Time to peak concentration (Tmax) of a single SC dose of icatibant was reported.

Pharmacokinetic (PK) population consisted of participants who were treated with icatibant and had sufficient icatibant plasma concentration-time measurements to derive primary PK parameters. Here the number of participants analyzed signifies participants who were evaluable for this measure.

Maximum plasma concentration (Cmax) of a single SC dose of icatibant was reported.

The PK population consisted of participants who were treated with icatibant and had sufficient icatibant plasma concentration-time measurements to derive primary PK parameters. Here the number of participants analyzed signifies participants who were evaluable for this measure.

Total plasma clearance (CL/F) of a single SC dose of icatibant was reported.

The PK population consisted of participants who were treated with icatibant and had sufficient icatibant plasma concentration time measurements to derive primary PK parameters. Here the number of participants analyzed signifies participants who were evaluable for this measure.

Area under the plasma concentration-time curve from time zero to 4 hours post-dose (AUC0-4) of a single SC dose of icatibant was reported.

The PK population consisted of participants who were treated with icatibant and had sufficient icatibant plasma concentration time measurements to derive primary PK parameters. Here the number of participants analyzed signifies participants who were evaluable for this measure.

Area under the plasma concentration-time curve from time zero to 6 hours post-dose (AUC0-t) of a single SC dose of icatibant was reported.

The PK population consisted of participants who were treated with icatibant and had sufficient icatibant plasma concentration time measurements to derive primary PK parameters. Here the number of participants analyzed signifies participants who were evaluable for this measure.

Area under the plasma concentration-time curve from time zero to infinity (AUC0-inf) of a single SC dose of icatibant was reported.

The PK population consisted of participants who were treated with icatibant and had sufficient icatibant plasma concentration time measurements to derive primary PK parameters. Here the number of participants analyzed signifies participants who were evaluable for this measure.

Volume of distribution (Vz/F) of a single SC dose of icatibant was reported.

The PK population consisted of participants who were treated with icatibant and had sufficient icatibant plasma concentration time measurements to derive primary PK parameters. Here the number of participants analyzed signifies participants who were evaluable for this measure.

Elimination half-life (t1/2) of a single SC dose of icatibant was reported.

The PK population consisted of participants who were treated with icatibant and had sufficient icatibant plasma concentration time measurements to derive primary PK parameters. Here the number of participants analyzed signifies participants who were evaluable for this measure.

Vital signs included pulse rate, blood pressure, respiration rate, and temperature. The number of participants who reported clinically significant changes in vital signs were reported.

Safety population consisted of participants who were treated with icatibant at least once during the study.

A standard 12-lead ECG was performed after 10 minutes at rest when the participant was seated or supine following treatment. The number of participants who reported clinically significant changes in ECGs were reported.

Safety population consisted of participants who were treated with icatibant at least once during the study.

Clinical laboratory evaluations included clinical chemistry (including liver function tests), hematology, urinalysis. The number of participants who reported clinically significant changes in clinical laboratory evaluations were reported.

Safety population consisted of participants who were treated with icatibant at least once during the study.

The number of participants who reported anti-icatibant antibodies were reported.

Safety population consisted of participants who were treated with icatibant at least once during the study.

An AE was any noxious, pathologic, or unintended change in anatomical, physiologic, or metabolic function as indicated by physical signs, symptoms, or laboratory changes occurring in a clinical study, whether or not considered investigational product related.

Safety population consisted of participants who were treated with icatibant at least once during the study.

The number of participants with injection site reactions (erythema, swelling, burning sensation, itching/pruritus, warm sensation, cutaneous pain, or other) that occured after initial icatibant administration was reported.

Safety population consisted of participants who were treated with icatibant at least once during the study. Here the number of participants analyzed signifies participants who were evaluable for this measure.

The number of participants with injection site reactions (erythema, swelling, burning sensation, itching/pruritus, warm sensation, cutaneous pain, or other) that occurred after subsequent icatibant administration by study-site personnel (health care practitioner [HCP] administration) or by caregiver/self (caregiver administration) was reported. In the below table, E-2 refers to icatibant exposure 2 and E-3 refers to icatibant exposure 3.

Safety population consisted of participants who were treated with icatibant at least once during the study. Here the number of participants analyzed signifies participants who received subsequent icatibant exposures 2 and 3.

Reproductive hormone levels of follicle-stimulating hormone (FSH), luteinizing hormone (LH), estradiol, and progesterone in females, and FSH, LH, and testosterone in males were measured. The number of participants with clinically significant changes in reproductive hormones was reported.

Safety population consisted of participants who were treated with icatibant at least once during the study.

