Trial Outcomes & Findings for A Study of Recombinant Von Willebrand Factor (rVWF) in Pediatric and Adult Participants With Severe Von Willebrand Disease (VWD) (NCT NCT03879135)

Last Updated: 2025-09-03

Results Overview

sABR was derived as \[number of treated bleeds\] / \[duration in years\]. Bleeds with unknown causality were considered as spontaneous. Bleeds were categorized based on the investigator assessment of cause. sABR during the first 12 months of prophylactic treatment with rVWF (vonicog alfa) was reported.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

38 participants

Primary outcome timeframe

Up to 12 months

Results posted on

2025-09-03

Participant Flow

Participants took part in the study at 23 investigative sites globally from 1 April 2019 to 30 January 2025.

A total of 38 participants with diagnosis of Von Willebrand disease were enrolled. Only participants who received treatment in study(N=35) were included in analysis. These participants received recombinant von Willebrand factor (rVWF) \[vonicog alfa\], 50±10 international units per kilogram (IU/kg),intravenous(IV) infusion in either prophylaxis or on demand cohorts. Some participants received supportive treatment with ADVATE for treating bleeding episodes (BEs) if deemed necessary by investigator.

Participant milestones

Participant milestones
Measure	Cohort 1: Prophylaxis Adult participants who transitioned from the phase 3 prophylaxis parent study 071301 (NCT02973087) received the same prophylactic dose, 50±10 IU/kg, IV infusion of vonicog alfa twice weekly as in parent study 071301.	Cohort 2: Prophylaxis Adult participants who transitioned from parent study 071301 (NCT02973087) with no clinically significant BE for the past 6 months started this continuation study at a lower dose/frequency of vonicog alfa once weekly or twice weekly prophylactic dose, 50±10 IU/kg, IV infusion compared to the dose received (50±10 IU/kg, IV infusion, thrice weekly) in parent study 071301.	Cohort 3: Prophylaxis Adolescent participants (aged 12 to less than \[\<\]18 years) who transitioned from the phase 3 OD and surgery parent study 071102 (NCT02932618) switched from receiving vonicog alfa OD treatment to receiving prophylactic dose of vonicog alfa 50±10 IU/kg, IV infusion, once weekly or twice weekly in this continuation study.	Cohort 4: Prophylaxis Newly enrolled adult and adolescent (aged 12 to \<18 years) participants who switched from OD treatment with Von Willebrand Factor (VWF) products started 50±10 IU/kg, IV infusion once weekly prophylaxis with vonicog alfa in this continuation study.	Cohort 5: On Demand Pediatric participants of all ages from parent study 071102 (NCT02932618) continued receiving OD treatment of vonicog alfa 50±10 IU/kg, IV infusion, once weekly or twice weekly in this continuation study.	Cohort 6: On Demand Adult participants from parent study 071301 (NCT02973087) switched back from prophylactic treatment in study 071301 to OD treatment of vonicog alfa 50±10 IU/kg, IV infusion, once weekly or twice weekly in this continuation study.
Overall Study STARTED	10	1	1	5	16	2
Overall Study COMPLETED	10	1	1	3	15	1
Overall Study NOT COMPLETED	0	0	0	2	1	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Cohort 4: Prophylaxis Newly enrolled adult and adolescent (aged 12 to \<18 years) participants who switched from OD treatment with Von Willebrand Factor (VWF) products started 50±10 IU/kg, IV infusion once weekly prophylaxis with vonicog alfa in this continuation study.	Cohort 5: On Demand Pediatric participants of all ages from parent study 071102 (NCT02932618) continued receiving OD treatment of vonicog alfa 50±10 IU/kg, IV infusion, once weekly or twice weekly in this continuation study.	Cohort 6: On Demand Adult participants from parent study 071301 (NCT02973087) switched back from prophylactic treatment in study 071301 to OD treatment of vonicog alfa 50±10 IU/kg, IV infusion, once weekly or twice weekly in this continuation study.
Overall Study Physician Decision	1	0	0
Overall Study Withdrawal by Subject	0	0	1
Overall Study Site Closed by Sponsor	1	1	0

Baseline Characteristics

2 Participants aged 18 years old in cohort 5 were \<18 years of age at the time of enrollment in the parent study 071102 (NCT02932618). They turned 18 years prior to transitioning into this study, their inclusion aligns with the study design, ensuring continuity in cohort assignment, and the age classification at the time of initial enrollment remains relevant for analytical consistency.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Cohort 1: Prophylaxis n=10 Participants Adult participants who transitioned from the phase 3 prophylaxis parent study 071301 (NCT02973087) received the same prophylactic dose, 50±10 IU/kg, IV infusion of vonicog alfa twice weekly as in parent study 071301.	Cohort 2: Prophylaxis n=1 Participants Adult participants who transitioned from parent study 071301 (NCT02973087) with no clinically significant BE for the past 6 months started this continuation study at a lower dose/frequency of vonicog alfa once weekly or twice weekly prophylactic dose, 50±10 IU/kg, IV infusion compared to the dose received (50±10 IU/kg, IV infusion, thrice weekly) in parent study 071301.	Cohort 3: Prophylaxis n=1 Participants Adolescent participants (aged 12 to \<18 years) who transitioned from the phase 3 OD and surgery parent study 071102 (NCT02932618) switched from receiving vonicog alfa OD treatment to receiving prophylactic dose of vonicog alfa 50±10 IU/kg, IV infusion, once weekly or twice weekly in this continuation study.	Cohort 4: Prophylaxis n=5 Participants Newly enrolled adult and adolescent (aged 12 to \<18 years) participants who switched from OD treatment with Von Willebrand Factor (VWF) products started 50±10 IU/kg, IV infusion once weekly prophylaxis with vonicog alfa in this continuation study.	Cohort 5: On Demand n=16 Participants Pediatric participants of all ages from parent study 071102 (NCT02932618) continued receiving OD treatment of vonicog alfa 50±10 IU/kg, IV infusion, once weekly or twice weekly in this continuation study.	Cohort 6: On Demand n=2 Participants Adult participants from parent study 071301 (NCT02973087) switched back from prophylactic treatment in study 071301 to OD treatment of vonicog alfa 50±10 IU/kg, IV infusion, once weekly or twice weekly in this continuation study.	Total n=35 Participants Total of all reporting groups
Age, Customized <6 years	0 Participants n=5 Participants • 2 Participants aged 18 years old in cohort 5 were \<18 years of age at the time of enrollment in the parent study 071102 (NCT02932618). They turned 18 years prior to transitioning into this study, their inclusion aligns with the study design, ensuring continuity in cohort assignment, and the age classification at the time of initial enrollment remains relevant for analytical consistency.	0 Participants n=7 Participants • 2 Participants aged 18 years old in cohort 5 were \<18 years of age at the time of enrollment in the parent study 071102 (NCT02932618). They turned 18 years prior to transitioning into this study, their inclusion aligns with the study design, ensuring continuity in cohort assignment, and the age classification at the time of initial enrollment remains relevant for analytical consistency.	0 Participants n=5 Participants • 2 Participants aged 18 years old in cohort 5 were \<18 years of age at the time of enrollment in the parent study 071102 (NCT02932618). They turned 18 years prior to transitioning into this study, their inclusion aligns with the study design, ensuring continuity in cohort assignment, and the age classification at the time of initial enrollment remains relevant for analytical consistency.	0 Participants n=4 Participants • 2 Participants aged 18 years old in cohort 5 were \<18 years of age at the time of enrollment in the parent study 071102 (NCT02932618). They turned 18 years prior to transitioning into this study, their inclusion aligns with the study design, ensuring continuity in cohort assignment, and the age classification at the time of initial enrollment remains relevant for analytical consistency.	3 Participants n=21 Participants • 2 Participants aged 18 years old in cohort 5 were \<18 years of age at the time of enrollment in the parent study 071102 (NCT02932618). They turned 18 years prior to transitioning into this study, their inclusion aligns with the study design, ensuring continuity in cohort assignment, and the age classification at the time of initial enrollment remains relevant for analytical consistency.	0 Participants n=10 Participants • 2 Participants aged 18 years old in cohort 5 were \<18 years of age at the time of enrollment in the parent study 071102 (NCT02932618). They turned 18 years prior to transitioning into this study, their inclusion aligns with the study design, ensuring continuity in cohort assignment, and the age classification at the time of initial enrollment remains relevant for analytical consistency.	3 Participants n=115 Participants • 2 Participants aged 18 years old in cohort 5 were \<18 years of age at the time of enrollment in the parent study 071102 (NCT02932618). They turned 18 years prior to transitioning into this study, their inclusion aligns with the study design, ensuring continuity in cohort assignment, and the age classification at the time of initial enrollment remains relevant for analytical consistency.
Age, Customized >=6 to <12 years	0 Participants n=5 Participants • 2 Participants aged 18 years old in cohort 5 were \<18 years of age at the time of enrollment in the parent study 071102 (NCT02932618). They turned 18 years prior to transitioning into this study, their inclusion aligns with the study design, ensuring continuity in cohort assignment, and the age classification at the time of initial enrollment remains relevant for analytical consistency.	0 Participants n=7 Participants • 2 Participants aged 18 years old in cohort 5 were \<18 years of age at the time of enrollment in the parent study 071102 (NCT02932618). They turned 18 years prior to transitioning into this study, their inclusion aligns with the study design, ensuring continuity in cohort assignment, and the age classification at the time of initial enrollment remains relevant for analytical consistency.	0 Participants n=5 Participants • 2 Participants aged 18 years old in cohort 5 were \<18 years of age at the time of enrollment in the parent study 071102 (NCT02932618). They turned 18 years prior to transitioning into this study, their inclusion aligns with the study design, ensuring continuity in cohort assignment, and the age classification at the time of initial enrollment remains relevant for analytical consistency.	0 Participants n=4 Participants • 2 Participants aged 18 years old in cohort 5 were \<18 years of age at the time of enrollment in the parent study 071102 (NCT02932618). They turned 18 years prior to transitioning into this study, their inclusion aligns with the study design, ensuring continuity in cohort assignment, and the age classification at the time of initial enrollment remains relevant for analytical consistency.	5 Participants n=21 Participants • 2 Participants aged 18 years old in cohort 5 were \<18 years of age at the time of enrollment in the parent study 071102 (NCT02932618). They turned 18 years prior to transitioning into this study, their inclusion aligns with the study design, ensuring continuity in cohort assignment, and the age classification at the time of initial enrollment remains relevant for analytical consistency.	0 Participants n=10 Participants • 2 Participants aged 18 years old in cohort 5 were \<18 years of age at the time of enrollment in the parent study 071102 (NCT02932618). They turned 18 years prior to transitioning into this study, their inclusion aligns with the study design, ensuring continuity in cohort assignment, and the age classification at the time of initial enrollment remains relevant for analytical consistency.	5 Participants n=115 Participants • 2 Participants aged 18 years old in cohort 5 were \<18 years of age at the time of enrollment in the parent study 071102 (NCT02932618). They turned 18 years prior to transitioning into this study, their inclusion aligns with the study design, ensuring continuity in cohort assignment, and the age classification at the time of initial enrollment remains relevant for analytical consistency.
Age, Customized >=12 to <18 years	0 Participants n=5 Participants • 2 Participants aged 18 years old in cohort 5 were \<18 years of age at the time of enrollment in the parent study 071102 (NCT02932618). They turned 18 years prior to transitioning into this study, their inclusion aligns with the study design, ensuring continuity in cohort assignment, and the age classification at the time of initial enrollment remains relevant for analytical consistency.	0 Participants n=7 Participants • 2 Participants aged 18 years old in cohort 5 were \<18 years of age at the time of enrollment in the parent study 071102 (NCT02932618). They turned 18 years prior to transitioning into this study, their inclusion aligns with the study design, ensuring continuity in cohort assignment, and the age classification at the time of initial enrollment remains relevant for analytical consistency.	1 Participants n=5 Participants • 2 Participants aged 18 years old in cohort 5 were \<18 years of age at the time of enrollment in the parent study 071102 (NCT02932618). They turned 18 years prior to transitioning into this study, their inclusion aligns with the study design, ensuring continuity in cohort assignment, and the age classification at the time of initial enrollment remains relevant for analytical consistency.	2 Participants n=4 Participants • 2 Participants aged 18 years old in cohort 5 were \<18 years of age at the time of enrollment in the parent study 071102 (NCT02932618). They turned 18 years prior to transitioning into this study, their inclusion aligns with the study design, ensuring continuity in cohort assignment, and the age classification at the time of initial enrollment remains relevant for analytical consistency.	6 Participants n=21 Participants • 2 Participants aged 18 years old in cohort 5 were \<18 years of age at the time of enrollment in the parent study 071102 (NCT02932618). They turned 18 years prior to transitioning into this study, their inclusion aligns with the study design, ensuring continuity in cohort assignment, and the age classification at the time of initial enrollment remains relevant for analytical consistency.	0 Participants n=10 Participants • 2 Participants aged 18 years old in cohort 5 were \<18 years of age at the time of enrollment in the parent study 071102 (NCT02932618). They turned 18 years prior to transitioning into this study, their inclusion aligns with the study design, ensuring continuity in cohort assignment, and the age classification at the time of initial enrollment remains relevant for analytical consistency.	9 Participants n=115 Participants • 2 Participants aged 18 years old in cohort 5 were \<18 years of age at the time of enrollment in the parent study 071102 (NCT02932618). They turned 18 years prior to transitioning into this study, their inclusion aligns with the study design, ensuring continuity in cohort assignment, and the age classification at the time of initial enrollment remains relevant for analytical consistency.
Age, Customized >=18 years	10 Participants n=5 Participants • 2 Participants aged 18 years old in cohort 5 were \<18 years of age at the time of enrollment in the parent study 071102 (NCT02932618). They turned 18 years prior to transitioning into this study, their inclusion aligns with the study design, ensuring continuity in cohort assignment, and the age classification at the time of initial enrollment remains relevant for analytical consistency.	1 Participants n=7 Participants • 2 Participants aged 18 years old in cohort 5 were \<18 years of age at the time of enrollment in the parent study 071102 (NCT02932618). They turned 18 years prior to transitioning into this study, their inclusion aligns with the study design, ensuring continuity in cohort assignment, and the age classification at the time of initial enrollment remains relevant for analytical consistency.	0 Participants n=5 Participants • 2 Participants aged 18 years old in cohort 5 were \<18 years of age at the time of enrollment in the parent study 071102 (NCT02932618). They turned 18 years prior to transitioning into this study, their inclusion aligns with the study design, ensuring continuity in cohort assignment, and the age classification at the time of initial enrollment remains relevant for analytical consistency.	3 Participants n=4 Participants • 2 Participants aged 18 years old in cohort 5 were \<18 years of age at the time of enrollment in the parent study 071102 (NCT02932618). They turned 18 years prior to transitioning into this study, their inclusion aligns with the study design, ensuring continuity in cohort assignment, and the age classification at the time of initial enrollment remains relevant for analytical consistency.	2 Participants n=21 Participants • 2 Participants aged 18 years old in cohort 5 were \<18 years of age at the time of enrollment in the parent study 071102 (NCT02932618). They turned 18 years prior to transitioning into this study, their inclusion aligns with the study design, ensuring continuity in cohort assignment, and the age classification at the time of initial enrollment remains relevant for analytical consistency.	2 Participants n=10 Participants • 2 Participants aged 18 years old in cohort 5 were \<18 years of age at the time of enrollment in the parent study 071102 (NCT02932618). They turned 18 years prior to transitioning into this study, their inclusion aligns with the study design, ensuring continuity in cohort assignment, and the age classification at the time of initial enrollment remains relevant for analytical consistency.	18 Participants n=115 Participants • 2 Participants aged 18 years old in cohort 5 were \<18 years of age at the time of enrollment in the parent study 071102 (NCT02932618). They turned 18 years prior to transitioning into this study, their inclusion aligns with the study design, ensuring continuity in cohort assignment, and the age classification at the time of initial enrollment remains relevant for analytical consistency.
Sex: Female, Male Female	4 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	2 Participants n=4 Participants	9 Participants n=21 Participants	1 Participants n=10 Participants	17 Participants n=115 Participants
Sex: Female, Male Male	6 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	3 Participants n=4 Participants	7 Participants n=21 Participants	1 Participants n=10 Participants	18 Participants n=115 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants	0 Participants n=10 Participants	2 Participants n=115 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	8 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	5 Participants n=4 Participants	14 Participants n=21 Participants	2 Participants n=10 Participants	30 Participants n=115 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants	0 Participants n=10 Participants	3 Participants n=115 Participants
Race (NIH/OMB) American Indian or Alaska Native	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=10 Participants	0 Participants n=115 Participants
Race (NIH/OMB) Asian	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=10 Participants	0 Participants n=115 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	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=10 Participants	0 Participants n=115 Participants
Race (NIH/OMB) Black or African American	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=10 Participants	0 Participants n=115 Participants
Race (NIH/OMB) White	9 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	4 Participants n=4 Participants	14 Participants n=21 Participants	2 Participants n=10 Participants	30 Participants n=115 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants	0 Participants n=10 Participants	1 Participants n=115 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	1 Participants n=21 Participants	0 Participants n=10 Participants	4 Participants n=115 Participants

PRIMARY outcome

Timeframe: Up to 12 months

Population: The FAS consisted of all participants who satisfied all the entry criteria and received any amount of study drug.

