Trial Outcomes & Findings for Non-vitamin K Antagonist Oral Anticoagulants in Patients With Atrial High Rate Episodes (NCT NCT02618577)

NCT ID: NCT02618577

Last Updated: 2025-02-06

Results Overview

Time from randomisation to the first occurrence of stroke, systemic embolism, or cardiovascular death; incidence of first occurence of outcome measure.

• Recruitment status: TERMINATED
• Study phase: PHASE3
• Target enrollment: 2608 participants
• Primary outcome timeframe: 28 months
• Results posted on: 2025-02-06

Participant Flow

Participant milestones

Measure	Edoxaban Edoxaban will be applied in NOAH at the therapeutic dose approved for stroke prevention in non-valvular AF, i.e. 60 mg OD with a reduction of dose to 30 mg OD in patients with one of the following characteristics: Impaired renal function (CrCl 15-50 ml/min), or low body weight (≤60 kg), or patients receiving the glycoprotein-P inhibitors cyclosporin, dronedarone, erythromycin, or ketoconazole. Edoxaban: Edoxaban will be applied at the therapeutic dose approved for stroke prevention in non-valvular AF, i.e. 60 mg OD with a reduction of dose to 30 mg OD in patients with one of the following characteristics: Impaired renal function (CrCl 15-50 ml/min), or low body weight (≤60 kg), or patients receiving the glycoprotein-P inhibitors cyclosporin, dronedarone, erythromycin, or ketoconazole.	ASA or Placebo Either one tablet of ASA 100 mg plus one placebo tablet matching in colour, form and size to edoxaban 60 mg or one placebo tablet matching in colour, weight, form and size to ASA 100 mg plus one placebo tablet matching in colour, form and size to edoxaban 60 mg will be administered per day depending on the indication for use of antiplatelet therapy as assessed by the responsible investigator ASA: ASA 100 mg tablets or Placebo, based on accepted indication for the latter, including peripherial or coronary artery disease, a prior myocardial infarction, or a prior stroke.
Overall Study STARTED	1306	1302
Overall Study COMPLETED	500	472
Overall Study NOT COMPLETED	806	830

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Edoxaban n=1270 Participants Edoxaban will be applied in NOAH at the therapeutic dose approved for stroke prevention in non-valvular AF, i.e. 60 mg OD with a reduction of dose to 30 mg OD in patients with one of the following characteristics: Impaired renal function (CrCl 15-50 ml/min), or low body weight (≤60 kg), or patients receiving the glycoprotein-P inhibitors cyclosporin, dronedarone, erythromycin, or ketoconazole. Edoxaban: Edoxaban will be applied at the therapeutic dose approved for stroke prevention in non-valvular AF, i.e. 60 mg OD with a reduction of dose to 30 mg OD in patients with one of the following characteristics: Impaired renal function (CrCl 15-50 ml/min), or low body weight (≤60 kg), or patients receiving the glycoprotein-P inhibitors cyclosporin, dronedarone, erythromycin, or ketoconazole.	ASA or Placebo n=1264 Participants Either one tablet of ASA 100 mg plus one placebo tablet matching in colour, form and size to edoxaban 60 mg or one placebo tablet matching in colour, weight, form and size to ASA 100 mg plus one placebo tablet matching in colour, form and size to edoxaban 60 mg will be administered per day depending on the indication for use of antiplatelet therapy as assessed by the responsible investigator ASA: ASA 100 mg tablets or Placebo, based on accepted indication for the latter, including peripherial or coronary artery disease, a prior myocardial infarction, or a prior stroke.	Total n=2534 Participants Total of all reporting groups
Age, Continuous	77.4 years STANDARD_DEVIATION 6.5 • n=1270 Participants	77.5 years STANDARD_DEVIATION 6.8 • n=1264 Participants	77.5 years STANDARD_DEVIATION 6.7 • n=2534 Participants
Sex: Female, Male Female	469 Participants n=1270 Participants	478 Participants n=1264 Participants	947 Participants n=2534 Participants
Sex: Female, Male Male	801 Participants n=1270 Participants	786 Participants n=1264 Participants	1587 Participants n=2534 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment Romania	7 participants n=1270 Participants	7 participants n=1264 Participants	14 participants n=2534 Participants
Region of Enrollment Hungary	35 participants n=1270 Participants	35 participants n=1264 Participants	70 participants n=2534 Participants
Region of Enrollment Czechia	6 participants n=1270 Participants	6 participants n=1264 Participants	12 participants n=2534 Participants
Region of Enrollment Ukraine	179 participants n=1270 Participants	172 participants n=1264 Participants	351 participants n=2534 Participants
Region of Enrollment United Kingdom	76 participants n=1270 Participants	80 participants n=1264 Participants	156 participants n=2534 Participants
Region of Enrollment Portugal	13 participants n=1270 Participants	12 participants n=1264 Participants	25 participants n=2534 Participants
Region of Enrollment Spain	176 participants n=1270 Participants	177 participants n=1264 Participants	353 participants n=2534 Participants
Region of Enrollment Greece	4 participants n=1270 Participants	3 participants n=1264 Participants	7 participants n=2534 Participants
Region of Enrollment Austria	108 participants n=1270 Participants	113 participants n=1264 Participants	221 participants n=2534 Participants
Region of Enrollment Netherlands	22 participants n=1270 Participants	28 participants n=1264 Participants	50 participants n=2534 Participants
Region of Enrollment Sweden	9 participants n=1270 Participants	7 participants n=1264 Participants	16 participants n=2534 Participants
Region of Enrollment Belgium	15 participants n=1270 Participants	8 participants n=1264 Participants	23 participants n=2534 Participants
Region of Enrollment Poland	137 participants n=1270 Participants	135 participants n=1264 Participants	272 participants n=2534 Participants
Region of Enrollment Denmark	11 participants n=1270 Participants	7 participants n=1264 Participants	18 participants n=2534 Participants
Region of Enrollment Italy	82 participants n=1270 Participants	76 participants n=1264 Participants	158 participants n=2534 Participants
Region of Enrollment Bulgaria	9 participants n=1270 Participants	12 participants n=1264 Participants	21 participants n=2534 Participants
Region of Enrollment France	41 participants n=1270 Participants	41 participants n=1264 Participants	82 participants n=2534 Participants
Region of Enrollment Germany	340 participants n=1270 Participants	345 participants n=1264 Participants	685 participants n=2534 Participants

