The percentage of bleed treatments successfully resulting in bleed resolution. Analysis only considers the patient's opinion of effectiveness at 9 hours, with a rating of "Effective" considered as successful treatment.

Analysis set is all bleed episodes, regardless of bleed type or initial dose level

The percentage of bleed treatments successfully resulting in bleed resolution. Analysis only considers the patient's opinion of effectiveness at 9 hours, with a rating of "Effective" considered as successful treatment.

Analysis set is spontaneous bleed episodes treated with any initial dose

The percentage of participants with effective pain relief. Pain relief was a subjective assessment made by the patient during treatment of a bleed episode.

Analysis set is all bleed episodes, regardless of bleed type or initial dose level

The percentage of participants with effective pain relief. Pain relief was a subjective assessment made by the patient during treatment of a bleed episode.

Analysis set is spontaneous bleed episodes treated with any initial dose

Effective haemostasis at 3 different time points for all bleeds. Patient reported outcomes are reported over 1 hour, 3 hours and 6 hours.

Analysis set is all bleed episodes, regardless of bleed type or initial dose level

Effective haemostasis at 3 different time points for all bleeds. Patient reported outcomes are reported over 1 hour, 3 hours and 6 hours.

Analysis set is spontaneous bleed episodes treated with any initial dose

Effective pain relief at 3 different time points for all bleeds. Patient reported outcomes are reported over 1 hour, 3 hours and 6 hours.

Analysis set is all bleed episodes, regardless of bleed type or initial dose level

Effective pain relief at 3 different time points for spontaneous bleeds. Patient reported outcomes are reported over 1 hour, 3 hours and 6 hours.

Analysis set is spontaneous bleed episodes treated with any initial dose

The median number of injections required to treat individual bleed episodes.

Analysis set is all bleed episodes, regardless of bleed type or initial dose level

The median number of injections required to treat individual bleed episodes.

Analysis set is spontaneous bleed episodes treated with any initial dose

The median total cumulative dose required to treat individual bleed episodes.

Analysis set is all bleed episodes, regardless of bleed type or initial dose level. Excludes bleeds episodes with greater than 24 hours between 1st and 2nd rFVII dose where total cumulative dose recorded likely reflects treatment of re-bleeding or prophylactic/maintenance dosing

The median total cumulative dose required to treat individual bleed episodes.

Analysis set is spontaneous bleed episodes. Excludes bleeds episodes with > 24 hours between 1st and 2nd rFVII dose where total cumulative dose recorded likely reflects treatment of re-bleeding or prophylactic/maintenance dosing, and 2 bleed episodes categorised as CNS that would not meet criteria of mild to moderate spontaneous bleed episodes

Patient rate of satisfaction with symptom relief for the bleed episode overall on a 7-point Likert scale. Completion of questionnaire was voluntary. A Likert scale is an ordered, multiple choice questionnaire from which respondents choose one option that best aligns with their view of the particular outcome being measured. Scale answers ranged from extremely satisfied to extremely dissatisfied. The percentage of bleed episodes for which patients reported "extremely satisfied", "very satisfied" or "satisfied" is presented.

Analysis set is all bleed episodes, regardless of bleed type or initial dose level

Patient rate of satisfaction with symptom relief for the bleed episode overall on a 7-point Likert scale. Completion of questionnaire was voluntary. A Likert scale is an ordered, multiple choice questionnaire from which respondents choose one option that best aligns with their view of the particular outcome being measured. Scale answers ranged from extremely satisfied to extremely dissatisfied. The percentage of bleed episodes for which patients reported "extremely satisfied", "very satisfied" or "satisfied" is presented.

Analysis set is spontaneous bleed episodes treated with any initial dose

Rate of ease of use related to activated recombinant human factor VII on a 7-point Likert scale. Completion of questionnaire was voluntary. A Likert scale is an ordered, multiple choice questionnaire from which respondents choose one option that best aligns with their view of the particular outcome being measured. Scale answers ranged from extremely difficult to extremely easy. The percentage of bleed episodes for which patients reported "extremely easy", "very easy" or "easy" is presented.