Outcome measures

Outcome measures
Measure	Cohort 1: Prophylaxis n=10 Participants Adult participants who transitioned from the phase 3 prophylaxis parent study 071301 (NCT02973087) received the same prophylactic dose, 50±10 IU/kg, IV infusion of vonicog alfa twice weekly as in parent study 071301.	Cohort 2: Prophylaxis n=1 Participants Adult participants who transitioned from parent study 071301 (NCT02973087) with no clinically significant BE for the past 6 months started this continuation study at a lower dose/frequency of vonicog alfa once weekly or twice weekly prophylactic dose, 50±10 IU/kg, IV infusion compared to the dose received (50±10 IU/kg, IV infusion, thrice weekly) in parent study 071301.	Cohort 3: Prophylaxis n=1 Participants Adolescent participants (aged 12 to less than \[\<\]18 years) who transitioned from the phase 3 OD and surgery parent study 071102 (NCT02932618) switched from receiving vonicog alfa OD treatment to receiving prophylactic dose of vonicog alfa 50±10 IU/kg, IV infusion, once weekly or twice weekly in this continuation study.	Cohort 4: Prophylaxis n=5 Participants Newly enrolled adult and adolescent (aged 12 to \<18 years) participants who switched from OD treatment with Von Willebrand Factor (VWF) products started 50±10 IU/kg, IV infusion once weekly prophylaxis with vonicog alfa in this continuation study.	Cohort 5: On Demand Pediatric participants of all ages from parent study 071102 (NCT02932618) continued receiving OD treatment of vonicog alfa 50±10 IU/kg, IV infusion, once weekly or twice weekly in this continuation study.	Cohort 6: On Demand Adult participants from parent study 071301 (NCT02973087) switched back from prophylactic treatment in study 071301 to OD treatment of vonicog alfa 50±10 IU/kg, IV infusion, once weekly or twice weekly in this continuation study.
Spontaneous Annualized Bleeding Rate (sABR)	1.430 spontaneous bleeds per year Standard Deviation 2.3894	1.040 spontaneous bleeds per year Standard Deviation NA Standard deviation was not estimable for a single participant.	0.000 spontaneous bleeds per year Standard Deviation NA Standard deviation was not estimable for a single participant.	3.022 spontaneous bleeds per year Standard Deviation 2.4746	—	—

SECONDARY outcome

Timeframe: Up to 5.8 years

Population: The Safety Analysis Set (SAS) consisted of all participants who received any amount of vonicog alfa as obtained from the study drug administration eDiary, study drug administration details eCRF, or PK infusion eCRF.

An adverse event (AE): any untoward medical occurrence in a participant administered a pharmaceutical product; the untoward medical occurrence does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product whether or not it is related to medicinal product. TEAE was defined as any AE that started after the first administration of study drug in this continuation study. Serious TEAEs: any untoward medical occurrence that: 1) results in death, 2) is life-threatening, 3) requires inpatient hospitalization or prolongation of existing hospitalization, 4) results in persistent or significant disability/incapacity, 5) leads to a congenital anomaly/birth defect in the offspring of the participant or 6) is medically important.

Outcome measures

Outcome measures
Measure	Cohort 1: Prophylaxis n=10 Participants Adult participants who transitioned from the phase 3 prophylaxis parent study 071301 (NCT02973087) received the same prophylactic dose, 50±10 IU/kg, IV infusion of vonicog alfa twice weekly as in parent study 071301.	Cohort 2: Prophylaxis n=1 Participants Adult participants who transitioned from parent study 071301 (NCT02973087) with no clinically significant BE for the past 6 months started this continuation study at a lower dose/frequency of vonicog alfa once weekly or twice weekly prophylactic dose, 50±10 IU/kg, IV infusion compared to the dose received (50±10 IU/kg, IV infusion, thrice weekly) in parent study 071301.	Cohort 3: Prophylaxis n=1 Participants Adolescent participants (aged 12 to less than \[\<\]18 years) who transitioned from the phase 3 OD and surgery parent study 071102 (NCT02932618) switched from receiving vonicog alfa OD treatment to receiving prophylactic dose of vonicog alfa 50±10 IU/kg, IV infusion, once weekly or twice weekly in this continuation study.	Cohort 4: Prophylaxis n=5 Participants Newly enrolled adult and adolescent (aged 12 to \<18 years) participants who switched from OD treatment with Von Willebrand Factor (VWF) products started 50±10 IU/kg, IV infusion once weekly prophylaxis with vonicog alfa in this continuation study.	Cohort 5: On Demand n=16 Participants Pediatric participants of all ages from parent study 071102 (NCT02932618) continued receiving OD treatment of vonicog alfa 50±10 IU/kg, IV infusion, once weekly or twice weekly in this continuation study.	Cohort 6: On Demand n=2 Participants Adult participants from parent study 071301 (NCT02973087) switched back from prophylactic treatment in study 071301 to OD treatment of vonicog alfa 50±10 IU/kg, IV infusion, once weekly or twice weekly in this continuation study.
Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious TEAEs TEAEs	8 Participants	1 Participants	1 Participants	4 Participants	15 Participants	2 Participants
Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious TEAEs Serious TEAEs	3 Participants	0 Participants	0 Participants	1 Participants	3 Participants	1 Participants

SECONDARY outcome

Timeframe: Up to 5.8 years

Population: The SAS consisted of all participants who received any amount of vonicog alfa as obtained from the study drug administration eDiary, study drug administration details eCRF, or PK infusion eCRF.

An AE is defined as any untoward medical occurrence in a participant administered IP that does not necessarily have a causal relationship with the treatment. TEAE was defined as any AE that started after the first administration of study drug in this continuation study. Severity of TEAEs was determined by following definitions: Mild: No limitation of usual activities; Moderate: Some limitation of usual activities and may required therapeutic intervention; Severe: Inability to carry out usual activities with sequelae, which required therapeutic intervention. Number of participants with TEAEs based on severity of TEAEs were reported.

Outcome measures

Outcome measures
Measure	Cohort 1: Prophylaxis n=10 Participants Adult participants who transitioned from the phase 3 prophylaxis parent study 071301 (NCT02973087) received the same prophylactic dose, 50±10 IU/kg, IV infusion of vonicog alfa twice weekly as in parent study 071301.	Cohort 2: Prophylaxis n=1 Participants Adult participants who transitioned from parent study 071301 (NCT02973087) with no clinically significant BE for the past 6 months started this continuation study at a lower dose/frequency of vonicog alfa once weekly or twice weekly prophylactic dose, 50±10 IU/kg, IV infusion compared to the dose received (50±10 IU/kg, IV infusion, thrice weekly) in parent study 071301.	Cohort 3: Prophylaxis n=1 Participants Adolescent participants (aged 12 to less than \[\<\]18 years) who transitioned from the phase 3 OD and surgery parent study 071102 (NCT02932618) switched from receiving vonicog alfa OD treatment to receiving prophylactic dose of vonicog alfa 50±10 IU/kg, IV infusion, once weekly or twice weekly in this continuation study.	Cohort 4: Prophylaxis n=5 Participants Newly enrolled adult and adolescent (aged 12 to \<18 years) participants who switched from OD treatment with Von Willebrand Factor (VWF) products started 50±10 IU/kg, IV infusion once weekly prophylaxis with vonicog alfa in this continuation study.	Cohort 5: On Demand n=16 Participants Pediatric participants of all ages from parent study 071102 (NCT02932618) continued receiving OD treatment of vonicog alfa 50±10 IU/kg, IV infusion, once weekly or twice weekly in this continuation study.	Cohort 6: On Demand n=2 Participants Adult participants from parent study 071301 (NCT02973087) switched back from prophylactic treatment in study 071301 to OD treatment of vonicog alfa 50±10 IU/kg, IV infusion, once weekly or twice weekly in this continuation study.
Number of Participants Based on Severity of TEAEs Mild	7 Participants	1 Participants	1 Participants	4 Participants	14 Participants	2 Participants
Number of Participants Based on Severity of TEAEs Moderate	7 Participants	0 Participants	0 Participants	3 Participants	11 Participants	1 Participants
Number of Participants Based on Severity of TEAEs Severe	3 Participants	0 Participants	0 Participants	1 Participants	1 Participants	2 Participants

SECONDARY outcome

Timeframe: Up to 5.8 years

Outcome measures

Outcome measures
Measure	Cohort 1: Prophylaxis n=10 Participants Adult participants who transitioned from the phase 3 prophylaxis parent study 071301 (NCT02973087) received the same prophylactic dose, 50±10 IU/kg, IV infusion of vonicog alfa twice weekly as in parent study 071301.	Cohort 2: Prophylaxis n=1 Participants Adult participants who transitioned from parent study 071301 (NCT02973087) with no clinically significant BE for the past 6 months started this continuation study at a lower dose/frequency of vonicog alfa once weekly or twice weekly prophylactic dose, 50±10 IU/kg, IV infusion compared to the dose received (50±10 IU/kg, IV infusion, thrice weekly) in parent study 071301.	Cohort 3: Prophylaxis n=1 Participants Adolescent participants (aged 12 to less than \[\<\]18 years) who transitioned from the phase 3 OD and surgery parent study 071102 (NCT02932618) switched from receiving vonicog alfa OD treatment to receiving prophylactic dose of vonicog alfa 50±10 IU/kg, IV infusion, once weekly or twice weekly in this continuation study.	Cohort 4: Prophylaxis n=5 Participants Newly enrolled adult and adolescent (aged 12 to \<18 years) participants who switched from OD treatment with Von Willebrand Factor (VWF) products started 50±10 IU/kg, IV infusion once weekly prophylaxis with vonicog alfa in this continuation study.	Cohort 5: On Demand n=16 Participants Pediatric participants of all ages from parent study 071102 (NCT02932618) continued receiving OD treatment of vonicog alfa 50±10 IU/kg, IV infusion, once weekly or twice weekly in this continuation study.	Cohort 6: On Demand n=2 Participants Adult participants from parent study 071301 (NCT02973087) switched back from prophylactic treatment in study 071301 to OD treatment of vonicog alfa 50±10 IU/kg, IV infusion, once weekly or twice weekly in this continuation study.
Number of Participants Based on Causality of TEAEs	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Up to 5.8 years

Thromboembolism defined as formation of a clot (thrombus) in a blood vessel that breaks loose, is carried by the blood stream and could plug another vessel. Number of participants with thromboembolic events as TEAEs of special interest were reported.

Outcome measures

Outcome measures
Measure	Cohort 1: Prophylaxis n=10 Participants Adult participants who transitioned from the phase 3 prophylaxis parent study 071301 (NCT02973087) received the same prophylactic dose, 50±10 IU/kg, IV infusion of vonicog alfa twice weekly as in parent study 071301.	Cohort 2: Prophylaxis n=1 Participants Adult participants who transitioned from parent study 071301 (NCT02973087) with no clinically significant BE for the past 6 months started this continuation study at a lower dose/frequency of vonicog alfa once weekly or twice weekly prophylactic dose, 50±10 IU/kg, IV infusion compared to the dose received (50±10 IU/kg, IV infusion, thrice weekly) in parent study 071301.	Cohort 3: Prophylaxis n=1 Participants Adolescent participants (aged 12 to less than \[\<\]18 years) who transitioned from the phase 3 OD and surgery parent study 071102 (NCT02932618) switched from receiving vonicog alfa OD treatment to receiving prophylactic dose of vonicog alfa 50±10 IU/kg, IV infusion, once weekly or twice weekly in this continuation study.	Cohort 4: Prophylaxis n=5 Participants Newly enrolled adult and adolescent (aged 12 to \<18 years) participants who switched from OD treatment with Von Willebrand Factor (VWF) products started 50±10 IU/kg, IV infusion once weekly prophylaxis with vonicog alfa in this continuation study.	Cohort 5: On Demand n=16 Participants Pediatric participants of all ages from parent study 071102 (NCT02932618) continued receiving OD treatment of vonicog alfa 50±10 IU/kg, IV infusion, once weekly or twice weekly in this continuation study.	Cohort 6: On Demand n=2 Participants Adult participants from parent study 071301 (NCT02973087) switched back from prophylactic treatment in study 071301 to OD treatment of vonicog alfa 50±10 IU/kg, IV infusion, once weekly or twice weekly in this continuation study.
Number of Participants With Thromboembolic Events	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Up to 5.8 years

Hypersensitivity (also called hypersensitivity reaction or intolerance) defined as undesirable reactions produced by the normal immune system, including allergies and autoimmunity. Potential hypersensitivity events were identified by broad search criteria and then medically assessed. Number of participants with hypersensitivity reactions as TEAEs of special interest was calculated.

Outcome measures

Outcome measures
Measure	Cohort 1: Prophylaxis n=10 Participants Adult participants who transitioned from the phase 3 prophylaxis parent study 071301 (NCT02973087) received the same prophylactic dose, 50±10 IU/kg, IV infusion of vonicog alfa twice weekly as in parent study 071301.	Cohort 2: Prophylaxis n=1 Participants Adult participants who transitioned from parent study 071301 (NCT02973087) with no clinically significant BE for the past 6 months started this continuation study at a lower dose/frequency of vonicog alfa once weekly or twice weekly prophylactic dose, 50±10 IU/kg, IV infusion compared to the dose received (50±10 IU/kg, IV infusion, thrice weekly) in parent study 071301.	Cohort 3: Prophylaxis n=1 Participants Adolescent participants (aged 12 to less than \[\<\]18 years) who transitioned from the phase 3 OD and surgery parent study 071102 (NCT02932618) switched from receiving vonicog alfa OD treatment to receiving prophylactic dose of vonicog alfa 50±10 IU/kg, IV infusion, once weekly or twice weekly in this continuation study.	Cohort 4: Prophylaxis n=5 Participants Newly enrolled adult and adolescent (aged 12 to \<18 years) participants who switched from OD treatment with Von Willebrand Factor (VWF) products started 50±10 IU/kg, IV infusion once weekly prophylaxis with vonicog alfa in this continuation study.	Cohort 5: On Demand n=16 Participants Pediatric participants of all ages from parent study 071102 (NCT02932618) continued receiving OD treatment of vonicog alfa 50±10 IU/kg, IV infusion, once weekly or twice weekly in this continuation study.	Cohort 6: On Demand n=2 Participants Adult participants from parent study 071301 (NCT02973087) switched back from prophylactic treatment in study 071301 to OD treatment of vonicog alfa 50±10 IU/kg, IV infusion, once weekly or twice weekly in this continuation study.
Number of Participants With Hypersensitivity Reactions	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Up to 5.8 years

Three functional VWF assays for von Willebrand factor collagen binding (VWF:CB), von Willebrand factor: Ristocetin Cofactor (VWF:RCo) and von Willebrand factor VIII B (VWF:FVIIIB) were used to test the presence of neutralizing anti-VWF antibodies. Neutralizing antibodies to VWF:RCo, VWF:CB and VWF:FVIIIB activities were measured by assays based on the Bethesda assay established for quantitative analysis of FVIII inhibitors (Nijmegen modification of the Bethesda assay). Only confirmed neutralizing anti -VWF antibodies were considered inhibitors. Number of participants who developed neutralizing antibodies to rVWF were assessed.

