneous low dose (CSL830): A low dose of C1- esterase inhibitor (1500 IU) will be administered subcutaneously twice a week for four weeks.	Medium, Then High, CSL830 Dose n=3 Participants C1-esterase inhibitor - single intravenous dose(Berinert): A single intravenous dose of C1- esterase inhibitor at 20 units per kg body weight will be administered to all subjects prior to receiving the first dose of subcutaneous C1-esterase inhibitor (CSL830). C1-esterase inhibitor - subcutaneous medium dose (CSL830): A medium dose of C1-esterase inhibitor (3000 IU) will be administered subcutaneously twice a week for four weeks, then C1-esterase inhibitor - subcutaneous high dose (CSL830): A high dose of C1-esterase inhibitor (6000 IU) will administered subcutaneously twice a week for four weeks.	Low, Then High, CSL830 Dose n=3 Participants C1-esterase inhibitor - single intravenous dose(Berinert): A single intravenous dose of C1- esterase inhibitor at 20 units per kg body weight will be administered to all subjects prior to receiving the first dose of subcutaneous C1-esterase inhibitor (CSL830). C1-esterase inhibitor - subcutaneous low dose (CSL830): A low dose of C1- esterase inhibitor (1500 IU) will be administered subcutaneously twice a week for four weeks, then C1-esterase inhibitor - subcutaneous high dose (CSL830): A high dose of C1-esterase inhibitor (6000 IU) will administered subcutaneously twice a week for four weeks.	High, Then Low, CSL830 Dose n=3 Participants C1-esterase inhibitor - single intravenous dose:(Berinert): A single intravenous dose of C1- esterase inhibitor at 20 units per kg body weight will be administered to all subjects prior to receiving the first dose of subcutaneous C1-esterase inhibitor (CSL830). C1-esterase inhibitor - subcutaneous high dose (CSL830): A high dose of C1-esterase inhibitor (6000 IU) will be administered subcutaneously twice a week for four weeks, then C1-esterase inhibitor - subcutaneous low dose (CSL830): A low dose of C1- esterase inhibitor (1500 IU) will administered subcutaneously twice a week for four weeks.	High, Then Medium, CSL830 Dose n=3 Participants C1-esterase inhibitor - single intravenous dose(Berinert): A single intravenous dose of C1- esterase inhibitor at 20 units per kg body weight will be administered to all subjects prior to receiving the first dose of subcutaneous C1-esterase inhibitor (CSL830). C1-esterase inhibitor - subcutaneous high dose (CSL830): A high dose of C1-esterase inhibitor (6000 IU) will be administered subcutaneously twice a week for four weeks, then C1-esterase inhibitor - subcutaneous medium dose (CSL830): A medium dose of C1-esterase inhibitor (3000 IU) will be administered subcutaneously twice a week for four weeks.	Total n=18 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants
Age, Categorical Between 18 and 65 years	3 Participants n=5 Participants	3 Participants n=7 Participants	2 Participants n=5 Participants	3 Participants n=4 Participants	3 Participants n=21 Participants	3 Participants n=8 Participants	17 Participants n=8 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	1 Participants n=8 Participants
Sex: Female, Male Female	2 Participants n=5 Participants	2 Participants n=7 Participants	1 Participants n=5 Participants	2 Participants n=4 Participants	2 Participants n=21 Participants	2 Participants n=8 Participants	11 Participants n=8 Participants
Sex: Female, Male Male	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants	1 Participants n=4 Participants	1 Participants n=21 Participants	1 Participants n=8 Participants	7 Participants n=8 Participants

PRIMARY outcome

Timeframe: at the fourth week of each dosing regimen

Population: Complete Analysis Set (CAS) - Subjects received at least 1 dose (complete or incomplete) of the dosing regimen of CSL830 and provided at least 1 C1-INH functional activity measurement during the dosing regimen (prior to the use of any prohibited concomitant therapy or prohibited change in dosage of a concomitant therapy)

Mean trough C1-esterase inhibitor functional activity of the low, medium and high subcutaneous dose regimens, based on modeling and simulation

Outcome measures

Measure	CSL830 (Low Dose) n=12 Participants A low dose of C1-esterase inhibitor (1500 IU) administered subcutaneously twice a week for four weeks	CSL830 (Medium Dose) n=12 Participants A medium dose of C1-esterase inhibitor (3000 IU) administered subcutaneously twice a week for four weeks	CSL830 (High Dose) n=12 Participants A high dose of C1-esterase inhibitor (6000 IU) administered subcutaneously twice a week for four weeks
Modeled C1-esterase Inhibitor Functional Activity Trough Level	30.3 percent functional activity Standard Deviation 9.07	45.9 percent functional activity Standard Deviation 14.35	80.6 percent functional activity Standard Deviation 23.47

SECONDARY outcome

Timeframe: during the last week of 4-week dose regimen

Population: As-observed analysis set - subset of the full analysis set (FAS). FAS consisted of all enrolled subjects (all subjects who gave informed consent).

Mean trough C1-esterase inhibitor functional activity of the low, medium and high subcutaneous dose regimens

Outcome measures

Measure	CSL830 (Low Dose) n=12 Participants A low dose of C1-esterase inhibitor (1500 IU) administered subcutaneously twice a week for four weeks	CSL830 (Medium Dose) n=11 Participants A medium dose of C1-esterase inhibitor (3000 IU) administered subcutaneously twice a week for four weeks	CSL830 (High Dose) n=12 Participants A high dose of C1-esterase inhibitor (6000 IU) administered subcutaneously twice a week for four weeks
As-observed C1-esterase Inhibitor Functional Activity Trough Level	31.7 percent functional activity Standard Deviation 9.97	44.3 percent functional activity Standard Deviation 17.73	80.5 percent functional activity Standard Deviation 24.92

SECONDARY outcome

Timeframe: during the last week of 4-week dose regimen

Population: As-observed analysis set

Mean trough C1-esterase inhibitor concentration of the low, medium and high subcutaneous dose regimens

Outcome measures

Measure	CSL830 (Low Dose) n=12 Participants A low dose of C1-esterase inhibitor (1500 IU) administered subcutaneously twice a week for four weeks	CSL830 (Medium Dose) n=11 Participants A medium dose of C1-esterase inhibitor (3000 IU) administered subcutaneously twice a week for four weeks	CSL830 (High Dose) n=12 Participants A high dose of C1-esterase inhibitor (6000 IU) administered subcutaneously twice a week for four weeks
C1-esterase Inhibitor Concentration Trough Level	0.06 mg/mL Standard Deviation 0.024	0.15 mg/mL Standard Deviation 0.130	0.23 mg/mL Standard Deviation 0.158

SECONDARY outcome

Timeframe: during the last week of 4-week dose regimen

Population: As-observed analysis set

Mean trough C4 concentration of the low, medium and high subcutaneous dose regimens

Outcome measures

Measure	CSL830 (Low Dose) n=12 Participants A low dose of C1-esterase inhibitor (1500 IU) administered subcutaneously twice a week for four weeks	CSL830 (Medium Dose) n=11 Participants A medium dose of C1-esterase inhibitor (3000 IU) administered subcutaneously twice a week for four weeks	CSL830 (High Dose) n=12 Participants A high dose of C1-esterase inhibitor (6000 IU) administered subcutaneously twice a week for four weeks
C4 Concentration Trough Level	11.1 mg/dL Standard Deviation 4.45	14.1 mg/dL Standard Deviation 5.28	18.4 mg/dL Standard Deviation 6.55

SECONDARY outcome

Timeframe: Baseline and during the last week of 4-week dose regimen

Population: As-observed analysis set

Mean change from baseline of C1-esterase inhibitor functional activity of the low, medium and high subcutaneous dose regimens

Outcome measures

Measure	CSL830 (Low Dose) n=12 Participants A low dose of C1-esterase inhibitor (1500 IU) administered subcutaneously twice a week for four weeks	CSL830 (Medium Dose) n=11 Participants A medium dose of C1-esterase inhibitor (3000 IU) administered subcutaneously twice a week for four weeks	CSL830 (High Dose) n=12 Participants A high dose of C1-esterase inhibitor (6000 IU) administered subcutaneously twice a week for four weeks
Change From Baseline in C1-esterase Inhibitor Functional Activity	16.4 percent functional activity Standard Deviation 7.41	33.2 percent functional activity Standard Deviation 11.32	63.3 percent functional activity Standard Deviation 21.33

SECONDARY outcome

Timeframe: Baseline and during the last week of 4-week dose regimen

Population: As-observed analysis set

Mean change from baseline of C1-esterase inhibitor concentration of the low, medium and high subcutaneous dose regimens

Outcome measures

Measure	CSL830 (Low Dose) n=12 Participants A low dose of C1-esterase inhibitor (1500 IU) administered subcutaneously twice a week for four weeks	CSL830 (Medium Dose) n=11 Participants A medium dose of C1-esterase inhibitor (3000 IU) administered subcutaneously twice a week for four weeks	CSL830 (High Dose) n=12 Participants A high dose of C1-esterase inhibitor (6000 IU) administered subcutaneously twice a week for four weeks
Change From Baseline in C1-esterase Inhibitor Concentration	0.02 mg/mL Standard Deviation 0.018	0.05 mg/mL Standard Deviation 0.029	0.14 mg/mL Standard Deviation 0.047

SECONDARY outcome

Timeframe: Baseline and during the last week of 4-week dose regimen

Population: As-observed analysis set

Mean change from baseline of C4 concentration of the low, medium and high subcutaneous dose regimens

Outcome measures

Measure	CSL830 (Low Dose) n=12 Participants A low dose of C1-esterase inhibitor (1500 IU) administered subcutaneously twice a week for four weeks	CSL830 (Medium Dose) n=11 Participants A medium dose of C1-esterase inhibitor (3000 IU) administered subcutaneously twice a week for four weeks	CSL830 (High Dose) n=12 Participants A high dose of C1-esterase inhibitor (6000 IU) administered subcutaneously twice a week for four weeks
Change From Baseline in C4 Concentration	4.3 mg/dL Standard Deviation 3.00	5.6 mg/dL Standard Deviation 11.90	9.1 mg/dL Standard Deviation 10.89

Adverse Events

Berinert

Serious events: 1 serious events

Other events: 4 other events

Deaths: 0 deaths

CSL830 (Low Dose)

Serious events: 0 serious events

Other events: 10 other events

Deaths: 0 deaths

CSL830 (Medium Dose)

Serious events: 0 serious events

Other events: 8 other events

Deaths: 0 deaths

CSL830 (High Dose)

