Trial Outcomes & Findings for BAY81-8973 Pediatric Safety and Efficacy Trial (NCT NCT01311648)

Last Updated: 2023-12-05

Results Overview

Annualized number (mean +/- standard deviation) of total bleeds that occurred within 48 hours after all prophylaxis infusions (Part A: 6 months and at least 50 exposure days \[EDs\]; Part B: at least 50 EDs or until inhibitor development) was summarized and reported. Total bleeds: sum of spontaneous bleeds, trauma bleeds (only treated bleeds were classified as spontaneous or trauma), untreated bleeds and 'other' bleeds ('other' bleeds were infusions with reason given as 'other').

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

94 participants

Primary outcome timeframe

Within 48 hours post infusion

Results posted on

2023-12-05

Participant Flow

The study was conducted at multiple centers in 18 countries and consisted of: Part A - between 09-JUN-2011 (FPFV) and 02-JAN-2013 (LPLV); Part B - between 19-SEP-2012 (FPFV) and 09-SEP-2019 (LPLV); Extension study - between 21-DEC-2011 (FPFV) and 27-OCT-2020 (LPLV).

Overall, 58 participants were screened in Part A, of which 7 participants were screening failures and 51 participants received the study drug; 52 participants were screened in Part B, of which 9 participants were screening failures and 43 participants received the study drug. 46 participants from Part A and 36 from Part B entered the optional extension study.

Participant milestones

Participant milestones
Measure	PTPs 0-12 Years Previously treated patients (PTPs) aged below 12 years received BAY81-8973 25-50 IU/kg at least 2x/week for 6 months and at least 50 exposure days (EDs) in main study - Part A. Participants having reached at least 50 EDs in main study - Part A were offered participation in an open label extension study (optional). Participants who transitioned from main study - Part A to the extension study received BAY81-8973, 25-50 IU/kg at least 2x/week for at least 100 cumulative EDs (main study - Part A and extension study).	PUPs/MTPs 0-<6 Years Previously untreated patients (PUPs) or minimally treated patients (MTPs, patients who had no more than 3 exposure days \[EDs\] with any FVIII product) received BAY81-8973 15-50 IU/kg at least 1x/week for at least 50 EDs or until inhibitor development in main study - Part B. Participants having reached at least 50 EDs in main study - Part B were offered participation in an open label extension study and received BAY81-8973 25-50 IU/kg at least 2x/week for at least 100 cumulative EDs (main study - Part B and extension study); participants who developed an inhibitor in main study - Part B were offered participation in open label extension study and received Immune Tolerance Induction (ITI) treatment with BAY81-8973 until successful eradication of the inhibitor, or until failure, for approximately 18 months.
Main Study STARTED	51	43
Main Study Started 0-<6 Years	25	43
Main Study Started 6-12 Years	26	0
Main Study COMPLETED	51	22
Main Study NOT COMPLETED	0	21
Extension Study STARTED	46	36
Extension Study COMPLETED	45	25
Extension Study NOT COMPLETED	1	11

Reasons for withdrawal

Reasons for withdrawal
Measure	PTPs 0-12 Years Previously treated patients (PTPs) aged below 12 years received BAY81-8973 25-50 IU/kg at least 2x/week for 6 months and at least 50 exposure days (EDs) in main study - Part A. Participants having reached at least 50 EDs in main study - Part A were offered participation in an open label extension study (optional). Participants who transitioned from main study - Part A to the extension study received BAY81-8973, 25-50 IU/kg at least 2x/week for at least 100 cumulative EDs (main study - Part A and extension study).	PUPs/MTPs 0-<6 Years Previously untreated patients (PUPs) or minimally treated patients (MTPs, patients who had no more than 3 exposure days \[EDs\] with any FVIII product) received BAY81-8973 15-50 IU/kg at least 1x/week for at least 50 EDs or until inhibitor development in main study - Part B. Participants having reached at least 50 EDs in main study - Part B were offered participation in an open label extension study and received BAY81-8973 25-50 IU/kg at least 2x/week for at least 100 cumulative EDs (main study - Part B and extension study); participants who developed an inhibitor in main study - Part B were offered participation in open label extension study and received Immune Tolerance Induction (ITI) treatment with BAY81-8973 until successful eradication of the inhibitor, or until failure, for approximately 18 months.
Main Study Protocol Violation	0	1
Main Study Adverse Event	0	1
Main Study Inhibitor management	0	17
Main Study Withdrawal by Subject	0	2
Extension Study Physician Decision	0	1
Extension Study ITI therapy with marketed product	0	1
Extension Study Incorrect visit planning	0	1
Extension Study Family's decision	0	1
Extension Study Failure of ITI therapy	0	3
Extension Study Long travel	0	1
Extension Study Diagnosed with von Willebrand disease	1	0
Extension Study Withdrawal by Subject	0	1
Extension Study Inhibitor management	0	2

Baseline Characteristics

BAY81-8973 Pediatric Safety and Efficacy Trial

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Main Study - Part A: PTPs 0-<6 Years n=25 Participants Previously treated patients (PTPs) aged below 6 years received BAY81-8973 25-50 IU/kg at least 2x/week for 6 months and at least 50 exposure days (ED) in main study - Part A.	Main Study - Part A: PTPs 6-12 Years n=26 Participants Previously treated patients (PTPs) aged 6 to 12 years received BAY81-8973 25-50 IU/kg at least 2x/week for 6 months and at least 50 exposure days (ED) in main study - Part A.	Main Study - Part B: PUPs/MTPs 0-<6 Years n=43 Participants Previously untreated patients (PUPs) or minimally treated patients (MTPs, patients who had no more then 3 exposure days (EDs) with any FVIII product) received BAY81-8973 15-50 IU/kg at least 1x/week for 50 EDs or until inhibitor development in main study - Part B.	Total n=94 Participants Total of all reporting groups
Age, Continuous	3.8 Years STANDARD_DEVIATION 1.3 • n=5 Participants	8.8 Years STANDARD_DEVIATION 1.8 • n=7 Participants	1.1 Years STANDARD_DEVIATION 0.8 • n=5 Participants	3.9 Years STANDARD_DEVIATION 3.4 • n=4 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Sex: Female, Male Male	25 Participants n=5 Participants	26 Participants n=7 Participants	43 Participants n=5 Participants	94 Participants n=4 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants	0 Participants n=7 Participants	9 Participants n=5 Participants	10 Participants n=4 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	23 Participants n=5 Participants	25 Participants n=7 Participants	34 Participants n=5 Participants	82 Participants n=4 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	2 Participants n=4 Participants
Race/Ethnicity, Customized White	24 Participants n=5 Participants	24 Participants n=7 Participants	37 Participants n=5 Participants	85 Participants n=4 Participants
Race/Ethnicity, Customized Black	1 Participants n=5 Participants	2 Participants n=7 Participants	1 Participants n=5 Participants	4 Participants n=4 Participants
Race/Ethnicity, Customized American Indian or Alaska native	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	1 Participants n=4 Participants
Race/Ethnicity, Customized White, American Indian or Alaska native	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	1 Participants n=4 Participants
Race/Ethnicity, Customized Not reported	0 Participants n=5 Participants	0 Participants n=7 Participants	3 Participants n=5 Participants	3 Participants n=4 Participants

PRIMARY outcome

Timeframe: Within 48 hours post infusion

Population: Intent-to-treat (ITT) analysis set - main study: all participants of the SAF in main study who had infusion/bleeding data from the electronic patient diary (EPD)

Outcome measures

Outcome measures
Measure	Main Study - Part A: PTPs 0-<6 Years n=25 Participants Previously treated patients (PTPs) aged below 6 years received BAY81-8973 25-50 IU/kg at least 2x/week for 6 months and at least 50 exposure days (ED) in main study - Part A.	Main Study - Part A: PTPs 6-12 Years n=26 Participants Previously treated patients (PTPs) aged 6 to 12 years received BAY81-8973 25-50 IU/kg at least 2x/week for 6 months and at least 50 exposure days (ED) in main study - Part A.	Main Study - Part B: PUPs/MTPs 0-<6 Years n=43 Participants Previously untreated patients (PUPs) or minimally treated patients (MTPs, patients who had no more then 3 exposure days (EDs) with any FVIII product) received BAY81-8973 15-50 IU/kg at least 1x/week for 50 EDs or until inhibitor development in main study - Part B.
Annualized Number of Total Bleeds Within 48 h	2.23 Bleeds Standard Deviation 2.77 • Interval 2.77 to	1.86 Bleeds Standard Deviation 3.08 • Interval 3.08 to	1.9 Bleeds Standard Deviation 3.3 • Interval 3.3 to

PRIMARY outcome

Timeframe: Within 48 hours post infusion

Population: Intent-to-treat (ITT) analysis set - main study: all participants of the SAF in main study who had infusion/bleeding data from the electronic patient diary (EPD)

Annualized number (median \[inter-quartile range (Q1-Q3)\]) of total bleeds that occurred within 48 hours after all prophylaxis infusions (Part A: 6 months and at least 50 exposure days \[EDs\]; Part B: at least 50 EDs or until inhibitor development) was summarized and reported. Total bleeds: sum of spontaneous bleeds, trauma bleeds (only treated bleeds were classified as spontaneous or trauma), untreated bleeds and 'other' bleeds ('other' bleeds were infusions with reason given as 'other').