The TOSR was defined as the duration of time in hours from study drug administration to the earliest time post-treatment at which there was at least a 20 percent (%) improvement in the average post-treatment symptom score with no worsening of any single component score for the initial icatibant exposure. The investigator used a symptom score to assess the severities of symptoms of acute cutaneous, abdominal, and laryngeal attacks of hereditary angioedema (HAE) using the following 5-point scale: 0=none (absence of symptoms), 1=mild (no to mild interference with daily activities), 2=moderate (moderate interference with daily activities), 3=severe (severe interference with daily activities) and 4=very severe (very severe interference with daily activities). TOSR for participants who received initial icatibant administration was reported.

Efficacy population consisted of participants who were treated with icatibant for their first and any additional attacks during the study. Here the number of participants analyzed signifies participants who were evaluable for this measure.

The TOSR was defined as the duration of time in hours from study drug administration to the earliest time post-treatment at which there was at least a 20% improvement in the composite (or average) post-treatment symptom score with no worsening of any single component score. The investigator used a symptom score to assess the severities of symptoms of acute cutaneous, abdominal, and laryngeal attacks of HAE using the following 5-point scale: 0=none (absence of symptoms), 1=mild (no to mild interference with daily activities), 2=moderate (moderate interference with daily activities), 3=severe (severe interference with daily activities) and 4=very severe (very severe interference with daily activities). TOSR for participants who received subsequent icatibant administration by HCP administration or by caregiver/ self-administration was reported.

Efficacy population consisted of participants who were treated with icatibant for their first and any additional attacks during the study. Here the number of participants analyzed signifies participants who received subsequent icatibant exposures 2 and 3.

The TOSR was defined as the earliest time at which the post-treatment score improved by at least one level. Participants of 4 years age and older self-assessed their HAE-related pain using the FPS-R instrument. FPS-R is a self-reported measure used to assess the intensity of children's pain and it is scored using a 0 to 10 scale (0=no pain to 10=very much pain). TOSR for participants who received initial icatibant administration was reported.

Efficacy population consisted of participants who were treated with icatibant for their first and any additional attacks during the study. Here the number of participants analyzed signifies participants with FPS-R data.

The TOSR was defined as the earliest time at which the post-treatment score improved by at least one level. Participants of 4 years age and older self-assessed their HAE-related pain using the FPS-R instrument. FPS-R is a self-reported measure used to assess the intensity of children's pain and it is scored using a 0 to 10 scale (0=no pain to 10=very much pain). TOSR for participants who received subsequent icatibant administration by HCP administration or by caregiver/ self-administration was reported.

Efficacy population consisted of participants who were treated with icatibant for their first and any additional attacks during the study. Here the number of participants analyzed signifies participants with FPS-R data.

The TOSR was defined as the earliest time at which a 20% improvement was seen in the total post-treatment score. Participants of 4 years age and younger underwent investigator assessment of HAE-related pain (cutaneous, abdominal, and laryngeal) using the FLACC comportmental pain scale. Each of the 5 categories was scored from 0 to 2. Face(F): 0 (no particular expression/smile) - 2 (frequent to constant frown clenched jaw quivering chin); Legs(L): 0 (normal position/relaxed) - 2 (kicking/legs drawn up); Activity(A): 0 (lying quietly, normal position, moves easily) - 2 (arched rigid/jerking); Cry(C): 0 (No cry [awake/asleep]) - 2 (crying steadily/screams/sobs or frequent complaints); Consolability(C): 0 (content/relaxed) - 2 (difficult to console/comfort), resulting in a total score between 0 and 10.

Efficacy population consisted of participants who were treated with icatibant for their first and any additional attacks during the study. Here the number of participants analyzed signifies participants of 4 years and younger with FLACC data.

Time to minimum symptom was defined as the duration of time in hours from study drug administration to the earliest time post-treatment at which all symptoms were either mild or absent for the investigator-reported symptom score. The investigator used a symptom score to assess the severities of symptoms of acute cutaneous, abdominal, and laryngeal attacks of HAE using the following 5-point scale: 0=none (absence of symptoms), 1=mild (no to mild interference with daily activities), 2=moderate (moderate interference with daily activities), 3=severe (severe interference with daily activities) and 4=very severe (very severe interference with daily activities). Time to minimum symptom for participants who received initial icatibant administration was reported.

Efficacy population consisted of participants who were treated with icatibant for their first and any additional attacks during the study. Here the number of participants analyzed signifies participants who were evaluable for this measure.