Serious events: 1 serious events

Other events: 9 other events

Deaths: 0 deaths

Serious adverse events

Measure	Berinert n=18 participants at risk C1-esterase inhibitor - single intravenous dose: A single intravenous dose of C1-esterase inhibitor (Berinert) at 20 units per kg body weight will be administered to all subjects prior to receiving the first dose of subcutaneous C1-esterase inhibitor.	CSL830 (Low Dose) n=12 participants at risk A low dose of C1-esterase inhibitor (1500 IU) administered subcutaneously twice a week for four weeks	CSL830 (Medium Dose) n=12 participants at risk A medium dose of C1-esterase inhibitor (3000 IU) administered subcutaneously twice a week for four weeks	CSL830 (High Dose) n=12 participants at risk A high dose of C1-esterase inhibitor (6000 IU) administered subcutaneously twice a week for four weeks
Nervous system disorders Syncope	5.6% 1/18 • Number of events 1 • Up to 14 weeks per subject The safety set consisted of all enrolled subjects who received at least 1 dose (complete or incomplete) of study drug (Berinert or CSL830). Subjects were included in the safety set for a dosing regimen only if they received at least 1 dose of that dosing regimen (e.g., a subject who discontinued prior to taking the dosing period 2 dosing regimen was not included in the safety set for that dosing regimen).	0.00% 0/12 • Up to 14 weeks per subject The safety set consisted of all enrolled subjects who received at least 1 dose (complete or incomplete) of study drug (Berinert or CSL830). Subjects were included in the safety set for a dosing regimen only if they received at least 1 dose of that dosing regimen (e.g., a subject who discontinued prior to taking the dosing period 2 dosing regimen was not included in the safety set for that dosing regimen).	0.00% 0/12 • Up to 14 weeks per subject The safety set consisted of all enrolled subjects who received at least 1 dose (complete or incomplete) of study drug (Berinert or CSL830). Subjects were included in the safety set for a dosing regimen only if they received at least 1 dose of that dosing regimen (e.g., a subject who discontinued prior to taking the dosing period 2 dosing regimen was not included in the safety set for that dosing regimen).	0.00% 0/12 • Up to 14 weeks per subject The safety set consisted of all enrolled subjects who received at least 1 dose (complete or incomplete) of study drug (Berinert or CSL830). Subjects were included in the safety set for a dosing regimen only if they received at least 1 dose of that dosing regimen (e.g., a subject who discontinued prior to taking the dosing period 2 dosing regimen was not included in the safety set for that dosing regimen).
Vascular disorders Hypovolemic shock	0.00% 0/18 • Up to 14 weeks per subject The safety set consisted of all enrolled subjects who received at least 1 dose (complete or incomplete) of study drug (Berinert or CSL830). Subjects were included in the safety set for a dosing regimen only if they received at least 1 dose of that dosing regimen (e.g., a subject who discontinued prior to taking the dosing period 2 dosing regimen was not included in the safety set for that dosing regimen).	0.00% 0/12 • Up to 14 weeks per subject The safety set consisted of all enrolled subjects who received at least 1 dose (complete or incomplete) of study drug (Berinert or CSL830). Subjects were included in the safety set for a dosing regimen only if they received at least 1 dose of that dosing regimen (e.g., a subject who discontinued prior to taking the dosing period 2 dosing regimen was not included in the safety set for that dosing regimen).	0.00% 0/12 • Up to 14 weeks per subject The safety set consisted of all enrolled subjects who received at least 1 dose (complete or incomplete) of study drug (Berinert or CSL830). Subjects were included in the safety set for a dosing regimen only if they received at least 1 dose of that dosing regimen (e.g., a subject who discontinued prior to taking the dosing period 2 dosing regimen was not included in the safety set for that dosing regimen).	8.3% 1/12 • Number of events 1 • Up to 14 weeks per subject The safety set consisted of all enrolled subjects who received at least 1 dose (complete or incomplete) of study drug (Berinert or CSL830). Subjects were included in the safety set for a dosing regimen only if they received at least 1 dose of that dosing regimen (e.g., a subject who discontinued prior to taking the dosing period 2 dosing regimen was not included in the safety set for that dosing regimen).