Outcome measures

Outcome measures
Measure	Cohort 1: Prophylaxis n=10 Participants Adult participants who transitioned from the phase 3 prophylaxis parent study 071301 (NCT02973087) received the same prophylactic dose, 50±10 IU/kg, IV infusion of vonicog alfa twice weekly as in parent study 071301.	Cohort 2: Prophylaxis n=1 Participants Adult participants who transitioned from parent study 071301 (NCT02973087) with no clinically significant BE for the past 6 months started this continuation study at a lower dose/frequency of vonicog alfa once weekly or twice weekly prophylactic dose, 50±10 IU/kg, IV infusion compared to the dose received (50±10 IU/kg, IV infusion, thrice weekly) in parent study 071301.	Cohort 3: Prophylaxis n=1 Participants Adolescent participants (aged 12 to less than \[\<\]18 years) who transitioned from the phase 3 OD and surgery parent study 071102 (NCT02932618) switched from receiving vonicog alfa OD treatment to receiving prophylactic dose of vonicog alfa 50±10 IU/kg, IV infusion, once weekly or twice weekly in this continuation study.	Cohort 4: Prophylaxis n=5 Participants Newly enrolled adult and adolescent (aged 12 to \<18 years) participants who switched from OD treatment with Von Willebrand Factor (VWF) products started 50±10 IU/kg, IV infusion once weekly prophylaxis with vonicog alfa in this continuation study.	Cohort 5: On Demand n=16 Participants Pediatric participants of all ages from parent study 071102 (NCT02932618) continued receiving OD treatment of vonicog alfa 50±10 IU/kg, IV infusion, once weekly or twice weekly in this continuation study.	Cohort 6: On Demand n=2 Participants Adult participants from parent study 071301 (NCT02973087) switched back from prophylactic treatment in study 071301 to OD treatment of vonicog alfa 50±10 IU/kg, IV infusion, once weekly or twice weekly in this continuation study.
Number of Participants Who Developed Neutralizing Antibodies to Von Willebrand Factor (VWF)	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Up to 5.8 years

Three functional VWF assays for von Willebrand factor collagen binding (VWF:CB), von Willebrand factor: Ristocetin Cofactor (VWF:RCo) and von Willebrand factor VIII B (VWF:FVIIIB) were used to test the presence of neutralizing anti-VWF antibodies. Neutralizing antibodies to VWF:RCo, VWF:CB and VWF:FVIIIB activities was measured by assays based on the Bethesda assay established for quantitative analysis of FVIII inhibitors (Nijmegen modification of the Bethesda assay). Only confirmed neutralizing anti -VWF antibodies were considered inhibitors. Number of participants who developed neutralizing antibodies to FVIII were assessed.

Outcome measures

Outcome measures
Measure	Cohort 1: Prophylaxis n=10 Participants Adult participants who transitioned from the phase 3 prophylaxis parent study 071301 (NCT02973087) received the same prophylactic dose, 50±10 IU/kg, IV infusion of vonicog alfa twice weekly as in parent study 071301.	Cohort 2: Prophylaxis n=1 Participants Adult participants who transitioned from parent study 071301 (NCT02973087) with no clinically significant BE for the past 6 months started this continuation study at a lower dose/frequency of vonicog alfa once weekly or twice weekly prophylactic dose, 50±10 IU/kg, IV infusion compared to the dose received (50±10 IU/kg, IV infusion, thrice weekly) in parent study 071301.	Cohort 3: Prophylaxis n=1 Participants Adolescent participants (aged 12 to less than \[\<\]18 years) who transitioned from the phase 3 OD and surgery parent study 071102 (NCT02932618) switched from receiving vonicog alfa OD treatment to receiving prophylactic dose of vonicog alfa 50±10 IU/kg, IV infusion, once weekly or twice weekly in this continuation study.	Cohort 4: Prophylaxis n=5 Participants Newly enrolled adult and adolescent (aged 12 to \<18 years) participants who switched from OD treatment with Von Willebrand Factor (VWF) products started 50±10 IU/kg, IV infusion once weekly prophylaxis with vonicog alfa in this continuation study.	Cohort 5: On Demand n=16 Participants Pediatric participants of all ages from parent study 071102 (NCT02932618) continued receiving OD treatment of vonicog alfa 50±10 IU/kg, IV infusion, once weekly or twice weekly in this continuation study.	Cohort 6: On Demand n=2 Participants Adult participants from parent study 071301 (NCT02973087) switched back from prophylactic treatment in study 071301 to OD treatment of vonicog alfa 50±10 IU/kg, IV infusion, once weekly or twice weekly in this continuation study.
Number of Participants Who Developed Neutralizing Antibodies to Factor VIII (FVIII)	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Up to 5.8 years

The presence of total binding anti-VWF antibodies was determined by an enzyme-linked immunosorbent assay (ELISA) employing polyclonal anti-human Immunoglobulin (Ig) antibodies (IgG, IgM and IgA). Number of participants who developed of total binding antibodies to rVWF were assessed.

Outcome measures

Outcome measures
Measure	Cohort 1: Prophylaxis n=10 Participants Adult participants who transitioned from the phase 3 prophylaxis parent study 071301 (NCT02973087) received the same prophylactic dose, 50±10 IU/kg, IV infusion of vonicog alfa twice weekly as in parent study 071301.	Cohort 2: Prophylaxis n=1 Participants Adult participants who transitioned from parent study 071301 (NCT02973087) with no clinically significant BE for the past 6 months started this continuation study at a lower dose/frequency of vonicog alfa once weekly or twice weekly prophylactic dose, 50±10 IU/kg, IV infusion compared to the dose received (50±10 IU/kg, IV infusion, thrice weekly) in parent study 071301.	Cohort 3: Prophylaxis n=1 Participants Adolescent participants (aged 12 to less than \[\<\]18 years) who transitioned from the phase 3 OD and surgery parent study 071102 (NCT02932618) switched from receiving vonicog alfa OD treatment to receiving prophylactic dose of vonicog alfa 50±10 IU/kg, IV infusion, once weekly or twice weekly in this continuation study.	Cohort 4: Prophylaxis n=5 Participants Newly enrolled adult and adolescent (aged 12 to \<18 years) participants who switched from OD treatment with Von Willebrand Factor (VWF) products started 50±10 IU/kg, IV infusion once weekly prophylaxis with vonicog alfa in this continuation study.	Cohort 5: On Demand n=16 Participants Pediatric participants of all ages from parent study 071102 (NCT02932618) continued receiving OD treatment of vonicog alfa 50±10 IU/kg, IV infusion, once weekly or twice weekly in this continuation study.	Cohort 6: On Demand n=2 Participants Adult participants from parent study 071301 (NCT02973087) switched back from prophylactic treatment in study 071301 to OD treatment of vonicog alfa 50±10 IU/kg, IV infusion, once weekly or twice weekly in this continuation study.
Number of Participants Who Developed Total Binding Antibodies to Von Willebrand Factor (VWF)	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Up to 5.8 years

Binding antibodies against FVIII were analyzed using a proprietary enzyme immunoassay. Number of participants who developed of total binding antibodies to FVIII were assessed.

Outcome measures

Outcome measures
Measure	Cohort 1: Prophylaxis n=10 Participants Adult participants who transitioned from the phase 3 prophylaxis parent study 071301 (NCT02973087) received the same prophylactic dose, 50±10 IU/kg, IV infusion of vonicog alfa twice weekly as in parent study 071301.	Cohort 2: Prophylaxis n=1 Participants Adult participants who transitioned from parent study 071301 (NCT02973087) with no clinically significant BE for the past 6 months started this continuation study at a lower dose/frequency of vonicog alfa once weekly or twice weekly prophylactic dose, 50±10 IU/kg, IV infusion compared to the dose received (50±10 IU/kg, IV infusion, thrice weekly) in parent study 071301.	Cohort 3: Prophylaxis n=1 Participants Adolescent participants (aged 12 to less than \[\<\]18 years) who transitioned from the phase 3 OD and surgery parent study 071102 (NCT02932618) switched from receiving vonicog alfa OD treatment to receiving prophylactic dose of vonicog alfa 50±10 IU/kg, IV infusion, once weekly or twice weekly in this continuation study.	Cohort 4: Prophylaxis n=5 Participants Newly enrolled adult and adolescent (aged 12 to \<18 years) participants who switched from OD treatment with Von Willebrand Factor (VWF) products started 50±10 IU/kg, IV infusion once weekly prophylaxis with vonicog alfa in this continuation study.	Cohort 5: On Demand n=16 Participants Pediatric participants of all ages from parent study 071102 (NCT02932618) continued receiving OD treatment of vonicog alfa 50±10 IU/kg, IV infusion, once weekly or twice weekly in this continuation study.	Cohort 6: On Demand n=2 Participants Adult participants from parent study 071301 (NCT02973087) switched back from prophylactic treatment in study 071301 to OD treatment of vonicog alfa 50±10 IU/kg, IV infusion, once weekly or twice weekly in this continuation study.
Number of Participants Who Developed Total Binding Antibodies to Factor VIII (FVIII)	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants

SECONDARY outcome

Timeframe: Up to 5.8 years

Total Ig antibodies (IgG, IgA, IgM) against CHO protein were analyzed using ELISA. Number of participants who developed binding antibodies to CHO proteins were assessed.

Outcome measures

Outcome measures
Measure	Cohort 1: Prophylaxis n=10 Participants Adult participants who transitioned from the phase 3 prophylaxis parent study 071301 (NCT02973087) received the same prophylactic dose, 50±10 IU/kg, IV infusion of vonicog alfa twice weekly as in parent study 071301.	Cohort 2: Prophylaxis n=1 Participants Adult participants who transitioned from parent study 071301 (NCT02973087) with no clinically significant BE for the past 6 months started this continuation study at a lower dose/frequency of vonicog alfa once weekly or twice weekly prophylactic dose, 50±10 IU/kg, IV infusion compared to the dose received (50±10 IU/kg, IV infusion, thrice weekly) in parent study 071301.	Cohort 3: Prophylaxis n=1 Participants Adolescent participants (aged 12 to less than \[\<\]18 years) who transitioned from the phase 3 OD and surgery parent study 071102 (NCT02932618) switched from receiving vonicog alfa OD treatment to receiving prophylactic dose of vonicog alfa 50±10 IU/kg, IV infusion, once weekly or twice weekly in this continuation study.	Cohort 4: Prophylaxis n=5 Participants Newly enrolled adult and adolescent (aged 12 to \<18 years) participants who switched from OD treatment with Von Willebrand Factor (VWF) products started 50±10 IU/kg, IV infusion once weekly prophylaxis with vonicog alfa in this continuation study.	Cohort 5: On Demand n=16 Participants Pediatric participants of all ages from parent study 071102 (NCT02932618) continued receiving OD treatment of vonicog alfa 50±10 IU/kg, IV infusion, once weekly or twice weekly in this continuation study.	Cohort 6: On Demand n=2 Participants Adult participants from parent study 071301 (NCT02973087) switched back from prophylactic treatment in study 071301 to OD treatment of vonicog alfa 50±10 IU/kg, IV infusion, once weekly or twice weekly in this continuation study.
Number of Participants Who Developed Binding Antibodies to Chinese Hamster Ovary (CHO) Proteins	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Up to 5.8 years

Detection and quantification of IgG antibodies originating from human plasma that were directed against mouse-IgG (HAMA: human anti- mouse antibodies) were assessed using ELISA (Medac, Hamburg, Germany). Number of participants who developed binding antibodies to Mouse IgG were assessed.

Outcome measures

Outcome measures
Measure	Cohort 1: Prophylaxis n=10 Participants Adult participants who transitioned from the phase 3 prophylaxis parent study 071301 (NCT02973087) received the same prophylactic dose, 50±10 IU/kg, IV infusion of vonicog alfa twice weekly as in parent study 071301.	Cohort 2: Prophylaxis n=1 Participants Adult participants who transitioned from parent study 071301 (NCT02973087) with no clinically significant BE for the past 6 months started this continuation study at a lower dose/frequency of vonicog alfa once weekly or twice weekly prophylactic dose, 50±10 IU/kg, IV infusion compared to the dose received (50±10 IU/kg, IV infusion, thrice weekly) in parent study 071301.	Cohort 3: Prophylaxis n=1 Participants Adolescent participants (aged 12 to less than \[\<\]18 years) who transitioned from the phase 3 OD and surgery parent study 071102 (NCT02932618) switched from receiving vonicog alfa OD treatment to receiving prophylactic dose of vonicog alfa 50±10 IU/kg, IV infusion, once weekly or twice weekly in this continuation study.	Cohort 4: Prophylaxis n=5 Participants Newly enrolled adult and adolescent (aged 12 to \<18 years) participants who switched from OD treatment with Von Willebrand Factor (VWF) products started 50±10 IU/kg, IV infusion once weekly prophylaxis with vonicog alfa in this continuation study.	Cohort 5: On Demand n=16 Participants Pediatric participants of all ages from parent study 071102 (NCT02932618) continued receiving OD treatment of vonicog alfa 50±10 IU/kg, IV infusion, once weekly or twice weekly in this continuation study.	Cohort 6: On Demand n=2 Participants Adult participants from parent study 071301 (NCT02973087) switched back from prophylactic treatment in study 071301 to OD treatment of vonicog alfa 50±10 IU/kg, IV infusion, once weekly or twice weekly in this continuation study.
Number of Participants Who Developed Binding Antibodies to Mouse Immunoglobulin G (IgG)	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Up to 5.8 years

Total Ig antibodies (IgG, IgA, IgM) against human furin were analyzed using ELISA. Number of participants who developed binding antibodies to rFurin were assessed.

Outcome measures

Outcome measures
Measure	Cohort 1: Prophylaxis n=10 Participants Adult participants who transitioned from the phase 3 prophylaxis parent study 071301 (NCT02973087) received the same prophylactic dose, 50±10 IU/kg, IV infusion of vonicog alfa twice weekly as in parent study 071301.	Cohort 2: Prophylaxis n=1 Participants Adult participants who transitioned from parent study 071301 (NCT02973087) with no clinically significant BE for the past 6 months started this continuation study at a lower dose/frequency of vonicog alfa once weekly or twice weekly prophylactic dose, 50±10 IU/kg, IV infusion compared to the dose received (50±10 IU/kg, IV infusion, thrice weekly) in parent study 071301.	Cohort 3: Prophylaxis n=1 Participants Adolescent participants (aged 12 to less than \[\<\]18 years) who transitioned from the phase 3 OD and surgery parent study 071102 (NCT02932618) switched from receiving vonicog alfa OD treatment to receiving prophylactic dose of vonicog alfa 50±10 IU/kg, IV infusion, once weekly or twice weekly in this continuation study.	Cohort 4: Prophylaxis n=5 Participants Newly enrolled adult and adolescent (aged 12 to \<18 years) participants who switched from OD treatment with Von Willebrand Factor (VWF) products started 50±10 IU/kg, IV infusion once weekly prophylaxis with vonicog alfa in this continuation study.	Cohort 5: On Demand n=16 Participants Pediatric participants of all ages from parent study 071102 (NCT02932618) continued receiving OD treatment of vonicog alfa 50±10 IU/kg, IV infusion, once weekly or twice weekly in this continuation study.	Cohort 6: On Demand n=2 Participants Adult participants from parent study 071301 (NCT02973087) switched back from prophylactic treatment in study 071301 to OD treatment of vonicog alfa 50±10 IU/kg, IV infusion, once weekly or twice weekly in this continuation study.
Number of Participants Who Develop Binding Antibodies to Recombinant Furin (rFurin)	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Up to 5.8 years

Vital signs included blood pressure (systolic and diastolic), pulse rate, respiratory rate and body temperature. Number of participants with clinically significant change from baseline in vital signs were assessed.

Outcome measures

Outcome measures
Measure	Cohort 1: Prophylaxis n=10 Participants Adult participants who transitioned from the phase 3 prophylaxis parent study 071301 (NCT02973087) received the same prophylactic dose, 50±10 IU/kg, IV infusion of vonicog alfa twice weekly as in parent study 071301.	Cohort 2: Prophylaxis n=1 Participants Adult participants who transitioned from parent study 071301 (NCT02973087) with no clinically significant BE for the past 6 months started this continuation study at a lower dose/frequency of vonicog alfa once weekly or twice weekly prophylactic dose, 50±10 IU/kg, IV infusion compared to the dose received (50±10 IU/kg, IV infusion, thrice weekly) in parent study 071301.	Cohort 3: Prophylaxis n=1 Participants Adolescent participants (aged 12 to less than \[\<\]18 years) who transitioned from the phase 3 OD and surgery parent study 071102 (NCT02932618) switched from receiving vonicog alfa OD treatment to receiving prophylactic dose of vonicog alfa 50±10 IU/kg, IV infusion, once weekly or twice weekly in this continuation study.	Cohort 4: Prophylaxis n=5 Participants Newly enrolled adult and adolescent (aged 12 to \<18 years) participants who switched from OD treatment with Von Willebrand Factor (VWF) products started 50±10 IU/kg, IV infusion once weekly prophylaxis with vonicog alfa in this continuation study.	Cohort 5: On Demand n=16 Participants Pediatric participants of all ages from parent study 071102 (NCT02932618) continued receiving OD treatment of vonicog alfa 50±10 IU/kg, IV infusion, once weekly or twice weekly in this continuation study.	Cohort 6: On Demand n=2 Participants Adult participants from parent study 071301 (NCT02973087) switched back from prophylactic treatment in study 071301 to OD treatment of vonicog alfa 50±10 IU/kg, IV infusion, once weekly or twice weekly in this continuation study.
Number of Participants With Clinically Significant Changes in Vital Signs	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Up to 5.8 years

Clinical laboratory parameters included serum chemistry, hematology and urinalysis assessments. Number of participants with clinically significant change from baseline in clinical laboratory parameters were assessed.