Outcome measures

Outcome measures
Measure	Main Study - Part A: PTPs 0-<6 Years n=25 Participants Previously treated patients (PTPs) aged below 6 years received BAY81-8973 25-50 IU/kg at least 2x/week for 6 months and at least 50 exposure days (ED) in main study - Part A.	Main Study - Part A: PTPs 6-12 Years n=26 Participants Previously treated patients (PTPs) aged 6 to 12 years received BAY81-8973 25-50 IU/kg at least 2x/week for 6 months and at least 50 exposure days (ED) in main study - Part A.	Main Study - Part B: PUPs/MTPs 0-<6 Years n=43 Participants Previously untreated patients (PUPs) or minimally treated patients (MTPs, patients who had no more then 3 exposure days (EDs) with any FVIII product) received BAY81-8973 15-50 IU/kg at least 1x/week for 50 EDs or until inhibitor development in main study - Part B.
Annualized Number of Total Bleeds Within 48 h	1.88 Bleeds Inter-Quartile Range 0.00 • Interval 0.0 to 3.97	0.00 Bleeds Inter-Quartile Range 0.00 • Interval 0.0 to 1.96	0.0 Bleeds Inter-Quartile Range 0.0 • Interval 0.0 to 2.2

SECONDARY outcome

Timeframe: Part A: 6 months and at least 50 exposure days (EDs) (median 73 EDs; median 6 months); Part B: at least 50 EDs or until inhibitor development (median 46 EDs; median 8 months)

Population: Intent-to-treat (ITT) analysis set - main study: all participants of the SAF in main study who had infusion/bleeding data from the electronic patient diary (EPD)

Annualized number (mean +/- standard deviation) of total bleeds that occurred during prophylaxis treatment was summarized and reported. Total bleeds: sum of spontaneous bleeds, trauma bleeds (only treated bleeds were classified as spontaneous or trauma), untreated bleeds and 'other' bleeds ('other' bleeds were infusions with reason given as 'other').

Outcome measures

Outcome measures
Measure	Main Study - Part A: PTPs 0-<6 Years n=25 Participants Previously treated patients (PTPs) aged below 6 years received BAY81-8973 25-50 IU/kg at least 2x/week for 6 months and at least 50 exposure days (ED) in main study - Part A.	Main Study - Part A: PTPs 6-12 Years n=26 Participants Previously treated patients (PTPs) aged 6 to 12 years received BAY81-8973 25-50 IU/kg at least 2x/week for 6 months and at least 50 exposure days (ED) in main study - Part A.	Main Study - Part B: PUPs/MTPs 0-<6 Years n=43 Participants Previously untreated patients (PUPs) or minimally treated patients (MTPs, patients who had no more then 3 exposure days (EDs) with any FVIII product) received BAY81-8973 15-50 IU/kg at least 1x/week for 50 EDs or until inhibitor development in main study - Part B.
Annualized Number of Total Bleeds During Prophylaxis Treatment	4.16 Bleeds Standard Deviation 5.02 • Interval 5.02 to	3.37 Bleeds Standard Deviation 5.01 • Interval 5.01 to	7.1 Bleeds Standard Deviation 8.6 • Interval 8.6 to

SECONDARY outcome

Timeframe: Part A: 6 months and at least 50 exposure days (EDs) (median 73 EDs; median 6 months); Part B: at least 50 EDs or until inhibitor development (median 46 EDs; median 8 months)

Population: Intent-to-treat (ITT) analysis set - main study: all participants of the SAF in main study who had infusion/bleeding data from the electronic patient diary (EPD)

Annualized number (median \[inter-quartile range (Q1-Q3)\]) of total bleeds that occurred during prophylaxis treatment was summarized and reported. Total bleeds: sum of spontaneous bleeds, trauma bleeds (only treated bleeds were classified as spontaneous or trauma), untreated bleeds and 'other' bleeds ('other' bleeds were infusions with reason given as 'other').

Outcome measures

Outcome measures
Measure	Main Study - Part A: PTPs 0-<6 Years n=25 Participants Previously treated patients (PTPs) aged below 6 years received BAY81-8973 25-50 IU/kg at least 2x/week for 6 months and at least 50 exposure days (ED) in main study - Part A.	Main Study - Part A: PTPs 6-12 Years n=26 Participants Previously treated patients (PTPs) aged 6 to 12 years received BAY81-8973 25-50 IU/kg at least 2x/week for 6 months and at least 50 exposure days (ED) in main study - Part A.	Main Study - Part B: PUPs/MTPs 0-<6 Years n=43 Participants Previously untreated patients (PUPs) or minimally treated patients (MTPs, patients who had no more then 3 exposure days (EDs) with any FVIII product) received BAY81-8973 15-50 IU/kg at least 1x/week for 50 EDs or until inhibitor development in main study - Part B.
Annualized Number of Total Bleeds During Prophylaxis Treatment	2.03 Bleeds Inter-Quartile Range 0.00 • Interval 0.0 to 6.02	0.93 Bleeds Inter-Quartile Range 0.00 • Interval 0.0 to 5.77	4.7 Bleeds Inter-Quartile Range 2.1 • Interval 2.1 to 8.9

SECONDARY outcome

Timeframe: Part A: 6 months and at least 50 exposure days (EDs) (median 73 EDs; median 6 months); Part B: at least 50 EDs or until inhibitor development (median 46 EDs; median 8 months)

Population: Participants in SAF in main study who underwent major or minor surgeries during the study

For participants who underwent major or minor surgeries during the study, hemostasis during the surgeries was assessed as excellent, good, moderate or poor. Number of surgeries per assessment was summarized and reported.

Outcome measures

Outcome measures
Measure	Main Study - Part A: PTPs 0-<6 Years Previously treated patients (PTPs) aged below 6 years received BAY81-8973 25-50 IU/kg at least 2x/week for 6 months and at least 50 exposure days (ED) in main study - Part A.	Main Study - Part A: PTPs 6-12 Years n=1 Surgeries Previously treated patients (PTPs) aged 6 to 12 years received BAY81-8973 25-50 IU/kg at least 2x/week for 6 months and at least 50 exposure days (ED) in main study - Part A.	Main Study - Part B: PUPs/MTPs 0-<6 Years n=6 Surgeries Previously untreated patients (PUPs) or minimally treated patients (MTPs, patients who had no more then 3 exposure days (EDs) with any FVIII product) received BAY81-8973 15-50 IU/kg at least 1x/week for 50 EDs or until inhibitor development in main study - Part B.
Hemostatic Control During Major and Minor Surgeries Minor surgery · Excellent	0 Surgeries	0 Surgeries	3 Surgeries
Hemostatic Control During Major and Minor Surgeries Minor surgery · Good	0 Surgeries	0 Surgeries	1 Surgeries
Hemostatic Control During Major and Minor Surgeries Minor surgery · Moderate	0 Surgeries	0 Surgeries	0 Surgeries
Hemostatic Control During Major and Minor Surgeries Minor surgery · Poor	0 Surgeries	0 Surgeries	0 Surgeries
Hemostatic Control During Major and Minor Surgeries Minor surgery · Not available	0 Surgeries	0 Surgeries	1 Surgeries
Hemostatic Control During Major and Minor Surgeries Major surgery · Excellent	0 Surgeries	0 Surgeries	0 Surgeries
Hemostatic Control During Major and Minor Surgeries Major surgery · Good	0 Surgeries	1 Surgeries	1 Surgeries
Hemostatic Control During Major and Minor Surgeries Major surgery · Moderate	0 Surgeries	0 Surgeries	0 Surgeries
Hemostatic Control During Major and Minor Surgeries Major surgery · Poor	0 Surgeries	0 Surgeries	0 Surgeries
Hemostatic Control During Major and Minor Surgeries Major surgery · Not available	0 Surgeries	0 Surgeries	0 Surgeries

SECONDARY outcome

Timeframe: Part A: 6 months and at least 50 exposure days (EDs) (median 73 EDs; median 6 months); Part B: at least 50 EDs or until inhibitor development (median 46 EDs; median 8 months)

Population: Participants in main study - safety analysis set (SAF, all participants who entered Study Part A or Part B and received at least one infusion of study medication) with inhibitor measurements done

Number of participants with confirmed positive FVIII inhibitor titer (≥ 0.6 Bethesda unit \[BU/mL\]) during the main study was summarized and classified as participants developing low titer inhibitor (i.e. ≥ 0.6 to ≤ 5.0 BU/mL) and participants developing high titer inhibitor (i.e. \> 5.0 BU/mL).

Outcome measures

Outcome measures
Measure	Main Study - Part A: PTPs 0-<6 Years n=25 Participants Previously treated patients (PTPs) aged below 6 years received BAY81-8973 25-50 IU/kg at least 2x/week for 6 months and at least 50 exposure days (ED) in main study - Part A.	Main Study - Part A: PTPs 6-12 Years n=26 Participants Previously treated patients (PTPs) aged 6 to 12 years received BAY81-8973 25-50 IU/kg at least 2x/week for 6 months and at least 50 exposure days (ED) in main study - Part A.	Main Study - Part B: PUPs/MTPs 0-<6 Years n=42 Participants Previously untreated patients (PUPs) or minimally treated patients (MTPs, patients who had no more then 3 exposure days (EDs) with any FVIII product) received BAY81-8973 15-50 IU/kg at least 1x/week for 50 EDs or until inhibitor development in main study - Part B.
Number of Participants With Inhibitor Development in Main Study Low titer inhibitor	0 Participants	0 Participants	6 Participants
Number of Participants With Inhibitor Development in Main Study High titer inhibitor	0 Participants	0 Participants	17 Participants

SECONDARY outcome

Timeframe: From start of extension study to at least 100 cumulative exposure days (EDs) (median 421 EDs; median 3.8 years)

Population: All participants who entered the extension study and had not developed inhibitors during the main study Part A or Part B

Number of participants who had not developed an inhibitor during the main study but developed an inhibitor (confirmed positive FVIII inhibitor titer \[≥ 0.6 BU/mL\]) during the extension study was summarized and classified as participants developing low titer inhibitor (i.e. ≥ 0.6 to ≤ 5.0 BU/mL) and participants developing high titer inhibitor (i.e. \> 5.0 BU/mL).