Other adverse events

Measure	Berinert n=18 participants at risk C1-esterase inhibitor - single intravenous dose: A single intravenous dose of C1-esterase inhibitor (Berinert) at 20 units per kg body weight will be administered to all subjects prior to receiving the first dose of subcutaneous C1-esterase inhibitor.	CSL830 (Low Dose) n=12 participants at risk A low dose of C1-esterase inhibitor (1500 IU) administered subcutaneously twice a week for four weeks	CSL830 (Medium Dose) n=12 participants at risk A medium dose of C1-esterase inhibitor (3000 IU) administered subcutaneously twice a week for four weeks	CSL830 (High Dose) n=12 participants at risk A high dose of C1-esterase inhibitor (6000 IU) administered subcutaneously twice a week for four weeks
General disorders Injection site erythema	0.00% 0/18 • Up to 14 weeks per subject The safety set consisted of all enrolled subjects who received at least 1 dose (complete or incomplete) of study drug (Berinert or CSL830). Subjects were included in the safety set for a dosing regimen only if they received at least 1 dose of that dosing regimen (e.g., a subject who discontinued prior to taking the dosing period 2 dosing regimen was not included in the safety set for that dosing regimen).	16.7% 2/12 • Number of events 5 • Up to 14 weeks per subject The safety set consisted of all enrolled subjects who received at least 1 dose (complete or incomplete) of study drug (Berinert or CSL830). Subjects were included in the safety set for a dosing regimen only if they received at least 1 dose of that dosing regimen (e.g., a subject who discontinued prior to taking the dosing period 2 dosing regimen was not included in the safety set for that dosing regimen).	16.7% 2/12 • Number of events 3 • Up to 14 weeks per subject The safety set consisted of all enrolled subjects who received at least 1 dose (complete or incomplete) of study drug (Berinert or CSL830). Subjects were included in the safety set for a dosing regimen only if they received at least 1 dose of that dosing regimen (e.g., a subject who discontinued prior to taking the dosing period 2 dosing regimen was not included in the safety set for that dosing regimen).	41.7% 5/12 • Number of events 19 • Up to 14 weeks per subject The safety set consisted of all enrolled subjects who received at least 1 dose (complete or incomplete) of study drug (Berinert or CSL830). Subjects were included in the safety set for a dosing regimen only if they received at least 1 dose of that dosing regimen (e.g., a subject who discontinued prior to taking the dosing period 2 dosing regimen was not included in the safety set for that dosing regimen).
General disorders Injection site pain	0.00% 0/18 • Up to 14 weeks per subject The safety set consisted of all enrolled subjects who received at least 1 dose (complete or incomplete) of study drug (Berinert or CSL830). Subjects were included in the safety set for a dosing regimen only if they received at least 1 dose of that dosing regimen (e.g., a subject who discontinued prior to taking the dosing period 2 dosing regimen was not included in the safety set for that dosing regimen).	41.7% 5/12 • Number of events 13 • Up to 14 weeks per subject The safety set consisted of all enrolled subjects who received at least 1 dose (complete or incomplete) of study drug (Berinert or CSL830). Subjects were included in the safety set for a dosing regimen only if they received at least 1 dose of that dosing regimen (e.g., a subject who discontinued prior to taking the dosing period 2 dosing regimen was not included in the safety set for that dosing regimen).	0.00% 0/12 • Up to 14 weeks per subject The safety set consisted of all enrolled subjects who received at least 1 dose (complete or incomplete) of study drug (Berinert or CSL830). Subjects were included in the safety set for a dosing regimen only if they received at least 1 dose of that dosing regimen (e.g., a subject who discontinued prior to taking the dosing period 2 dosing regimen was not included in the safety set for that dosing regimen).	16.7% 2/12 • Number of events 12 • Up to 14 weeks per subject The safety set consisted of all enrolled subjects who received at least 1 dose (complete or incomplete) of study drug (Berinert or CSL830). Subjects were included in the safety set for a dosing regimen only if they received at least 1 dose of that dosing regimen (e.g., a subject who discontinued prior to taking the dosing period 2 dosing regimen was not included in the safety set for that dosing regimen).
General disorders Injection site swelling	0.00% 0/18 • Up to 14 weeks per subject The safety set consisted of all enrolled subjects who received at least 1 dose (complete or incomplete) of study drug (Berinert or CSL830). Subjects were included in the safety set for a dosing regimen only if they received at least 1 dose of that dosing regimen (e.g., a subject who discontinued prior to taking the dosing period 2 dosing regimen was not included in the safety set for that dosing regimen).	8.3% 1/12 • Number of events 1 • Up to 14 weeks per subject The safety set consisted of all enrolled subjects who received at least 1 dose (complete or incomplete) of study drug (Berinert or CSL830). Subjects were included in the safety set for a dosing regimen only if they received at least 1 dose of that dosing regimen (e.g., a subject who discontinued prior to taking the dosing period 2 dosing regimen was not included in the safety set for that dosing regimen).	0.00% 0/12 • Up to 14 weeks per subject The safety set consisted of all enrolled subjects who received at least 1 dose (complete or incomplete) of study drug (Berinert or CSL830). Subjects were included in the safety set for a dosing regimen only if they received at least 1 dose of that dosing regimen (e.g., a subject who discontinued prior to taking the dosing period 2 dosing regimen was not included in the safety set for that dosing regimen).	16.7% 2/12 • Number of events 3 • Up to 14 weeks per subject The safety set consisted of all enrolled subjects who received at least 1 dose (complete or incomplete) of study drug (Berinert or CSL830). Subjects were included in the safety set for a dosing regimen only if they received at least 1 dose of that dosing regimen (e.g., a subject who discontinued prior to taking the dosing period 2 dosing regimen was not included in the safety set for that dosing regimen).
General disorders Injection site haematoma	0.00% 0/18 • Up to 14 weeks per subject The safety set consisted of all enrolled subjects who received at least 1 dose (complete or incomplete) of study drug (Berinert or CSL830). Subjects were included in the safety set for a dosing regimen only if they received at least 1 dose of that dosing regimen (e.g., a subject who discontinued prior to taking the dosing period 2 dosing regimen was not included in the safety set for that dosing regimen).	8.3% 1/12 • Number of events 1 • Up to 14 weeks per subject The safety set consisted of all enrolled subjects who received at least 1 dose (complete or incomplete) of study drug (Berinert or CSL830). Subjects were included in the safety set for a dosing regimen only if they received at least 1 dose of that dosing regimen (e.g., a subject who discontinued prior to taking the dosing period 2 dosing regimen was not included in the safety set for that dosing regimen).	8.3% 1/12 • Number of events 1 • Up to 14 weeks per subject The safety set consisted of all enrolled subjects who received at least 1 dose (complete or incomplete) of study drug (Berinert or CSL830). Subjects were included in the safety set for a dosing regimen only if they received at least 1 dose of that dosing regimen (e.g., a subject who discontinued prior to taking the dosing period 2 dosing regimen was not included in the safety set for that dosing regimen).	0.00% 0/12 • Up to 14 weeks per subject The safety set consisted of all enrolled subjects who received at least 1 dose (complete or incomplete) of study drug (Berinert or CSL830). Subjects were included in the safety set for a dosing regimen only if they received at least 1 dose of that dosing regimen (e.g., a subject who discontinued prior to taking the dosing period 2 dosing regimen was not included in the safety set for that dosing regimen).
General disorders Chest pain	5.6% 1/18 • Number of events 1 • Up to 14 weeks per subject The safety set consisted of all enrolled subjects who received at least 1 dose (complete or incomplete) of study drug (Berinert or CSL830). Subjects were included in the safety set for a dosing regimen only if they received at least 1 dose of that dosing regimen (e.g., a subject who discontinued prior to taking the dosing period 2 dosing regimen was not included in the safety set for that dosing regimen).	0.00% 0/12 • Up to 14 weeks per subject The safety set consisted of all enrolled subjects who received at least 1 dose (complete or incomplete) of study drug (Berinert or CSL830). Subjects were included in the safety set for a dosing regimen only if they received at least 1 dose of that dosing regimen (e.g., a subject who discontinued prior to taking the dosing period 2 dosing regimen was not included in the safety set for that dosing regimen).	0.00% 0/12 • Up to 14 weeks per subject The safety set consisted of all enrolled subjects who received at least 1 dose (complete or incomplete) of study drug (Berinert or CSL830). Subjects were included in the safety set for a dosing regimen only if they received at least 1 dose of that dosing regimen (e.g., a subject who discontinued prior to taking the dosing period 2 dosing regimen was not included in the safety set for that dosing regimen).	0.00% 0/12 • Up to 14 weeks per subject The safety set consisted of all enrolled subjects who received at least 1 dose (complete or incomplete) of study drug (Berinert or CSL830). Subjects were included in the safety set for a dosing regimen only if they received at least 1 dose of that dosing regimen (e.g., a subject who discontinued prior to taking the dosing period 2 dosing regimen was not included in the safety set for that dosing regimen).
General disorders Fatigue	0.00% 0/18 • Up to 14 weeks per subject The safety set consisted of all enrolled subjects who received at least 1 dose (complete or incomplete) of study drug (Berinert or CSL830). Subjects were included in the safety set for a dosing regimen only if they received at least 1 dose of that dosing regimen (e.g., a subject who discontinued prior to taking the dosing period 2 dosing regimen was not included in the safety set for that dosing regimen).	0.00% 0/12 • Up to 14 weeks per subject The safety set consisted of all enrolled subjects who received at least 1 dose (complete or incomplete) of study drug (Berinert or CSL830). Subjects were included in the safety set for a dosing regimen only if they received at least 1 dose of that dosing regimen (e.g., a subject who discontinued prior to taking the dosing period 2 dosing regimen was not included in the safety set for that dosing regimen).	8.3% 1/12 • Number of events 1 • Up to 14 weeks per subject The safety set consisted of all enrolled subjects who received at least 1 dose (complete or incomplete) of study drug (Berinert or CSL830). Subjects were included in the safety set for a dosing regimen only if they received at least 1 dose of that dosing regimen (e.g., a subject who discontinued prior to taking the dosing period 2 dosing regimen was not included in the safety set for that dosing regimen).	0.00% 0/12 • Up to 14 weeks per subject The safety set consisted of all enrolled subjects who received at least 1 dose (complete or incomplete) of study drug (Berinert or CSL830). Subjects were included in the safety set for a dosing regimen only if they received at least 1 dose of that dosing regimen (e.g., a subject who discontinued prior to taking the dosing period 2 dosing regimen was not included in the safety set for that dosing regimen).
General disorders Induration	0.00% 0/18 • Up to 14 weeks per subject The safety set consisted of all enrolled subjects who received at least 1 dose (complete or incomplete) of study drug (Berinert or CSL830). Subjects were included in the safety set for a dosing regimen only if they received at least 1 dose of that dosing regimen (e.g., a subject who discontinued prior to taking the dosing period 2 dosing regimen was not included in the safety set for that dosing regimen).	8.3% 1/12 • Number of events 1 • Up to 14 weeks per subject The safety set consisted of all enrolled subjects who received at least 1 dose (complete or incomplete) of study drug (Berinert or CSL830). Subjects were included in the safety set for a dosing regimen only if they received at least 1 dose of that dosing regimen (e.g., a subject who discontinued prior to taking the dosing period 2 dosing regimen was not included in the safety set for that dosing regimen).	0.00% 0/12 • Up to 14 weeks per subject The safety set consisted of all enrolled subjects who received at least 1 dose (complete or incomplete) of study drug (Berinert or CSL830). Subjects were included in the safety set for a dosing regimen only if they received at least 1 dose of that dosing regimen (e.g., a subject who discontinued prior to taking the dosing period 2 dosing regimen was not included in the safety set for that dosing regimen).	0.00% 0/12 • Up to 14 weeks per subject The safety set consisted of all enrolled subjects who received at least 1 dose (complete or incomplete) of study drug (Berinert or CSL830). Subjects were included in the safety set for a dosing regimen only if they received at least 1 dose of that dosing regimen (e.g., a subject who discontinued prior to taking the dosing period 2 dosing regimen was not included in the safety set for that dosing regimen).
General disorders Injection site paraesthesia	0.00% 0/18 • Up to 14 weeks per subject The safety set consisted of all enrolled subjects who received at least 1 dose (complete or incomplete) of study drug (Berinert or CSL830). Subjects were included in the safety set for a dosing regimen only if they received at least 1 dose of that dosing regimen (e.g., a subject who discontinued prior to taking the dosing period 2 dosing regimen was not included in the safety set for that dosing regimen).	8.3% 1/12 • Number of events 3 • Up to 14 weeks per subject The safety set consisted of all enrolled subjects who received at least 1 dose (complete or incomplete) of study drug (Berinert or CSL830). Subjects were included in the safety set for a dosing regimen only if they received at least 1 dose of that dosing regimen (e.g., a subject who discontinued prior to taking the dosing period 2 dosing regimen was not included in the safety set for that dosing regimen).	0.00% 0/12 • Up to 14 weeks per subject The safety set consisted of all enrolled subjects who received at least 1 dose (complete or incomplete) of study drug (Berinert or CSL830). Subjects were included in the safety set for a dosing regimen only if they received at least 1 dose of that dosing regimen (e.g., a subject who discontinued prior to taking the dosing period 2 dosing regimen was not included in the safety set for that dosing regimen).	0.00% 0/12 • Up to 14 weeks per subject The safety set consisted of all enrolled subjects who received at least 1 dose (complete or incomplete) of study drug (Berinert or CSL830). Subjects were included in the safety set for a dosing regimen only if they received at least 1 dose of that dosing regimen (e.g., a subject who discontinued prior to taking the dosing period 2 dosing regimen was not included in the safety set for that dosing regimen).