Outcome measures

Outcome measures
Measure	Cohort 1: Prophylaxis n=10 Participants Adult participants who transitioned from the phase 3 prophylaxis parent study 071301 (NCT02973087) received the same prophylactic dose, 50±10 IU/kg, IV infusion of vonicog alfa twice weekly as in parent study 071301.	Cohort 2: Prophylaxis n=1 Participants Adult participants who transitioned from parent study 071301 (NCT02973087) with no clinically significant BE for the past 6 months started this continuation study at a lower dose/frequency of vonicog alfa once weekly or twice weekly prophylactic dose, 50±10 IU/kg, IV infusion compared to the dose received (50±10 IU/kg, IV infusion, thrice weekly) in parent study 071301.	Cohort 3: Prophylaxis n=1 Participants Adolescent participants (aged 12 to less than \[\<\]18 years) who transitioned from the phase 3 OD and surgery parent study 071102 (NCT02932618) switched from receiving vonicog alfa OD treatment to receiving prophylactic dose of vonicog alfa 50±10 IU/kg, IV infusion, once weekly or twice weekly in this continuation study.	Cohort 4: Prophylaxis n=5 Participants Newly enrolled adult and adolescent (aged 12 to \<18 years) participants who switched from OD treatment with Von Willebrand Factor (VWF) products started 50±10 IU/kg, IV infusion once weekly prophylaxis with vonicog alfa in this continuation study.	Cohort 5: On Demand n=16 Participants Pediatric participants of all ages from parent study 071102 (NCT02932618) continued receiving OD treatment of vonicog alfa 50±10 IU/kg, IV infusion, once weekly or twice weekly in this continuation study.	Cohort 6: On Demand n=2 Participants Adult participants from parent study 071301 (NCT02973087) switched back from prophylactic treatment in study 071301 to OD treatment of vonicog alfa 50±10 IU/kg, IV infusion, once weekly or twice weekly in this continuation study.
Number of Participants With Clinically Significant Changes in Laboratory Parameters Serum Chemistry	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Clinically Significant Changes in Laboratory Parameters Hematology	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Clinically Significant Changes in Laboratory Parameters Urinalysis	0 Participants	0 Participants	0 Participants	0 Participants	NA Participants No postbaseline results were collected for any urinalysis parameters in the OD cohorts.	NA Participants No postbaseline results were collected for any urinalysis parameters in the OD cohorts.

SECONDARY outcome

Timeframe: Up to 5.8 years

Population: The FAS consisted of all participants who satisfied all the entry criteria and received any amount of study drug.

sABR was derived as \[number of treated bleeds\] / \[duration in years\]. Bleeds with unknown causality were considered as spontaneous. Bleeds were categorized based on the investigator assessment of cause. sABR during prophylaxis treatment with rVWF (vonicog alfa) while enrolled in the study were reported.

Outcome measures

Outcome measures
Measure	Cohort 1: Prophylaxis n=10 Participants Adult participants who transitioned from the phase 3 prophylaxis parent study 071301 (NCT02973087) received the same prophylactic dose, 50±10 IU/kg, IV infusion of vonicog alfa twice weekly as in parent study 071301.	Cohort 2: Prophylaxis n=1 Participants Adult participants who transitioned from parent study 071301 (NCT02973087) with no clinically significant BE for the past 6 months started this continuation study at a lower dose/frequency of vonicog alfa once weekly or twice weekly prophylactic dose, 50±10 IU/kg, IV infusion compared to the dose received (50±10 IU/kg, IV infusion, thrice weekly) in parent study 071301.	Cohort 3: Prophylaxis n=1 Participants Adolescent participants (aged 12 to less than \[\<\]18 years) who transitioned from the phase 3 OD and surgery parent study 071102 (NCT02932618) switched from receiving vonicog alfa OD treatment to receiving prophylactic dose of vonicog alfa 50±10 IU/kg, IV infusion, once weekly or twice weekly in this continuation study.	Cohort 4: Prophylaxis n=5 Participants Newly enrolled adult and adolescent (aged 12 to \<18 years) participants who switched from OD treatment with Von Willebrand Factor (VWF) products started 50±10 IU/kg, IV infusion once weekly prophylaxis with vonicog alfa in this continuation study.	Cohort 5: On Demand Pediatric participants of all ages from parent study 071102 (NCT02932618) continued receiving OD treatment of vonicog alfa 50±10 IU/kg, IV infusion, once weekly or twice weekly in this continuation study.	Cohort 6: On Demand Adult participants from parent study 071301 (NCT02973087) switched back from prophylactic treatment in study 071301 to OD treatment of vonicog alfa 50±10 IU/kg, IV infusion, once weekly or twice weekly in this continuation study.
Spontaneous Annualized Bleeding Rate (sABR) Under Prophylactic Treatment	1.122 spontaneous bleeds per year Standard Deviation 2.1084	0.330 spontaneous bleeds per year Standard Deviation NA Standard deviation was not estimable for a single participant.	0.000 spontaneous bleeds per year Standard Deviation NA Standard deviation was not estimable for a single participant.	2.110 spontaneous bleeds per year Standard Deviation 1.9954	—	—

SECONDARY outcome

Timeframe: Up to 5.8 years

Population: The FAS consisted of all participants who satisfied all the entry criteria and received any amount of study drug.

Categorized as ≥ 0 to \< 1 infusion per week, ≥ 1 to \< 2 infusions per week, ≥ 2 to \< 3 infusions per week, ≥ 3 infusions per week. The number of participants categorized based on number of infusions per week during prophylactic treatment with rVWF (vonicog alfa) were reported.

Outcome measures

Outcome measures
Measure	Cohort 1: Prophylaxis n=10 Participants Adult participants who transitioned from the phase 3 prophylaxis parent study 071301 (NCT02973087) received the same prophylactic dose, 50±10 IU/kg, IV infusion of vonicog alfa twice weekly as in parent study 071301.	Cohort 2: Prophylaxis n=1 Participants Adult participants who transitioned from parent study 071301 (NCT02973087) with no clinically significant BE for the past 6 months started this continuation study at a lower dose/frequency of vonicog alfa once weekly or twice weekly prophylactic dose, 50±10 IU/kg, IV infusion compared to the dose received (50±10 IU/kg, IV infusion, thrice weekly) in parent study 071301.	Cohort 3: Prophylaxis n=1 Participants Adolescent participants (aged 12 to less than \[\<\]18 years) who transitioned from the phase 3 OD and surgery parent study 071102 (NCT02932618) switched from receiving vonicog alfa OD treatment to receiving prophylactic dose of vonicog alfa 50±10 IU/kg, IV infusion, once weekly or twice weekly in this continuation study.	Cohort 4: Prophylaxis n=5 Participants Newly enrolled adult and adolescent (aged 12 to \<18 years) participants who switched from OD treatment with Von Willebrand Factor (VWF) products started 50±10 IU/kg, IV infusion once weekly prophylaxis with vonicog alfa in this continuation study.	Cohort 5: On Demand Pediatric participants of all ages from parent study 071102 (NCT02932618) continued receiving OD treatment of vonicog alfa 50±10 IU/kg, IV infusion, once weekly or twice weekly in this continuation study.	Cohort 6: On Demand Adult participants from parent study 071301 (NCT02973087) switched back from prophylactic treatment in study 071301 to OD treatment of vonicog alfa 50±10 IU/kg, IV infusion, once weekly or twice weekly in this continuation study.
Number of Participants Categorized Based on Weekly Number of Infusions ≥2 to <3	3 Participants Interval 40.0 to	0 Participants	0 Participants	0 Participants	—	—
Number of Participants Categorized Based on Weekly Number of Infusions ≥0 to <1	1 Participants Interval 0.0 to	0 Participants	0 Participants	0 Participants	—	—
Number of Participants Categorized Based on Weekly Number of Infusions ≥ 1to <2	6 Participants Interval 60.0 to	1 Participants	1 Participants	5 Participants	—	—
Number of Participants Categorized Based on Weekly Number of Infusions ≥3	0 Participants Interval 0.0 to	0 Participants	0 Participants	0 Participants	—	—

SECONDARY outcome

Timeframe: Up to 5.8 years

Population: The FAS consisted of all participants who satisfied all entry criteria and received any amount of study drug.

The sABR was the number of spontaneous bleeds divided by the observation period in years, where an observation period = (date of completion/termination-date of first dose+1)/365.2425. sABR was categorized based on number of BEs as 0, greater than (\>) 0 through 2, \>2 through 5, \>5 during the prophylactic treatment with rVWF (vonicog alfa). Bleeding at multiple locations related to the same injury was counted as single BE. BEs of unknown cause were counted as spontaneous bleeds. Number of participants categorized based on sABR during prophylactic treatment with rVWF (vonicog alfa) were reported.

Outcome measures

Outcome measures
Measure	Cohort 1: Prophylaxis n=10 Participants Adult participants who transitioned from the phase 3 prophylaxis parent study 071301 (NCT02973087) received the same prophylactic dose, 50±10 IU/kg, IV infusion of vonicog alfa twice weekly as in parent study 071301.	Cohort 2: Prophylaxis n=1 Participants Adult participants who transitioned from parent study 071301 (NCT02973087) with no clinically significant BE for the past 6 months started this continuation study at a lower dose/frequency of vonicog alfa once weekly or twice weekly prophylactic dose, 50±10 IU/kg, IV infusion compared to the dose received (50±10 IU/kg, IV infusion, thrice weekly) in parent study 071301.	Cohort 3: Prophylaxis n=1 Participants Adolescent participants (aged 12 to less than \[\<\]18 years) who transitioned from the phase 3 OD and surgery parent study 071102 (NCT02932618) switched from receiving vonicog alfa OD treatment to receiving prophylactic dose of vonicog alfa 50±10 IU/kg, IV infusion, once weekly or twice weekly in this continuation study.	Cohort 4: Prophylaxis n=5 Participants Newly enrolled adult and adolescent (aged 12 to \<18 years) participants who switched from OD treatment with Von Willebrand Factor (VWF) products started 50±10 IU/kg, IV infusion once weekly prophylaxis with vonicog alfa in this continuation study.	Cohort 5: On Demand Pediatric participants of all ages from parent study 071102 (NCT02932618) continued receiving OD treatment of vonicog alfa 50±10 IU/kg, IV infusion, once weekly or twice weekly in this continuation study.	Cohort 6: On Demand Adult participants from parent study 071301 (NCT02973087) switched back from prophylactic treatment in study 071301 to OD treatment of vonicog alfa 50±10 IU/kg, IV infusion, once weekly or twice weekly in this continuation study.
Number of Participants Categorized Based on Spontaneous Annualized Bleeding Rate (sABR) 0 bleeds/year	5 Participants	0 Participants	1 Participants	0 Participants	—	—
Number of Participants Categorized Based on Spontaneous Annualized Bleeding Rate (sABR) >0 to ≤2 bleeds/year	3 Participants	1 Participants	0 Participants	3 Participants	—	—
Number of Participants Categorized Based on Spontaneous Annualized Bleeding Rate (sABR) >2 to ≤5 bleeds/year	1 Participants	0 Participants	0 Participants	1 Participants	—	—
Number of Participants Categorized Based on Spontaneous Annualized Bleeding Rate (sABR) >5 bleeds/year	1 Participants	0 Participants	0 Participants	1 Participants	—	—

SECONDARY outcome

Timeframe: Up to 5.8 years

Population: The FAS consisted of all participants who satisfied all entry criteria and received any amount of study drug.

Time to event estimates and confidence intervals obtained from Kaplan-Meier analysis. Participants with 0 bleeds during each study period were censored at the date of the last day in that study period.

Outcome measures

Outcome measures
Measure	Cohort 1: Prophylaxis n=10 Participants Adult participants who transitioned from the phase 3 prophylaxis parent study 071301 (NCT02973087) received the same prophylactic dose, 50±10 IU/kg, IV infusion of vonicog alfa twice weekly as in parent study 071301.	Cohort 2: Prophylaxis n=1 Participants Adult participants who transitioned from parent study 071301 (NCT02973087) with no clinically significant BE for the past 6 months started this continuation study at a lower dose/frequency of vonicog alfa once weekly or twice weekly prophylactic dose, 50±10 IU/kg, IV infusion compared to the dose received (50±10 IU/kg, IV infusion, thrice weekly) in parent study 071301.	Cohort 3: Prophylaxis n=1 Participants Adolescent participants (aged 12 to less than \[\<\]18 years) who transitioned from the phase 3 OD and surgery parent study 071102 (NCT02932618) switched from receiving vonicog alfa OD treatment to receiving prophylactic dose of vonicog alfa 50±10 IU/kg, IV infusion, once weekly or twice weekly in this continuation study.	Cohort 4: Prophylaxis n=5 Participants Newly enrolled adult and adolescent (aged 12 to \<18 years) participants who switched from OD treatment with Von Willebrand Factor (VWF) products started 50±10 IU/kg, IV infusion once weekly prophylaxis with vonicog alfa in this continuation study.	Cohort 5: On Demand Pediatric participants of all ages from parent study 071102 (NCT02932618) continued receiving OD treatment of vonicog alfa 50±10 IU/kg, IV infusion, once weekly or twice weekly in this continuation study.	Cohort 6: On Demand Adult participants from parent study 071301 (NCT02973087) switched back from prophylactic treatment in study 071301 to OD treatment of vonicog alfa 50±10 IU/kg, IV infusion, once weekly or twice weekly in this continuation study.
Time to First Bleeding Event on Prophylaxis Treatment	172 days Interval 5.0 to The upper limit of 95% Confidence interval was not estimable due to censoring.	141 days The lower and upper limit of 95% Confidence interval was not estimable for a single participant.	NA days Median was not estimable due to censoring, and the lower and upper limit of 95% Confidence interval was not estimable for a single participant.	88 days Interval 9.0 to The upper limit of 95% Confidence interval was not estimable due to censoring.	—	—

SECONDARY outcome

Timeframe: Up to 5.8 years

Population: The FAS consisted of all participants who satisfied all entry criteria and received any amount of study drug. Number analyzed is the number of participants with data available for analyses for the specified category.

sABR was derived as \[number of treated bleeds\] / \[duration in years\]. sABR for BEs based on location of bleeding: Skin, Muscle, Mucosal Nasal, Mucosal Oral, Joint, Gastrointestinal (GI), Menstrual/Heavy Menstrual, Venipuncture Site, Soft Tissue, Body Cavity, Hematuria, Central Nervous System (CNS) and Other, while on prophylactic treatment with rVWF (vonicog alfa) were reported.