PRIMARY outcome

Timeframe: 28 months

Population: The primary analysis is in the modified intention-to-treat population, consisting of all randomised patients with a qualifying AHRE and intake of at least one dose of study drug.

Time from randomisation to the first occurrence of stroke, systemic embolism, or cardiovascular death; incidence of first occurence of outcome measure.

Outcome measures

Measure	Edoxaban n=2556 patient-years Edoxaban will be applied in NOAH at the therapeutic dose approved for stroke prevention in non-valvular AF, i.e. 60 mg OD with a reduction of dose to 30 mg OD in patients with one of the following characteristics: Impaired renal function (CrCl 15-50 ml/min), or low body weight (≤60 kg), or patients receiving the glycoprotein-P inhibitors cyclosporin, dronedarone, erythromycin, or ketoconazole. Edoxaban: Edoxaban will be applied at the therapeutic dose approved for stroke prevention in non-valvular AF, i.e. 60 mg OD with a reduction of dose to 30 mg OD in patients with one of the following characteristics: Impaired renal function (CrCl 15-50 ml/min), or low body weight (≤60 kg), or patients receiving the glycoprotein-P inhibitors cyclosporin, dronedarone, erythromycin, or ketoconazole.	ASA or Placebo n=2494 patient-years Either one tablet of ASA 100 mg plus one placebo tablet matching in colour, form and size to edoxaban 60 mg or one placebo tablet matching in colour, weight, form and size to ASA 100 mg plus one placebo tablet matching in colour, form and size to edoxaban 60 mg will be administered per day depending on the indication for use of antiplatelet therapy as assessed by the responsible investigator ASA: ASA 100 mg tablets or Placebo, based on accepted indication for the latter, including peripherial or coronary artery disease, a prior myocardial infarction, or a prior stroke.
Composite of Stroke, Systemic Embolism, or Cardiovascular Death	3.3 number of new events per 100 pat.-years	4.0 number of new events per 100 pat.-years

SECONDARY outcome

Timeframe: 28 months

Time from randomisation to the first occurrence of ischemic stroke; incidence of first occurence of outcome measure.

Outcome measures

Measure	Edoxaban n=2572 patient-years Edoxaban will be applied in NOAH at the therapeutic dose approved for stroke prevention in non-valvular AF, i.e. 60 mg OD with a reduction of dose to 30 mg OD in patients with one of the following characteristics: Impaired renal function (CrCl 15-50 ml/min), or low body weight (≤60 kg), or patients receiving the glycoprotein-P inhibitors cyclosporin, dronedarone, erythromycin, or ketoconazole. Edoxaban: Edoxaban will be applied at the therapeutic dose approved for stroke prevention in non-valvular AF, i.e. 60 mg OD with a reduction of dose to 30 mg OD in patients with one of the following characteristics: Impaired renal function (CrCl 15-50 ml/min), or low body weight (≤60 kg), or patients receiving the glycoprotein-P inhibitors cyclosporin, dronedarone, erythromycin, or ketoconazole.	ASA or Placebo n=2518 patient-years Either one tablet of ASA 100 mg plus one placebo tablet matching in colour, form and size to edoxaban 60 mg or one placebo tablet matching in colour, weight, form and size to ASA 100 mg plus one placebo tablet matching in colour, form and size to edoxaban 60 mg will be administered per day depending on the indication for use of antiplatelet therapy as assessed by the responsible investigator ASA: ASA 100 mg tablets or Placebo, based on accepted indication for the latter, including peripherial or coronary artery disease, a prior myocardial infarction, or a prior stroke.
Components of the Primary Outcome, Stroke	0.9 number of new events per 100 pat.-years	1.1 number of new events per 100 pat.-years