General disorders Pyrexia	0.00% 0/18 • Up to 14 weeks per subject The safety set consisted of all enrolled subjects who received at least 1 dose (complete or incomplete) of study drug (Berinert or CSL830). Subjects were included in the safety set for a dosing regimen only if they received at least 1 dose of that dosing regimen (e.g., a subject who discontinued prior to taking the dosing period 2 dosing regimen was not included in the safety set for that dosing regimen).	8.3% 1/12 • Number of events 1 • Up to 14 weeks per subject The safety set consisted of all enrolled subjects who received at least 1 dose (complete or incomplete) of study drug (Berinert or CSL830). Subjects were included in the safety set for a dosing regimen only if they received at least 1 dose of that dosing regimen (e.g., a subject who discontinued prior to taking the dosing period 2 dosing regimen was not included in the safety set for that dosing regimen).	0.00% 0/12 • Up to 14 weeks per subject The safety set consisted of all enrolled subjects who received at least 1 dose (complete or incomplete) of study drug (Berinert or CSL830). Subjects were included in the safety set for a dosing regimen only if they received at least 1 dose of that dosing regimen (e.g., a subject who discontinued prior to taking the dosing period 2 dosing regimen was not included in the safety set for that dosing regimen).	0.00% 0/12 • Up to 14 weeks per subject The safety set consisted of all enrolled subjects who received at least 1 dose (complete or incomplete) of study drug (Berinert or CSL830). Subjects were included in the safety set for a dosing regimen only if they received at least 1 dose of that dosing regimen (e.g., a subject who discontinued prior to taking the dosing period 2 dosing regimen was not included in the safety set for that dosing regimen).
General disorders Swelling	0.00% 0/18 • Up to 14 weeks per subject The safety set consisted of all enrolled subjects who received at least 1 dose (complete or incomplete) of study drug (Berinert or CSL830). Subjects were included in the safety set for a dosing regimen only if they received at least 1 dose of that dosing regimen (e.g., a subject who discontinued prior to taking the dosing period 2 dosing regimen was not included in the safety set for that dosing regimen).	0.00% 0/12 • Up to 14 weeks per subject The safety set consisted of all enrolled subjects who received at least 1 dose (complete or incomplete) of study drug (Berinert or CSL830). Subjects were included in the safety set for a dosing regimen only if they received at least 1 dose of that dosing regimen (e.g., a subject who discontinued prior to taking the dosing period 2 dosing regimen was not included in the safety set for that dosing regimen).	0.00% 0/12 • Up to 14 weeks per subject The safety set consisted of all enrolled subjects who received at least 1 dose (complete or incomplete) of study drug (Berinert or CSL830). Subjects were included in the safety set for a dosing regimen only if they received at least 1 dose of that dosing regimen (e.g., a subject who discontinued prior to taking the dosing period 2 dosing regimen was not included in the safety set for that dosing regimen).	8.3% 1/12 • Number of events 1 • Up to 14 weeks per subject The safety set consisted of all enrolled subjects who received at least 1 dose (complete or incomplete) of study drug (Berinert or CSL830). Subjects were included in the safety set for a dosing regimen only if they received at least 1 dose of that dosing regimen (e.g., a subject who discontinued prior to taking the dosing period 2 dosing regimen was not included in the safety set for that dosing regimen).
Infections and infestations Nasopharyngitis	0.00% 0/18 • Up to 14 weeks per subject The safety set consisted of all enrolled subjects who received at least 1 dose (complete or incomplete) of study drug (Berinert or CSL830). Subjects were included in the safety set for a dosing regimen only if they received at least 1 dose of that dosing regimen (e.g., a subject who discontinued prior to taking the dosing period 2 dosing regimen was not included in the safety set for that dosing regimen).	8.3% 1/12 • Number of events 2 • Up to 14 weeks per subject The safety set consisted of all enrolled subjects who received at least 1 dose (complete or incomplete) of study drug (Berinert or CSL830). Subjects were included in the safety set for a dosing regimen only if they received at least 1 dose of that dosing regimen (e.g., a subject who discontinued prior to taking the dosing period 2 dosing regimen was not included in the safety set for that dosing regimen).	0.00% 0/12 • Up to 14 weeks per subject The safety set consisted of all enrolled subjects who received at least 1 dose (complete or incomplete) of study drug (Berinert or CSL830). Subjects were included in the safety set for a dosing regimen only if they received at least 1 dose of that dosing regimen (e.g., a subject who discontinued prior to taking the dosing period 2 dosing regimen was not included in the safety set for that dosing regimen).	16.7% 2/12 • Number of events 3 • Up to 14 weeks per subject The safety set consisted of all enrolled subjects who received at least 1 dose (complete or incomplete) of study drug (Berinert or CSL830). Subjects were included in the safety set for a dosing regimen only if they received at least 1 dose of that dosing regimen (e.g., a subject who discontinued prior to taking the dosing period 2 dosing regimen was not included in the safety set for that dosing regimen).
Infections and infestations Acute sinusitis	0.00% 0/18 • Up to 14 weeks per subject The safety set consisted of all enrolled subjects who received at least 1 dose (complete or incomplete) of study drug (Berinert or CSL830). Subjects were included in the safety set for a dosing regimen only if they received at least 1 dose of that dosing regimen (e.g., a subject who discontinued prior to taking the dosing period 2 dosing regimen was not included in the safety set for that dosing regimen).	8.3% 1/12 • Number of events 1 • Up to 14 weeks per subject The safety set consisted of all enrolled subjects who received at least 1 dose (complete or incomplete) of study drug (Berinert or CSL830). Subjects were included in the safety set for a dosing regimen only if they received at least 1 dose of that dosing regimen (e.g., a subject who discontinued prior to taking the dosing period 2 dosing regimen was not included in the safety set for that dosing regimen).	0.00% 0/12 • Up to 14 weeks per subject The safety set consisted of all enrolled subjects who received at least 1 dose (complete or incomplete) of study drug (Berinert or CSL830). Subjects were included in the safety set for a dosing regimen only if they received at least 1 dose of that dosing regimen (e.g., a subject who discontinued prior to taking the dosing period 2 dosing regimen was not included in the safety set for that dosing regimen).	0.00% 0/12 • Up to 14 weeks per subject The safety set consisted of all enrolled subjects who received at least 1 dose (complete or incomplete) of study drug (Berinert or CSL830). Subjects were included in the safety set for a dosing regimen only if they received at least 1 dose of that dosing regimen (e.g., a subject who discontinued prior to taking the dosing period 2 dosing regimen was not included in the safety set for that dosing regimen).
Infections and infestations Influenza	0.00% 0/18 • Up to 14 weeks per subject The safety set consisted of all enrolled subjects who received at least 1 dose (complete or incomplete) of study drug (Berinert or CSL830). Subjects were included in the safety set for a dosing regimen only if they received at least 1 dose of that dosing regimen (e.g., a subject who discontinued prior to taking the dosing period 2 dosing regimen was not included in the safety set for that dosing regimen).	8.3% 1/12 • Number of events 1 • Up to 14 weeks per subject The safety set consisted of all enrolled subjects who received at least 1 dose (complete or incomplete) of study drug (Berinert or CSL830). Subjects were included in the safety set for a dosing regimen only if they received at least 1 dose of that dosing regimen (e.g., a subject who discontinued prior to taking the dosing period 2 dosing regimen was not included in the safety set for that dosing regimen).	0.00% 0/12 • Up to 14 weeks per subject The safety set consisted of all enrolled subjects who received at least 1 dose (complete or incomplete) of study drug (Berinert or CSL830). Subjects were included in the safety set for a dosing regimen only if they received at least 1 dose of that dosing regimen (e.g., a subject who discontinued prior to taking the dosing period 2 dosing regimen was not included in the safety set for that dosing regimen).	0.00% 0/12 • Up to 14 weeks per subject The safety set consisted of all enrolled subjects who received at least 1 dose (complete or incomplete) of study drug (Berinert or CSL830). Subjects were included in the safety set for a dosing regimen only if they received at least 1 dose of that dosing regimen (e.g., a subject who discontinued prior to taking the dosing period 2 dosing regimen was not included in the safety set for that dosing regimen).
Infections and infestations Upper respiratory tract infection	5.6% 1/18 • Number of events 1 • Up to 14 weeks per subject The safety set consisted of all enrolled subjects who received at least 1 dose (complete or incomplete) of study drug (Berinert or CSL830). Subjects were included in the safety set for a dosing regimen only if they received at least 1 dose of that dosing regimen (e.g., a subject who discontinued prior to taking the dosing period 2 dosing regimen was not included in the safety set for that dosing regimen).	0.00% 0/12 • Up to 14 weeks per subject The safety set consisted of all enrolled subjects who received at least 1 dose (complete or incomplete) of study drug (Berinert or CSL830). Subjects were included in the safety set for a dosing regimen only if they received at least 1 dose of that dosing regimen (e.g., a subject who discontinued prior to taking the dosing period 2 dosing regimen was not included in the safety set for that dosing regimen).	0.00% 0/12 • Up to 14 weeks per subject The safety set consisted of all enrolled subjects who received at least 1 dose (complete or incomplete) of study drug (Berinert or CSL830). Subjects were included in the safety set for a dosing regimen only if they received at least 1 dose of that dosing regimen (e.g., a subject who discontinued prior to taking the dosing period 2 dosing regimen was not included in the safety set for that dosing regimen).	0.00% 0/12 • Up to 14 weeks per subject The safety set consisted of all enrolled subjects who received at least 1 dose (complete or incomplete) of study drug (Berinert or CSL830). Subjects were included in the safety set for a dosing regimen only if they received at least 1 dose of that dosing regimen (e.g., a subject who discontinued prior to taking the dosing period 2 dosing regimen was not included in the safety set for that dosing regimen).
Nervous system disorders Headache	0.00% 0/18 • Up to 14 weeks per subject The safety set consisted of all enrolled subjects who received at least 1 dose (complete or incomplete) of study drug (Berinert or CSL830). Subjects were included in the safety set for a dosing regimen only if they received at least 1 dose of that dosing regimen (e.g., a subject who discontinued prior to taking the dosing period 2 dosing regimen was not included in the safety set for that dosing regimen).	0.00% 0/12 • Up to 14 weeks per subject The safety set consisted of all enrolled subjects who received at least 1 dose (complete or incomplete) of study drug (Berinert or CSL830). Subjects were included in the safety set for a dosing regimen only if they received at least 1 dose of that dosing regimen (e.g., a subject who discontinued prior to taking the dosing period 2 dosing regimen was not included in the safety set for that dosing regimen).	16.7% 2/12 • Number of events 3 • Up to 14 weeks per subject The safety set consisted of all enrolled subjects who received at least 1 dose (complete or incomplete) of study drug (Berinert or CSL830). Subjects were included in the safety set for a dosing regimen only if they received at least 1 dose of that dosing regimen (e.g., a subject who discontinued prior to taking the dosing period 2 dosing regimen was not included in the safety set for that dosing regimen).	16.7% 2/12 • Number of events 2 • Up to 14 weeks per subject The safety set consisted of all enrolled subjects who received at least 1 dose (complete or incomplete) of study drug (Berinert or CSL830). Subjects were included in the safety set for a dosing regimen only if they received at least 1 dose of that dosing regimen (e.g., a subject who discontinued prior to taking the dosing period 2 dosing regimen was not included in the safety set for that dosing regimen).
Nervous system disorders Disturbance in attention	0.00% 0/18 • Up to 14 weeks per subject The safety set consisted of all enrolled subjects who received at least 1 dose (complete or incomplete) of study drug (Berinert or CSL830). Subjects were included in the safety set for a dosing regimen only if they received at least 1 dose of that dosing regimen (e.g., a subject who discontinued prior to taking the dosing period 2 dosing regimen was not included in the safety set for that dosing regimen).	0.00% 0/12 • Up to 14 weeks per subject The safety set consisted of all enrolled subjects who received at least 1 dose (complete or incomplete) of study drug (Berinert or CSL830). Subjects were included in the safety set for a dosing regimen only if they received at least 1 dose of that dosing regimen (e.g., a subject who discontinued prior to taking the dosing period 2 dosing regimen was not included in the safety set for that dosing regimen).	0.00% 0/12 • Up to 14 weeks per subject The safety set consisted of all enrolled subjects who received at least 1 dose (complete or incomplete) of study drug (Berinert or CSL830). Subjects were included in the safety set for a dosing regimen only if they received at least 1 dose of that dosing regimen (e.g., a subject who discontinued prior to taking the dosing period 2 dosing regimen was not included in the safety set for that dosing regimen).	8.3% 1/12 • Number of events 1 • Up to 14 weeks per subject The safety set consisted of all enrolled subjects who received at least 1 dose (complete or incomplete) of study drug (Berinert or CSL830). Subjects were included in the safety set for a dosing regimen only if they received at least 1 dose of that dosing regimen (e.g., a subject who discontinued prior to taking the dosing period 2 dosing regimen was not included in the safety set for that dosing regimen).
Nervous system disorders Dizziness	0.00% 0/18 • Up to 14 weeks per subject The safety set consisted of all enrolled subjects who received at least 1 dose (complete or incomplete) of study drug (Berinert or CSL830). Subjects were included in the safety set for a dosing regimen only if they received at least 1 dose of that dosing regimen (e.g., a subject who discontinued prior to taking the dosing period 2 dosing regimen was not included in the safety set for that dosing regimen).	0.00% 0/12 • Up to 14 weeks per subject The safety set consisted of all enrolled subjects who received at least 1 dose (complete or incomplete) of study drug (Berinert or CSL830). Subjects were included in the safety set for a dosing regimen only if they received at least 1 dose of that dosing regimen (e.g., a subject who discontinued prior to taking the dosing period 2 dosing regimen was not included in the safety set for that dosing regimen).	0.00% 0/12 • Up to 14 weeks per subject The safety set consisted of all enrolled subjects who received at least 1 dose (complete or incomplete) of study drug (Berinert or CSL830). Subjects were included in the safety set for a dosing regimen only if they received at least 1 dose of that dosing regimen (e.g., a subject who discontinued prior to taking the dosing period 2 dosing regimen was not included in the safety set for that dosing regimen).	8.3% 1/12 • Number of events 1 • Up to 14 weeks per subject The safety set consisted of all enrolled subjects who received at least 1 dose (complete or incomplete) of study drug (Berinert or CSL830). Subjects were included in the safety set for a dosing regimen only if they received at least 1 dose of that dosing regimen (e.g., a subject who discontinued prior to taking the dosing period 2 dosing regimen was not included in the safety set for that dosing regimen).