Outcome measures

Outcome measures
Measure	Main Study - Part A: PTPs 0-<6 Years n=46 Participants Previously treated patients (PTPs) aged below 6 years received BAY81-8973 25-50 IU/kg at least 2x/week for 6 months and at least 50 exposure days (ED) in main study - Part A.	Main Study - Part A: PTPs 6-12 Years n=16 Participants Previously treated patients (PTPs) aged 6 to 12 years received BAY81-8973 25-50 IU/kg at least 2x/week for 6 months and at least 50 exposure days (ED) in main study - Part A.	Main Study - Part B: PUPs/MTPs 0-<6 Years Previously untreated patients (PUPs) or minimally treated patients (MTPs, patients who had no more then 3 exposure days (EDs) with any FVIII product) received BAY81-8973 15-50 IU/kg at least 1x/week for 50 EDs or until inhibitor development in main study - Part B.
Number of Participants With New Inhibitor Development in Extension Study Low titer inhibitor (incl. false-positive)	1 Participants	0 Participants	—
Number of Participants With New Inhibitor Development in Extension Study High titer inhibitor	0 Participants	0 Participants	—

SECONDARY outcome

Timeframe: Part A: 6 months and at least 50 exposure days (EDs) (median 73 EDs; median 6 months); Part B: at least 50 EDs or until inhibitor development (median 46 EDs; median 8 months)

Population: Participants in intent-to-treat (ITT) analysis set in main study with valid FVIII recovery values

Incremental recovery of Factor VIII (FVIII) at 20-30 min after end of infusions was determined and mean recovery values were reported.

Outcome measures

Outcome measures
Measure	Main Study - Part A: PTPs 0-<6 Years n=25 Participants Previously treated patients (PTPs) aged below 6 years received BAY81-8973 25-50 IU/kg at least 2x/week for 6 months and at least 50 exposure days (ED) in main study - Part A.	Main Study - Part A: PTPs 6-12 Years n=26 Participants Previously treated patients (PTPs) aged 6 to 12 years received BAY81-8973 25-50 IU/kg at least 2x/week for 6 months and at least 50 exposure days (ED) in main study - Part A.	Main Study - Part B: PUPs/MTPs 0-<6 Years n=32 Participants Previously untreated patients (PUPs) or minimally treated patients (MTPs, patients who had no more then 3 exposure days (EDs) with any FVIII product) received BAY81-8973 15-50 IU/kg at least 1x/week for 50 EDs or until inhibitor development in main study - Part B.
Factor VIII Recovery Values Participants with low titer inhibitor	—	—	0.86 International unit (IU)/dL per IU/kg Standard Deviation 0.56
Factor VIII Recovery Values Participants with high titer inhibitor	—	—	0.38 International unit (IU)/dL per IU/kg Standard Deviation 0.42
Factor VIII Recovery Values Participants without inhibitor	1.63 International unit (IU)/dL per IU/kg Standard Deviation 0.31	1.72 International unit (IU)/dL per IU/kg Standard Deviation 0.46	1.76 International unit (IU)/dL per IU/kg Standard Deviation 0.55

SECONDARY outcome

Timeframe: Part A: 6 months and at least 50 exposure days (EDs) (median 73 EDs; median 6 months); Part B: at least 50 EDs or until inhibitor development (median 46 EDs; median 8 months)

Population: Intent-to-treat (ITT) analysis set - main study: all participants of the SAF in main study who had infusion/bleeding data from the electronic patient diary (EPD)

Factor VIII (FVIII) usage/consumption was summarized for all infusions. Consumption per participant's body weight per year was calculated and reported.

Outcome measures

Outcome measures
Measure	Main Study - Part A: PTPs 0-<6 Years n=25 Participants Previously treated patients (PTPs) aged below 6 years received BAY81-8973 25-50 IU/kg at least 2x/week for 6 months and at least 50 exposure days (ED) in main study - Part A.	Main Study - Part A: PTPs 6-12 Years n=26 Participants Previously treated patients (PTPs) aged 6 to 12 years received BAY81-8973 25-50 IU/kg at least 2x/week for 6 months and at least 50 exposure days (ED) in main study - Part A.	Main Study - Part B: PUPs/MTPs 0-<6 Years n=43 Participants Previously untreated patients (PUPs) or minimally treated patients (MTPs, patients who had no more then 3 exposure days (EDs) with any FVIII product) received BAY81-8973 15-50 IU/kg at least 1x/week for 50 EDs or until inhibitor development in main study - Part B.
Consumption of Factor VIII in All Infusions	5499.1 international units/kilogram/year Standard Deviation 1996.2 • Interval 1996.2 to	4679.1 international units/kilogram/year Standard Deviation 1688.7 • Interval 1688.7 to	2195.8 international units/kilogram/year Standard Deviation 1903.6 • Interval 1903.6 to

SECONDARY outcome

Timeframe: Part A: 6 months and at least 50 exposure days (EDs) (median 73 EDs; median 6 months); Part B: at least 50 EDs or until inhibitor development (median 46 EDs; median 8 months)

Population: Participants in intent-to-treat (ITT) analysis set in main study with at least one dose of prophylaxis treatment with study drug

Factor VIII (FVIII) usage/consumption was summarized for prophylaxis infusions. Consumption per participant's body weight per year was calculated and reported.

Outcome measures

Outcome measures
Measure	Main Study - Part A: PTPs 0-<6 Years n=25 Participants Previously treated patients (PTPs) aged below 6 years received BAY81-8973 25-50 IU/kg at least 2x/week for 6 months and at least 50 exposure days (ED) in main study - Part A.	Main Study - Part A: PTPs 6-12 Years n=26 Participants Previously treated patients (PTPs) aged 6 to 12 years received BAY81-8973 25-50 IU/kg at least 2x/week for 6 months and at least 50 exposure days (ED) in main study - Part A.	Main Study - Part B: PUPs/MTPs 0-<6 Years n=42 Participants Previously untreated patients (PUPs) or minimally treated patients (MTPs, patients who had no more then 3 exposure days (EDs) with any FVIII product) received BAY81-8973 15-50 IU/kg at least 1x/week for 50 EDs or until inhibitor development in main study - Part B.
Consumption of FVIII in Infusions for Prophylaxis	5224.8 international units/kilogram/year Standard Deviation 1760.2 • Interval 1760.2 to	4492.7 international units/kilogram/year Standard Deviation 1667.6 • Interval 1667.6 to	1486.6 international units/kilogram/year Standard Deviation 963.3 • Interval 963.3 to

SECONDARY outcome

Timeframe: Part A: 6 months and at least 50 exposure days (EDs) (median 73 EDs; median 6 months); Part B: at least 50 EDs or until inhibitor development (median 46 EDs; median 8 months)

Population: Participants in intent-to-treat (ITT) analysis set in main study with at least one bleed treated with study drug

Factor VIII (FVIII) usage/consumption was summarized for infusions used to treat breakthrough bleeds. Consumption per participant's body weight per year was calculated and reported.

Outcome measures

Outcome measures
Measure	Main Study - Part A: PTPs 0-<6 Years n=15 Participants Previously treated patients (PTPs) aged below 6 years received BAY81-8973 25-50 IU/kg at least 2x/week for 6 months and at least 50 exposure days (ED) in main study - Part A.	Main Study - Part A: PTPs 6-12 Years n=11 Participants Previously treated patients (PTPs) aged 6 to 12 years received BAY81-8973 25-50 IU/kg at least 2x/week for 6 months and at least 50 exposure days (ED) in main study - Part A.	Main Study - Part B: PUPs/MTPs 0-<6 Years n=35 Participants Previously untreated patients (PUPs) or minimally treated patients (MTPs, patients who had no more then 3 exposure days (EDs) with any FVIII product) received BAY81-8973 15-50 IU/kg at least 1x/week for 50 EDs or until inhibitor development in main study - Part B.
Consumption of FVIII in Infusions for the Treatment of Bleeds	457.07 international units/kilogram/year Standard Deviation 526.87 • Interval 526.87 to	391.64 international units/kilogram/year Standard Deviation 219.61 • Interval 219.61 to	835.4 international units/kilogram/year Standard Deviation 1926.4 • Interval 1926.4 to

SECONDARY outcome

Timeframe: Part A: 6 months and at least 50 exposure days (EDs) (median 73 EDs; median 6 months); Part B: at least 50 EDs or until inhibitor development (median 46 EDs; median 8 months)

Population: Participants in intent-to-treat (ITT) analysis set in main study with at least one bleed

The number of infusions used to treat a bleed was defined as the first infusion to treat the bleed plus all follow-up infusions to treat the same bleed, if any. The mean value of number of infusions for each bleed was calculated and reported.

Outcome measures

Outcome measures
Measure	Main Study - Part A: PTPs 0-<6 Years n=15 Participants Previously treated patients (PTPs) aged below 6 years received BAY81-8973 25-50 IU/kg at least 2x/week for 6 months and at least 50 exposure days (ED) in main study - Part A.	Main Study - Part A: PTPs 6-12 Years n=13 Participants Previously treated patients (PTPs) aged 6 to 12 years received BAY81-8973 25-50 IU/kg at least 2x/week for 6 months and at least 50 exposure days (ED) in main study - Part A.	Main Study - Part B: PUPs/MTPs 0-<6 Years n=37 Participants Previously untreated patients (PUPs) or minimally treated patients (MTPs, patients who had no more then 3 exposure days (EDs) with any FVIII product) received BAY81-8973 15-50 IU/kg at least 1x/week for 50 EDs or until inhibitor development in main study - Part B.
Number of Infusions Per Bleed	1.3 Infusions Standard Deviation 1.8 • Interval 1.8 to	1.4 Infusions Standard Deviation 1.7 • Interval 1.7 to	1.7 Infusions Standard Deviation 8.7 • Interval 8.7 to

SECONDARY outcome

Timeframe: Part A: 6 months and at least 50 exposure days (EDs) (median 73 EDs; median 6 months); Part B: at least 50 EDs or until inhibitor development (median 46 EDs; median 8 months)

Population: Participants in intent-to-treat (ITT) analysis set in main study with at least one bleed

Participants or caregivers were asked to assess the response to treatment of bleeds as excellent, good, moderate or poor. Percentage of bleeds per assessment was summarized and reported.