SECONDARY outcome

Timeframe: 28 months

PCI, CABG

Outcome measures

Measure	Edoxaban n=2532 patient-years Edoxaban will be applied in NOAH at the therapeutic dose approved for stroke prevention in non-valvular AF, i.e. 60 mg OD with a reduction of dose to 30 mg OD in patients with one of the following characteristics: Impaired renal function (CrCl 15-50 ml/min), or low body weight (≤60 kg), or patients receiving the glycoprotein-P inhibitors cyclosporin, dronedarone, erythromycin, or ketoconazole. Edoxaban: Edoxaban will be applied at the therapeutic dose approved for stroke prevention in non-valvular AF, i.e. 60 mg OD with a reduction of dose to 30 mg OD in patients with one of the following characteristics: Impaired renal function (CrCl 15-50 ml/min), or low body weight (≤60 kg), or patients receiving the glycoprotein-P inhibitors cyclosporin, dronedarone, erythromycin, or ketoconazole.	ASA or Placebo n=2484 patient-years Either one tablet of ASA 100 mg plus one placebo tablet matching in colour, form and size to edoxaban 60 mg or one placebo tablet matching in colour, weight, form and size to ASA 100 mg plus one placebo tablet matching in colour, form and size to edoxaban 60 mg will be administered per day depending on the indication for use of antiplatelet therapy as assessed by the responsible investigator ASA: ASA 100 mg tablets or Placebo, based on accepted indication for the latter, including peripherial or coronary artery disease, a prior myocardial infarction, or a prior stroke.
Major Adverse Cardiac Events (MACEs: Cardiac Death, Myocardial Infarction, Acute Coronary Syndrome (ACS)	3.6 number of new events per 100 pat.-years	4.1 number of new events per 100 pat.-years

SECONDARY outcome

Timeframe: 28 months

All-cause death

Outcome measures

Measure	Edoxaban n=2595 patient-years Edoxaban will be applied in NOAH at the therapeutic dose approved for stroke prevention in non-valvular AF, i.e. 60 mg OD with a reduction of dose to 30 mg OD in patients with one of the following characteristics: Impaired renal function (CrCl 15-50 ml/min), or low body weight (≤60 kg), or patients receiving the glycoprotein-P inhibitors cyclosporin, dronedarone, erythromycin, or ketoconazole. Edoxaban: Edoxaban will be applied at the therapeutic dose approved for stroke prevention in non-valvular AF, i.e. 60 mg OD with a reduction of dose to 30 mg OD in patients with one of the following characteristics: Impaired renal function (CrCl 15-50 ml/min), or low body weight (≤60 kg), or patients receiving the glycoprotein-P inhibitors cyclosporin, dronedarone, erythromycin, or ketoconazole.	ASA or Placebo n=2539 patient-years Either one tablet of ASA 100 mg plus one placebo tablet matching in colour, form and size to edoxaban 60 mg or one placebo tablet matching in colour, weight, form and size to ASA 100 mg plus one placebo tablet matching in colour, form and size to edoxaban 60 mg will be administered per day depending on the indication for use of antiplatelet therapy as assessed by the responsible investigator ASA: ASA 100 mg tablets or Placebo, based on accepted indication for the latter, including peripherial or coronary artery disease, a prior myocardial infarction, or a prior stroke.
All-cause Death	4.3 number of new events per 100 pat.-years	3.7 number of new events per 100 pat.-years

SECONDARY outcome

Timeframe: 28 months

according to the International Society on Thrombosis and Haemostasis (ISTH) definitions

Outcome measures

Measure	Edoxaban n=2533 patient-years Edoxaban will be applied in NOAH at the therapeutic dose approved for stroke prevention in non-valvular AF, i.e. 60 mg OD with a reduction of dose to 30 mg OD in patients with one of the following characteristics: Impaired renal function (CrCl 15-50 ml/min), or low body weight (≤60 kg), or patients receiving the glycoprotein-P inhibitors cyclosporin, dronedarone, erythromycin, or ketoconazole. Edoxaban: Edoxaban will be applied at the therapeutic dose approved for stroke prevention in non-valvular AF, i.e. 60 mg OD with a reduction of dose to 30 mg OD in patients with one of the following characteristics: Impaired renal function (CrCl 15-50 ml/min), or low body weight (≤60 kg), or patients receiving the glycoprotein-P inhibitors cyclosporin, dronedarone, erythromycin, or ketoconazole.	ASA or Placebo n=2507 patient-years Either one tablet of ASA 100 mg plus one placebo tablet matching in colour, form and size to edoxaban 60 mg or one placebo tablet matching in colour, weight, form and size to ASA 100 mg plus one placebo tablet matching in colour, form and size to edoxaban 60 mg will be administered per day depending on the indication for use of antiplatelet therapy as assessed by the responsible investigator ASA: ASA 100 mg tablets or Placebo, based on accepted indication for the latter, including peripherial or coronary artery disease, a prior myocardial infarction, or a prior stroke.
Major Bleeding Events	2.1 number of new events per 100 pat.-years	1.0 number of new events per 100 pat.-years

SECONDARY outcome

Timeframe: Baseline, 12 months and 24 months.

Adjusted mean change from baseline at 12 and 24 months of Quality of life as assessed by the EuroQol Group 5-Dimension 5-Level questionnaire (EQ-5D-5L): The resulting score of the UK index ranges from 1 (for the best state) to - 0.285 (for the worst state), with 5.1% of the states valued as worse than dead. EQ5D- VAS: visual-analogue scale (0 worst to 100 best).

Subscales of the UK index score were combined by adding up EQ-5D-5L index values with STATA using the English (ENG) Devlin value set, Version 1.1 (Updated 01/12/2020).