Analysis set is all bleed episodes, regardless of bleed type or initial dose level

Rate of ease of use related to activated recombinant human factor VII on a 7-point Likert scale. Completion of questionnaire was voluntary. A Likert scale is an ordered, multiple choice questionnaire from which respondents choose one option that best aligns with their view of the particular outcome being measured. Scale answers ranged from extremely difficult to extremely easy. The percentage of bleed episodes for which patients reported "extremely easy", "very easy" or "easy" is presented.

Analysis set is spontaneous bleed episodes treated with any initial dose

Median time to achievement of haemostasis/bleed cessation calculated using Kaplan Meier life table methods. If approximately 50% or less of bleeds achieved the endpoint in a given initial dose subgroup, the median cannot be calculated and it is reported as not applicable

Analysis set is all bleed episodes, regardless of bleed type or initial dose level

Median time to achievement of haemostasis/bleed cessation calculated using Kaplan Meier life table methods. If approximately 50% or less of bleeds achieved the endpoint in a given initial dose subgroup, the median cannot be calculated and it is reported as not applicable

Analysis set is spontaneous bleed episodes treated with any initial dose

Median time to achievement of haemostasis/bleed cessation calculated using Kaplan Meier life table methods. If approximately 50% or less of bleeds achieved the endpoint in a given initial dose subgroup, the median cannot be calculated and it is reported as not applicable.

Analysis set is spontaneous bleed episodes treated with any initial dose, excluding bleed episodes treated with more than one dose for which > 24 hours between the 1st and 2nd dose was reported (bleed episodes with > 24 hours between 1st and 2nd rFVIIa dose likely reflects treatment of re-bleeding or prophylactic/maintenance dosing)

The Haemo-QoL is a specific multidimensional validated and reliable questionnaire used to assess quality of life in patients with haemophilia. Scores are reported on a 0 to 100 scale-higher scores indicate more impairment.

A subset of paediatric subjects age 4 to 16 (inclusive) included in the study that completed the questionnaire at baseline and/or at discontinuation

The adult Haemo-QoL-A is a specific multidimensional validated and reliable questionnaire used to assess quality of life in patients with haemophilia. Scores are reported on a 0 to 100 scale-higher scores indicate more impairment.

A subset of adult subjects above 16 years included in the study that completed the questionnaire at baseline and/or at discontinuation

Percentage of bleeds with effective haemostasis within 9 hours of first injection of activated recombinant human factor VII. Patient reported assessments were sorted into 3 sub-categories: "effective" = bleed resolved or substantially improved; "partially effective" = bleed with some improvement; "ineffective" = bleed with no change or with worsening.

Analysis set is all bleed episodes, regardless of bleed type or initial dose level

Percentage of bleeds with effective haemostasis within 9 hours of first injection of activated recombinant human factor VII. Patient reported assessments were sorted into 3 sub-categories: "effective" = bleed resolved or substantially improved; "partially effective" = bleed with some improvement; "ineffective" = bleed with no change or with worsening.

Analysis set is spontaneous bleed episodes treated with any initial dose

Percentage of bleeds with effective pain relief within 9 hours of first injection of activated recombinant human factor VII. Patient reported assessments were sorted into 3 sub-categories: "Better" = pain resolved or decreased substantially; "Same" = no change; "Worsened" = pain worsening.

Analysis set is all bleed episodes, regardless of bleed type or initial dose level

Percentage of bleeds with effective pain relief within 9 hours of first injection of activated recombinant human factor VII. Patient reported assessments were sorted into 3 sub-categories: "Better" = pain resolved or decreased substantially; "Same" = no change; "Worsened" = pain worsening.

Analysis set is spontaneous bleed episodes treated with any initial dose