Outcome measures

Outcome measures
Measure	Main Study - Part A: PTPs 0-<6 Years n=44 Bleeds assessed for the response Previously treated patients (PTPs) aged below 6 years received BAY81-8973 25-50 IU/kg at least 2x/week for 6 months and at least 50 exposure days (ED) in main study - Part A.	Main Study - Part A: PTPs 6-12 Years n=37 Bleeds assessed for the response Previously treated patients (PTPs) aged 6 to 12 years received BAY81-8973 25-50 IU/kg at least 2x/week for 6 months and at least 50 exposure days (ED) in main study - Part A.	Main Study - Part B: PUPs/MTPs 0-<6 Years n=105 Bleeds assessed for the response Previously untreated patients (PUPs) or minimally treated patients (MTPs, patients who had no more then 3 exposure days (EDs) with any FVIII product) received BAY81-8973 15-50 IU/kg at least 1x/week for 50 EDs or until inhibitor development in main study - Part B.
Response to Treatment of Bleeds Excellent	20 Bleeds assessed for the response	12 Bleeds assessed for the response	27 Bleeds assessed for the response
Response to Treatment of Bleeds Good	23 Bleeds assessed for the response	18 Bleeds assessed for the response	56 Bleeds assessed for the response
Response to Treatment of Bleeds Moderate	0 Bleeds assessed for the response	7 Bleeds assessed for the response	16 Bleeds assessed for the response
Response to Treatment of Bleeds Poor	1 Bleeds assessed for the response	0 Bleeds assessed for the response	6 Bleeds assessed for the response

SECONDARY outcome

Timeframe: Pre-infusion and until 24 hours post infusion

Population: Participants in PK analysis set (PKS) - A with evaluable data for this endpoint (PKS - A: all participants who entered main study - Part A and received at least one infusion of study medication with evaluable pharmacokinetic data)

Half-life (t1/2) of BAY81-8973 in plasma was measured. Geometric mean and percentage geometric coefficient of variation (%CV) were reported.

Outcome measures

Outcome measures
Measure	Main Study - Part A: PTPs 0-<6 Years n=2 Participants Previously treated patients (PTPs) aged below 6 years received BAY81-8973 25-50 IU/kg at least 2x/week for 6 months and at least 50 exposure days (ED) in main study - Part A.	Main Study - Part A: PTPs 6-12 Years n=9 Participants Previously treated patients (PTPs) aged 6 to 12 years received BAY81-8973 25-50 IU/kg at least 2x/week for 6 months and at least 50 exposure days (ED) in main study - Part A.	Main Study - Part B: PUPs/MTPs 0-<6 Years Previously untreated patients (PUPs) or minimally treated patients (MTPs, patients who had no more then 3 exposure days (EDs) with any FVIII product) received BAY81-8973 15-50 IU/kg at least 1x/week for 50 EDs or until inhibitor development in main study - Part B.
Half-life (t1/2) of BAY81-8973 in Plasma	13.2 Hours Geometric Coefficient of Variation 39.7	12.1 Hours Geometric Coefficient of Variation 16.3	—