Karnofsky Performance Scale is an 11-point scale from 0 to 100 (0 worst to 100 best).

Outcome measures

Measure	Edoxaban n=1270 Participants Edoxaban will be applied in NOAH at the therapeutic dose approved for stroke prevention in non-valvular AF, i.e. 60 mg OD with a reduction of dose to 30 mg OD in patients with one of the following characteristics: Impaired renal function (CrCl 15-50 ml/min), or low body weight (≤60 kg), or patients receiving the glycoprotein-P inhibitors cyclosporin, dronedarone, erythromycin, or ketoconazole. Edoxaban: Edoxaban will be applied at the therapeutic dose approved for stroke prevention in non-valvular AF, i.e. 60 mg OD with a reduction of dose to 30 mg OD in patients with one of the following characteristics: Impaired renal function (CrCl 15-50 ml/min), or low body weight (≤60 kg), or patients receiving the glycoprotein-P inhibitors cyclosporin, dronedarone, erythromycin, or ketoconazole.	ASA or Placebo n=1264 Participants Either one tablet of ASA 100 mg plus one placebo tablet matching in colour, form and size to edoxaban 60 mg or one placebo tablet matching in colour, weight, form and size to ASA 100 mg plus one placebo tablet matching in colour, form and size to edoxaban 60 mg will be administered per day depending on the indication for use of antiplatelet therapy as assessed by the responsible investigator ASA: ASA 100 mg tablets or Placebo, based on accepted indication for the latter, including peripherial or coronary artery disease, a prior myocardial infarction, or a prior stroke.
Quality of Life Changes at 12 and 24 Months Compared to Baseline EQ-5D-5L UK Index to FU12	-0.01 adjusted mean change from baseline Interval -0.03 to 0.0	-0.01 adjusted mean change from baseline Interval -0.02 to 0.01
Quality of Life Changes at 12 and 24 Months Compared to Baseline EQ-5D-5L UK Index to FU24	-0.04 adjusted mean change from baseline Interval -0.05 to -0.02	-0.03 adjusted mean change from baseline Interval -0.05 to -0.02
Quality of Life Changes at 12 and 24 Months Compared to Baseline EQ-5D-5L VAS to FU12	-0.75 adjusted mean change from baseline Interval -2.08 to 0.57	-0.71 adjusted mean change from baseline Interval -2.06 to 0.64
Quality of Life Changes at 12 and 24 Months Compared to Baseline EQ-5D-5L VAS to FU24	-1.72 adjusted mean change from baseline Interval -3.18 to -0.27	-1.68 adjusted mean change from baseline Interval -3.16 to 0.2
Quality of Life Changes at 12 and 24 Months Compared to Baseline Karnofsky score to FU12	-1.14 adjusted mean change from baseline Interval -1.98 to -0.31	-1.41 adjusted mean change from baseline Interval -2.26 to -0.57
Quality of Life Changes at 12 and 24 Months Compared to Baseline Karnofsky score to FU24	-2.28 adjusted mean change from baseline Interval -3.23 to -1.33	-2.55 adjusted mean change from baseline Interval -3.5 to -1.59

SECONDARY outcome

Timeframe: Baseline, 12 months and 24 months.

Adjusted change from baseline at 12 and 24 months measured by the Perception of Anticoagulant Treatment Questionnaire: For convenience score, a 0 - 100 scale; for satisfaction score a 0 - 100 scale; for both scores, the higher the score, the higher the convenience/satisfaction.

Outcome measures

Measure	Edoxaban n=1270 Participants Edoxaban will be applied in NOAH at the therapeutic dose approved for stroke prevention in non-valvular AF, i.e. 60 mg OD with a reduction of dose to 30 mg OD in patients with one of the following characteristics: Impaired renal function (CrCl 15-50 ml/min), or low body weight (≤60 kg), or patients receiving the glycoprotein-P inhibitors cyclosporin, dronedarone, erythromycin, or ketoconazole. Edoxaban: Edoxaban will be applied at the therapeutic dose approved for stroke prevention in non-valvular AF, i.e. 60 mg OD with a reduction of dose to 30 mg OD in patients with one of the following characteristics: Impaired renal function (CrCl 15-50 ml/min), or low body weight (≤60 kg), or patients receiving the glycoprotein-P inhibitors cyclosporin, dronedarone, erythromycin, or ketoconazole.	ASA or Placebo n=1264 Participants Either one tablet of ASA 100 mg plus one placebo tablet matching in colour, form and size to edoxaban 60 mg or one placebo tablet matching in colour, weight, form and size to ASA 100 mg plus one placebo tablet matching in colour, form and size to edoxaban 60 mg will be administered per day depending on the indication for use of antiplatelet therapy as assessed by the responsible investigator ASA: ASA 100 mg tablets or Placebo, based on accepted indication for the latter, including peripherial or coronary artery disease, a prior myocardial infarction, or a prior stroke.
Patient Satisfaction at 12 and 24 Months Compared to Baseline PACT-Q convenience to FU24	1.35 scores on a scale (with 95% Confidence I Interval 0.2 to 2.49	1.47 scores on a scale (with 95% Confidence I Interval 0.32 to 2.61
Patient Satisfaction at 12 and 24 Months Compared to Baseline PACT-Q convenience to FU12	0.84 scores on a scale (with 95% Confidence I Interval -0.26 to 1.93	0.96 scores on a scale (with 95% Confidence I Interval -0.14 to 2.05
Patient Satisfaction at 12 and 24 Months Compared to Baseline PACT-Q satisfaction to FU12	2.97 scores on a scale (with 95% Confidence I Interval 1.36 to 4.57	4.01 scores on a scale (with 95% Confidence I Interval 2.39 to 5.62
Patient Satisfaction at 12 and 24 Months Compared to Baseline PACT-Q satisfaction to FU24	3.80 scores on a scale (with 95% Confidence I Interval 2.12 to 5.48	4.84 scores on a scale (with 95% Confidence I Interval 3.15 to 6.52