Nervous system disorders Hypotonia	0.00% 0/18 • Up to 14 weeks per subject The safety set consisted of all enrolled subjects who received at least 1 dose (complete or incomplete) of study drug (Berinert or CSL830). Subjects were included in the safety set for a dosing regimen only if they received at least 1 dose of that dosing regimen (e.g., a subject who discontinued prior to taking the dosing period 2 dosing regimen was not included in the safety set for that dosing regimen).	0.00% 0/12 • Up to 14 weeks per subject The safety set consisted of all enrolled subjects who received at least 1 dose (complete or incomplete) of study drug (Berinert or CSL830). Subjects were included in the safety set for a dosing regimen only if they received at least 1 dose of that dosing regimen (e.g., a subject who discontinued prior to taking the dosing period 2 dosing regimen was not included in the safety set for that dosing regimen).	0.00% 0/12 • Up to 14 weeks per subject The safety set consisted of all enrolled subjects who received at least 1 dose (complete or incomplete) of study drug (Berinert or CSL830). Subjects were included in the safety set for a dosing regimen only if they received at least 1 dose of that dosing regimen (e.g., a subject who discontinued prior to taking the dosing period 2 dosing regimen was not included in the safety set for that dosing regimen).	8.3% 1/12 • Number of events 1 • Up to 14 weeks per subject The safety set consisted of all enrolled subjects who received at least 1 dose (complete or incomplete) of study drug (Berinert or CSL830). Subjects were included in the safety set for a dosing regimen only if they received at least 1 dose of that dosing regimen (e.g., a subject who discontinued prior to taking the dosing period 2 dosing regimen was not included in the safety set for that dosing regimen).
Nervous system disorders Migraine	0.00% 0/18 • Up to 14 weeks per subject The safety set consisted of all enrolled subjects who received at least 1 dose (complete or incomplete) of study drug (Berinert or CSL830). Subjects were included in the safety set for a dosing regimen only if they received at least 1 dose of that dosing regimen (e.g., a subject who discontinued prior to taking the dosing period 2 dosing regimen was not included in the safety set for that dosing regimen).	0.00% 0/12 • Up to 14 weeks per subject The safety set consisted of all enrolled subjects who received at least 1 dose (complete or incomplete) of study drug (Berinert or CSL830). Subjects were included in the safety set for a dosing regimen only if they received at least 1 dose of that dosing regimen (e.g., a subject who discontinued prior to taking the dosing period 2 dosing regimen was not included in the safety set for that dosing regimen).	0.00% 0/12 • Up to 14 weeks per subject The safety set consisted of all enrolled subjects who received at least 1 dose (complete or incomplete) of study drug (Berinert or CSL830). Subjects were included in the safety set for a dosing regimen only if they received at least 1 dose of that dosing regimen (e.g., a subject who discontinued prior to taking the dosing period 2 dosing regimen was not included in the safety set for that dosing regimen).	8.3% 1/12 • Number of events 1 • Up to 14 weeks per subject The safety set consisted of all enrolled subjects who received at least 1 dose (complete or incomplete) of study drug (Berinert or CSL830). Subjects were included in the safety set for a dosing regimen only if they received at least 1 dose of that dosing regimen (e.g., a subject who discontinued prior to taking the dosing period 2 dosing regimen was not included in the safety set for that dosing regimen).
Nervous system disorders Neuritis	0.00% 0/18 • Up to 14 weeks per subject The safety set consisted of all enrolled subjects who received at least 1 dose (complete or incomplete) of study drug (Berinert or CSL830). Subjects were included in the safety set for a dosing regimen only if they received at least 1 dose of that dosing regimen (e.g., a subject who discontinued prior to taking the dosing period 2 dosing regimen was not included in the safety set for that dosing regimen).	8.3% 1/12 • Number of events 1 • Up to 14 weeks per subject The safety set consisted of all enrolled subjects who received at least 1 dose (complete or incomplete) of study drug (Berinert or CSL830). Subjects were included in the safety set for a dosing regimen only if they received at least 1 dose of that dosing regimen (e.g., a subject who discontinued prior to taking the dosing period 2 dosing regimen was not included in the safety set for that dosing regimen).	0.00% 0/12 • Up to 14 weeks per subject The safety set consisted of all enrolled subjects who received at least 1 dose (complete or incomplete) of study drug (Berinert or CSL830). Subjects were included in the safety set for a dosing regimen only if they received at least 1 dose of that dosing regimen (e.g., a subject who discontinued prior to taking the dosing period 2 dosing regimen was not included in the safety set for that dosing regimen).	0.00% 0/12 • Up to 14 weeks per subject The safety set consisted of all enrolled subjects who received at least 1 dose (complete or incomplete) of study drug (Berinert or CSL830). Subjects were included in the safety set for a dosing regimen only if they received at least 1 dose of that dosing regimen (e.g., a subject who discontinued prior to taking the dosing period 2 dosing regimen was not included in the safety set for that dosing regimen).
Congenital, familial and genetic disorders Hereditary angioedema	5.6% 1/18 • Number of events 2 • Up to 14 weeks per subject The safety set consisted of all enrolled subjects who received at least 1 dose (complete or incomplete) of study drug (Berinert or CSL830). Subjects were included in the safety set for a dosing regimen only if they received at least 1 dose of that dosing regimen (e.g., a subject who discontinued prior to taking the dosing period 2 dosing regimen was not included in the safety set for that dosing regimen).	16.7% 2/12 • Number of events 9 • Up to 14 weeks per subject The safety set consisted of all enrolled subjects who received at least 1 dose (complete or incomplete) of study drug (Berinert or CSL830). Subjects were included in the safety set for a dosing regimen only if they received at least 1 dose of that dosing regimen (e.g., a subject who discontinued prior to taking the dosing period 2 dosing regimen was not included in the safety set for that dosing regimen).	16.7% 2/12 • Number of events 5 • Up to 14 weeks per subject The safety set consisted of all enrolled subjects who received at least 1 dose (complete or incomplete) of study drug (Berinert or CSL830). Subjects were included in the safety set for a dosing regimen only if they received at least 1 dose of that dosing regimen (e.g., a subject who discontinued prior to taking the dosing period 2 dosing regimen was not included in the safety set for that dosing regimen).	8.3% 1/12 • Number of events 1 • Up to 14 weeks per subject The safety set consisted of all enrolled subjects who received at least 1 dose (complete or incomplete) of study drug (Berinert or CSL830). Subjects were included in the safety set for a dosing regimen only if they received at least 1 dose of that dosing regimen (e.g., a subject who discontinued prior to taking the dosing period 2 dosing regimen was not included in the safety set for that dosing regimen).
Gastrointestinal disorders Nausea	5.6% 1/18 • Number of events 1 • Up to 14 weeks per subject The safety set consisted of all enrolled subjects who received at least 1 dose (complete or incomplete) of study drug (Berinert or CSL830). Subjects were included in the safety set for a dosing regimen only if they received at least 1 dose of that dosing regimen (e.g., a subject who discontinued prior to taking the dosing period 2 dosing regimen was not included in the safety set for that dosing regimen).	8.3% 1/12 • Number of events 1 • Up to 14 weeks per subject The safety set consisted of all enrolled subjects who received at least 1 dose (complete or incomplete) of study drug (Berinert or CSL830). Subjects were included in the safety set for a dosing regimen only if they received at least 1 dose of that dosing regimen (e.g., a subject who discontinued prior to taking the dosing period 2 dosing regimen was not included in the safety set for that dosing regimen).	0.00% 0/12 • Up to 14 weeks per subject The safety set consisted of all enrolled subjects who received at least 1 dose (complete or incomplete) of study drug (Berinert or CSL830). Subjects were included in the safety set for a dosing regimen only if they received at least 1 dose of that dosing regimen (e.g., a subject who discontinued prior to taking the dosing period 2 dosing regimen was not included in the safety set for that dosing regimen).	8.3% 1/12 • Number of events 1 • Up to 14 weeks per subject The safety set consisted of all enrolled subjects who received at least 1 dose (complete or incomplete) of study drug (Berinert or CSL830). Subjects were included in the safety set for a dosing regimen only if they received at least 1 dose of that dosing regimen (e.g., a subject who discontinued prior to taking the dosing period 2 dosing regimen was not included in the safety set for that dosing regimen).
Gastrointestinal disorders Vomiting	0.00% 0/18 • Up to 14 weeks per subject The safety set consisted of all enrolled subjects who received at least 1 dose (complete or incomplete) of study drug (Berinert or CSL830). Subjects were included in the safety set for a dosing regimen only if they received at least 1 dose of that dosing regimen (e.g., a subject who discontinued prior to taking the dosing period 2 dosing regimen was not included in the safety set for that dosing regimen).	8.3% 1/12 • Number of events 1 • Up to 14 weeks per subject The safety set consisted of all enrolled subjects who received at least 1 dose (complete or incomplete) of study drug (Berinert or CSL830). Subjects were included in the safety set for a dosing regimen only if they received at least 1 dose of that dosing regimen (e.g., a subject who discontinued prior to taking the dosing period 2 dosing regimen was not included in the safety set for that dosing regimen).	0.00% 0/12 • Up to 14 weeks per subject The safety set consisted of all enrolled subjects who received at least 1 dose (complete or incomplete) of study drug (Berinert or CSL830). Subjects were included in the safety set for a dosing regimen only if they received at least 1 dose of that dosing regimen (e.g., a subject who discontinued prior to taking the dosing period 2 dosing regimen was not included in the safety set for that dosing regimen).	8.3% 1/12 • Number of events 1 • Up to 14 weeks per subject The safety set consisted of all enrolled subjects who received at least 1 dose (complete or incomplete) of study drug (Berinert or CSL830). Subjects were included in the safety set for a dosing regimen only if they received at least 1 dose of that dosing regimen (e.g., a subject who discontinued prior to taking the dosing period 2 dosing regimen was not included in the safety set for that dosing regimen).
Gastrointestinal disorders Abdominal discomfort	0.00% 0/18 • Up to 14 weeks per subject The safety set consisted of all enrolled subjects who received at least 1 dose (complete or incomplete) of study drug (Berinert or CSL830). Subjects were included in the safety set for a dosing regimen only if they received at least 1 dose of that dosing regimen (e.g., a subject who discontinued prior to taking the dosing period 2 dosing regimen was not included in the safety set for that dosing regimen).	0.00% 0/12 • Up to 14 weeks per subject The safety set consisted of all enrolled subjects who received at least 1 dose (complete or incomplete) of study drug (Berinert or CSL830). Subjects were included in the safety set for a dosing regimen only if they received at least 1 dose of that dosing regimen (e.g., a subject who discontinued prior to taking the dosing period 2 dosing regimen was not included in the safety set for that dosing regimen).	8.3% 1/12 • Number of events 1 • Up to 14 weeks per subject The safety set consisted of all enrolled subjects who received at least 1 dose (complete or incomplete) of study drug (Berinert or CSL830). Subjects were included in the safety set for a dosing regimen only if they received at least 1 dose of that dosing regimen (e.g., a subject who discontinued prior to taking the dosing period 2 dosing regimen was not included in the safety set for that dosing regimen).	0.00% 0/12 • Up to 14 weeks per subject The safety set consisted of all enrolled subjects who received at least 1 dose (complete or incomplete) of study drug (Berinert or CSL830). Subjects were included in the safety set for a dosing regimen only if they received at least 1 dose of that dosing regimen (e.g., a subject who discontinued prior to taking the dosing period 2 dosing regimen was not included in the safety set for that dosing regimen).
Gastrointestinal disorders Abdominal pain upper	0.00% 0/18 • Up to 14 weeks per subject The safety set consisted of all enrolled subjects who received at least 1 dose (complete or incomplete) of study drug (Berinert or CSL830). Subjects were included in the safety set for a dosing regimen only if they received at least 1 dose of that dosing regimen (e.g., a subject who discontinued prior to taking the dosing period 2 dosing regimen was not included in the safety set for that dosing regimen).	0.00% 0/12 • Up to 14 weeks per subject The safety set consisted of all enrolled subjects who received at least 1 dose (complete or incomplete) of study drug (Berinert or CSL830). Subjects were included in the safety set for a dosing regimen only if they received at least 1 dose of that dosing regimen (e.g., a subject who discontinued prior to taking the dosing period 2 dosing regimen was not included in the safety set for that dosing regimen).	0.00% 0/12 • Up to 14 weeks per subject The safety set consisted of all enrolled subjects who received at least 1 dose (complete or incomplete) of study drug (Berinert or CSL830). Subjects were included in the safety set for a dosing regimen only if they received at least 1 dose of that dosing regimen (e.g., a subject who discontinued prior to taking the dosing period 2 dosing regimen was not included in the safety set for that dosing regimen).	8.3% 1/12 • Number of events 1 • Up to 14 weeks per subject The safety set consisted of all enrolled subjects who received at least 1 dose (complete or incomplete) of study drug (Berinert or CSL830). Subjects were included in the safety set for a dosing regimen only if they received at least 1 dose of that dosing regimen (e.g., a subject who discontinued prior to taking the dosing period 2 dosing regimen was not included in the safety set for that dosing regimen).