Outcome measures

Outcome measures
Measure	Cohort 1: Prophylaxis n=10 Participants Adult participants who transitioned from the phase 3 prophylaxis parent study 071301 (NCT02973087) received the same prophylactic dose, 50±10 IU/kg, IV infusion of vonicog alfa twice weekly as in parent study 071301.	Cohort 2: Prophylaxis n=1 Participants Adult participants who transitioned from parent study 071301 (NCT02973087) with no clinically significant BE for the past 6 months started this continuation study at a lower dose/frequency of vonicog alfa once weekly or twice weekly prophylactic dose, 50±10 IU/kg, IV infusion compared to the dose received (50±10 IU/kg, IV infusion, thrice weekly) in parent study 071301.	Cohort 3: Prophylaxis n=1 Participants Adolescent participants (aged 12 to less than \[\<\]18 years) who transitioned from the phase 3 OD and surgery parent study 071102 (NCT02932618) switched from receiving vonicog alfa OD treatment to receiving prophylactic dose of vonicog alfa 50±10 IU/kg, IV infusion, once weekly or twice weekly in this continuation study.	Cohort 4: Prophylaxis n=5 Participants Newly enrolled adult and adolescent (aged 12 to \<18 years) participants who switched from OD treatment with Von Willebrand Factor (VWF) products started 50±10 IU/kg, IV infusion once weekly prophylaxis with vonicog alfa in this continuation study.	Cohort 5: On Demand Pediatric participants of all ages from parent study 071102 (NCT02932618) continued receiving OD treatment of vonicog alfa 50±10 IU/kg, IV infusion, once weekly or twice weekly in this continuation study.	Cohort 6: On Demand Adult participants from parent study 071301 (NCT02973087) switched back from prophylactic treatment in study 071301 to OD treatment of vonicog alfa 50±10 IU/kg, IV infusion, once weekly or twice weekly in this continuation study.
Spontaneous Annualized Bleeding Rate (sABR) by Location of Bleeding Skin	0.033 bleeds per year Standard Deviation 0.1044	0.000 bleeds per year Standard Deviation NA Standard deviation was not estimable for a single participant.	0.000 bleeds per year Standard Deviation NA Standard deviation was not estimable for a single participant.	0.000 bleeds per year Standard Deviation 0.0000	—	—
Spontaneous Annualized Bleeding Rate (sABR) by Location of Bleeding Muscle	0.000 bleeds per year Standard Deviation 0.0000	0.000 bleeds per year Standard Deviation NA Standard deviation was not estimable for a single participant.	0.000 bleeds per year Standard Deviation NA Standard deviation was not estimable for a single participant.	0.068 bleeds per year Standard Deviation 0.1521	—	—
Spontaneous Annualized Bleeding Rate (sABR) by Location of Bleeding Mucosal, Nasal	0.199 bleeds per year Standard Deviation 0.3542	0.000 bleeds per year Standard Deviation NA Standard deviation was not estimable for a single participant.	0.000 bleeds per year Standard Deviation NA Standard deviation was not estimable for a single participant.	0.068 bleeds per year Standard Deviation 0.1521	—	—
Spontaneous Annualized Bleeding Rate (sABR) by Location of Bleeding Mucosal, Oral	0.268 bleeds per year Standard Deviation 0.7358	0.330 bleeds per year Standard Deviation NA Standard deviation was not estimable for a single participant.	0.000 bleeds per year Standard Deviation NA Standard deviation was not estimable for a single participant.	0.268 bleeds per year Standard Deviation 0.5993	—	—
Spontaneous Annualized Bleeding Rate (sABR) by Location of Bleeding Joint	0.067 bleeds per year Standard Deviation 0.2119	0.000 bleeds per year Standard Deviation NA Standard deviation was not estimable for a single participant.	0.000 bleeds per year Standard Deviation NA Standard deviation was not estimable for a single participant.	1.370 bleeds per year Standard Deviation 2.3644	—	—
Spontaneous Annualized Bleeding Rate (sABR) by Location of Bleeding GI	0.000 bleeds per year Standard Deviation 0.0000	0.000 bleeds per year Standard Deviation NA Standard deviation was not estimable for a single participant.	0.000 bleeds per year Standard Deviation NA Standard deviation was not estimable for a single participant.	0.136 bleeds per year Standard Deviation 0.3041	—	—
Spontaneous Annualized Bleeding Rate (sABR) by Location of Bleeding Menstrual/Heavy Menstrual	2.770 bleeds per year Standard Deviation 3.9174	0.000 bleeds per year Standard Deviation NA Standard deviation was not estimable for a single participant.	—	0.500 bleeds per year Standard Deviation 0.7071	—	—
Spontaneous Annualized Bleeding Rate (sABR) by Location of Bleeding Venipuncture Site	0.000 bleeds per year Standard Deviation 0.0000	0.000 bleeds per year Standard Deviation NA Standard deviation was not estimable for a single participant.	0.000 bleeds per year Standard Deviation NA Standard deviation was not estimable for a single participant.	0.000 bleeds per year Standard Deviation 0.0000	—	—
Spontaneous Annualized Bleeding Rate (sABR) by Location of Bleeding Soft Tissue	0.000 bleeds per year Standard Deviation 0.0000	0.000 bleeds per year Standard Deviation NA Standard deviation was not estimable for a single participant.	0.000 bleeds per year Standard Deviation NA Standard deviation was not estimable for a single participant.	0.000 bleeds per year Standard Deviation 0.0000	—	—
Spontaneous Annualized Bleeding Rate (sABR) by Location of Bleeding Body Cavity	0.000 bleeds per year Standard Deviation 0.0000	0.000 bleeds per year Standard Deviation NA Standard deviation was not estimable for a single participant.	0.000 bleeds per year Standard Deviation NA Standard deviation was not estimable for a single participant.	0.000 bleeds per year Standard Deviation 0.0000	—	—
Spontaneous Annualized Bleeding Rate (sABR) by Location of Bleeding Hematuria	0.000 bleeds per year Standard Deviation 0.0000	0.000 bleeds per year Standard Deviation NA Standard deviation was not estimable for a single participant.	0.000 bleeds per year Standard Deviation NA Standard deviation was not estimable for a single participant.	0.000 bleeds per year Standard Deviation 0.0000	—	—
Spontaneous Annualized Bleeding Rate (sABR) by Location of Bleeding CNS	0.000 bleeds per year Standard Deviation 0.0000	0.000 bleeds per year Standard Deviation NA Standard deviation was not estimable for a single participant.	0.000 bleeds per year Standard Deviation NA Standard deviation was not estimable for a single participant.	0.000 bleeds per year Standard Deviation 0.0000	—	—
Spontaneous Annualized Bleeding Rate (sABR) by Location of Bleeding Other	0.067 bleeds per year Standard Deviation 0.1413	0.000 bleeds per year Standard Deviation NA Standard deviation was not estimable for a single participant.	0.000 bleeds per year Standard Deviation NA Standard deviation was not estimable for a single participant.	0.068 bleeds per year Standard Deviation 0.1521	—	—

SECONDARY outcome

Timeframe: Up to 5.8 years

Population: The FAS consisted of all participants who satisfied all the entry criteria and received any amount of study drug.

Total number of infusions during prophylactic treatment with rVWF (vonicog alfa) were reported.

Outcome measures

Outcome measures
Measure	Cohort 1: Prophylaxis n=10 Participants Adult participants who transitioned from the phase 3 prophylaxis parent study 071301 (NCT02973087) received the same prophylactic dose, 50±10 IU/kg, IV infusion of vonicog alfa twice weekly as in parent study 071301.	Cohort 2: Prophylaxis n=1 Participants Adult participants who transitioned from parent study 071301 (NCT02973087) with no clinically significant BE for the past 6 months started this continuation study at a lower dose/frequency of vonicog alfa once weekly or twice weekly prophylactic dose, 50±10 IU/kg, IV infusion compared to the dose received (50±10 IU/kg, IV infusion, thrice weekly) in parent study 071301.	Cohort 3: Prophylaxis n=1 Participants Adolescent participants (aged 12 to less than \[\<\]18 years) who transitioned from the phase 3 OD and surgery parent study 071102 (NCT02932618) switched from receiving vonicog alfa OD treatment to receiving prophylactic dose of vonicog alfa 50±10 IU/kg, IV infusion, once weekly or twice weekly in this continuation study.	Cohort 4: Prophylaxis n=5 Participants Newly enrolled adult and adolescent (aged 12 to \<18 years) participants who switched from OD treatment with Von Willebrand Factor (VWF) products started 50±10 IU/kg, IV infusion once weekly prophylaxis with vonicog alfa in this continuation study.	Cohort 5: On Demand Pediatric participants of all ages from parent study 071102 (NCT02932618) continued receiving OD treatment of vonicog alfa 50±10 IU/kg, IV infusion, once weekly or twice weekly in this continuation study.	Cohort 6: On Demand Adult participants from parent study 071301 (NCT02973087) switched back from prophylactic treatment in study 071301 to OD treatment of vonicog alfa 50±10 IU/kg, IV infusion, once weekly or twice weekly in this continuation study.
Total Number of Infusions During Prophylactic Treatment	287.8 infusions Standard Deviation 53.42	157.0 infusions Standard Deviation NA Standard deviation was not estimable for a single participant.	177.0 infusions Standard Deviation NA Standard deviation was not estimable for a single participant.	159.2 infusions Standard Deviation 41.55	—	—

SECONDARY outcome

Timeframe: Up to 5.8 years

Population: The FAS consisted of all participants who satisfied all the entry criteria and received any amount of study drug.

Average number of infusions per week during prophylactic treatment with rVWF (vonicog alfa) were reported.

Outcome measures

Outcome measures
Measure	Cohort 1: Prophylaxis n=10 Participants Adult participants who transitioned from the phase 3 prophylaxis parent study 071301 (NCT02973087) received the same prophylactic dose, 50±10 IU/kg, IV infusion of vonicog alfa twice weekly as in parent study 071301.	Cohort 2: Prophylaxis n=1 Participants Adult participants who transitioned from parent study 071301 (NCT02973087) with no clinically significant BE for the past 6 months started this continuation study at a lower dose/frequency of vonicog alfa once weekly or twice weekly prophylactic dose, 50±10 IU/kg, IV infusion compared to the dose received (50±10 IU/kg, IV infusion, thrice weekly) in parent study 071301.	Cohort 3: Prophylaxis n=1 Participants Adolescent participants (aged 12 to less than \[\<\]18 years) who transitioned from the phase 3 OD and surgery parent study 071102 (NCT02932618) switched from receiving vonicog alfa OD treatment to receiving prophylactic dose of vonicog alfa 50±10 IU/kg, IV infusion, once weekly or twice weekly in this continuation study.	Cohort 4: Prophylaxis n=5 Participants Newly enrolled adult and adolescent (aged 12 to \<18 years) participants who switched from OD treatment with Von Willebrand Factor (VWF) products started 50±10 IU/kg, IV infusion once weekly prophylaxis with vonicog alfa in this continuation study.	Cohort 5: On Demand Pediatric participants of all ages from parent study 071102 (NCT02932618) continued receiving OD treatment of vonicog alfa 50±10 IU/kg, IV infusion, once weekly or twice weekly in this continuation study.	Cohort 6: On Demand Adult participants from parent study 071301 (NCT02973087) switched back from prophylactic treatment in study 071301 to OD treatment of vonicog alfa 50±10 IU/kg, IV infusion, once weekly or twice weekly in this continuation study.
Average Number of Infusions Per Week During Prophylactic Treatment	1.87 infusions per week Standard Deviation 0.351	1.01 infusions per week Standard Deviation NA Standard deviation was not estimable for a single participant.	1.14 infusions per week Standard Deviation NA Standard deviation was not estimable for a single participant.	1.38 infusions per week Standard Deviation 0.372	—	—

SECONDARY outcome

Timeframe: Up to 5.8 years

Population: The FAS consisted of all participants who satisfied all the entry criteria and received any amount of study drug.

For each participant, the body weight-adjusted dose (IU/kg) was derived as the number of units of rVWF infused (IU) divided by the last available body weight (kilogram \[kg\]) prior to the infusion. Total weight adjusted consumption of rVWF (vonicog alfa) per participant during prophylactic treatment with rVWF (vonicog alfa) was reported as International Units per kilogram (IU/kg).

Outcome measures

Outcome measures
Measure	Cohort 1: Prophylaxis n=10 Participants Adult participants who transitioned from the phase 3 prophylaxis parent study 071301 (NCT02973087) received the same prophylactic dose, 50±10 IU/kg, IV infusion of vonicog alfa twice weekly as in parent study 071301.	Cohort 2: Prophylaxis n=1 Participants Adult participants who transitioned from parent study 071301 (NCT02973087) with no clinically significant BE for the past 6 months started this continuation study at a lower dose/frequency of vonicog alfa once weekly or twice weekly prophylactic dose, 50±10 IU/kg, IV infusion compared to the dose received (50±10 IU/kg, IV infusion, thrice weekly) in parent study 071301.	Cohort 3: Prophylaxis n=1 Participants Adolescent participants (aged 12 to less than \[\<\]18 years) who transitioned from the phase 3 OD and surgery parent study 071102 (NCT02932618) switched from receiving vonicog alfa OD treatment to receiving prophylactic dose of vonicog alfa 50±10 IU/kg, IV infusion, once weekly or twice weekly in this continuation study.	Cohort 4: Prophylaxis n=5 Participants Newly enrolled adult and adolescent (aged 12 to \<18 years) participants who switched from OD treatment with Von Willebrand Factor (VWF) products started 50±10 IU/kg, IV infusion once weekly prophylaxis with vonicog alfa in this continuation study.	Cohort 5: On Demand Pediatric participants of all ages from parent study 071102 (NCT02932618) continued receiving OD treatment of vonicog alfa 50±10 IU/kg, IV infusion, once weekly or twice weekly in this continuation study.	Cohort 6: On Demand Adult participants from parent study 071301 (NCT02973087) switched back from prophylactic treatment in study 071301 to OD treatment of vonicog alfa 50±10 IU/kg, IV infusion, once weekly or twice weekly in this continuation study.
Total Weight Adjusted Consumption of Recombinant Von Willebrand Factor (rVWF) (Vonicog Alfa) Per Participant During Prophylactic Treatment	14953.497 IU/kg Standard Deviation 3349.4461	9992.460 IU/kg Standard Deviation NA Standard deviation was not estimable for a single participant.	9270.620 IU/kg Standard Deviation NA Standard deviation was not estimable for a single participant.	9171.746 IU/kg Standard Deviation 1505.5667	—	—

SECONDARY outcome

Timeframe: Up to 5.8 years

Population: The FAS consisted of all participants who satisfied all the entry criteria and received any amount of study drug.

Transfusion free maintenance of hemoglobin levels during prophylactic treatment with rVWF (vonicog alfa) were reported.

Outcome measures

Outcome measures
Measure	Cohort 1: Prophylaxis n=10 Participants Adult participants who transitioned from the phase 3 prophylaxis parent study 071301 (NCT02973087) received the same prophylactic dose, 50±10 IU/kg, IV infusion of vonicog alfa twice weekly as in parent study 071301.	Cohort 2: Prophylaxis n=1 Participants Adult participants who transitioned from parent study 071301 (NCT02973087) with no clinically significant BE for the past 6 months started this continuation study at a lower dose/frequency of vonicog alfa once weekly or twice weekly prophylactic dose, 50±10 IU/kg, IV infusion compared to the dose received (50±10 IU/kg, IV infusion, thrice weekly) in parent study 071301.	Cohort 3: Prophylaxis n=1 Participants Adolescent participants (aged 12 to less than \[\<\]18 years) who transitioned from the phase 3 OD and surgery parent study 071102 (NCT02932618) switched from receiving vonicog alfa OD treatment to receiving prophylactic dose of vonicog alfa 50±10 IU/kg, IV infusion, once weekly or twice weekly in this continuation study.	Cohort 4: Prophylaxis n=5 Participants Newly enrolled adult and adolescent (aged 12 to \<18 years) participants who switched from OD treatment with Von Willebrand Factor (VWF) products started 50±10 IU/kg, IV infusion once weekly prophylaxis with vonicog alfa in this continuation study.	Cohort 5: On Demand Pediatric participants of all ages from parent study 071102 (NCT02932618) continued receiving OD treatment of vonicog alfa 50±10 IU/kg, IV infusion, once weekly or twice weekly in this continuation study.	Cohort 6: On Demand Adult participants from parent study 071301 (NCT02973087) switched back from prophylactic treatment in study 071301 to OD treatment of vonicog alfa 50±10 IU/kg, IV infusion, once weekly or twice weekly in this continuation study.
Number of Participants Who Achieved Transfusion-free Maintenance of Hemoglobin Levels	8 Participants	1 Participants	1 Participants	5 Participants	—	—

SECONDARY outcome

Timeframe: Up to 5.8 years

Population: The FAS consisted of all participants who satisfied all the entry criteria and received any amount of study drug. Overall number of participants analyzed is the number of participants with data available for analyses at Baseline. Number analyzed is the number of participants with data available for analyses at the specified timepoint.

Change from baseline in ferritin levels over time during prophylactic treatment with rVWF (vonicog alfa) were reported. Baseline Ferritin lab assay for rollover participants in cohorts 1, 2 and 3 were not mandatory per protocol at the Screening Visit of this study as the results from End of Study (EOS) visit of parent studies were expected to be utilized for rollover cohorts 1-3. However, many participants in cohort 1 did not have this data collected at EOS Visit of parent study 071301 and no participant in cohorts 2 and 3 had this data collected at EOS Visit of parent studies 071301 and 071102.