Adverse Events

Main Study - Part A: PTPs 0-<6 Years

Serious events: 0 serious events

Other events: 16 other events

Deaths: 0 deaths

Main Study - Part A: PTPs 6-12 Years

Serious events: 5 serious events

Other events: 19 other events

Deaths: 0 deaths

Main Study - Part B: PUPs/MTPs 0-<6 Years

Serious events: 26 serious events

Other events: 28 other events

Deaths: 0 deaths

Extension Study - Former Part A Participants

Serious events: 23 serious events

Other events: 41 other events

Deaths: 0 deaths

Extension Study - Former Part B Participants

Serious events: 14 serious events

Other events: 24 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Main Study - Part A: PTPs 0-<6 Years n=25 participants at risk Previously treated patients (PTPs) aged below 6 years received BAY81-8973 25-50 IU/kg at least 2x/week for 6 months and at least 50 exposure days (ED) in main study - Part A.	Main Study - Part A: PTPs 6-12 Years n=26 participants at risk Previously treated patients (PTPs) aged 6 to 12 years received BAY81-8973 25-50 IU/kg at least 2x/week for 6 months and at least 50 exposure days (ED) in main study - Part A.	Main Study - Part B: PUPs/MTPs 0-<6 Years n=43 participants at risk Previously untreated patients (PUPs) or minimally treated patients (MTPs, patients who had no more then 3 exposure days (EDs) with any FVIII product) received BAY81-8973 15-50 IU/kg at least 1x/week for 50 EDs or until inhibitor development in main study - Part B.	Extension Study - Former Part A Participants n=46 participants at risk Participants having reached at least 50 exposure days (EDs) in main study - Part A were offered participation in an open label extension study (optional). Participants who transitioned from main study - Part A to the extension study received BAY81-8973, 25-50 IU/kg at least 2x/week for at least 100 cumulative EDs (main study - Part A and extension study).	Extension Study - Former Part B Participants n=36 participants at risk Participants having reached at least 50 exposure days (EDs) in main study - Part B were offered participation in an open label extension study and received BAY81-8973 25-50 IU/kg at least 2x/week for at least 100 cumulative EDs (main study - Part B and extension study); participants who developed an inhibitor in main study - Part B were offered participation in open label extension study and received Immune Tolerance Induction (ITI) treatment with BAY81-8973 until successful eradication of the inhibitor, or until failure, for approximately 18 months.
Infections and infestations Gastroenteritis rotavirus	0.00% 0/25 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	0.00% 0/26 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	0.00% 0/43 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	0.00% 0/46 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	5.6% 2/36 • Number of events 2 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)
Infections and infestations Gastroenteritis staphylococcal	0.00% 0/25 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	0.00% 0/26 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	2.3% 1/43 • Number of events 1 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	0.00% 0/46 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	0.00% 0/36 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)
Infections and infestations Gastroenteritis viral	0.00% 0/25 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	0.00% 0/26 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	2.3% 1/43 • Number of events 1 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	0.00% 0/46 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	0.00% 0/36 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)
Infections and infestations Nasopharyngitis	0.00% 0/25 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	0.00% 0/26 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	0.00% 0/43 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	2.2% 1/46 • Number of events 1 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	0.00% 0/36 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)
Infections and infestations Otitis media acute	0.00% 0/25 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	0.00% 0/26 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	0.00% 0/43 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	0.00% 0/46 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	2.8% 1/36 • Number of events 1 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)
Blood and lymphatic system disorders Blood loss anaemia	0.00% 0/25 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	3.8% 1/26 • Number of events 1 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	0.00% 0/43 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	0.00% 0/46 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	5.6% 2/36 • Number of events 3 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)
Blood and lymphatic system disorders Factor VIII inhibition	0.00% 0/25 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	0.00% 0/26 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	2.3% 1/43 • Number of events 1 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	0.00% 0/46 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	0.00% 0/36 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)
Blood and lymphatic system disorders Thrombocytopenia	0.00% 0/25 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	0.00% 0/26 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	0.00% 0/43 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	2.2% 1/46 • Number of events 1 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	0.00% 0/36 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)
Gastrointestinal disorders Abdominal pain	0.00% 0/25 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	0.00% 0/26 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	0.00% 0/43 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	2.2% 1/46 • Number of events 3 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	0.00% 0/36 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)
Gastrointestinal disorders Gastritis	0.00% 0/25 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	0.00% 0/26 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	0.00% 0/43 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	2.2% 1/46 • Number of events 1 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	0.00% 0/36 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)
Gastrointestinal disorders Gastritis haemorrhagic	0.00% 0/25 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	0.00% 0/26 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	0.00% 0/43 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	2.2% 1/46 • Number of events 1 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	0.00% 0/36 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)
Gastrointestinal disorders Gastrointestinal haemorrhage	0.00% 0/25 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	0.00% 0/26 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	0.00% 0/43 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	0.00% 0/46 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	2.8% 1/36 • Number of events 1 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)
Gastrointestinal disorders Mouth haemorrhage	0.00% 0/25 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	0.00% 0/26 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	0.00% 0/43 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	0.00% 0/46 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	2.8% 1/36 • Number of events 2 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)
Gastrointestinal disorders Vomiting	0.00% 0/25 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	0.00% 0/26 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	2.3% 1/43 • Number of events 1 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	0.00% 0/46 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	0.00% 0/36 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)
General disorders Catheter site granuloma	0.00% 0/25 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	0.00% 0/26 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	0.00% 0/43 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	0.00% 0/46 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	2.8% 1/36 • Number of events 1 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)
General disorders Catheter site haematoma	0.00% 0/25 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	0.00% 0/26 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	2.3% 1/43 • Number of events 1 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	0.00% 0/46 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	2.8% 1/36 • Number of events 1 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)
General disorders Catheter site haemorrhage	0.00% 0/25 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	0.00% 0/26 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	0.00% 0/43 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	0.00% 0/46 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	5.6% 2/36 • Number of events 2 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)
General disorders Catheter site related reaction	0.00% 0/25 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	0.00% 0/26 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	0.00% 0/43 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	0.00% 0/46 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	2.8% 1/36 • Number of events 1 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)
General disorders Decreased activity	0.00% 0/25 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	0.00% 0/26 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	2.3% 1/43 • Number of events 1 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	0.00% 0/46 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	0.00% 0/36 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)
General disorders Extravasation	0.00% 0/25 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	0.00% 0/26 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	2.3% 1/43 • Number of events 1 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	0.00% 0/46 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	0.00% 0/36 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)
General disorders Facial pain	0.00% 0/25 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	0.00% 0/26 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	2.3% 1/43 • Number of events 1 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	0.00% 0/46 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	0.00% 0/36 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)
General disorders Pyrexia	0.00% 0/25 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	0.00% 0/26 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	2.3% 1/43 • Number of events 1 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	2.2% 1/46 • Number of events 1 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	0.00% 0/36 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)
Infections and infestations Appendicitis	0.00% 0/25 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	0.00% 0/26 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	0.00% 0/43 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	2.2% 1/46 • Number of events 1 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	0.00% 0/36 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)
Infections and infestations Bacteraemia	0.00% 0/25 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	0.00% 0/26 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	0.00% 0/43 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	0.00% 0/46 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	2.8% 1/36 • Number of events 1 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)
Infections and infestations Bacterial infection	0.00% 0/25 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	3.8% 1/26 • Number of events 1 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	0.00% 0/43 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	0.00% 0/46 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	0.00% 0/36 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)
Infections and infestations Bronchitis	0.00% 0/25 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	0.00% 0/26 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	0.00% 0/43 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	2.2% 1/46 • Number of events 1 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	0.00% 0/36 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)
Infections and infestations Cellulitis	0.00% 0/25 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	0.00% 0/26 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	0.00% 0/43 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	2.2% 1/46 • Number of events 1 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	0.00% 0/36 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)
Infections and infestations Cellulitis orbital	0.00% 0/25 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	0.00% 0/26 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	0.00% 0/43 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	0.00% 0/46 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	2.8% 1/36 • Number of events 1 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)
Infections and infestations Enterococcal sepsis	0.00% 0/25 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	0.00% 0/26 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	0.00% 0/43 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	0.00% 0/46 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	2.8% 1/36 • Number of events 1 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)
Infections and infestations Epidemic pleurodynia	0.00% 0/25 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	0.00% 0/26 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	0.00% 0/43 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	2.2% 1/46 • Number of events 1 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	0.00% 0/36 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)
Infections and infestations Escherichia urinary tract infection	0.00% 0/25 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	0.00% 0/26 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	2.3% 1/43 • Number of events 1 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	0.00% 0/46 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	0.00% 0/36 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)
Infections and infestations Gastroenteritis	0.00% 0/25 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	3.8% 1/26 • Number of events 1 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	0.00% 0/43 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	0.00% 0/46 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	2.8% 1/36 • Number of events 1 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)
Infections and infestations Peritonsillar abscess	0.00% 0/25 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	0.00% 0/26 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	0.00% 0/43 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	2.2% 1/46 • Number of events 1 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	0.00% 0/36 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)
Infections and infestations Pneumonia	0.00% 0/25 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	0.00% 0/26 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	0.00% 0/43 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	2.2% 1/46 • Number of events 1 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	0.00% 0/36 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)
Infections and infestations Pulpitis dental	0.00% 0/25 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	0.00% 0/26 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	0.00% 0/43 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	2.2% 1/46 • Number of events 1 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	0.00% 0/36 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)
Infections and infestations Respiratory tract infection	0.00% 0/25 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	0.00% 0/26 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	0.00% 0/43 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	2.2% 1/46 • Number of events 1 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	0.00% 0/36 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)
Infections and infestations Sepsis	0.00% 0/25 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	0.00% 0/26 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	0.00% 0/43 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	0.00% 0/46 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	2.8% 1/36 • Number of events 1 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)
Infections and infestations Tonsillitis	0.00% 0/25 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	0.00% 0/26 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	0.00% 0/43 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	2.2% 1/46 • Number of events 1 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	0.00% 0/36 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)