Gastrointestinal disorders Aphthous stomatitis	0.00% 0/18 • Up to 14 weeks per subject The safety set consisted of all enrolled subjects who received at least 1 dose (complete or incomplete) of study drug (Berinert or CSL830). Subjects were included in the safety set for a dosing regimen only if they received at least 1 dose of that dosing regimen (e.g., a subject who discontinued prior to taking the dosing period 2 dosing regimen was not included in the safety set for that dosing regimen).	0.00% 0/12 • Up to 14 weeks per subject The safety set consisted of all enrolled subjects who received at least 1 dose (complete or incomplete) of study drug (Berinert or CSL830). Subjects were included in the safety set for a dosing regimen only if they received at least 1 dose of that dosing regimen (e.g., a subject who discontinued prior to taking the dosing period 2 dosing regimen was not included in the safety set for that dosing regimen).	8.3% 1/12 • Number of events 1 • Up to 14 weeks per subject The safety set consisted of all enrolled subjects who received at least 1 dose (complete or incomplete) of study drug (Berinert or CSL830). Subjects were included in the safety set for a dosing regimen only if they received at least 1 dose of that dosing regimen (e.g., a subject who discontinued prior to taking the dosing period 2 dosing regimen was not included in the safety set for that dosing regimen).	0.00% 0/12 • Up to 14 weeks per subject The safety set consisted of all enrolled subjects who received at least 1 dose (complete or incomplete) of study drug (Berinert or CSL830). Subjects were included in the safety set for a dosing regimen only if they received at least 1 dose of that dosing regimen (e.g., a subject who discontinued prior to taking the dosing period 2 dosing regimen was not included in the safety set for that dosing regimen).
Gastrointestinal disorders Diarrrhoea	0.00% 0/18 • Up to 14 weeks per subject The safety set consisted of all enrolled subjects who received at least 1 dose (complete or incomplete) of study drug (Berinert or CSL830). Subjects were included in the safety set for a dosing regimen only if they received at least 1 dose of that dosing regimen (e.g., a subject who discontinued prior to taking the dosing period 2 dosing regimen was not included in the safety set for that dosing regimen).	0.00% 0/12 • Up to 14 weeks per subject The safety set consisted of all enrolled subjects who received at least 1 dose (complete or incomplete) of study drug (Berinert or CSL830). Subjects were included in the safety set for a dosing regimen only if they received at least 1 dose of that dosing regimen (e.g., a subject who discontinued prior to taking the dosing period 2 dosing regimen was not included in the safety set for that dosing regimen).	0.00% 0/12 • Up to 14 weeks per subject The safety set consisted of all enrolled subjects who received at least 1 dose (complete or incomplete) of study drug (Berinert or CSL830). Subjects were included in the safety set for a dosing regimen only if they received at least 1 dose of that dosing regimen (e.g., a subject who discontinued prior to taking the dosing period 2 dosing regimen was not included in the safety set for that dosing regimen).	8.3% 1/12 • Number of events 1 • Up to 14 weeks per subject The safety set consisted of all enrolled subjects who received at least 1 dose (complete or incomplete) of study drug (Berinert or CSL830). Subjects were included in the safety set for a dosing regimen only if they received at least 1 dose of that dosing regimen (e.g., a subject who discontinued prior to taking the dosing period 2 dosing regimen was not included in the safety set for that dosing regimen).
Gastrointestinal disorders Toothache	0.00% 0/18 • Up to 14 weeks per subject The safety set consisted of all enrolled subjects who received at least 1 dose (complete or incomplete) of study drug (Berinert or CSL830). Subjects were included in the safety set for a dosing regimen only if they received at least 1 dose of that dosing regimen (e.g., a subject who discontinued prior to taking the dosing period 2 dosing regimen was not included in the safety set for that dosing regimen).	8.3% 1/12 • Number of events 1 • Up to 14 weeks per subject The safety set consisted of all enrolled subjects who received at least 1 dose (complete or incomplete) of study drug (Berinert or CSL830). Subjects were included in the safety set for a dosing regimen only if they received at least 1 dose of that dosing regimen (e.g., a subject who discontinued prior to taking the dosing period 2 dosing regimen was not included in the safety set for that dosing regimen).	0.00% 0/12 • Up to 14 weeks per subject The safety set consisted of all enrolled subjects who received at least 1 dose (complete or incomplete) of study drug (Berinert or CSL830). Subjects were included in the safety set for a dosing regimen only if they received at least 1 dose of that dosing regimen (e.g., a subject who discontinued prior to taking the dosing period 2 dosing regimen was not included in the safety set for that dosing regimen).	0.00% 0/12 • Up to 14 weeks per subject The safety set consisted of all enrolled subjects who received at least 1 dose (complete or incomplete) of study drug (Berinert or CSL830). Subjects were included in the safety set for a dosing regimen only if they received at least 1 dose of that dosing regimen (e.g., a subject who discontinued prior to taking the dosing period 2 dosing regimen was not included in the safety set for that dosing regimen).
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/18 • Up to 14 weeks per subject The safety set consisted of all enrolled subjects who received at least 1 dose (complete or incomplete) of study drug (Berinert or CSL830). Subjects were included in the safety set for a dosing regimen only if they received at least 1 dose of that dosing regimen (e.g., a subject who discontinued prior to taking the dosing period 2 dosing regimen was not included in the safety set for that dosing regimen).	8.3% 1/12 • Number of events 1 • Up to 14 weeks per subject The safety set consisted of all enrolled subjects who received at least 1 dose (complete or incomplete) of study drug (Berinert or CSL830). Subjects were included in the safety set for a dosing regimen only if they received at least 1 dose of that dosing regimen (e.g., a subject who discontinued prior to taking the dosing period 2 dosing regimen was not included in the safety set for that dosing regimen).	8.3% 1/12 • Number of events 1 • Up to 14 weeks per subject The safety set consisted of all enrolled subjects who received at least 1 dose (complete or incomplete) of study drug (Berinert or CSL830). Subjects were included in the safety set for a dosing regimen only if they received at least 1 dose of that dosing regimen (e.g., a subject who discontinued prior to taking the dosing period 2 dosing regimen was not included in the safety set for that dosing regimen).	0.00% 0/12 • Up to 14 weeks per subject The safety set consisted of all enrolled subjects who received at least 1 dose (complete or incomplete) of study drug (Berinert or CSL830). Subjects were included in the safety set for a dosing regimen only if they received at least 1 dose of that dosing regimen (e.g., a subject who discontinued prior to taking the dosing period 2 dosing regimen was not included in the safety set for that dosing regimen).
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/18 • Up to 14 weeks per subject The safety set consisted of all enrolled subjects who received at least 1 dose (complete or incomplete) of study drug (Berinert or CSL830). Subjects were included in the safety set for a dosing regimen only if they received at least 1 dose of that dosing regimen (e.g., a subject who discontinued prior to taking the dosing period 2 dosing regimen was not included in the safety set for that dosing regimen).	8.3% 1/12 • Number of events 1 • Up to 14 weeks per subject The safety set consisted of all enrolled subjects who received at least 1 dose (complete or incomplete) of study drug (Berinert or CSL830). Subjects were included in the safety set for a dosing regimen only if they received at least 1 dose of that dosing regimen (e.g., a subject who discontinued prior to taking the dosing period 2 dosing regimen was not included in the safety set for that dosing regimen).	0.00% 0/12 • Up to 14 weeks per subject The safety set consisted of all enrolled subjects who received at least 1 dose (complete or incomplete) of study drug (Berinert or CSL830). Subjects were included in the safety set for a dosing regimen only if they received at least 1 dose of that dosing regimen (e.g., a subject who discontinued prior to taking the dosing period 2 dosing regimen was not included in the safety set for that dosing regimen).	0.00% 0/12 • Up to 14 weeks per subject The safety set consisted of all enrolled subjects who received at least 1 dose (complete or incomplete) of study drug (Berinert or CSL830). Subjects were included in the safety set for a dosing regimen only if they received at least 1 dose of that dosing regimen (e.g., a subject who discontinued prior to taking the dosing period 2 dosing regimen was not included in the safety set for that dosing regimen).
Musculoskeletal and connective tissue disorders Muscle spasms	0.00% 0/18 • Up to 14 weeks per subject The safety set consisted of all enrolled subjects who received at least 1 dose (complete or incomplete) of study drug (Berinert or CSL830). Subjects were included in the safety set for a dosing regimen only if they received at least 1 dose of that dosing regimen (e.g., a subject who discontinued prior to taking the dosing period 2 dosing regimen was not included in the safety set for that dosing regimen).	8.3% 1/12 • Number of events 1 • Up to 14 weeks per subject The safety set consisted of all enrolled subjects who received at least 1 dose (complete or incomplete) of study drug (Berinert or CSL830). Subjects were included in the safety set for a dosing regimen only if they received at least 1 dose of that dosing regimen (e.g., a subject who discontinued prior to taking the dosing period 2 dosing regimen was not included in the safety set for that dosing regimen).	0.00% 0/12 • Up to 14 weeks per subject The safety set consisted of all enrolled subjects who received at least 1 dose (complete or incomplete) of study drug (Berinert or CSL830). Subjects were included in the safety set for a dosing regimen only if they received at least 1 dose of that dosing regimen (e.g., a subject who discontinued prior to taking the dosing period 2 dosing regimen was not included in the safety set for that dosing regimen).	0.00% 0/12 • Up to 14 weeks per subject The safety set consisted of all enrolled subjects who received at least 1 dose (complete or incomplete) of study drug (Berinert or CSL830). Subjects were included in the safety set for a dosing regimen only if they received at least 1 dose of that dosing regimen (e.g., a subject who discontinued prior to taking the dosing period 2 dosing regimen was not included in the safety set for that dosing regimen).
Musculoskeletal and connective tissue disorders Myalgia	0.00% 0/18 • Up to 14 weeks per subject The safety set consisted of all enrolled subjects who received at least 1 dose (complete or incomplete) of study drug (Berinert or CSL830). Subjects were included in the safety set for a dosing regimen only if they received at least 1 dose of that dosing regimen (e.g., a subject who discontinued prior to taking the dosing period 2 dosing regimen was not included in the safety set for that dosing regimen).	0.00% 0/12 • Up to 14 weeks per subject The safety set consisted of all enrolled subjects who received at least 1 dose (complete or incomplete) of study drug (Berinert or CSL830). Subjects were included in the safety set for a dosing regimen only if they received at least 1 dose of that dosing regimen (e.g., a subject who discontinued prior to taking the dosing period 2 dosing regimen was not included in the safety set for that dosing regimen).	8.3% 1/12 • Number of events 1 • Up to 14 weeks per subject The safety set consisted of all enrolled subjects who received at least 1 dose (complete or incomplete) of study drug (Berinert or CSL830). Subjects were included in the safety set for a dosing regimen only if they received at least 1 dose of that dosing regimen (e.g., a subject who discontinued prior to taking the dosing period 2 dosing regimen was not included in the safety set for that dosing regimen).	0.00% 0/12 • Up to 14 weeks per subject The safety set consisted of all enrolled subjects who received at least 1 dose (complete or incomplete) of study drug (Berinert or CSL830). Subjects were included in the safety set for a dosing regimen only if they received at least 1 dose of that dosing regimen (e.g., a subject who discontinued prior to taking the dosing period 2 dosing regimen was not included in the safety set for that dosing regimen).
Musculoskeletal and connective tissue disorders Myositis	0.00% 0/18 • Up to 14 weeks per subject The safety set consisted of all enrolled subjects who received at least 1 dose (complete or incomplete) of study drug (Berinert or CSL830). Subjects were included in the safety set for a dosing regimen only if they received at least 1 dose of that dosing regimen (e.g., a subject who discontinued prior to taking the dosing period 2 dosing regimen was not included in the safety set for that dosing regimen).	8.3% 1/12 • Number of events 1 • Up to 14 weeks per subject The safety set consisted of all enrolled subjects who received at least 1 dose (complete or incomplete) of study drug (Berinert or CSL830). Subjects were included in the safety set for a dosing regimen only if they received at least 1 dose of that dosing regimen (e.g., a subject who discontinued prior to taking the dosing period 2 dosing regimen was not included in the safety set for that dosing regimen).	0.00% 0/12 • Up to 14 weeks per subject The safety set consisted of all enrolled subjects who received at least 1 dose (complete or incomplete) of study drug (Berinert or CSL830). Subjects were included in the safety set for a dosing regimen only if they received at least 1 dose of that dosing regimen (e.g., a subject who discontinued prior to taking the dosing period 2 dosing regimen was not included in the safety set for that dosing regimen).	0.00% 0/12 • Up to 14 weeks per subject The safety set consisted of all enrolled subjects who received at least 1 dose (complete or incomplete) of study drug (Berinert or CSL830). Subjects were included in the safety set for a dosing regimen only if they received at least 1 dose of that dosing regimen (e.g., a subject who discontinued prior to taking the dosing period 2 dosing regimen was not included in the safety set for that dosing regimen).
Reproductive system and breast disorders Dysmenorrhoea	0.00% 0/18 • Up to 14 weeks per subject The safety set consisted of all enrolled subjects who received at least 1 dose (complete or incomplete) of study drug (Berinert or CSL830). Subjects were included in the safety set for a dosing regimen only if they received at least 1 dose of that dosing regimen (e.g., a subject who discontinued prior to taking the dosing period 2 dosing regimen was not included in the safety set for that dosing regimen).	8.3% 1/12 • Number of events 1 • Up to 14 weeks per subject The safety set consisted of all enrolled subjects who received at least 1 dose (complete or incomplete) of study drug (Berinert or CSL830). Subjects were included in the safety set for a dosing regimen only if they received at least 1 dose of that dosing regimen (e.g., a subject who discontinued prior to taking the dosing period 2 dosing regimen was not included in the safety set for that dosing regimen).	16.7% 2/12 • Number of events 2 • Up to 14 weeks per subject The safety set consisted of all enrolled subjects who received at least 1 dose (complete or incomplete) of study drug (Berinert or CSL830). Subjects were included in the safety set for a dosing regimen only if they received at least 1 dose of that dosing regimen (e.g., a subject who discontinued prior to taking the dosing period 2 dosing regimen was not included in the safety set for that dosing regimen).	0.00% 0/12 • Up to 14 weeks per subject The safety set consisted of all enrolled subjects who received at least 1 dose (complete or incomplete) of study drug (Berinert or CSL830). Subjects were included in the safety set for a dosing regimen only if they received at least 1 dose of that dosing regimen (e.g., a subject who discontinued prior to taking the dosing period 2 dosing regimen was not included in the safety set for that dosing regimen).