Outcome measures

Outcome measures
Measure	Cohort 1: Prophylaxis n=2 Participants Adult participants who transitioned from the phase 3 prophylaxis parent study 071301 (NCT02973087) received the same prophylactic dose, 50±10 IU/kg, IV infusion of vonicog alfa twice weekly as in parent study 071301.	Cohort 2: Prophylaxis Adult participants who transitioned from parent study 071301 (NCT02973087) with no clinically significant BE for the past 6 months started this continuation study at a lower dose/frequency of vonicog alfa once weekly or twice weekly prophylactic dose, 50±10 IU/kg, IV infusion compared to the dose received (50±10 IU/kg, IV infusion, thrice weekly) in parent study 071301.	Cohort 3: Prophylaxis Adolescent participants (aged 12 to less than \[\<\]18 years) who transitioned from the phase 3 OD and surgery parent study 071102 (NCT02932618) switched from receiving vonicog alfa OD treatment to receiving prophylactic dose of vonicog alfa 50±10 IU/kg, IV infusion, once weekly or twice weekly in this continuation study.	Cohort 4: Prophylaxis n=5 Participants Newly enrolled adult and adolescent (aged 12 to \<18 years) participants who switched from OD treatment with Von Willebrand Factor (VWF) products started 50±10 IU/kg, IV infusion once weekly prophylaxis with vonicog alfa in this continuation study.	Cohort 5: On Demand Pediatric participants of all ages from parent study 071102 (NCT02932618) continued receiving OD treatment of vonicog alfa 50±10 IU/kg, IV infusion, once weekly or twice weekly in this continuation study.	Cohort 6: On Demand Adult participants from parent study 071301 (NCT02973087) switched back from prophylactic treatment in study 071301 to OD treatment of vonicog alfa 50±10 IU/kg, IV infusion, once weekly or twice weekly in this continuation study.
Change From Baseline in Ferritin Levels Over Time Baseline	148.5 picomole per liter (pmol/L) Standard Deviation 171.83	—	—	90.8 picomole per liter (pmol/L) Standard Deviation 110.82	—	—
Change From Baseline in Ferritin Levels Over Time Month 1	11.0 picomole per liter (pmol/L) Standard Deviation 18.38	—	—	-31.0 picomole per liter (pmol/L) Standard Deviation 44.89	—	—
Change From Baseline in Ferritin Levels Over Time Month 2	0.0 picomole per liter (pmol/L) Standard Deviation 1.41	—	—	-43.8 picomole per liter (pmol/L) Standard Deviation 59.60	—	—
Change From Baseline in Ferritin Levels Over Time Month 3	-18.5 picomole per liter (pmol/L) Standard Deviation 21.92	—	—	-33.3 picomole per liter (pmol/L) Standard Deviation 64.57	—	—
Change From Baseline in Ferritin Levels Over Time Month 6	2.0 picomole per liter (pmol/L) Standard Deviation 2.83	—	—	-16.6 picomole per liter (pmol/L) Standard Deviation 19.88	—	—
Change From Baseline in Ferritin Levels Over Time Month 9	58.5 picomole per liter (pmol/L) Standard Deviation 91.22	—	—	-12.8 picomole per liter (pmol/L) Standard Deviation 53.05	—	—
Change From Baseline in Ferritin Levels Over Time Month 12	19.0 picomole per liter (pmol/L) Standard Deviation 26.87	—	—	-27.0 picomole per liter (pmol/L) Standard Deviation 27.51	—	—
Change From Baseline in Ferritin Levels Over Time Month 15	5.5 picomole per liter (pmol/L) Standard Deviation 13.44	—	—	-25.7 picomole per liter (pmol/L) Standard Deviation 80.16	—	—
Change From Baseline in Ferritin Levels Over Time Month 18	18.0 picomole per liter (pmol/L) Standard Deviation 46.67	—	—	-49.7 picomole per liter (pmol/L) Standard Deviation 52.56	—	—
Change From Baseline in Ferritin Levels Over Time Month 21	37.5 picomole per liter (pmol/L) Standard Deviation 64.35	—	—	-59.3 picomole per liter (pmol/L) Standard Deviation 50.16	—	—
Change From Baseline in Ferritin Levels Over Time Month 24	12.0 picomole per liter (pmol/L) Standard Deviation 26.87	—	—	-53.3 picomole per liter (pmol/L) Standard Deviation 91.22	—	—
Change From Baseline in Ferritin Levels Over Time Month 27	34.0 picomole per liter (pmol/L) Standard Deviation 60.81	—	—	-54.0 picomole per liter (pmol/L) Standard Deviation 55.56	—	—
Change From Baseline in Ferritin Levels Over Time Month 30	46.5 picomole per liter (pmol/L) Standard Deviation 77.07	—	—	-70.7 picomole per liter (pmol/L) Standard Deviation 70.12	—	—
Change From Baseline in Ferritin Levels Over Time Month 33	71.5 picomole per liter (pmol/L) Standard Deviation 106.77	—	—	-21.3 picomole per liter (pmol/L) Standard Deviation 114.00	—	—
Change From Baseline in Ferritin Levels Over Time End of Study	38.5 picomole per liter (pmol/L) Standard Deviation 48.79	—	—	-27.6 picomole per liter (pmol/L) Standard Deviation 52.46	—	—

SECONDARY outcome

Timeframe: Initial 12 months of study

Population: The FAS consisted of all participants who satisfied all the entry criteria and received any amount of study drug. Overall number of participants analyzed is the number of participants with treated bleeding episodes and overall number of units analyzed is the number of bleeding episodes treated in the initial 12 months of the study.

Overall Hemostatic Efficacy Rating at resolution of bleed with respect to treatment of BEs for initial 12 months of study in OD cohorts. Hemostatic efficacy for treatment of BEs was rated on 4-point Likert scale as:excellent=full relief of pain\&cessation of objective signs of bleeding after single infusion,no additional infusion is required for control of bleeding\&administration of further infusion to maintain hemostasis would not affect scoring;good=definite pain relief\&/or improvement in signs of bleeding after single infusion,possibly requires \>2 infusions for complete resolution\&administration of further infusion to maintain hemostasis would not affect scoring;fair=probable\&/or slight relief of pain\&slight improvement in signs of bleeding after single infusion,required multiple infusions for complete resolution;none=no improvement of signs/symptoms or conditions worsen.Missing=number of unique BEs without any overall hemostatic efficacy rating at resolution of breakthrough BE.

Outcome measures

Outcome measures
Measure	Cohort 1: Prophylaxis n=76 bleeding episodes Adult participants who transitioned from the phase 3 prophylaxis parent study 071301 (NCT02973087) received the same prophylactic dose, 50±10 IU/kg, IV infusion of vonicog alfa twice weekly as in parent study 071301.	Cohort 2: Prophylaxis n=24 bleeding episodes Adult participants who transitioned from parent study 071301 (NCT02973087) with no clinically significant BE for the past 6 months started this continuation study at a lower dose/frequency of vonicog alfa once weekly or twice weekly prophylactic dose, 50±10 IU/kg, IV infusion compared to the dose received (50±10 IU/kg, IV infusion, thrice weekly) in parent study 071301.	Cohort 3: Prophylaxis Adolescent participants (aged 12 to less than \[\<\]18 years) who transitioned from the phase 3 OD and surgery parent study 071102 (NCT02932618) switched from receiving vonicog alfa OD treatment to receiving prophylactic dose of vonicog alfa 50±10 IU/kg, IV infusion, once weekly or twice weekly in this continuation study.	Cohort 4: Prophylaxis Newly enrolled adult and adolescent (aged 12 to \<18 years) participants who switched from OD treatment with Von Willebrand Factor (VWF) products started 50±10 IU/kg, IV infusion once weekly prophylaxis with vonicog alfa in this continuation study.	Cohort 5: On Demand Pediatric participants of all ages from parent study 071102 (NCT02932618) continued receiving OD treatment of vonicog alfa 50±10 IU/kg, IV infusion, once weekly or twice weekly in this continuation study.	Cohort 6: On Demand Adult participants from parent study 071301 (NCT02973087) switched back from prophylactic treatment in study 071301 to OD treatment of vonicog alfa 50±10 IU/kg, IV infusion, once weekly or twice weekly in this continuation study.
Overall Hemostatic Efficacy Rating Excellent	74 bleeding episodes	21 bleeding episodes	—	—	—	—
Overall Hemostatic Efficacy Rating Good	1 bleeding episodes	0 bleeding episodes	—	—	—	—
Overall Hemostatic Efficacy Rating Fair	0 bleeding episodes	0 bleeding episodes	—	—	—	—
Overall Hemostatic Efficacy Rating None	0 bleeding episodes	0 bleeding episodes	—	—	—	—
Overall Hemostatic Efficacy Rating Missing	1 bleeding episodes	3 bleeding episodes	—	—	—	—

SECONDARY outcome

Timeframe: Up to 5.8 years

Population: The FAS consisted of all participants who satisfied all the entry criteria and received any amount of study drug. Overall number of units analyzed is the number of bleeding episodes treated with vonicog alfa.

Number of infusions of rVWF (vonicog alfa) utilized to treat BEs during OD treatment while enrolled in the study were reported.

Outcome measures

Outcome measures
Measure	Cohort 1: Prophylaxis n=167 bleeding episodes Adult participants who transitioned from the phase 3 prophylaxis parent study 071301 (NCT02973087) received the same prophylactic dose, 50±10 IU/kg, IV infusion of vonicog alfa twice weekly as in parent study 071301.	Cohort 2: Prophylaxis n=35 bleeding episodes Adult participants who transitioned from parent study 071301 (NCT02973087) with no clinically significant BE for the past 6 months started this continuation study at a lower dose/frequency of vonicog alfa once weekly or twice weekly prophylactic dose, 50±10 IU/kg, IV infusion compared to the dose received (50±10 IU/kg, IV infusion, thrice weekly) in parent study 071301.	Cohort 3: Prophylaxis Adolescent participants (aged 12 to less than \[\<\]18 years) who transitioned from the phase 3 OD and surgery parent study 071102 (NCT02932618) switched from receiving vonicog alfa OD treatment to receiving prophylactic dose of vonicog alfa 50±10 IU/kg, IV infusion, once weekly or twice weekly in this continuation study.	Cohort 4: Prophylaxis Newly enrolled adult and adolescent (aged 12 to \<18 years) participants who switched from OD treatment with Von Willebrand Factor (VWF) products started 50±10 IU/kg, IV infusion once weekly prophylaxis with vonicog alfa in this continuation study.	Cohort 5: On Demand Pediatric participants of all ages from parent study 071102 (NCT02932618) continued receiving OD treatment of vonicog alfa 50±10 IU/kg, IV infusion, once weekly or twice weekly in this continuation study.	Cohort 6: On Demand Adult participants from parent study 071301 (NCT02973087) switched back from prophylactic treatment in study 071301 to OD treatment of vonicog alfa 50±10 IU/kg, IV infusion, once weekly or twice weekly in this continuation study.
Number of Infusions of Vonicog Alfa	1.1 infusions Standard Deviation 0.65	1.2 infusions Standard Deviation 0.45	—	—	—	—

SECONDARY outcome

Timeframe: Up to 5.8 years

Population: The FAS consisted of all participants who satisfied all the entry criteria and received any amount of study drug. Overall number of participants analyzed is the number of participants with ADVATE-treated bleeding episodes. Overall number of units analyzed is the number of bleeding episodes treated with ADVATE.

Number of infusions of ADVATE (rFVIII, octocog alfa) utilized to treat BEs during OD treatment while enrolled in the study were reported.

Outcome measures

Outcome measures
Measure	Cohort 1: Prophylaxis n=46 bleeding episodes Adult participants who transitioned from the phase 3 prophylaxis parent study 071301 (NCT02973087) received the same prophylactic dose, 50±10 IU/kg, IV infusion of vonicog alfa twice weekly as in parent study 071301.	Cohort 2: Prophylaxis n=2 bleeding episodes Adult participants who transitioned from parent study 071301 (NCT02973087) with no clinically significant BE for the past 6 months started this continuation study at a lower dose/frequency of vonicog alfa once weekly or twice weekly prophylactic dose, 50±10 IU/kg, IV infusion compared to the dose received (50±10 IU/kg, IV infusion, thrice weekly) in parent study 071301.	Cohort 3: Prophylaxis Adolescent participants (aged 12 to less than \[\<\]18 years) who transitioned from the phase 3 OD and surgery parent study 071102 (NCT02932618) switched from receiving vonicog alfa OD treatment to receiving prophylactic dose of vonicog alfa 50±10 IU/kg, IV infusion, once weekly or twice weekly in this continuation study.	Cohort 4: Prophylaxis Newly enrolled adult and adolescent (aged 12 to \<18 years) participants who switched from OD treatment with Von Willebrand Factor (VWF) products started 50±10 IU/kg, IV infusion once weekly prophylaxis with vonicog alfa in this continuation study.	Cohort 5: On Demand Pediatric participants of all ages from parent study 071102 (NCT02932618) continued receiving OD treatment of vonicog alfa 50±10 IU/kg, IV infusion, once weekly or twice weekly in this continuation study.	Cohort 6: On Demand Adult participants from parent study 071301 (NCT02973087) switched back from prophylactic treatment in study 071301 to OD treatment of vonicog alfa 50±10 IU/kg, IV infusion, once weekly or twice weekly in this continuation study.
Number of Infusions of ADVATE	1.1 infusions Standard Deviation 0.25	1.0 infusions Standard Deviation 0.00	—	—	—	—

SECONDARY outcome

Timeframe: Up to 5.8 years

Weight-adjusted consumption (IU/kg) was derived as the total units infused (IU) divided by the last available body weight (kg) prior to the infusion. Weight-adjusted consumption of rVWF (vonicog alfa) per bleeding episode during OD treatment while enrolled in the study were reported.

Outcome measures

Outcome measures
Measure	Cohort 1: Prophylaxis n=165 bleeding episodes Adult participants who transitioned from the phase 3 prophylaxis parent study 071301 (NCT02973087) received the same prophylactic dose, 50±10 IU/kg, IV infusion of vonicog alfa twice weekly as in parent study 071301.	Cohort 2: Prophylaxis n=35 bleeding episodes Adult participants who transitioned from parent study 071301 (NCT02973087) with no clinically significant BE for the past 6 months started this continuation study at a lower dose/frequency of vonicog alfa once weekly or twice weekly prophylactic dose, 50±10 IU/kg, IV infusion compared to the dose received (50±10 IU/kg, IV infusion, thrice weekly) in parent study 071301.	Cohort 3: Prophylaxis Adolescent participants (aged 12 to less than \[\<\]18 years) who transitioned from the phase 3 OD and surgery parent study 071102 (NCT02932618) switched from receiving vonicog alfa OD treatment to receiving prophylactic dose of vonicog alfa 50±10 IU/kg, IV infusion, once weekly or twice weekly in this continuation study.	Cohort 4: Prophylaxis Newly enrolled adult and adolescent (aged 12 to \<18 years) participants who switched from OD treatment with Von Willebrand Factor (VWF) products started 50±10 IU/kg, IV infusion once weekly prophylaxis with vonicog alfa in this continuation study.	Cohort 5: On Demand Pediatric participants of all ages from parent study 071102 (NCT02932618) continued receiving OD treatment of vonicog alfa 50±10 IU/kg, IV infusion, once weekly or twice weekly in this continuation study.	Cohort 6: On Demand Adult participants from parent study 071301 (NCT02973087) switched back from prophylactic treatment in study 071301 to OD treatment of vonicog alfa 50±10 IU/kg, IV infusion, once weekly or twice weekly in this continuation study.
Weight-adjusted Consumption of Vonicog Alfa Per Bleeding Episode	56.109 IU/kg per bleeding episode Standard Deviation 33.1312	61.713 IU/kg per bleeding episode Standard Deviation 26.6936	—	—	—	—

SECONDARY outcome

Timeframe: Up to 5.8 years

Population: The FAS consisted of all participants who satisfied all the entry criteria and received any amount of study drug. Overall number of participants analyzed is the number of participants with ADVATE-treated bleeding episodes. Overall number of units analyzed is the number of bleeding episodes treated with ADVATE.

Weight-adjusted consumption (IU/kg) was derived as the total units infused (IU) divided by the last available body weight (kg) prior to the infusion. Weight-adjusted consumption of ADVATE (rFVIII, octocog alfa) per bleeding episode during OD treatment while enrolled in the study were reported.