Infections and infestations Tooth abscess	0.00% 0/25 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	3.8% 1/26 • Number of events 1 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	0.00% 0/43 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	0.00% 0/46 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	0.00% 0/36 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)
Infections and infestations Tracheitis	0.00% 0/25 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	0.00% 0/26 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	0.00% 0/43 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	2.2% 1/46 • Number of events 2 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	0.00% 0/36 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)
Infections and infestations Upper respiratory tract infection	0.00% 0/25 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	0.00% 0/26 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	0.00% 0/43 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	0.00% 0/46 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	2.8% 1/36 • Number of events 1 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)
Infections and infestations Vascular device infection	0.00% 0/25 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	0.00% 0/26 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	0.00% 0/43 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	4.3% 2/46 • Number of events 3 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	8.3% 3/36 • Number of events 4 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)
Infections and infestations Viral infection	0.00% 0/25 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	3.8% 1/26 • Number of events 1 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	0.00% 0/43 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	2.2% 1/46 • Number of events 1 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	0.00% 0/36 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)
Injury, poisoning and procedural complications Craniocerebral injury	0.00% 0/25 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	0.00% 0/26 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	2.3% 1/43 • Number of events 1 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	0.00% 0/46 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	2.8% 1/36 • Number of events 1 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)
Injury, poisoning and procedural complications Injury	0.00% 0/25 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	0.00% 0/26 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	0.00% 0/43 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	2.2% 1/46 • Number of events 1 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	0.00% 0/36 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)
Injury, poisoning and procedural complications Mouth injury	0.00% 0/25 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	0.00% 0/26 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	2.3% 1/43 • Number of events 1 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	0.00% 0/46 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	0.00% 0/36 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)
Injury, poisoning and procedural complications Post procedural haemorrhage	0.00% 0/25 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	0.00% 0/26 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	0.00% 0/43 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	0.00% 0/46 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	2.8% 1/36 • Number of events 1 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)
Injury, poisoning and procedural complications Radius fracture	0.00% 0/25 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	0.00% 0/26 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	0.00% 0/43 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	4.3% 2/46 • Number of events 2 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	0.00% 0/36 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)
Injury, poisoning and procedural complications Subcutaneous haematoma	0.00% 0/25 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	0.00% 0/26 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	0.00% 0/43 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	0.00% 0/46 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	2.8% 1/36 • Number of events 1 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)
Injury, poisoning and procedural complications Subdural haematoma	0.00% 0/25 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	0.00% 0/26 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	0.00% 0/43 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	0.00% 0/46 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	2.8% 1/36 • Number of events 1 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)
Injury, poisoning and procedural complications Traumatic haemorrhage	0.00% 0/25 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	0.00% 0/26 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	0.00% 0/43 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	0.00% 0/46 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	2.8% 1/36 • Number of events 1 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)
Injury, poisoning and procedural complications Traumatic haemothorax	0.00% 0/25 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	0.00% 0/26 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	0.00% 0/43 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	0.00% 0/46 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	2.8% 1/36 • Number of events 1 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)
Injury, poisoning and procedural complications Ulna fracture	0.00% 0/25 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	0.00% 0/26 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	0.00% 0/43 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	2.2% 1/46 • Number of events 1 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	0.00% 0/36 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)
Investigations Anti factor VIII antibody positive	0.00% 0/25 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	0.00% 0/26 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	51.2% 22/43 • Number of events 24 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	2.2% 1/46 • Number of events 1 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	0.00% 0/36 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)
Investigations Catheterisation cardiac	0.00% 0/25 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	0.00% 0/26 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	0.00% 0/43 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	0.00% 0/46 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	2.8% 1/36 • Number of events 1 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)
Investigations Electroencephalogram abnormal	0.00% 0/25 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	0.00% 0/26 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	0.00% 0/43 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	2.2% 1/46 • Number of events 1 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	0.00% 0/36 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)
Metabolism and nutrition disorders Dehydration	0.00% 0/25 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	0.00% 0/26 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	0.00% 0/43 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	0.00% 0/46 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	2.8% 1/36 • Number of events 1 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)
Metabolism and nutrition disorders Metabolic syndrome	0.00% 0/25 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	0.00% 0/26 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	0.00% 0/43 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	2.2% 1/46 • Number of events 1 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	0.00% 0/36 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)
Musculoskeletal and connective tissue disorders Arthritis reactive	0.00% 0/25 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	0.00% 0/26 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	0.00% 0/43 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	2.2% 1/46 • Number of events 1 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	0.00% 0/36 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)
Musculoskeletal and connective tissue disorders Haemarthrosis	0.00% 0/25 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	0.00% 0/26 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	7.0% 3/43 • Number of events 5 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	2.2% 1/46 • Number of events 1 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	8.3% 3/36 • Number of events 3 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)
Musculoskeletal and connective tissue disorders Haematoma muscle	0.00% 0/25 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	0.00% 0/26 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	2.3% 1/43 • Number of events 1 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	2.2% 1/46 • Number of events 1 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	2.8% 1/36 • Number of events 1 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)
Musculoskeletal and connective tissue disorders Soft tissue haemorrhage	0.00% 0/25 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	0.00% 0/26 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	4.7% 2/43 • Number of events 2 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	0.00% 0/46 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	0.00% 0/36 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)
Nervous system disorders Cerebral haemorrhage	0.00% 0/25 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	0.00% 0/26 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	2.3% 1/43 • Number of events 1 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	0.00% 0/46 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	0.00% 0/36 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)
Nervous system disorders Encephalomalacia	0.00% 0/25 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	3.8% 1/26 • Number of events 1 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	0.00% 0/43 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	0.00% 0/46 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	0.00% 0/36 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)
Nervous system disorders Multiple sclerosis	0.00% 0/25 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	0.00% 0/26 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	0.00% 0/43 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	2.2% 1/46 • Number of events 1 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	0.00% 0/36 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)
Nervous system disorders Subarachnoid haemorrhage	0.00% 0/25 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	0.00% 0/26 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	0.00% 0/43 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	0.00% 0/46 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	2.8% 1/36 • Number of events 1 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)
Product Issues Device failure	0.00% 0/25 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	0.00% 0/26 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	0.00% 0/43 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	2.2% 1/46 • Number of events 1 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	2.8% 1/36 • Number of events 1 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)
Product Issues Device occlusion	0.00% 0/25 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	0.00% 0/26 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	0.00% 0/43 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	2.2% 1/46 • Number of events 1 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	0.00% 0/36 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)
Product Issues Internal device exposed	0.00% 0/25 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	0.00% 0/26 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	0.00% 0/43 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	0.00% 0/46 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	2.8% 1/36 • Number of events 1 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)
Renal and urinary disorders Haematuria	0.00% 0/25 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	0.00% 0/26 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	0.00% 0/43 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	2.2% 1/46 • Number of events 1 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	0.00% 0/36 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)
Respiratory, thoracic and mediastinal disorders Epistaxis	0.00% 0/25 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	0.00% 0/26 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	0.00% 0/43 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	0.00% 0/46 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	2.8% 1/36 • Number of events 1 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)
Respiratory, thoracic and mediastinal disorders Laryngeal haematoma	0.00% 0/25 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	0.00% 0/26 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	0.00% 0/43 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	2.2% 1/46 • Number of events 1 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	0.00% 0/36 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)
Respiratory, thoracic and mediastinal disorders Nasal polyps	0.00% 0/25 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	0.00% 0/26 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	0.00% 0/43 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	2.2% 1/46 • Number of events 1 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	0.00% 0/36 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)
Skin and subcutaneous tissue disorders Drug eruption	0.00% 0/25 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	0.00% 0/26 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	0.00% 0/43 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	2.2% 1/46 • Number of events 1 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	0.00% 0/36 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)
Surgical and medical procedures Adenotonsillectomy	0.00% 0/25 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	0.00% 0/26 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	0.00% 0/43 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	2.2% 1/46 • Number of events 1 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	0.00% 0/36 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)
Surgical and medical procedures Central venous catheter removal	0.00% 0/25 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	0.00% 0/26 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	0.00% 0/43 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	2.2% 1/46 • Number of events 1 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	5.6% 2/36 • Number of events 2 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)
Surgical and medical procedures Central venous catheterisation	0.00% 0/25 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	0.00% 0/26 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	2.3% 1/43 • Number of events 1 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	4.3% 2/46 • Number of events 2 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	11.1% 4/36 • Number of events 4 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)
Surgical and medical procedures Dental cleaning	0.00% 0/25 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	3.8% 1/26 • Number of events 1 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	0.00% 0/43 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	0.00% 0/46 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	0.00% 0/36 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)
Surgical and medical procedures Immune tolerance induction	0.00% 0/25 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	0.00% 0/26 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	0.00% 0/43 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	0.00% 0/46 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	5.6% 2/36 • Number of events 3 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)
Surgical and medical procedures Tooth extraction	0.00% 0/25 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	0.00% 0/26 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	0.00% 0/43 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	2.2% 1/46 • Number of events 1 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	0.00% 0/36 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)
Vascular disorders Haematoma	0.00% 0/25 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	0.00% 0/26 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	2.3% 1/43 • Number of events 1 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	0.00% 0/46 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	2.8% 1/36 • Number of events 2 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)