Reproductive system and breast disorders Metrorrhagia	0.00% 0/18 • Up to 14 weeks per subject The safety set consisted of all enrolled subjects who received at least 1 dose (complete or incomplete) of study drug (Berinert or CSL830). Subjects were included in the safety set for a dosing regimen only if they received at least 1 dose of that dosing regimen (e.g., a subject who discontinued prior to taking the dosing period 2 dosing regimen was not included in the safety set for that dosing regimen).	0.00% 0/12 • Up to 14 weeks per subject The safety set consisted of all enrolled subjects who received at least 1 dose (complete or incomplete) of study drug (Berinert or CSL830). Subjects were included in the safety set for a dosing regimen only if they received at least 1 dose of that dosing regimen (e.g., a subject who discontinued prior to taking the dosing period 2 dosing regimen was not included in the safety set for that dosing regimen).	8.3% 1/12 • Number of events 1 • Up to 14 weeks per subject The safety set consisted of all enrolled subjects who received at least 1 dose (complete or incomplete) of study drug (Berinert or CSL830). Subjects were included in the safety set for a dosing regimen only if they received at least 1 dose of that dosing regimen (e.g., a subject who discontinued prior to taking the dosing period 2 dosing regimen was not included in the safety set for that dosing regimen).	8.3% 1/12 • Number of events 1 • Up to 14 weeks per subject The safety set consisted of all enrolled subjects who received at least 1 dose (complete or incomplete) of study drug (Berinert or CSL830). Subjects were included in the safety set for a dosing regimen only if they received at least 1 dose of that dosing regimen (e.g., a subject who discontinued prior to taking the dosing period 2 dosing regimen was not included in the safety set for that dosing regimen).
Reproductive system and breast disorders Ovarian Cyst ruptured	0.00% 0/18 • Up to 14 weeks per subject The safety set consisted of all enrolled subjects who received at least 1 dose (complete or incomplete) of study drug (Berinert or CSL830). Subjects were included in the safety set for a dosing regimen only if they received at least 1 dose of that dosing regimen (e.g., a subject who discontinued prior to taking the dosing period 2 dosing regimen was not included in the safety set for that dosing regimen).	0.00% 0/12 • Up to 14 weeks per subject The safety set consisted of all enrolled subjects who received at least 1 dose (complete or incomplete) of study drug (Berinert or CSL830). Subjects were included in the safety set for a dosing regimen only if they received at least 1 dose of that dosing regimen (e.g., a subject who discontinued prior to taking the dosing period 2 dosing regimen was not included in the safety set for that dosing regimen).	8.3% 1/12 • Number of events 1 • Up to 14 weeks per subject The safety set consisted of all enrolled subjects who received at least 1 dose (complete or incomplete) of study drug (Berinert or CSL830). Subjects were included in the safety set for a dosing regimen only if they received at least 1 dose of that dosing regimen (e.g., a subject who discontinued prior to taking the dosing period 2 dosing regimen was not included in the safety set for that dosing regimen).	0.00% 0/12 • Up to 14 weeks per subject The safety set consisted of all enrolled subjects who received at least 1 dose (complete or incomplete) of study drug (Berinert or CSL830). Subjects were included in the safety set for a dosing regimen only if they received at least 1 dose of that dosing regimen (e.g., a subject who discontinued prior to taking the dosing period 2 dosing regimen was not included in the safety set for that dosing regimen).
Reproductive system and breast disorders Uterine spasm	0.00% 0/18 • Up to 14 weeks per subject The safety set consisted of all enrolled subjects who received at least 1 dose (complete or incomplete) of study drug (Berinert or CSL830). Subjects were included in the safety set for a dosing regimen only if they received at least 1 dose of that dosing regimen (e.g., a subject who discontinued prior to taking the dosing period 2 dosing regimen was not included in the safety set for that dosing regimen).	8.3% 1/12 • Number of events 1 • Up to 14 weeks per subject The safety set consisted of all enrolled subjects who received at least 1 dose (complete or incomplete) of study drug (Berinert or CSL830). Subjects were included in the safety set for a dosing regimen only if they received at least 1 dose of that dosing regimen (e.g., a subject who discontinued prior to taking the dosing period 2 dosing regimen was not included in the safety set for that dosing regimen).	0.00% 0/12 • Up to 14 weeks per subject The safety set consisted of all enrolled subjects who received at least 1 dose (complete or incomplete) of study drug (Berinert or CSL830). Subjects were included in the safety set for a dosing regimen only if they received at least 1 dose of that dosing regimen (e.g., a subject who discontinued prior to taking the dosing period 2 dosing regimen was not included in the safety set for that dosing regimen).	0.00% 0/12 • Up to 14 weeks per subject The safety set consisted of all enrolled subjects who received at least 1 dose (complete or incomplete) of study drug (Berinert or CSL830). Subjects were included in the safety set for a dosing regimen only if they received at least 1 dose of that dosing regimen (e.g., a subject who discontinued prior to taking the dosing period 2 dosing regimen was not included in the safety set for that dosing regimen).
Reproductive system and breast disorders Vaginal discharge	0.00% 0/18 • Up to 14 weeks per subject The safety set consisted of all enrolled subjects who received at least 1 dose (complete or incomplete) of study drug (Berinert or CSL830). Subjects were included in the safety set for a dosing regimen only if they received at least 1 dose of that dosing regimen (e.g., a subject who discontinued prior to taking the dosing period 2 dosing regimen was not included in the safety set for that dosing regimen).	8.3% 1/12 • Number of events 1 • Up to 14 weeks per subject The safety set consisted of all enrolled subjects who received at least 1 dose (complete or incomplete) of study drug (Berinert or CSL830). Subjects were included in the safety set for a dosing regimen only if they received at least 1 dose of that dosing regimen (e.g., a subject who discontinued prior to taking the dosing period 2 dosing regimen was not included in the safety set for that dosing regimen).	0.00% 0/12 • Up to 14 weeks per subject The safety set consisted of all enrolled subjects who received at least 1 dose (complete or incomplete) of study drug (Berinert or CSL830). Subjects were included in the safety set for a dosing regimen only if they received at least 1 dose of that dosing regimen (e.g., a subject who discontinued prior to taking the dosing period 2 dosing regimen was not included in the safety set for that dosing regimen).	0.00% 0/12 • Up to 14 weeks per subject The safety set consisted of all enrolled subjects who received at least 1 dose (complete or incomplete) of study drug (Berinert or CSL830). Subjects were included in the safety set for a dosing regimen only if they received at least 1 dose of that dosing regimen (e.g., a subject who discontinued prior to taking the dosing period 2 dosing regimen was not included in the safety set for that dosing regimen).
Injury, poisoning and procedural complications Mouth injury	5.6% 1/18 • Number of events 1 • Up to 14 weeks per subject The safety set consisted of all enrolled subjects who received at least 1 dose (complete or incomplete) of study drug (Berinert or CSL830). Subjects were included in the safety set for a dosing regimen only if they received at least 1 dose of that dosing regimen (e.g., a subject who discontinued prior to taking the dosing period 2 dosing regimen was not included in the safety set for that dosing regimen).	0.00% 0/12 • Up to 14 weeks per subject The safety set consisted of all enrolled subjects who received at least 1 dose (complete or incomplete) of study drug (Berinert or CSL830). Subjects were included in the safety set for a dosing regimen only if they received at least 1 dose of that dosing regimen (e.g., a subject who discontinued prior to taking the dosing period 2 dosing regimen was not included in the safety set for that dosing regimen).	0.00% 0/12 • Up to 14 weeks per subject The safety set consisted of all enrolled subjects who received at least 1 dose (complete or incomplete) of study drug (Berinert or CSL830). Subjects were included in the safety set for a dosing regimen only if they received at least 1 dose of that dosing regimen (e.g., a subject who discontinued prior to taking the dosing period 2 dosing regimen was not included in the safety set for that dosing regimen).	0.00% 0/12 • Up to 14 weeks per subject The safety set consisted of all enrolled subjects who received at least 1 dose (complete or incomplete) of study drug (Berinert or CSL830). Subjects were included in the safety set for a dosing regimen only if they received at least 1 dose of that dosing regimen (e.g., a subject who discontinued prior to taking the dosing period 2 dosing regimen was not included in the safety set for that dosing regimen).
Injury, poisoning and procedural complications Muscle rupture	0.00% 0/18 • Up to 14 weeks per subject The safety set consisted of all enrolled subjects who received at least 1 dose (complete or incomplete) of study drug (Berinert or CSL830). Subjects were included in the safety set for a dosing regimen only if they received at least 1 dose of that dosing regimen (e.g., a subject who discontinued prior to taking the dosing period 2 dosing regimen was not included in the safety set for that dosing regimen).	8.3% 1/12 • Number of events 1 • Up to 14 weeks per subject The safety set consisted of all enrolled subjects who received at least 1 dose (complete or incomplete) of study drug (Berinert or CSL830). Subjects were included in the safety set for a dosing regimen only if they received at least 1 dose of that dosing regimen (e.g., a subject who discontinued prior to taking the dosing period 2 dosing regimen was not included in the safety set for that dosing regimen).	0.00% 0/12 • Up to 14 weeks per subject The safety set consisted of all enrolled subjects who received at least 1 dose (complete or incomplete) of study drug (Berinert or CSL830). Subjects were included in the safety set for a dosing regimen only if they received at least 1 dose of that dosing regimen (e.g., a subject who discontinued prior to taking the dosing period 2 dosing regimen was not included in the safety set for that dosing regimen).	0.00% 0/12 • Up to 14 weeks per subject The safety set consisted of all enrolled subjects who received at least 1 dose (complete or incomplete) of study drug (Berinert or CSL830). Subjects were included in the safety set for a dosing regimen only if they received at least 1 dose of that dosing regimen (e.g., a subject who discontinued prior to taking the dosing period 2 dosing regimen was not included in the safety set for that dosing regimen).
Investigations Urine analysis abnormal	0.00% 0/18 • Up to 14 weeks per subject The safety set consisted of all enrolled subjects who received at least 1 dose (complete or incomplete) of study drug (Berinert or CSL830). Subjects were included in the safety set for a dosing regimen only if they received at least 1 dose of that dosing regimen (e.g., a subject who discontinued prior to taking the dosing period 2 dosing regimen was not included in the safety set for that dosing regimen).	8.3% 1/12 • Number of events 1 • Up to 14 weeks per subject The safety set consisted of all enrolled subjects who received at least 1 dose (complete or incomplete) of study drug (Berinert or CSL830). Subjects were included in the safety set for a dosing regimen only if they received at least 1 dose of that dosing regimen (e.g., a subject who discontinued prior to taking the dosing period 2 dosing regimen was not included in the safety set for that dosing regimen).	0.00% 0/12 • Up to 14 weeks per subject The safety set consisted of all enrolled subjects who received at least 1 dose (complete or incomplete) of study drug (Berinert or CSL830). Subjects were included in the safety set for a dosing regimen only if they received at least 1 dose of that dosing regimen (e.g., a subject who discontinued prior to taking the dosing period 2 dosing regimen was not included in the safety set for that dosing regimen).	0.00% 0/12 • Up to 14 weeks per subject The safety set consisted of all enrolled subjects who received at least 1 dose (complete or incomplete) of study drug (Berinert or CSL830). Subjects were included in the safety set for a dosing regimen only if they received at least 1 dose of that dosing regimen (e.g., a subject who discontinued prior to taking the dosing period 2 dosing regimen was not included in the safety set for that dosing regimen).
Investigations Urine leukocyte esterase positive	0.00% 0/18 • Up to 14 weeks per subject The safety set consisted of all enrolled subjects who received at least 1 dose (complete or incomplete) of study drug (Berinert or CSL830). Subjects were included in the safety set for a dosing regimen only if they received at least 1 dose of that dosing regimen (e.g., a subject who discontinued prior to taking the dosing period 2 dosing regimen was not included in the safety set for that dosing regimen).	0.00% 0/12 • Up to 14 weeks per subject The safety set consisted of all enrolled subjects who received at least 1 dose (complete or incomplete) of study drug (Berinert or CSL830). Subjects were included in the safety set for a dosing regimen only if they received at least 1 dose of that dosing regimen (e.g., a subject who discontinued prior to taking the dosing period 2 dosing regimen was not included in the safety set for that dosing regimen).	8.3% 1/12 • Number of events 1 • Up to 14 weeks per subject The safety set consisted of all enrolled subjects who received at least 1 dose (complete or incomplete) of study drug (Berinert or CSL830). Subjects were included in the safety set for a dosing regimen only if they received at least 1 dose of that dosing regimen (e.g., a subject who discontinued prior to taking the dosing period 2 dosing regimen was not included in the safety set for that dosing regimen).	8.3% 1/12 • Number of events 1 • Up to 14 weeks per subject The safety set consisted of all enrolled subjects who received at least 1 dose (complete or incomplete) of study drug (Berinert or CSL830). Subjects were included in the safety set for a dosing regimen only if they received at least 1 dose of that dosing regimen (e.g., a subject who discontinued prior to taking the dosing period 2 dosing regimen was not included in the safety set for that dosing regimen).
Metabolism and nutrition disorders Diabetes mellitus	0.00% 0/18 • Up to 14 weeks per subject The safety set consisted of all enrolled subjects who received at least 1 dose (complete or incomplete) of study drug (Berinert or CSL830). Subjects were included in the safety set for a dosing regimen only if they received at least 1 dose of that dosing regimen (e.g., a subject who discontinued prior to taking the dosing period 2 dosing regimen was not included in the safety set for that dosing regimen).	0.00% 0/12 • Up to 14 weeks per subject The safety set consisted of all enrolled subjects who received at least 1 dose (complete or incomplete) of study drug (Berinert or CSL830). Subjects were included in the safety set for a dosing regimen only if they received at least 1 dose of that dosing regimen (e.g., a subject who discontinued prior to taking the dosing period 2 dosing regimen was not included in the safety set for that dosing regimen).	0.00% 0/12 • Up to 14 weeks per subject The safety set consisted of all enrolled subjects who received at least 1 dose (complete or incomplete) of study drug (Berinert or CSL830). Subjects were included in the safety set for a dosing regimen only if they received at least 1 dose of that dosing regimen (e.g., a subject who discontinued prior to taking the dosing period 2 dosing regimen was not included in the safety set for that dosing regimen).	8.3% 1/12 • Number of events 1 • Up to 14 weeks per subject The safety set consisted of all enrolled subjects who received at least 1 dose (complete or incomplete) of study drug (Berinert or CSL830). Subjects were included in the safety set for a dosing regimen only if they received at least 1 dose of that dosing regimen (e.g., a subject who discontinued prior to taking the dosing period 2 dosing regimen was not included in the safety set for that dosing regimen).