Outcome measures

Outcome measures
Measure	Cohort 1: Prophylaxis n=46 bleeding episodes Adult participants who transitioned from the phase 3 prophylaxis parent study 071301 (NCT02973087) received the same prophylactic dose, 50±10 IU/kg, IV infusion of vonicog alfa twice weekly as in parent study 071301.	Cohort 2: Prophylaxis n=2 bleeding episodes Adult participants who transitioned from parent study 071301 (NCT02973087) with no clinically significant BE for the past 6 months started this continuation study at a lower dose/frequency of vonicog alfa once weekly or twice weekly prophylactic dose, 50±10 IU/kg, IV infusion compared to the dose received (50±10 IU/kg, IV infusion, thrice weekly) in parent study 071301.	Cohort 3: Prophylaxis Adolescent participants (aged 12 to less than \[\<\]18 years) who transitioned from the phase 3 OD and surgery parent study 071102 (NCT02932618) switched from receiving vonicog alfa OD treatment to receiving prophylactic dose of vonicog alfa 50±10 IU/kg, IV infusion, once weekly or twice weekly in this continuation study.	Cohort 4: Prophylaxis Newly enrolled adult and adolescent (aged 12 to \<18 years) participants who switched from OD treatment with Von Willebrand Factor (VWF) products started 50±10 IU/kg, IV infusion once weekly prophylaxis with vonicog alfa in this continuation study.	Cohort 5: On Demand Pediatric participants of all ages from parent study 071102 (NCT02932618) continued receiving OD treatment of vonicog alfa 50±10 IU/kg, IV infusion, once weekly or twice weekly in this continuation study.	Cohort 6: On Demand Adult participants from parent study 071301 (NCT02973087) switched back from prophylactic treatment in study 071301 to OD treatment of vonicog alfa 50±10 IU/kg, IV infusion, once weekly or twice weekly in this continuation study.
Weight-adjusted Consumption of ADVATE Per Bleeding Episode	39.217 IU/kg per bleeding episode Standard Deviation 11.0752	35.175 IU/kg per bleeding episode Standard Deviation 2.2274	—	—	—	—

Adverse Events

Cohort 1: Prophylaxis: Adult ≥18 Years

Serious events: 3 serious events

Other events: 8 other events

Deaths: 0 deaths

Cohort 2: Prophylaxis: Adult ≥18 Years

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Cohort 3: Prophylaxis: Pediatric 12 to <18 Years

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Cohort 4: Prophylaxis: Pediatric 12 to <18 Years

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Cohort 4: Prophylaxis: Adult ≥18 Years

Serious events: 1 serious events

Other events: 2 other events

Deaths: 0 deaths

Cohort 5: On Demand: Pediatric <6 Years

Serious events: 2 serious events

Other events: 3 other events

Deaths: 0 deaths

Cohort 5: On Demand: Pediatric 6 to <12 Years

Serious events: 1 serious events

Other events: 5 other events

Deaths: 0 deaths

Cohort 5: On Demand: Pediatric 12 to <18 Years

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

Cohort 5: On Demand: Adult ≥18 Years

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Cohort 6: On Demand: Adult ≥18 Years

Serious events: 1 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Cohort 1: Prophylaxis: Adult ≥18 Years n=10 participants at risk Adult participants who transitioned from the phase 3 prophylaxis parent study 071301 (NCT02973087) received the same prophylactic dose, 50±10 IU/kg, IV infusion of vonicog alfa twice weekly as in parent study 071301.	Cohort 2: Prophylaxis: Adult ≥18 Years n=1 participants at risk Adult participants who transitioned from parent study 071301 (NCT02973087) with no clinically significant BE for the past 6 months started this continuation study at a lower dose/frequency of vonicog alfa once weekly or twice weekly prophylactic dose, 50±10 IU/kg, IV infusion compared to the dose received (50±10 IU/kg, IV infusion, thrice weekly) in parent study 071301.	Cohort 3: Prophylaxis: Pediatric 12 to <18 Years n=1 participants at risk Adolescent participants (aged 12 to \<18 years) who transitioned from the phase 3 OD and surgery parent study 071102 (NCT02932618) switched from receiving vonicog alfa OD treatment to receiving prophylactic dose of vonicog alfa 50±10 IU/kg, IV infusion, once weekly or twice weekly in this continuation study.	Cohort 4: Prophylaxis: Pediatric 12 to <18 Years n=2 participants at risk Newly enrolled adolescent (aged 12 to \<18 years) participants who switched from OD treatment with VWF products started 50±10 IU/kg, IV infusion once weekly prophylaxis with vonicog alfa in this continuation study.	Cohort 4: Prophylaxis: Adult ≥18 Years n=3 participants at risk Newly enrolled adult participants who switched from OD treatment with VWF products started 50±10 IU/kg, IV infusion once weekly prophylaxis with vonicog alfa in this continuation study.	Cohort 5: On Demand: Pediatric <6 Years n=3 participants at risk Pediatric participants of \<6 years of age from Parent Study 071102/NCT02932618 continued receiving OD treatment of vonicog alfa 50±10 IU/kg, IV infusion, once weekly or twice weekly in this continuation study.	Cohort 5: On Demand: Pediatric 6 to <12 Years n=5 participants at risk Pediatric participants of 6 to \<12 years age from parent study 071102 (NCT02932618) continued receiving OD treatment of vonicog alfa 50±10 IU/kg, IV infusion, once weekly or twice weekly in this continuation study.	Cohort 5: On Demand: Pediatric 12 to <18 Years n=6 participants at risk Pediatric participants of 12 to \<18 years of age from parent study 071102 (NCT02932618) continued receiving OD treatment of vonicog alfa 50±10 IU/kg, IV infusion, once weekly or twice weekly in this continuation study.	Cohort 5: On Demand: Adult ≥18 Years n=2 participants at risk Adult Participants from Parent Study 071102/NCT02932618 continued receiving OD treatment of vonicog alfa 50±10 IU/kg, IV infusion, once weekly or twice weekly in this continuation study.	Cohort 6: On Demand: Adult ≥18 Years n=2 participants at risk Adult participants from parent study 071301 (NCT02973087) switched back from prophylactic treatment in Study 071301 to OD treatment of vonicog alfa 50±10 IU/kg, IV infusion, once weekly or twice weekly in this continuation study.
Blood and lymphatic system disorders Anaemia	10.0% 1/10 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/1 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/1 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/2 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/3 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/3 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/5 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/6 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/2 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/2 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.
Infections and infestations Bacteraemia	10.0% 1/10 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/1 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/1 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/2 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/3 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/3 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/5 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/6 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/2 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/2 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.
Infections and infestations Coronavirus infection	0.00% 0/10 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/1 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/1 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/2 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/3 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	33.3% 1/3 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/5 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/6 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/2 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/2 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.
Injury, poisoning and procedural complications Fall	0.00% 0/10 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/1 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/1 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/2 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/3 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	33.3% 1/3 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/5 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/6 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/2 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/2 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.
Injury, poisoning and procedural complications Fibula fracture	0.00% 0/10 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/1 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/1 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/2 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	33.3% 1/3 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/3 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/5 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/6 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/2 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/2 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.
Investigations Haemoglobin decreased	10.0% 1/10 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/1 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/1 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/2 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/3 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/3 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/5 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/6 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/2 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/2 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.
Vascular disorders Hypotension	0.00% 0/10 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/1 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/1 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/2 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/3 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	33.3% 1/3 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/5 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/6 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/2 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/2 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.
General disorders Medical device site extravasation	0.00% 0/10 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/1 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/1 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/2 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/3 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	33.3% 1/3 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/5 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/6 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/2 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/2 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.
Reproductive system and breast disorders Ovarian cyst ruptured	0.00% 0/10 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/1 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/1 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/2 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/3 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/3 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/5 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/6 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/2 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	50.0% 1/2 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.
Infections and infestations Pneumonia	0.00% 0/10 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/1 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/1 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/2 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	33.3% 1/3 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/3 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/5 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/6 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/2 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/2 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.
Injury, poisoning and procedural complications Post procedural haemorrhage	10.0% 1/10 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/1 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/1 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/2 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/3 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/3 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/5 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/6 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/2 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/2 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.
Injury, poisoning and procedural complications Spinal compression fracture	0.00% 0/10 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/1 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/1 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/2 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/3 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/3 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	20.0% 1/5 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/6 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/2 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/2 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.
Injury, poisoning and procedural complications Tibia fracture	0.00% 0/10 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/1 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/1 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/2 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	33.3% 1/3 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/3 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/5 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/6 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/2 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/2 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.