Other adverse events

Other adverse events
Measure	Main Study - Part A: PTPs 0-<6 Years n=25 participants at risk Previously treated patients (PTPs) aged below 6 years received BAY81-8973 25-50 IU/kg at least 2x/week for 6 months and at least 50 exposure days (ED) in main study - Part A.	Main Study - Part A: PTPs 6-12 Years n=26 participants at risk Previously treated patients (PTPs) aged 6 to 12 years received BAY81-8973 25-50 IU/kg at least 2x/week for 6 months and at least 50 exposure days (ED) in main study - Part A.	Main Study - Part B: PUPs/MTPs 0-<6 Years n=43 participants at risk Previously untreated patients (PUPs) or minimally treated patients (MTPs, patients who had no more then 3 exposure days (EDs) with any FVIII product) received BAY81-8973 15-50 IU/kg at least 1x/week for 50 EDs or until inhibitor development in main study - Part B.	Extension Study - Former Part A Participants n=46 participants at risk Participants having reached at least 50 exposure days (EDs) in main study - Part A were offered participation in an open label extension study (optional). Participants who transitioned from main study - Part A to the extension study received BAY81-8973, 25-50 IU/kg at least 2x/week for at least 100 cumulative EDs (main study - Part A and extension study).	Extension Study - Former Part B Participants n=36 participants at risk Participants having reached at least 50 exposure days (EDs) in main study - Part B were offered participation in an open label extension study and received BAY81-8973 25-50 IU/kg at least 2x/week for at least 100 cumulative EDs (main study - Part B and extension study); participants who developed an inhibitor in main study - Part B were offered participation in open label extension study and received Immune Tolerance Induction (ITI) treatment with BAY81-8973 until successful eradication of the inhibitor, or until failure, for approximately 18 months.
Infections and infestations Ear infection	4.0% 1/25 • Number of events 1 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	0.00% 0/26 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	4.7% 2/43 • Number of events 2 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	8.7% 4/46 • Number of events 4 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	2.8% 1/36 • Number of events 4 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)
Blood and lymphatic system disorders Anaemia	0.00% 0/25 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	3.8% 1/26 • Number of events 3 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	7.0% 3/43 • Number of events 3 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	0.00% 0/46 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	8.3% 3/36 • Number of events 10 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)
Blood and lymphatic system disorders Blood loss anaemia	0.00% 0/25 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	0.00% 0/26 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	4.7% 2/43 • Number of events 2 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	2.2% 1/46 • Number of events 1 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	0.00% 0/36 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)
Blood and lymphatic system disorders Iron deficiency anaemia	0.00% 0/25 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	0.00% 0/26 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	2.3% 1/43 • Number of events 1 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	2.2% 1/46 • Number of events 5 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	5.6% 2/36 • Number of events 2 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)
Congenital, familial and genetic disorders Phimosis	0.00% 0/25 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	0.00% 0/26 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	0.00% 0/43 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	4.3% 2/46 • Number of events 3 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	0.00% 0/36 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)
Ear and labyrinth disorders Ear pain	0.00% 0/25 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	3.8% 1/26 • Number of events 1 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	2.3% 1/43 • Number of events 1 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	0.00% 0/46 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	5.6% 2/36 • Number of events 2 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)
Eye disorders Conjunctivitis allergic	0.00% 0/25 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	3.8% 1/26 • Number of events 1 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	0.00% 0/43 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	0.00% 0/46 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	0.00% 0/36 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)
Eye disorders Photophobia	0.00% 0/25 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	3.8% 1/26 • Number of events 1 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	0.00% 0/43 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	0.00% 0/46 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	0.00% 0/36 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)
Infections and infestations Enterovirus infection	0.00% 0/25 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	0.00% 0/26 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	0.00% 0/43 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	0.00% 0/46 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	5.6% 2/36 • Number of events 2 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)
Eye disorders Strabismus	0.00% 0/25 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	3.8% 1/26 • Number of events 3 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	0.00% 0/43 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	0.00% 0/46 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	0.00% 0/36 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)
Gastrointestinal disorders Abdominal pain	0.00% 0/25 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	3.8% 1/26 • Number of events 1 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	0.00% 0/43 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	10.9% 5/46 • Number of events 5 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	0.00% 0/36 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)
Gastrointestinal disorders Abdominal pain upper	4.0% 1/25 • Number of events 1 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	0.00% 0/26 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	0.00% 0/43 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	10.9% 5/46 • Number of events 5 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	0.00% 0/36 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)
Gastrointestinal disorders Constipation	0.00% 0/25 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	3.8% 1/26 • Number of events 1 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	2.3% 1/43 • Number of events 1 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	2.2% 1/46 • Number of events 1 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	2.8% 1/36 • Number of events 1 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)
Gastrointestinal disorders Dental caries	0.00% 0/25 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	3.8% 1/26 • Number of events 1 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	0.00% 0/43 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	2.2% 1/46 • Number of events 2 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	0.00% 0/36 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)
Gastrointestinal disorders Diarrhoea	8.0% 2/25 • Number of events 3 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	3.8% 1/26 • Number of events 2 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	14.0% 6/43 • Number of events 8 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	10.9% 5/46 • Number of events 5 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	2.8% 1/36 • Number of events 1 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)
Gastrointestinal disorders Functional gastrointestinal disorder	0.00% 0/25 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	3.8% 1/26 • Number of events 2 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	2.3% 1/43 • Number of events 1 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	0.00% 0/46 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	0.00% 0/36 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)
Gastrointestinal disorders Glossodynia	4.0% 1/25 • Number of events 1 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	0.00% 0/26 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	0.00% 0/43 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	0.00% 0/46 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	0.00% 0/36 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)
Gastrointestinal disorders Haematochezia	0.00% 0/25 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	3.8% 1/26 • Number of events 1 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	0.00% 0/43 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	0.00% 0/46 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	0.00% 0/36 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)
Gastrointestinal disorders Nausea	0.00% 0/25 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	0.00% 0/26 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	0.00% 0/43 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	6.5% 3/46 • Number of events 4 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	0.00% 0/36 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)
Gastrointestinal disorders Stomatitis	0.00% 0/25 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	3.8% 1/26 • Number of events 1 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	0.00% 0/43 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	0.00% 0/46 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	5.6% 2/36 • Number of events 2 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)
Gastrointestinal disorders Teething	0.00% 0/25 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	0.00% 0/26 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	4.7% 2/43 • Number of events 3 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	0.00% 0/46 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	0.00% 0/36 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)
Gastrointestinal disorders Toothache	0.00% 0/25 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	3.8% 1/26 • Number of events 1 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	0.00% 0/43 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	4.3% 2/46 • Number of events 3 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	2.8% 1/36 • Number of events 1 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)
Gastrointestinal disorders Vomiting	4.0% 1/25 • Number of events 1 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	3.8% 1/26 • Number of events 1 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	9.3% 4/43 • Number of events 8 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	8.7% 4/46 • Number of events 4 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	16.7% 6/36 • Number of events 10 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)
General disorders Catheter site haematoma	0.00% 0/25 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	0.00% 0/26 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	0.00% 0/43 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	0.00% 0/46 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	5.6% 2/36 • Number of events 3 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)
General disorders Fatigue	0.00% 0/25 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	3.8% 1/26 • Number of events 1 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	0.00% 0/43 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	0.00% 0/46 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	0.00% 0/36 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)
General disorders Hyperthermia	0.00% 0/25 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	3.8% 1/26 • Number of events 1 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	0.00% 0/43 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	0.00% 0/46 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	0.00% 0/36 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)
General disorders Infusion site swelling	0.00% 0/25 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	3.8% 1/26 • Number of events 1 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	0.00% 0/43 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	0.00% 0/46 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	0.00% 0/36 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)
General disorders Injection site bruising	0.00% 0/25 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	3.8% 1/26 • Number of events 1 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	0.00% 0/43 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	0.00% 0/46 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	0.00% 0/36 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)
General disorders Oedema peripheral	0.00% 0/25 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	0.00% 0/26 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	0.00% 0/43 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	4.3% 2/46 • Number of events 2 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	0.00% 0/36 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)
General disorders Peripheral swelling	0.00% 0/25 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	3.8% 1/26 • Number of events 1 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	0.00% 0/43 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	6.5% 3/46 • Number of events 4 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	0.00% 0/36 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)
General disorders Pyrexia	20.0% 5/25 • Number of events 10 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	7.7% 2/26 • Number of events 2 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	27.9% 12/43 • Number of events 19 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	17.4% 8/46 • Number of events 19 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	30.6% 11/36 • Number of events 21 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)
Immune system disorders Hypersensitivity	0.00% 0/25 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	3.8% 1/26 • Number of events 1 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	0.00% 0/43 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	0.00% 0/46 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	0.00% 0/36 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)
Infections and infestations Bronchiolitis	0.00% 0/25 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	0.00% 0/26 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	4.7% 2/43 • Number of events 4 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	2.2% 1/46 • Number of events 2 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	2.8% 1/36 • Number of events 1 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)
Infections and infestations Bronchitis	4.0% 1/25 • Number of events 1 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	0.00% 0/26 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	0.00% 0/43 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	4.3% 2/46 • Number of events 4 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	8.3% 3/36 • Number of events 5 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)
Infections and infestations Catheter site infection	0.00% 0/25 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	0.00% 0/26 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	0.00% 0/43 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	0.00% 0/46 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	5.6% 2/36 • Number of events 2 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)
Infections and infestations Conjunctivitis	8.0% 2/25 • Number of events 2 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	0.00% 0/26 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	7.0% 3/43 • Number of events 3 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	6.5% 3/46 • Number of events 4 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	5.6% 2/36 • Number of events 3 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)
Infections and infestations Cystitis	4.0% 1/25 • Number of events 1 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	0.00% 0/26 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	2.3% 1/43 • Number of events 1 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	0.00% 0/46 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	2.8% 1/36 • Number of events 1 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)
Infections and infestations Dysentery	0.00% 0/25 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	0.00% 0/26 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	0.00% 0/43 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	0.00% 0/46 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	5.6% 2/36 • Number of events 4 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)
Metabolism and nutrition disorders Iron deficiency	0.00% 0/25 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	0.00% 0/26 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	0.00% 0/43 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	0.00% 0/46 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	5.6% 2/36 • Number of events 3 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)
Infections and infestations Gastroenteritis	0.00% 0/25 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	3.8% 1/26 • Number of events 1 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	2.3% 1/43 • Number of events 1 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	2.2% 1/46 • Number of events 1 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	8.3% 3/36 • Number of events 5 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)
Infections and infestations Gastroenteritis viral	0.00% 0/25 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	0.00% 0/26 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	7.0% 3/43 • Number of events 3 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	4.3% 2/46 • Number of events 3 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	0.00% 0/36 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)
Infections and infestations Gastrointestinal viral infection	0.00% 0/25 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	3.8% 1/26 • Number of events 1 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	0.00% 0/43 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	0.00% 0/46 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	0.00% 0/36 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)
Infections and infestations Hand-foot-and-mouth disease	4.0% 1/25 • Number of events 1 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	0.00% 0/26 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	2.3% 1/43 • Number of events 1 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	0.00% 0/46 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	2.8% 1/36 • Number of events 1 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)
Infections and infestations Hookworm infection	4.0% 1/25 • Number of events 1 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	0.00% 0/26 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	0.00% 0/43 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	2.2% 1/46 • Number of events 1 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	0.00% 0/36 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)
Infections and infestations Influenza	0.00% 0/25 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	3.8% 1/26 • Number of events 1 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	9.3% 4/43 • Number of events 4 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	4.3% 2/46 • Number of events 2 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	2.8% 1/36 • Number of events 1 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)
Infections and infestations Laryngitis	0.00% 0/25 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	0.00% 0/26 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	2.3% 1/43 • Number of events 1 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	2.2% 1/46 • Number of events 1 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	8.3% 3/36 • Number of events 4 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)
Infections and infestations Nasopharyngitis	8.0% 2/25 • Number of events 3 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	7.7% 2/26 • Number of events 2 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	14.0% 6/43 • Number of events 16 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	28.3% 13/46 • Number of events 31 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	25.0% 9/36 • Number of events 23 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)
Infections and infestations Oral herpes	0.00% 0/25 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	3.8% 1/26 • Number of events 1 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	2.3% 1/43 • Number of events 1 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	0.00% 0/46 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	0.00% 0/36 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)
Infections and infestations Otitis media	4.0% 1/25 • Number of events 1 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	0.00% 0/26 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	2.3% 1/43 • Number of events 3 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	0.00% 0/46 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	5.6% 2/36 • Number of events 3 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)
Infections and infestations Otitis media acute	0.00% 0/25 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	3.8% 1/26 • Number of events 1 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	2.3% 1/43 • Number of events 1 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	0.00% 0/46 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	2.8% 1/36 • Number of events 2 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)
Infections and infestations Pharyngitis	0.00% 0/25 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	0.00% 0/26 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	0.00% 0/43 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	6.5% 3/46 • Number of events 3 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	2.8% 1/36 • Number of events 1 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)
Infections and infestations Pharyngitis streptococcal	0.00% 0/25 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	0.00% 0/26 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	0.00% 0/43 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	4.3% 2/46 • Number of events 2 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	0.00% 0/36 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)
Infections and infestations Pneumonia	4.0% 1/25 • Number of events 1 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	0.00% 0/26 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	2.3% 1/43 • Number of events 1 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	8.7% 4/46 • Number of events 4 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	0.00% 0/36 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)
Infections and infestations Respiratory tract infection	0.00% 0/25 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	0.00% 0/26 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	2.3% 1/43 • Number of events 1 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	10.9% 5/46 • Number of events 10 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	0.00% 0/36 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)
Infections and infestations Rhinitis	4.0% 1/25 • Number of events 1 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	3.8% 1/26 • Number of events 1 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	7.0% 3/43 • Number of events 4 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	13.0% 6/46 • Number of events 8 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	2.8% 1/36 • Number of events 3 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)