SECONDARY outcome

Timeframe: 28 months

estimated by quantification of relevant events, interventions, nights spent in hospital and cardiovascular therapies

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline and 24 months

Population: MoCA Stroke Severity in patients with a stroke estimated by the Modified Rankin Scale at FU24.

Autonomy status only in patients with stroke during study participation, assessed at 24 month by modified Rankin scale. (Score ranges from 1 to 8, a higher score indicates a higher grade of disability)

Outcome measures

Measure	Edoxaban n=10 Participants Edoxaban will be applied in NOAH at the therapeutic dose approved for stroke prevention in non-valvular AF, i.e. 60 mg OD with a reduction of dose to 30 mg OD in patients with one of the following characteristics: Impaired renal function (CrCl 15-50 ml/min), or low body weight (≤60 kg), or patients receiving the glycoprotein-P inhibitors cyclosporin, dronedarone, erythromycin, or ketoconazole. Edoxaban: Edoxaban will be applied at the therapeutic dose approved for stroke prevention in non-valvular AF, i.e. 60 mg OD with a reduction of dose to 30 mg OD in patients with one of the following characteristics: Impaired renal function (CrCl 15-50 ml/min), or low body weight (≤60 kg), or patients receiving the glycoprotein-P inhibitors cyclosporin, dronedarone, erythromycin, or ketoconazole.	ASA or Placebo n=14 Participants Either one tablet of ASA 100 mg plus one placebo tablet matching in colour, form and size to edoxaban 60 mg or one placebo tablet matching in colour, weight, form and size to ASA 100 mg plus one placebo tablet matching in colour, form and size to edoxaban 60 mg will be administered per day depending on the indication for use of antiplatelet therapy as assessed by the responsible investigator ASA: ASA 100 mg tablets or Placebo, based on accepted indication for the latter, including peripherial or coronary artery disease, a prior myocardial infarction, or a prior stroke.
Autonomy Status	3.0 Scores on a scale Interval 2.0 to 3.0	2.5 Scores on a scale Interval 2.0 to 3.0

SECONDARY outcome

Timeframe: 28 months

Time from randomisation to the first occurrence of systemic embolism; incidence of first occurence of outcome measure.

Outcome measures

Measure	Edoxaban n=2578 patient-years Edoxaban will be applied in NOAH at the therapeutic dose approved for stroke prevention in non-valvular AF, i.e. 60 mg OD with a reduction of dose to 30 mg OD in patients with one of the following characteristics: Impaired renal function (CrCl 15-50 ml/min), or low body weight (≤60 kg), or patients receiving the glycoprotein-P inhibitors cyclosporin, dronedarone, erythromycin, or ketoconazole. Edoxaban: Edoxaban will be applied at the therapeutic dose approved for stroke prevention in non-valvular AF, i.e. 60 mg OD with a reduction of dose to 30 mg OD in patients with one of the following characteristics: Impaired renal function (CrCl 15-50 ml/min), or low body weight (≤60 kg), or patients receiving the glycoprotein-P inhibitors cyclosporin, dronedarone, erythromycin, or ketoconazole.	ASA or Placebo n=2514 patient-years Either one tablet of ASA 100 mg plus one placebo tablet matching in colour, form and size to edoxaban 60 mg or one placebo tablet matching in colour, weight, form and size to ASA 100 mg plus one placebo tablet matching in colour, form and size to edoxaban 60 mg will be administered per day depending on the indication for use of antiplatelet therapy as assessed by the responsible investigator ASA: ASA 100 mg tablets or Placebo, based on accepted indication for the latter, including peripherial or coronary artery disease, a prior myocardial infarction, or a prior stroke.
Components of the Primary Outcome, Systemic Embolism	0.5 number of new events per 100 pat.-years	1.1 number of new events per 100 pat.-years

SECONDARY outcome

Timeframe: 28 months

Time from randomisation to the first occurrence of cardiovascular death; incidence of first occurence of outcome measure.