Other adverse events

Other adverse events
Measure	Cohort 1: Prophylaxis: Adult ≥18 Years n=10 participants at risk Adult participants who transitioned from the phase 3 prophylaxis parent study 071301 (NCT02973087) received the same prophylactic dose, 50±10 IU/kg, IV infusion of vonicog alfa twice weekly as in parent study 071301.	Cohort 2: Prophylaxis: Adult ≥18 Years n=1 participants at risk Adult participants who transitioned from parent study 071301 (NCT02973087) with no clinically significant BE for the past 6 months started this continuation study at a lower dose/frequency of vonicog alfa once weekly or twice weekly prophylactic dose, 50±10 IU/kg, IV infusion compared to the dose received (50±10 IU/kg, IV infusion, thrice weekly) in parent study 071301.	Cohort 3: Prophylaxis: Pediatric 12 to <18 Years n=1 participants at risk Adolescent participants (aged 12 to \<18 years) who transitioned from the phase 3 OD and surgery parent study 071102 (NCT02932618) switched from receiving vonicog alfa OD treatment to receiving prophylactic dose of vonicog alfa 50±10 IU/kg, IV infusion, once weekly or twice weekly in this continuation study.	Cohort 4: Prophylaxis: Pediatric 12 to <18 Years n=2 participants at risk Newly enrolled adolescent (aged 12 to \<18 years) participants who switched from OD treatment with VWF products started 50±10 IU/kg, IV infusion once weekly prophylaxis with vonicog alfa in this continuation study.	Cohort 4: Prophylaxis: Adult ≥18 Years n=3 participants at risk Newly enrolled adult participants who switched from OD treatment with VWF products started 50±10 IU/kg, IV infusion once weekly prophylaxis with vonicog alfa in this continuation study.	Cohort 5: On Demand: Pediatric <6 Years n=3 participants at risk Pediatric participants of \<6 years of age from Parent Study 071102/NCT02932618 continued receiving OD treatment of vonicog alfa 50±10 IU/kg, IV infusion, once weekly or twice weekly in this continuation study.	Cohort 5: On Demand: Pediatric 6 to <12 Years n=5 participants at risk Pediatric participants of 6 to \<12 years age from parent study 071102 (NCT02932618) continued receiving OD treatment of vonicog alfa 50±10 IU/kg, IV infusion, once weekly or twice weekly in this continuation study.	Cohort 5: On Demand: Pediatric 12 to <18 Years n=6 participants at risk Pediatric participants of 12 to \<18 years of age from parent study 071102 (NCT02932618) continued receiving OD treatment of vonicog alfa 50±10 IU/kg, IV infusion, once weekly or twice weekly in this continuation study.	Cohort 5: On Demand: Adult ≥18 Years n=2 participants at risk Adult Participants from Parent Study 071102/NCT02932618 continued receiving OD treatment of vonicog alfa 50±10 IU/kg, IV infusion, once weekly or twice weekly in this continuation study.	Cohort 6: On Demand: Adult ≥18 Years n=2 participants at risk Adult participants from parent study 071301 (NCT02973087) switched back from prophylactic treatment in Study 071301 to OD treatment of vonicog alfa 50±10 IU/kg, IV infusion, once weekly or twice weekly in this continuation study.
Infections and infestations Conjunctivitis	0.00% 0/10 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/1 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/1 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	50.0% 1/2 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/3 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/3 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/5 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/6 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/2 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/2 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.
Eye disorders Conjunctivitis allergic	0.00% 0/10 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/1 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/1 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/2 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/3 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/3 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	20.0% 1/5 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/6 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/2 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/2 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.
Infections and infestations Conjunctivitis bacterial	0.00% 0/10 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/1 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/1 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/2 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/3 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	33.3% 1/3 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/5 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/6 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/2 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/2 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.
Gastrointestinal disorders Constipation	10.0% 1/10 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/1 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/1 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/2 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/3 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/3 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	20.0% 1/5 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/6 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/2 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/2 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.
Injury, poisoning and procedural complications Contusion	20.0% 2/10 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/1 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/1 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/2 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/3 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/3 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/5 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/6 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/2 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/2 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.
Infections and infestations Coronavirus infection	0.00% 0/10 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/1 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/1 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/2 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/3 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	33.3% 1/3 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	20.0% 1/5 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/6 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/2 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/2 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.
Respiratory, thoracic and mediastinal disorders Cough	0.00% 0/10 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/1 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/1 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	50.0% 1/2 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/3 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	66.7% 2/3 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	20.0% 1/5 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	16.7% 1/6 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/2 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/2 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.
Infections and infestations Croup infectious	0.00% 0/10 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/1 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/1 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/2 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/3 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	33.3% 1/3 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/5 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/6 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/2 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/2 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.
Metabolism and nutrition disorders Decreased appetite	0.00% 0/10 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/1 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/1 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/2 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/3 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/3 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	20.0% 1/5 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/6 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/2 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/2 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.
Gastrointestinal disorders Dental caries	0.00% 0/10 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/1 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/1 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/2 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/3 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/3 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	20.0% 1/5 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/6 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/2 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/2 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.
Nervous system disorders Dizziness	10.0% 1/10 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/1 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/1 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/2 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/3 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/3 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/5 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/6 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/2 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/2 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.
Reproductive system and breast disorders Dysmenorrhoea	0.00% 0/10 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/1 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/1 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/2 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/3 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/3 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/5 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/6 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	50.0% 1/2 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/2 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.
Gastrointestinal disorders Dyspepsia	10.0% 1/10 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/1 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/1 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/2 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/3 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/3 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/5 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/6 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/2 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/2 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.
Gastrointestinal disorders Dysphagia	10.0% 1/10 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/1 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/1 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/2 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/3 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/3 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/5 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/6 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/2 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/2 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.
Skin and subcutaneous tissue disorders Dermatitis	0.00% 0/10 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/1 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/1 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/2 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/3 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/3 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/5 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	16.7% 1/6 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/2 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/2 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.
Product Issues Device malfunction	0.00% 0/10 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/1 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/1 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/2 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/3 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	33.3% 1/3 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/5 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/6 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/2 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/2 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.
Gastrointestinal disorders Diarrhoea	10.0% 1/10 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/1 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/1 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	50.0% 1/2 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/3 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	33.3% 1/3 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/5 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/6 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/2 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/2 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.
General disorders Chest discomfort	0.00% 0/10 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/1 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	100.0% 1/1 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/2 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/3 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/3 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/5 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/6 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/2 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/2 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.
Injury, poisoning and procedural complications Chest injury	0.00% 0/10 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/1 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/1 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/2 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	33.3% 1/3 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/3 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/5 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/6 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/2 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/2 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.
General disorders Chills	0.00% 0/10 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/1 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/1 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	50.0% 1/2 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/3 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/3 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/5 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/6 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/2 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/2 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.
Hepatobiliary disorders Cholecystitis	10.0% 1/10 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/1 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/1 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/2 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/3 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/3 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/5 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/6 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/2 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/2 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.
Hepatobiliary disorders Cholelithiasis	10.0% 1/10 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/1 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/1 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/2 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/3 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/3 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/5 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/6 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/2 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/2 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.
Gastrointestinal disorders Abdominal distension	10.0% 1/10 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/1 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/1 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/2 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/3 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/3 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/5 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/6 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/2 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/2 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.
Gastrointestinal disorders Abdominal pain	10.0% 1/10 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	100.0% 1/1 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/1 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	50.0% 1/2 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/3 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	33.3% 1/3 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/5 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/6 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/2 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/2 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.
Gastrointestinal disorders Abdominal pain upper	20.0% 2/10 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/1 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/1 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/2 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/3 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/3 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/5 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/6 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	50.0% 1/2 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/2 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.
Infections and infestations Acute sinusitis	0.00% 0/10 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/1 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/1 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/2 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/3 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/3 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/5 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	16.7% 1/6 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/2 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/2 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.
Investigations Alanine aminotransferase increased	0.00% 0/10 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/1 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/1 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/2 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	33.3% 1/3 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/3 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	20.0% 1/5 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	16.7% 1/6 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/2 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/2 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.
Blood and lymphatic system disorders Anaemia	10.0% 1/10 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/1 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/1 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/2 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	33.3% 1/3 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/3 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/5 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/6 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/2 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	50.0% 1/2 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.
Gastrointestinal disorders Angular cheilitis	0.00% 0/10 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	100.0% 1/1 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/1 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/2 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/3 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/3 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/5 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/6 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/2 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/2 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.
Investigations Anti factor VIII antibody positive	0.00% 0/10 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/1 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/1 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/2 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/3 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/3 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/5 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	16.7% 1/6 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/2 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/2 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.
Psychiatric disorders Anxiety	0.00% 0/10 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/1 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/1 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/2 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	33.3% 1/3 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/3 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/5 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/6 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/2 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/2 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.
Musculoskeletal and connective tissue disorders Arthralgia	10.0% 1/10 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/1 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/1 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/2 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/3 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/3 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/5 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	16.7% 1/6 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/2 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/2 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.
Injury, poisoning and procedural complications Arthropod bite	0.00% 0/10 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/1 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/1 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/2 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/3 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/3 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	20.0% 1/5 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/6 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/2 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/2 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.
Injury, poisoning and procedural complications Arthropod sting	10.0% 1/10 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/1 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/1 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/2 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/3 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	33.3% 1/3 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/5 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/6 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/2 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/2 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.
Investigations Aspartate aminotransferase increased	0.00% 0/10 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/1 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/1 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/2 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	33.3% 1/3 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/3 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/5 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	16.7% 1/6 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/2 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/2 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.
General disorders Asthenia	10.0% 1/10 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/1 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/1 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/2 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/3 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/3 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/5 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/6 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/2 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/2 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.
Respiratory, thoracic and mediastinal disorders Asthma	0.00% 0/10 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/1 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/1 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/2 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	33.3% 1/3 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/3 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/5 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/6 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/2 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/2 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.
Eye disorders Astigmatism	0.00% 0/10 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/1 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/1 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/2 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/3 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/3 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/5 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	16.7% 1/6 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/2 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	50.0% 1/2 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.
Respiratory, thoracic and mediastinal disorders Atelectasis	0.00% 0/10 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/1 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/1 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/2 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/3 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	33.3% 1/3 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/5 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/6 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/2 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/2 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.
Musculoskeletal and connective tissue disorders Back pain	10.0% 1/10 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/1 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/1 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/2 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/3 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/3 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/5 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/6 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/2 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/2 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.
Hepatobiliary disorders Bile duct stone	10.0% 1/10 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/1 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/1 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/2 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/3 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/3 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/5 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/6 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/2 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/2 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.
Investigations Blood triglycerides increased	0.00% 0/10 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/1 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/1 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/2 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	33.3% 1/3 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/3 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/5 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/6 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/2 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/2 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.
Injury, poisoning and procedural complications Bone contusion	10.0% 1/10 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/1 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/1 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/2 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/3 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/3 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/5 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/6 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/2 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/2 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.
Cardiac disorders Bundle branch block right	0.00% 0/10 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/1 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/1 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/2 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/3 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/3 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/5 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	16.7% 1/6 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/2 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/2 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.
Infections and infestations COVID-19	10.0% 1/10 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/1 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	100.0% 1/1 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/2 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	66.7% 2/3 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	100.0% 3/3 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	20.0% 1/5 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	50.0% 3/6 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	50.0% 1/2 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/2 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.
Eye disorders Cataract	10.0% 1/10 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/1 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/1 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/2 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/3 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/3 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/5 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/6 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/2 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/2 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.
Respiratory, thoracic and mediastinal disorders Catarrh	10.0% 1/10 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/1 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/1 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/2 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/3 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/3 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/5 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/6 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/2 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/2 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.
Ear and labyrinth disorders Cerumen impaction	10.0% 1/10 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/1 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/1 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/2 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/3 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/3 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/5 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/6 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/2 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/2 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/10 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/1 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/1 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/2 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/3 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/3 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/5 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/6 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/2 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	50.0% 1/2 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.
Ear and labyrinth disorders Ear pain	0.00% 0/10 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/1 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/1 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/2 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/3 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/3 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	20.0% 1/5 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/6 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/2 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/2 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.
Skin and subcutaneous tissue disorders Ecchymosis	10.0% 1/10 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/1 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/1 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/2 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/3 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/3 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/5 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/6 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/2 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/2 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.
Gastrointestinal disorders Enteritis	10.0% 1/10 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/1 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/1 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/2 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/3 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/3 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/5 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/6 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/2 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/2 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.
Blood and lymphatic system disorders Eosinophilia	0.00% 0/10 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/1 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/1 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/2 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/3 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/3 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	20.0% 1/5 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/6 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/2 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/2 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.
Injury, poisoning and procedural complications Epicondylitis	10.0% 1/10 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/1 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/1 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/2 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/3 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/3 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/5 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/6 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/2 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/2 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.
Gastrointestinal disorders Faeces discoloured	10.0% 1/10 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/1 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/1 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/2 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/3 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/3 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/5 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/6 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/2 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/2 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.
Injury, poisoning and procedural complications Fall	10.0% 1/10 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/1 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/1 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/2 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/3 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/3 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/5 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/6 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/2 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/2 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.
Gastrointestinal disorders Flatulence	0.00% 0/10 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/1 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/1 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/2 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/3 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/3 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/5 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/6 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/2 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	50.0% 1/2 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.
Injury, poisoning and procedural complications Fracture displacement	0.00% 0/10 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/1 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/1 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/2 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	33.3% 1/3 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/3 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/5 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/6 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/2 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/2 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.
Infections and infestations Gastroenteritis	0.00% 0/10 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	100.0% 1/1 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/1 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/2 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/3 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/3 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/5 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	16.7% 1/6 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/2 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/2 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.
Infections and infestations Gastroenteritis viral	0.00% 0/10 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/1 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/1 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/2 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/3 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	33.3% 1/3 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/5 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/6 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/2 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/2 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.
Gastrointestinal disorders Gastrooesophageal reflux disease	10.0% 1/10 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/1 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/1 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/2 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/3 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/3 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/5 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/6 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/2 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/2 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.
Infections and infestations Gingivitis	0.00% 0/10 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/1 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/1 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/2 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/3 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/3 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/5 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/6 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/2 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	50.0% 1/2 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.
Gastrointestinal disorders Haematochezia	0.00% 0/10 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/1 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/1 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/2 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/3 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	33.3% 1/3 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/5 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/6 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/2 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/2 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.
Renal and urinary disorders Haematuria	10.0% 1/10 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/1 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/1 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/2 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/3 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/3 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/5 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/6 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/2 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/2 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.
Hepatobiliary disorders Haemobilia	10.0% 1/10 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/1 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/1 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/2 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/3 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/3 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/5 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/6 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/2 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/2 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.
Musculoskeletal and connective tissue disorders Haemophilic arthropathy	10.0% 1/10 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/1 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/1 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/2 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/3 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/3 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/5 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/6 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/2 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/2 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.
Injury, poisoning and procedural complications Head injury	0.00% 0/10 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/1 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/1 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/2 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	33.3% 1/3 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	33.3% 1/3 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/5 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/6 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/2 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/2 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.
Nervous system disorders Headache	30.0% 3/10 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	100.0% 1/1 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/1 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	100.0% 2/2 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/3 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/3 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	20.0% 1/5 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/6 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	50.0% 1/2 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/2 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.
Hepatobiliary disorders Hepatomegaly	0.00% 0/10 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/1 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/1 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/2 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/3 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	33.3% 1/3 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/5 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/6 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/2 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/2 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.
Vascular disorders Hypertension	0.00% 0/10 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/1 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/1 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/2 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	33.3% 1/3 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/3 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/5 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/6 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/2 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/2 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.
Metabolism and nutrition disorders Hypomagnesaemia	10.0% 1/10 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/1 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/1 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/2 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/3 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/3 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/5 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/6 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/2 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/2 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.
Infections and infestations Influenza	0.00% 0/10 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/1 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/1 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/2 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/3 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/3 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/5 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	16.7% 1/6 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/2 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/2 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.
Injury, poisoning and procedural complications Infusion related reaction	0.00% 0/10 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/1 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/1 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	50.0% 1/2 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/3 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/3 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/5 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/6 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/2 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/2 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.
General disorders Infusion site rash	0.00% 0/10 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/1 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	100.0% 1/1 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/2 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/3 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/3 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/5 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/6 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/2 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/2 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.
Reproductive system and breast disorders Intermenstrual bleeding	0.00% 0/10 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/1 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/1 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	50.0% 1/2 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/3 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/3 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/5 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/6 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/2 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/2 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.
Metabolism and nutrition disorders Iron deficiency	0.00% 0/10 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/1 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/1 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/2 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	33.3% 1/3 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/3 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/5 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	16.7% 1/6 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	50.0% 1/2 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	50.0% 1/2 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.
Blood and lymphatic system disorders Iron deficiency anaemia	10.0% 1/10 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/1 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/1 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/2 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	33.3% 1/3 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/3 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	20.0% 1/5 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/6 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	50.0% 1/2 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/2 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.
Gastrointestinal disorders Irritable bowel syndrome	0.00% 0/10 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/1 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	100.0% 1/1 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/2 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/3 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/3 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/5 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/6 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/2 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/2 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.
Musculoskeletal and connective tissue disorders Joint effusion	0.00% 0/10 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/1 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/1 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	50.0% 1/2 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/3 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/3 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/5 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/6 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/2 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/2 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.
Injury, poisoning and procedural complications Joint injury	0.00% 0/10 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/1 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/1 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/2 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/3 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/3 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/5 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/6 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/2 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	50.0% 1/2 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.
Musculoskeletal and connective tissue disorders Juvenile idiopathic arthritis	0.00% 0/10 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/1 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/1 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	50.0% 1/2 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/3 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/3 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/5 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/6 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/2 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/2 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.
Infections and infestations Laryngitis	0.00% 0/10 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/1 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/1 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/2 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/3 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/3 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/5 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	16.7% 1/6 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/2 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/2 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.
Injury, poisoning and procedural complications Ligament sprain	0.00% 0/10 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/1 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/1 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/2 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/3 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/3 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/5 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/6 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	50.0% 1/2 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/2 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.
Injury, poisoning and procedural complications Limb injury	0.00% 0/10 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/1 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/1 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/2 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	33.3% 1/3 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/3 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	20.0% 1/5 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	16.7% 1/6 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/2 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/2 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.
Congenital, familial and genetic disorders Lymphatic malformation	0.00% 0/10 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/1 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/1 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/2 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	33.3% 1/3 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/3 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/5 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/6 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/2 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/2 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.
Injury, poisoning and procedural complications Meniscus injury	0.00% 0/10 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/1 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/1 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	50.0% 1/2 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/3 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/3 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/5 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/6 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/2 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/2 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.
Musculoskeletal and connective tissue disorders Muscle spasms	0.00% 0/10 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	100.0% 1/1 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/1 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	50.0% 1/2 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	33.3% 1/3 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/3 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/5 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/6 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/2 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/2 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.
Musculoskeletal and connective tissue disorders Musculoskeletal chest pain	0.00% 0/10 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/1 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/1 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/2 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/3 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/3 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	20.0% 1/5 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/6 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/2 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/2 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.
Respiratory, thoracic and mediastinal disorders Nasal congestion	0.00% 0/10 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/1 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/1 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/2 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/3 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	33.3% 1/3 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/5 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	16.7% 1/6 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/2 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/2 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.
Infections and infestations Nasopharyngitis	0.00% 0/10 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	100.0% 1/1 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/1 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	50.0% 1/2 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/3 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/3 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/5 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/6 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/2 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/2 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.
Gastrointestinal disorders Nausea	10.0% 1/10 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/1 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/1 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/2 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/3 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/3 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/5 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	16.7% 1/6 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/2 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/2 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.
Renal and urinary disorders Nephrolithiasis	10.0% 1/10 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/1 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/1 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/2 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/3 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/3 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/5 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/6 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/2 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/2 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.
Metabolism and nutrition disorders Obesity	0.00% 0/10 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/1 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/1 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/2 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/3 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/3 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/5 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	16.7% 1/6 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/2 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/2 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.
Infections and infestations Onychomycosis	0.00% 0/10 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/1 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/1 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/2 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/3 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/3 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/5 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	16.7% 1/6 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/2 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/2 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	0.00% 0/10 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	100.0% 1/1 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/1 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/2 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/3 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	33.3% 1/3 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/5 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	33.3% 2/6 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/2 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/2 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.
Infections and infestations Otitis media	0.00% 0/10 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/1 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/1 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/2 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/3 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	33.3% 1/3 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/5 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/6 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/2 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/2 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.
Infections and infestations Otitis media acute	0.00% 0/10 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/1 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/1 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/2 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/3 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/3 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/5 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	16.7% 1/6 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/2 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/2 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.
Musculoskeletal and connective tissue disorders Pain in extremity	10.0% 1/10 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/1 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/1 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	50.0% 1/2 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/3 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/3 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	20.0% 1/5 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/6 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	50.0% 1/2 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/2 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.
Cardiac disorders Palpitations	0.00% 0/10 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/1 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/1 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	50.0% 1/2 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/3 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/3 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/5 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/6 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/2 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/2 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.
Infections and infestations Periodontitis	0.00% 0/10 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/1 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/1 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/2 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/3 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/3 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	20.0% 1/5 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/6 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/2 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/2 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.
Skin and subcutaneous tissue disorders Perioral dermatitis	0.00% 0/10 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/1 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/1 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	50.0% 1/2 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/3 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/3 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/5 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/6 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/2 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/2 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.
General disorders Peripheral swelling	0.00% 0/10 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/1 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/1 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/2 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/3 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/3 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	20.0% 1/5 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/6 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/2 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/2 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.
Skin and subcutaneous tissue disorders Petechiae	10.0% 1/10 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/1 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/1 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/2 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/3 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/3 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/5 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/6 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/2 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/2 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.
Infections and infestations Pharyngitis	0.00% 0/10 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/1 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/1 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/2 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/3 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/3 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/5 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	16.7% 1/6 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/2 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/2 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.00% 0/10 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/1 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/1 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/2 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	33.3% 1/3 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/3 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/5 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/6 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/2 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/2 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.
Infections and infestations Pneumonia	10.0% 1/10 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/1 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/1 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/2 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	33.3% 1/3 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/3 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/5 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/6 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/2 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/2 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.
Injury, poisoning and procedural complications Procedural pain	20.0% 2/10 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/1 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/1 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/2 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/3 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/3 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/5 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/6 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/2 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/2 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.
Skin and subcutaneous tissue disorders Pruritus	10.0% 1/10 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/1 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/1 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/2 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/3 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/3 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/5 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/6 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/2 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/2 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.
General disorders Pyrexia	10.0% 1/10 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/1 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/1 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	50.0% 1/2 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	33.3% 1/3 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	66.7% 2/3 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/5 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/6 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/2 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/2 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.
Respiratory, thoracic and mediastinal disorders Respiratory tract congestion	0.00% 0/10 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/1 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/1 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/2 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/3 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/3 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/5 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	16.7% 1/6 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/2 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/2 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.
Infections and infestations Rhinitis	0.00% 0/10 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/1 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/1 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/2 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/3 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/3 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/5 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	16.7% 1/6 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/2 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/2 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.
Injury, poisoning and procedural complications Road traffic accident	0.00% 0/10 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/1 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/1 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/2 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/3 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/3 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/5 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	16.7% 1/6 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/2 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/2 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.
Investigations SARS-CoV-2 test positive	20.0% 2/10 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/1 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/1 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/2 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/3 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/3 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/5 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/6 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/2 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/2 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.
Gastrointestinal disorders Salivary hypersecretion	10.0% 1/10 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/1 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/1 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/2 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/3 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/3 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/5 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/6 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/2 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/2 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.
Investigations Serum ferritin decreased	0.00% 0/10 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	100.0% 1/1 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	100.0% 1/1 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/2 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/3 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/3 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/5 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/6 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/2 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/2 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.
Infections and infestations Sinusitis	0.00% 0/10 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/1 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	100.0% 1/1 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/2 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/3 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/3 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/5 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/6 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/2 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/2 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.
Skin and subcutaneous tissue disorders Skin disorder	10.0% 1/10 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/1 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/1 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/2 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/3 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/3 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/5 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/6 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/2 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/2 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.
Injury, poisoning and procedural complications Skin laceration	10.0% 1/10 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/1 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/1 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/2 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/3 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/3 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	20.0% 1/5 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/6 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/2 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/2 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.
Injury, poisoning and procedural complications Spinal compression fracture	0.00% 0/10 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/1 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/1 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/2 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/3 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/3 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	20.0% 1/5 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/6 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/2 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/2 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.
Injury, poisoning and procedural complications Stress fracture	10.0% 1/10 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/1 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/1 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/2 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/3 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/3 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/5 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/6 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/2 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/2 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.
Injury, poisoning and procedural complications Sunburn	0.00% 0/10 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/1 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/1 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/2 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/3 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	66.7% 2/3 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/5 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/6 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/2 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/2 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.
Musculoskeletal and connective tissue disorders Tendonitis	10.0% 1/10 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/1 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/1 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/2 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/3 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/3 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/5 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/6 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/2 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/2 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.
Gastrointestinal disorders Tooth deposit	0.00% 0/10 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/1 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/1 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/2 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/3 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/3 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/5 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	16.7% 1/6 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/2 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/2 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.
Gastrointestinal disorders Toothache	20.0% 2/10 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/1 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/1 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/2 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/3 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/3 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/5 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/6 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/2 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/2 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.
Infections and infestations Tracheobronchitis	0.00% 0/10 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/1 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/1 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/2 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/3 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	33.3% 1/3 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/5 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/6 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/2 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/2 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.
Injury, poisoning and procedural complications Traumatic haematoma	10.0% 1/10 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/1 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/1 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/2 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/3 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/3 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	20.0% 1/5 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/6 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/2 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/2 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.
Infections and infestations Upper respiratory tract infection	10.0% 1/10 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/1 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/1 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/2 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/3 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	33.3% 1/3 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	60.0% 3/5 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	16.7% 1/6 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	50.0% 1/2 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	50.0% 1/2 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.
Vascular disorders Varicose vein	10.0% 1/10 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/1 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/1 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/2 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/3 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/3 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/5 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/6 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/2 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/2 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.
Infections and infestations Viral infection	0.00% 0/10 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/1 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/1 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/2 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/3 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	33.3% 1/3 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/5 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	16.7% 1/6 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/2 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/2 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.
Infections and infestations Viral rhinitis	0.00% 0/10 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/1 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/1 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/2 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/3 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	33.3% 1/3 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/5 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/6 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/2 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/2 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.
Metabolism and nutrition disorders Vitamin B12 deficiency	10.0% 1/10 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/1 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/1 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/2 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/3 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/3 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/5 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/6 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/2 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/2 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.
Gastrointestinal disorders Vomiting	0.00% 0/10 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/1 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/1 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	50.0% 1/2 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	33.3% 1/3 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	100.0% 3/3 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/5 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	16.7% 1/6 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/2 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/2 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.
Injury, poisoning and procedural complications Wound	0.00% 0/10 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/1 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	100.0% 1/1 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/2 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/3 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/3 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/5 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/6 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/2 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/2 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.
Metabolism and nutrition disorders Zinc deficiency	0.00% 0/10 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/1 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/1 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/2 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/3 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/3 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	20.0% 1/5 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/6 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/2 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.	0.00% 0/2 • Up to 5.8 years The SAS consisted of all participants who received any amount of rVWF as obtained from the IP administration eDiary, Study Drug Administration Details eCRF or Pharmacokinetic Infusion eCRF.

Additional Information

Study Director

Takeda

Phone: +1-877-825-3327

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place