Metabolism and nutrition disorders Hypertriglyceridaemia	0.00% 0/18 • Up to 14 weeks per subject The safety set consisted of all enrolled subjects who received at least 1 dose (complete or incomplete) of study drug (Berinert or CSL830). Subjects were included in the safety set for a dosing regimen only if they received at least 1 dose of that dosing regimen (e.g., a subject who discontinued prior to taking the dosing period 2 dosing regimen was not included in the safety set for that dosing regimen).	0.00% 0/12 • Up to 14 weeks per subject The safety set consisted of all enrolled subjects who received at least 1 dose (complete or incomplete) of study drug (Berinert or CSL830). Subjects were included in the safety set for a dosing regimen only if they received at least 1 dose of that dosing regimen (e.g., a subject who discontinued prior to taking the dosing period 2 dosing regimen was not included in the safety set for that dosing regimen).	0.00% 0/12 • Up to 14 weeks per subject The safety set consisted of all enrolled subjects who received at least 1 dose (complete or incomplete) of study drug (Berinert or CSL830). Subjects were included in the safety set for a dosing regimen only if they received at least 1 dose of that dosing regimen (e.g., a subject who discontinued prior to taking the dosing period 2 dosing regimen was not included in the safety set for that dosing regimen).	8.3% 1/12 • Number of events 1 • Up to 14 weeks per subject The safety set consisted of all enrolled subjects who received at least 1 dose (complete or incomplete) of study drug (Berinert or CSL830). Subjects were included in the safety set for a dosing regimen only if they received at least 1 dose of that dosing regimen (e.g., a subject who discontinued prior to taking the dosing period 2 dosing regimen was not included in the safety set for that dosing regimen).
Metabolism and nutrition disorders Hyperuricaemia	5.6% 1/18 • Number of events 1 • Up to 14 weeks per subject The safety set consisted of all enrolled subjects who received at least 1 dose (complete or incomplete) of study drug (Berinert or CSL830). Subjects were included in the safety set for a dosing regimen only if they received at least 1 dose of that dosing regimen (e.g., a subject who discontinued prior to taking the dosing period 2 dosing regimen was not included in the safety set for that dosing regimen).	0.00% 0/12 • Up to 14 weeks per subject The safety set consisted of all enrolled subjects who received at least 1 dose (complete or incomplete) of study drug (Berinert or CSL830). Subjects were included in the safety set for a dosing regimen only if they received at least 1 dose of that dosing regimen (e.g., a subject who discontinued prior to taking the dosing period 2 dosing regimen was not included in the safety set for that dosing regimen).	0.00% 0/12 • Up to 14 weeks per subject The safety set consisted of all enrolled subjects who received at least 1 dose (complete or incomplete) of study drug (Berinert or CSL830). Subjects were included in the safety set for a dosing regimen only if they received at least 1 dose of that dosing regimen (e.g., a subject who discontinued prior to taking the dosing period 2 dosing regimen was not included in the safety set for that dosing regimen).	0.00% 0/12 • Up to 14 weeks per subject The safety set consisted of all enrolled subjects who received at least 1 dose (complete or incomplete) of study drug (Berinert or CSL830). Subjects were included in the safety set for a dosing regimen only if they received at least 1 dose of that dosing regimen (e.g., a subject who discontinued prior to taking the dosing period 2 dosing regimen was not included in the safety set for that dosing regimen).
Vascular disorders Flushing	0.00% 0/18 • Up to 14 weeks per subject The safety set consisted of all enrolled subjects who received at least 1 dose (complete or incomplete) of study drug (Berinert or CSL830). Subjects were included in the safety set for a dosing regimen only if they received at least 1 dose of that dosing regimen (e.g., a subject who discontinued prior to taking the dosing period 2 dosing regimen was not included in the safety set for that dosing regimen).	8.3% 1/12 • Number of events 4 • Up to 14 weeks per subject The safety set consisted of all enrolled subjects who received at least 1 dose (complete or incomplete) of study drug (Berinert or CSL830). Subjects were included in the safety set for a dosing regimen only if they received at least 1 dose of that dosing regimen (e.g., a subject who discontinued prior to taking the dosing period 2 dosing regimen was not included in the safety set for that dosing regimen).	0.00% 0/12 • Up to 14 weeks per subject The safety set consisted of all enrolled subjects who received at least 1 dose (complete or incomplete) of study drug (Berinert or CSL830). Subjects were included in the safety set for a dosing regimen only if they received at least 1 dose of that dosing regimen (e.g., a subject who discontinued prior to taking the dosing period 2 dosing regimen was not included in the safety set for that dosing regimen).	0.00% 0/12 • Up to 14 weeks per subject The safety set consisted of all enrolled subjects who received at least 1 dose (complete or incomplete) of study drug (Berinert or CSL830). Subjects were included in the safety set for a dosing regimen only if they received at least 1 dose of that dosing regimen (e.g., a subject who discontinued prior to taking the dosing period 2 dosing regimen was not included in the safety set for that dosing regimen).
Vascular disorders Haematoma	0.00% 0/18 • Up to 14 weeks per subject The safety set consisted of all enrolled subjects who received at least 1 dose (complete or incomplete) of study drug (Berinert or CSL830). Subjects were included in the safety set for a dosing regimen only if they received at least 1 dose of that dosing regimen (e.g., a subject who discontinued prior to taking the dosing period 2 dosing regimen was not included in the safety set for that dosing regimen).	8.3% 1/12 • Number of events 1 • Up to 14 weeks per subject The safety set consisted of all enrolled subjects who received at least 1 dose (complete or incomplete) of study drug (Berinert or CSL830). Subjects were included in the safety set for a dosing regimen only if they received at least 1 dose of that dosing regimen (e.g., a subject who discontinued prior to taking the dosing period 2 dosing regimen was not included in the safety set for that dosing regimen).	0.00% 0/12 • Up to 14 weeks per subject The safety set consisted of all enrolled subjects who received at least 1 dose (complete or incomplete) of study drug (Berinert or CSL830). Subjects were included in the safety set for a dosing regimen only if they received at least 1 dose of that dosing regimen (e.g., a subject who discontinued prior to taking the dosing period 2 dosing regimen was not included in the safety set for that dosing regimen).	0.00% 0/12 • Up to 14 weeks per subject The safety set consisted of all enrolled subjects who received at least 1 dose (complete or incomplete) of study drug (Berinert or CSL830). Subjects were included in the safety set for a dosing regimen only if they received at least 1 dose of that dosing regimen (e.g., a subject who discontinued prior to taking the dosing period 2 dosing regimen was not included in the safety set for that dosing regimen).
Cardiac disorders Angina pectoris	5.6% 1/18 • Number of events 1 • Up to 14 weeks per subject The safety set consisted of all enrolled subjects who received at least 1 dose (complete or incomplete) of study drug (Berinert or CSL830). Subjects were included in the safety set for a dosing regimen only if they received at least 1 dose of that dosing regimen (e.g., a subject who discontinued prior to taking the dosing period 2 dosing regimen was not included in the safety set for that dosing regimen).	0.00% 0/12 • Up to 14 weeks per subject The safety set consisted of all enrolled subjects who received at least 1 dose (complete or incomplete) of study drug (Berinert or CSL830). Subjects were included in the safety set for a dosing regimen only if they received at least 1 dose of that dosing regimen (e.g., a subject who discontinued prior to taking the dosing period 2 dosing regimen was not included in the safety set for that dosing regimen).	0.00% 0/12 • Up to 14 weeks per subject The safety set consisted of all enrolled subjects who received at least 1 dose (complete or incomplete) of study drug (Berinert or CSL830). Subjects were included in the safety set for a dosing regimen only if they received at least 1 dose of that dosing regimen (e.g., a subject who discontinued prior to taking the dosing period 2 dosing regimen was not included in the safety set for that dosing regimen).	0.00% 0/12 • Up to 14 weeks per subject The safety set consisted of all enrolled subjects who received at least 1 dose (complete or incomplete) of study drug (Berinert or CSL830). Subjects were included in the safety set for a dosing regimen only if they received at least 1 dose of that dosing regimen (e.g., a subject who discontinued prior to taking the dosing period 2 dosing regimen was not included in the safety set for that dosing regimen).
Renal and urinary disorders Renal pain	0.00% 0/18 • Up to 14 weeks per subject The safety set consisted of all enrolled subjects who received at least 1 dose (complete or incomplete) of study drug (Berinert or CSL830). Subjects were included in the safety set for a dosing regimen only if they received at least 1 dose of that dosing regimen (e.g., a subject who discontinued prior to taking the dosing period 2 dosing regimen was not included in the safety set for that dosing regimen).	8.3% 1/12 • Number of events 1 • Up to 14 weeks per subject The safety set consisted of all enrolled subjects who received at least 1 dose (complete or incomplete) of study drug (Berinert or CSL830). Subjects were included in the safety set for a dosing regimen only if they received at least 1 dose of that dosing regimen (e.g., a subject who discontinued prior to taking the dosing period 2 dosing regimen was not included in the safety set for that dosing regimen).	0.00% 0/12 • Up to 14 weeks per subject The safety set consisted of all enrolled subjects who received at least 1 dose (complete or incomplete) of study drug (Berinert or CSL830). Subjects were included in the safety set for a dosing regimen only if they received at least 1 dose of that dosing regimen (e.g., a subject who discontinued prior to taking the dosing period 2 dosing regimen was not included in the safety set for that dosing regimen).	0.00% 0/12 • Up to 14 weeks per subject The safety set consisted of all enrolled subjects who received at least 1 dose (complete or incomplete) of study drug (Berinert or CSL830). Subjects were included in the safety set for a dosing regimen only if they received at least 1 dose of that dosing regimen (e.g., a subject who discontinued prior to taking the dosing period 2 dosing regimen was not included in the safety set for that dosing regimen).
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	0.00% 0/18 • Up to 14 weeks per subject The safety set consisted of all enrolled subjects who received at least 1 dose (complete or incomplete) of study drug (Berinert or CSL830). Subjects were included in the safety set for a dosing regimen only if they received at least 1 dose of that dosing regimen (e.g., a subject who discontinued prior to taking the dosing period 2 dosing regimen was not included in the safety set for that dosing regimen).	0.00% 0/12 • Up to 14 weeks per subject The safety set consisted of all enrolled subjects who received at least 1 dose (complete or incomplete) of study drug (Berinert or CSL830). Subjects were included in the safety set for a dosing regimen only if they received at least 1 dose of that dosing regimen (e.g., a subject who discontinued prior to taking the dosing period 2 dosing regimen was not included in the safety set for that dosing regimen).	8.3% 1/12 • Number of events 1 • Up to 14 weeks per subject The safety set consisted of all enrolled subjects who received at least 1 dose (complete or incomplete) of study drug (Berinert or CSL830). Subjects were included in the safety set for a dosing regimen only if they received at least 1 dose of that dosing regimen (e.g., a subject who discontinued prior to taking the dosing period 2 dosing regimen was not included in the safety set for that dosing regimen).	0.00% 0/12 • Up to 14 weeks per subject The safety set consisted of all enrolled subjects who received at least 1 dose (complete or incomplete) of study drug (Berinert or CSL830). Subjects were included in the safety set for a dosing regimen only if they received at least 1 dose of that dosing regimen (e.g., a subject who discontinued prior to taking the dosing period 2 dosing regimen was not included in the safety set for that dosing regimen).
Skin and subcutaneous tissue disorders Rash	0.00% 0/18 • Up to 14 weeks per subject The safety set consisted of all enrolled subjects who received at least 1 dose (complete or incomplete) of study drug (Berinert or CSL830). Subjects were included in the safety set for a dosing regimen only if they received at least 1 dose of that dosing regimen (e.g., a subject who discontinued prior to taking the dosing period 2 dosing regimen was not included in the safety set for that dosing regimen).	8.3% 1/12 • Number of events 1 • Up to 14 weeks per subject The safety set consisted of all enrolled subjects who received at least 1 dose (complete or incomplete) of study drug (Berinert or CSL830). Subjects were included in the safety set for a dosing regimen only if they received at least 1 dose of that dosing regimen (e.g., a subject who discontinued prior to taking the dosing period 2 dosing regimen was not included in the safety set for that dosing regimen).	8.3% 1/12 • Number of events 1 • Up to 14 weeks per subject The safety set consisted of all enrolled subjects who received at least 1 dose (complete or incomplete) of study drug (Berinert or CSL830). Subjects were included in the safety set for a dosing regimen only if they received at least 1 dose of that dosing regimen (e.g., a subject who discontinued prior to taking the dosing period 2 dosing regimen was not included in the safety set for that dosing regimen).	0.00% 0/12 • Up to 14 weeks per subject The safety set consisted of all enrolled subjects who received at least 1 dose (complete or incomplete) of study drug (Berinert or CSL830). Subjects were included in the safety set for a dosing regimen only if they received at least 1 dose of that dosing regimen (e.g., a subject who discontinued prior to taking the dosing period 2 dosing regimen was not included in the safety set for that dosing regimen).

Additional Information

Study Director

CSL Behring

Phone: 610-878-4000

Email: clinicaltrials@cslbehring.com

Results disclosure agreements

• Principal investigator is a sponsor employee CSL agreements and restrictions on publishing may vary with individual investigators; however, CSL will not prohibit any investigator from publishing. CSL supports the publication of results from all centers of a multi-center trial and generally requires that reports based on single-site data not precede the primary publication of the entire clinical trial.
• Publication restrictions are in place

Restriction type: OTHER