Outcome measures

Measure	Edoxaban n=2595 patient-years Edoxaban will be applied in NOAH at the therapeutic dose approved for stroke prevention in non-valvular AF, i.e. 60 mg OD with a reduction of dose to 30 mg OD in patients with one of the following characteristics: Impaired renal function (CrCl 15-50 ml/min), or low body weight (≤60 kg), or patients receiving the glycoprotein-P inhibitors cyclosporin, dronedarone, erythromycin, or ketoconazole. Edoxaban: Edoxaban will be applied at the therapeutic dose approved for stroke prevention in non-valvular AF, i.e. 60 mg OD with a reduction of dose to 30 mg OD in patients with one of the following characteristics: Impaired renal function (CrCl 15-50 ml/min), or low body weight (≤60 kg), or patients receiving the glycoprotein-P inhibitors cyclosporin, dronedarone, erythromycin, or ketoconazole.	ASA or Placebo n=2539 patient-years Either one tablet of ASA 100 mg plus one placebo tablet matching in colour, form and size to edoxaban 60 mg or one placebo tablet matching in colour, weight, form and size to ASA 100 mg plus one placebo tablet matching in colour, form and size to edoxaban 60 mg will be administered per day depending on the indication for use of antiplatelet therapy as assessed by the responsible investigator ASA: ASA 100 mg tablets or Placebo, based on accepted indication for the latter, including peripherial or coronary artery disease, a prior myocardial infarction, or a prior stroke.
Components of the Primary Outcome, Cardiovascular Death	2.0 number of new events per 100 pat.-years	2.2 number of new events per 100 pat.-years