Time to minimum symptom was defined as the duration of time in hours from study drug administration to the earliest time post-treatment at which all symptoms were either mild or absent for the investigator-reported symptom score. The investigator used a symptom score to assess the severities of symptoms of acute cutaneous, abdominal, and laryngeal attacks of HAE using the following 5-point scale: 0=none (absence of symptoms), 1=mild (no to mild interference with daily activities), 2=moderate (moderate interference with daily activities), 3=severe (severe interference with daily activities) and 4=very severe (very severe interference with daily activities). Time to minimum symptom for participants who received subsequent icatibant administration by HCP administration or by caregiver/ self-administration was reported.

Efficacy population consisted of participants who were treated with icatibant for their first and any additional attacks during the study. Here the number of participants analyzed signifies participants who were evaluable for this measure.

Time to minimum symptoms was defined as the duration of time in hours from study drug administration to the earliest time at which post-treatment score improved to zero (or no pain). Participants of 4 years of age and older self-assessed their HAE-related pain using the FPS-R instrument. FPS-R is a self-reported measure used to assess the intensity of children's pain and it is scored using a 0 to 10 scale (0=no pain to 10=very much pain). Time to minimum symptom for participants who received initial icatibant administration was reported.

Efficacy population consisted of participants who were treated with icatibant for their first and any additional attacks during the study. Here the number of participants analyzed signifies participants with FPS-R data.

Time to minimum symptoms was defined as the duration of time in hours from study drug administration to the earliest time at which post-treatment score improved to zero (or no pain). Participants of 4 years of age and older self-assessed their HAE-related pain using the FPS-R instrument. FPS-R is a self-reported measure used to assess the intensity of children's pain and it is scored using a 0 to 10 scale (0=no pain to 10=very much pain). Time to minimum symptom for participants who received subsequent icatibant administration by HCP administration or by caregiver/ self-administration was reported.

Efficacy population consisted of participants who were treated with icatibant for their first and any additional attacks during the study. Here the number of participants analyzed signifies participants with FPS-R data.

Time to minimum symptoms was defined as the duration of time in hours from study drug administration to the earliest time at which the total post-treatment score improved to zero. Participants of 4 years age and younger underwent investigator assessment of HAE-related pain (cutaneous, abdominal, and laryngeal) using the FLACC comportmental pain scale. Each of the 5 categories was scored from 0 to 2. (F) Face: 0 (no particular expression/smile) - 2 (frequent to constant frown clenched jaw quivering chin); (L) Legs: 0 (normal position/relaxed) - 2 (kicking/legs drawn up); (A) Activity: 0 (lying quietly, normal position, moves easily) - 2 (arched rigid/jerking); (C) Cry: 0 (No cry [awake/asleep]) - 2 (crying steadily/screams/sobs or frequent complaints); (C) Consolability: 0 (content/relaxed) - 2 (difficult to console/comfort), resulting in a total score between 0 and 10.

Participants from efficacy population with FLACC data.

Rescue medication was any medication used after the administration of icatibant which, in the opinion of the investigator, was immediately necessary to alleviate acute symptoms which are judged by the investigator as resultant from the current HAE attack. Time to first use of rescue medication prior to the onset of symptom relief was calculated from the time of study drug administration to the first use of rescue medication prior to the onset of symptom relief. This analysis was not performed since as per protocol, "This analysis will only be performed if there are at least 5 participants for a given attack who used rescue medication prior to attaining symptom relief".

Efficacy population consisted of participants who were treated with icatibant for their first and any additional attacks during the study. Here the number of participants analyzed signifies participants who were evaluable for this measure.

The investigator used a symptom score to assess the severities of symptoms of acute cutaneous, abdominal, and laryngeal attacks of HAE using the following 5- point scale: 0=none (absence of symptoms), 1=mild (no to mild interference with daily activities), 2=moderate (moderate interference with daily activities), 3=severe (severe interference with daily activities) and 4=very severe (very severe interference with daily activities). The number of participants with a worsened severity of HAE symptoms at 4 hours post-dose from 2 hours postdose were reported.

Efficacy population consisted of participants who were treated with icatibant for their first and any additional attacks during the study. Here the number of participants analyzed signifies participants who evaluable for this endpoint.

The investigator used a symptom score to assess the severities of symptoms of acute cutaneous, abdominal, and laryngeal attacks of HAE using the following 5- point scale: 0=none (absence of symptoms), 1=mild (no to mild interference with daily activities), 2=moderate (moderate interference with daily activities), 3=severe (severe interference with daily activities) and 4=very severe (very severe interference with daily activities). The number of participants with a worsened severity of HAE symptoms at 4 hours post-dose from 2 hours post-dose were reported.

Efficacy population consisted of participants who were treated with icatibant for their first and any additional attacks during the study. The number of participants analyzed signifies participants evaluable for this endpoint.