Infections and infestations Tonsillitis	4.0% 1/25 • Number of events 2 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	3.8% 1/26 • Number of events 1 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	2.3% 1/43 • Number of events 1 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	21.7% 10/46 • Number of events 25 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	0.00% 0/36 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)
Infections and infestations Tooth abscess	4.0% 1/25 • Number of events 1 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	3.8% 1/26 • Number of events 2 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	0.00% 0/43 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	4.3% 2/46 • Number of events 2 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	0.00% 0/36 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)
Infections and infestations Tracheitis	0.00% 0/25 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	3.8% 1/26 • Number of events 1 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	2.3% 1/43 • Number of events 1 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	0.00% 0/46 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	2.8% 1/36 • Number of events 1 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)
Infections and infestations Upper respiratory tract infection	4.0% 1/25 • Number of events 1 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	3.8% 1/26 • Number of events 2 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	7.0% 3/43 • Number of events 3 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	13.0% 6/46 • Number of events 11 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	5.6% 2/36 • Number of events 2 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)
Infections and infestations Varicella	0.00% 0/25 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	3.8% 1/26 • Number of events 1 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	2.3% 1/43 • Number of events 1 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	4.3% 2/46 • Number of events 2 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	11.1% 4/36 • Number of events 4 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)
Infections and infestations Vascular device infection	4.0% 1/25 • Number of events 1 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	0.00% 0/26 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	0.00% 0/43 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	2.2% 1/46 • Number of events 2 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	2.8% 1/36 • Number of events 2 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)
Infections and infestations Viral infection	12.0% 3/25 • Number of events 3 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	7.7% 2/26 • Number of events 2 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	2.3% 1/43 • Number of events 1 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	13.0% 6/46 • Number of events 15 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	5.6% 2/36 • Number of events 4 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)
Infections and infestations Viral upper respiratory tract infection	0.00% 0/25 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	3.8% 1/26 • Number of events 1 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	0.00% 0/43 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	2.2% 1/46 • Number of events 2 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	0.00% 0/36 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)
Injury, poisoning and procedural complications Contusion	8.0% 2/25 • Number of events 3 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	0.00% 0/26 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	2.3% 1/43 • Number of events 1 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	4.3% 2/46 • Number of events 2 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	0.00% 0/36 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)
Injury, poisoning and procedural complications Eye contusion	0.00% 0/25 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	0.00% 0/26 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	0.00% 0/43 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	4.3% 2/46 • Number of events 2 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	2.8% 1/36 • Number of events 1 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)
Injury, poisoning and procedural complications Face injury	0.00% 0/25 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	0.00% 0/26 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	4.7% 2/43 • Number of events 2 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	0.00% 0/46 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	2.8% 1/36 • Number of events 1 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)
Injury, poisoning and procedural complications Fall	0.00% 0/25 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	0.00% 0/26 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	4.7% 2/43 • Number of events 2 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	4.3% 2/46 • Number of events 2 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	0.00% 0/36 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)
Injury, poisoning and procedural complications Genital contusion	4.0% 1/25 • Number of events 1 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	0.00% 0/26 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	0.00% 0/43 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	0.00% 0/46 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	0.00% 0/36 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)
Injury, poisoning and procedural complications Head injury	4.0% 1/25 • Number of events 1 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	0.00% 0/26 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	2.3% 1/43 • Number of events 1 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	2.2% 1/46 • Number of events 1 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	11.1% 4/36 • Number of events 4 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)
Injury, poisoning and procedural complications Joint injury	0.00% 0/25 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	0.00% 0/26 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	0.00% 0/43 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	4.3% 2/46 • Number of events 3 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	0.00% 0/36 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)
Injury, poisoning and procedural complications Limb injury	0.00% 0/25 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	3.8% 1/26 • Number of events 1 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	0.00% 0/43 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	19.6% 9/46 • Number of events 11 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	2.8% 1/36 • Number of events 1 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)
Injury, poisoning and procedural complications Lip injury	4.0% 1/25 • Number of events 1 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	0.00% 0/26 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	0.00% 0/43 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	0.00% 0/46 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	0.00% 0/36 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)
Injury, poisoning and procedural complications Procedural pain	0.00% 0/25 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	0.00% 0/26 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	0.00% 0/43 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	6.5% 3/46 • Number of events 3 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	0.00% 0/36 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)
Injury, poisoning and procedural complications Road traffic accident	0.00% 0/25 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	3.8% 1/26 • Number of events 1 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	0.00% 0/43 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	0.00% 0/46 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	0.00% 0/36 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)
Injury, poisoning and procedural complications Skin abrasion	0.00% 0/25 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	3.8% 1/26 • Number of events 1 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	0.00% 0/43 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	0.00% 0/46 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	0.00% 0/36 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)
Injury, poisoning and procedural complications Skin injury	4.0% 1/25 • Number of events 1 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	0.00% 0/26 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	0.00% 0/43 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	0.00% 0/46 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	0.00% 0/36 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)
Injury, poisoning and procedural complications Skin laceration	4.0% 1/25 • Number of events 1 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	0.00% 0/26 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	2.3% 1/43 • Number of events 1 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	0.00% 0/46 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	0.00% 0/36 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)
Injury, poisoning and procedural complications Subcutaneous haematoma	4.0% 1/25 • Number of events 1 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	0.00% 0/26 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	0.00% 0/43 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	0.00% 0/46 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	2.8% 1/36 • Number of events 1 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)
Injury, poisoning and procedural complications Tongue injury	4.0% 1/25 • Number of events 1 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	0.00% 0/26 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	0.00% 0/43 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	0.00% 0/46 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	0.00% 0/36 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)
Injury, poisoning and procedural complications Ulna fracture	0.00% 0/25 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	0.00% 0/26 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	0.00% 0/43 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	4.3% 2/46 • Number of events 2 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	0.00% 0/36 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)
Investigations Haemoglobin decreased	4.0% 1/25 • Number of events 1 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	0.00% 0/26 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	0.00% 0/43 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	0.00% 0/46 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	0.00% 0/36 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)
Investigations Neutrophil count increased	0.00% 0/25 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	3.8% 1/26 • Number of events 1 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	0.00% 0/43 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	0.00% 0/46 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	0.00% 0/36 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)
Investigations White blood cell count increased	0.00% 0/25 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	3.8% 1/26 • Number of events 1 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	0.00% 0/43 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	0.00% 0/46 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	0.00% 0/36 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)
Metabolism and nutrition disorders Dehydration	0.00% 0/25 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	3.8% 1/26 • Number of events 1 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	0.00% 0/43 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	0.00% 0/46 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	0.00% 0/36 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/25 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	7.7% 2/26 • Number of events 2 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	0.00% 0/43 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	13.0% 6/46 • Number of events 9 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	0.00% 0/36 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/25 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	0.00% 0/26 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	0.00% 0/43 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	4.3% 2/46 • Number of events 2 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	0.00% 0/36 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)
Musculoskeletal and connective tissue disorders Groin pain	0.00% 0/25 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	0.00% 0/26 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	0.00% 0/43 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	4.3% 2/46 • Number of events 2 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	0.00% 0/36 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)
Musculoskeletal and connective tissue disorders Joint swelling	0.00% 0/25 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	3.8% 1/26 • Number of events 1 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	0.00% 0/43 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	0.00% 0/46 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	0.00% 0/36 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)
Musculoskeletal and connective tissue disorders Pain in extremity	0.00% 0/25 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	3.8% 1/26 • Number of events 1 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	2.3% 1/43 • Number of events 1 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	8.7% 4/46 • Number of events 6 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	0.00% 0/36 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)
Musculoskeletal and connective tissue disorders Synovitis	4.0% 1/25 • Number of events 1 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	0.00% 0/26 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	0.00% 0/43 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	2.2% 1/46 • Number of events 1 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	0.00% 0/36 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Skin papilloma	0.00% 0/25 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	0.00% 0/26 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	0.00% 0/43 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	4.3% 2/46 • Number of events 2 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	0.00% 0/36 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)
Nervous system disorders Headache	8.0% 2/25 • Number of events 3 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	15.4% 4/26 • Number of events 4 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	0.00% 0/43 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	17.4% 8/46 • Number of events 23 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	0.00% 0/36 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)
Product Issues Device failure	0.00% 0/25 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	0.00% 0/26 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	0.00% 0/43 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	6.5% 3/46 • Number of events 3 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	0.00% 0/36 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)
Psychiatric disorders Attention deficit hyperactivity disorder	0.00% 0/25 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	0.00% 0/26 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	0.00% 0/43 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	4.3% 2/46 • Number of events 2 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	0.00% 0/36 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)
Reproductive system and breast disorders Perineal pain	0.00% 0/25 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	3.8% 1/26 • Number of events 1 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	0.00% 0/43 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	0.00% 0/46 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	0.00% 0/36 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)
Respiratory, thoracic and mediastinal disorders Adenoidal hypertrophy	0.00% 0/25 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	0.00% 0/26 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	0.00% 0/43 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	4.3% 2/46 • Number of events 2 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	0.00% 0/36 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)
Respiratory, thoracic and mediastinal disorders Asthma	0.00% 0/25 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	0.00% 0/26 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	2.3% 1/43 • Number of events 1 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	4.3% 2/46 • Number of events 3 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	0.00% 0/36 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)
Respiratory, thoracic and mediastinal disorders Cough	8.0% 2/25 • Number of events 4 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	15.4% 4/26 • Number of events 4 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	2.3% 1/43 • Number of events 1 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	19.6% 9/46 • Number of events 18 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	8.3% 3/36 • Number of events 6 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)
Respiratory, thoracic and mediastinal disorders Epistaxis	0.00% 0/25 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	0.00% 0/26 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	0.00% 0/43 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	4.3% 2/46 • Number of events 6 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	0.00% 0/36 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	0.00% 0/25 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	7.7% 2/26 • Number of events 3 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	0.00% 0/43 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	10.9% 5/46 • Number of events 8 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	0.00% 0/36 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)
Respiratory, thoracic and mediastinal disorders Productive cough	8.0% 2/25 • Number of events 3 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	0.00% 0/26 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	0.00% 0/43 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	2.2% 1/46 • Number of events 1 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	0.00% 0/36 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)
Respiratory, thoracic and mediastinal disorders Rhinitis allergic	4.0% 1/25 • Number of events 1 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	0.00% 0/26 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	0.00% 0/43 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	6.5% 3/46 • Number of events 3 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	0.00% 0/36 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)
Respiratory, thoracic and mediastinal disorders Rhinorrhoea	0.00% 0/25 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	0.00% 0/26 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	0.00% 0/43 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	4.3% 2/46 • Number of events 4 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	0.00% 0/36 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)
Respiratory, thoracic and mediastinal disorders Tonsillar hypertrophy	4.0% 1/25 • Number of events 1 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	0.00% 0/26 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	0.00% 0/43 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	0.00% 0/46 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	0.00% 0/36 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)
Skin and subcutaneous tissue disorders Dermatitis atopic	0.00% 0/25 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	0.00% 0/26 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	0.00% 0/43 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	0.00% 0/46 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	5.6% 2/36 • Number of events 2 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)
Skin and subcutaneous tissue disorders Ecchymosis	0.00% 0/25 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	0.00% 0/26 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	0.00% 0/43 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	4.3% 2/46 • Number of events 3 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	0.00% 0/36 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)
Skin and subcutaneous tissue disorders Pruritus	12.0% 3/25 • Number of events 3 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	0.00% 0/26 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	0.00% 0/43 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	0.00% 0/46 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	0.00% 0/36 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)
Skin and subcutaneous tissue disorders Rash	0.00% 0/25 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	7.7% 2/26 • Number of events 3 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	7.0% 3/43 • Number of events 3 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	6.5% 3/46 • Number of events 3 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	2.8% 1/36 • Number of events 3 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)
Surgical and medical procedures Central venous catheter removal	0.00% 0/25 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	0.00% 0/26 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	0.00% 0/43 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	4.3% 2/46 • Number of events 2 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	0.00% 0/36 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)
Surgical and medical procedures Tooth extraction	0.00% 0/25 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	7.7% 2/26 • Number of events 3 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	0.00% 0/43 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	4.3% 2/46 • Number of events 5 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	0.00% 0/36 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)
Respiratory, thoracic and mediastinal disorders Increased upper airway secretion	4.0% 1/25 • Number of events 1 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	0.00% 0/26 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	0.00% 0/43 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	0.00% 0/46 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)	0.00% 0/36 • Main study - Part A: from the first BAY81-8973 infusion until 3 days after the last infusion (median 6 months); Main study - Part B: from the first BAY81-8973 infusion until 7 days after the last infusion (median 8 months); Extension: from start of extension study until 3 days after the last infusion in extension study (median 3.1 years)

Additional Information

Therapeutic Area Head

Bayer

Phone: 1-888-8422937

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee The sponsor can review results communications prior to public release and can embargo communications regarding trial results within 60 days. The sponsor can require changes to the communication for any patentable subject matter or termed confidential information. The PI cannot publish the results prior the first multicenter publication. If there is no multicenter publication within 18 months after the trial completion the PI has the right to publish the results from the PI site
Publication restrictions are in place

Restriction type: OTHER