Adverse Events

Edoxaban

Serious events: 498 serious events

Other events: 718 other events

Deaths: 142 deaths

ASA or Placebo

Serious events: 467 serious events

Other events: 662 other events

Deaths: 125 deaths

Serious adverse events

Measure	Edoxaban n=1306 participants at risk Edoxaban will be applied in NOAH at the therapeutic dose approved for stroke prevention in non-valvular AF, i.e. 60 mg OD with a reduction of dose to 30 mg OD in patients with one of the following characteristics: Impaired renal function (CrCl 15-50 ml/min), or low body weight (≤60 kg), or patients receiving the glycoprotein-P inhibitors cyclosporin, dronedarone, erythromycin, or ketoconazole. Edoxaban: Edoxaban will be applied at the therapeutic dose approved for stroke prevention in non-valvular AF, i.e. 60 mg OD with a reduction of dose to 30 mg OD in patients with one of the following characteristics: Impaired renal function (CrCl 15-50 ml/min), or low body weight (≤60 kg), or patients receiving the glycoprotein-P inhibitors cyclosporin, dronedarone, erythromycin, or ketoconazole.	ASA or Placebo n=1302 participants at risk Either one tablet of ASA 100 mg plus one placebo tablet matching in colour, form and size to edoxaban 60 mg or one placebo tablet matching in colour, weight, form and size to ASA 100 mg plus one placebo tablet matching in colour, form and size to edoxaban 60 mg will be administered per day depending on the indication for use of antiplatelet therapy as assessed by the responsible investigator ASA: ASA 100 mg tablets or Placebo, based on accepted indication for the latter, including peripherial or coronary artery disease, a prior myocardial infarction, or a prior stroke.
Blood and lymphatic system disorders Anaemia	3.4% 44/1306 • Number of events 55 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	1.2% 16/1302 • Number of events 26 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Blood and lymphatic system disorders Anaemia vitamin B12 deficiency	0.00% 0/1306 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.08% 1/1302 • Number of events 2 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Blood and lymphatic system disorders Lymphadenopathy	0.08% 1/1306 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.08% 1/1302 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Blood and lymphatic system disorders Lymphadenopathy mediastinal	0.00% 0/1306 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.08% 1/1302 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Blood and lymphatic system disorders Paratracheal lymphadenopathy	0.08% 1/1306 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.00% 0/1302 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Blood and lymphatic system disorders Thrombocytopenia	0.00% 0/1306 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.08% 1/1302 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Cardiac disorders Acute coronary syndrome	0.23% 3/1306 • Number of events 3 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.69% 9/1302 • Number of events 9 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Cardiac disorders Acute myocardial infarction	1.1% 14/1306 • Number of events 20 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	1.5% 19/1302 • Number of events 21 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Cardiac disorders Angina pectoris	1.1% 14/1306 • Number of events 17 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.84% 11/1302 • Number of events 11 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Cardiac disorders Angina unstable	0.15% 2/1306 • Number of events 2 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.23% 3/1302 • Number of events 3 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Cardiac disorders Aortic valve stenosis	0.31% 4/1306 • Number of events 5 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.38% 5/1302 • Number of events 5 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Cardiac disorders Atrial fibrillation	2.9% 38/1306 • Number of events 50 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	3.0% 39/1302 • Number of events 51 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Cardiac disorders Atrial flutter	0.46% 6/1306 • Number of events 7 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.84% 11/1302 • Number of events 11 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Cardiac disorders Atrial thrombosis	0.08% 1/1306 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.00% 0/1302 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Cardiac disorders Bundle branch block left	0.08% 1/1306 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.00% 0/1302 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Cardiac disorders Cardiac amyloidosis	0.00% 0/1306 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.08% 1/1302 • Number of events 3 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Cardiac disorders Cardiac arrest	0.15% 2/1306 • Number of events 2 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.00% 0/1302 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Cardiac disorders Cardiac failure	7.1% 93/1306 • Number of events 145 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	6.9% 90/1302 • Number of events 131 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Cardiac disorders Cardiac failure acute	0.08% 1/1306 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.00% 0/1302 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Cardiac disorders Cardiac failure congestive	0.08% 1/1306 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.08% 1/1302 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Cardiac disorders Cardiogenic shock	0.08% 1/1306 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.08% 1/1302 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Cardiac disorders Cardiomyopathy	0.15% 2/1306 • Number of events 2 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.00% 0/1302 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Cardiac disorders Cardiovascular disorder	0.46% 6/1306 • Number of events 6 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.46% 6/1302 • Number of events 6 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Cardiac disorders Coronary artery disease	0.54% 7/1306 • Number of events 7 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.61% 8/1302 • Number of events 8 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Cardiac disorders Dilated cardiomyopathy	0.00% 0/1306 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.08% 1/1302 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Cardiac disorders Extrasystoles	0.00% 0/1306 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.08% 1/1302 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Cardiac disorders Intracardiac thrombus	0.00% 0/1306 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.08% 1/1302 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Cardiac disorders Ischaemic cardiomyopathy	0.08% 1/1306 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.00% 0/1302 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Cardiac disorders Mitral valve incompetence	0.23% 3/1306 • Number of events 4 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.23% 3/1302 • Number of events 4 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Cardiac disorders Mitral valve stenosis	0.08% 1/1306 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.00% 0/1302 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Cardiac disorders Myocardial infarction	0.38% 5/1306 • Number of events 5 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.46% 6/1302 • Number of events 6 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Cardiac disorders Myocardial ischaemia	0.08% 1/1306 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.00% 0/1302 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Cardiac disorders Palpitations	0.15% 2/1306 • Number of events 2 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.00% 0/1302 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Cardiac disorders Pericardial effusion	0.31% 4/1306 • Number of events 4 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.00% 0/1302 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Cardiac disorders Pericarditis	0.08% 1/1306 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.00% 0/1302 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Cardiac disorders Sinus tachycardia	0.00% 0/1306 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.08% 1/1302 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Cardiac disorders Tachyarrhythmia	0.15% 2/1306 • Number of events 2 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.00% 0/1302 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Cardiac disorders Tachycardia	0.08% 1/1306 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.00% 0/1302 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Cardiac disorders Tricuspid valve incompetence	0.00% 0/1306 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.08% 1/1302 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Cardiac disorders Ventricular arrhythmia	0.08% 1/1306 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.00% 0/1302 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Cardiac disorders Ventricular extrasystoles	0.08% 1/1306 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.00% 0/1302 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Cardiac disorders Ventricular fibrillation	0.00% 0/1306 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.15% 2/1302 • Number of events 3 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Cardiac disorders Ventricular tachycardia	0.38% 5/1306 • Number of events 5 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.31% 4/1302 • Number of events 5 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Congenital, familial and genetic disorders Haemophilia	0.00% 0/1306 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.08% 1/1302 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Congenital, familial and genetic disorders Phimosis	0.08% 1/1306 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.00% 0/1302 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Ear and labyrinth disorders Ear haemorrhage	0.08% 1/1306 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.00% 0/1302 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Ear and labyrinth disorders Ear pain	0.08% 1/1306 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.00% 0/1302 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Ear and labyrinth disorders Sudden hearing loss	0.00% 0/1306 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.08% 1/1302 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Ear and labyrinth disorders Tinnitus	0.00% 0/1306 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.08% 1/1302 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Ear and labyrinth disorders Vertigo	0.31% 4/1306 • Number of events 5 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.31% 4/1302 • Number of events 5 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Endocrine disorders Hyperparathyroidism	0.08% 1/1306 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.00% 0/1302 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Eye disorders Amaurosis fugax	0.31% 4/1306 • Number of events 4 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.00% 0/1302 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Eye disorders Eye haemorrhage	0.08% 1/1306 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.00% 0/1302 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Eye disorders Retinal artery occlusion	0.00% 0/1306 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.08% 1/1302 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Eye disorders Retinal haemorrhage	0.00% 0/1306 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.23% 3/1302 • Number of events 3 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Eye disorders Retinal vein occlusion	0.00% 0/1306 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.08% 1/1302 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Eye disorders Retinal vein thrombosis	0.08% 1/1306 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.08% 1/1302 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Eye disorders Vision blurred	0.08% 1/1306 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.00% 0/1302 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Eye disorders Visual field defect	0.00% 0/1306 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.08% 1/1302 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Eye disorders Vitreoretinal traction syndrome	0.08% 1/1306 • Number of events 2 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.00% 0/1302 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Gastrointestinal disorders Abdominal distension	0.08% 1/1306 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.00% 0/1302 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Gastrointestinal disorders Abdominal incarcerated hernia	0.08% 1/1306 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.00% 0/1302 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Gastrointestinal disorders Abdominal pain	0.38% 5/1306 • Number of events 5 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.15% 2/1302 • Number of events 2 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Gastrointestinal disorders Abdominal pain upper	0.00% 0/1306 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.08% 1/1302 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Gastrointestinal disorders Barrett's oesophagus	0.08% 1/1306 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.00% 0/1302 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Gastrointestinal disorders Colitis	0.08% 1/1306 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.15% 2/1302 • Number of events 2 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Gastrointestinal disorders Colitis ischaemic	0.00% 0/1306 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.08% 1/1302 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Gastrointestinal disorders Constipation	0.15% 2/1306 • Number of events 2 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.15% 2/1302 • Number of events 2 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Gastrointestinal disorders Diarrhoea	0.69% 9/1306 • Number of events 9 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.38% 5/1302 • Number of events 5 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Gastrointestinal disorders Diverticulum	0.31% 4/1306 • Number of events 4 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.46% 6/1302 • Number of events 6 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Gastrointestinal disorders Duodenal ulcer haemorrhage	0.31% 4/1306 • Number of events 4 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.23% 3/1302 • Number of events 3 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Gastrointestinal disorders Duodenitis	0.08% 1/1306 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.08% 1/1302 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Gastrointestinal disorders Enteritis	0.00% 0/1306 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.08% 1/1302 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Gastrointestinal disorders Faecaloma	0.08% 1/1306 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.00% 0/1302 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Gastrointestinal disorders Gastric ulcer	0.15% 2/1306 • Number of events 2 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.15% 2/1302 • Number of events 2 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Gastrointestinal disorders Gastritis	0.38% 5/1306 • Number of events 5 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.15% 2/1302 • Number of events 2 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Gastrointestinal disorders Gastritis erosive	0.00% 0/1306 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.08% 1/1302 • Number of events 2 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Gastrointestinal disorders Gastritis haemorrhagic	0.15% 2/1306 • Number of events 2 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.00% 0/1302 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Gastrointestinal disorders Gastrointestinal haemorrhage	3.8% 50/1306 • Number of events 66 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	1.5% 19/1302 • Number of events 23 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Gastrointestinal disorders Gastrointestinal necrosis	0.00% 0/1306 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.08% 1/1302 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Gastrointestinal disorders Gastrointestinal obstruction	0.08% 1/1306 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.00% 0/1302 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Gastrointestinal disorders Gastrointestinal perforation	0.00% 0/1306 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.08% 1/1302 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Gastrointestinal disorders Gastrointestinal ulcer haemorrhage	0.08% 1/1306 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.00% 0/1302 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Gastrointestinal disorders Gastrointestinal vascular malformation haemorrhagic	0.15% 2/1306 • Number of events 2 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.00% 0/1302 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Gastrointestinal disorders Gastrooesophageal reflux disease	0.23% 3/1306 • Number of events 3 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.00% 0/1302 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Gastrointestinal disorders Haematemesis	0.23% 3/1306 • Number of events 3 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.00% 0/1302 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Gastrointestinal disorders Haematochezia	0.46% 6/1306 • Number of events 6 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.15% 2/1302 • Number of events 2 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Gastrointestinal disorders Haemorrhoidal haemorrhage	0.08% 1/1306 • Number of events 2 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.00% 0/1302 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Gastrointestinal disorders Haemorrhoids	0.15% 2/1306 • Number of events 2 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.15% 2/1302 • Number of events 2 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Gastrointestinal disorders Haemorrhoids thrombosed	0.00% 0/1306 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.08% 1/1302 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Gastrointestinal disorders Hiatus hernia	0.00% 0/1306 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.08% 1/1302 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Gastrointestinal disorders Ileus	0.23% 3/1306 • Number of events 3 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.08% 1/1302 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Gastrointestinal disorders Inguinal hernia	0.00% 0/1306 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.23% 3/1302 • Number of events 4 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Gastrointestinal disorders Intestinal haemorrhage	0.08% 1/1306 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.00% 0/1302 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Gastrointestinal disorders Intestinal perforation	0.08% 1/1306 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.00% 0/1302 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Gastrointestinal disorders Intestinal polyp	0.08% 1/1306 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.00% 0/1302 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Gastrointestinal disorders Intra-abdominal haemorrhage	0.00% 0/1306 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.08% 1/1302 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Gastrointestinal disorders Large intestine perforation	0.00% 0/1306 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.08% 1/1302 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Gastrointestinal disorders Large intestine polyp	0.15% 2/1306 • Number of events 2 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.08% 1/1302 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Gastrointestinal disorders Melaena	0.31% 4/1306 • Number of events 4 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.31% 4/1302 • Number of events 4 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Gastrointestinal disorders Mesenteric artery embolism	0.00% 0/1306 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.08% 1/1302 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Gastrointestinal disorders Oesophageal haemorrhage	0.08% 1/1306 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.00% 0/1302 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Gastrointestinal disorders Oesophageal mucosa erythema	0.00% 0/1306 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.08% 1/1302 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Gastrointestinal disorders Oesophageal stenosis	0.00% 0/1306 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.08% 1/1302 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Gastrointestinal disorders Oesophageal ulcer	0.08% 1/1306 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.00% 0/1302 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Gastrointestinal disorders Pancreatitis	0.31% 4/1306 • Number of events 6 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.23% 3/1302 • Number of events 3 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Gastrointestinal disorders Pancreatitis acute	0.08% 1/1306 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.00% 0/1302 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Gastrointestinal disorders Proctitis	0.00% 0/1306 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.08% 1/1302 • Number of events 2 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Gastrointestinal disorders Proctitis haemorrhagic	0.00% 0/1306 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.08% 1/1302 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Gastrointestinal disorders Rectal haemorrhage	0.31% 4/1306 • Number of events 4 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.08% 1/1302 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Gastrointestinal disorders Rectal prolapse	0.15% 2/1306 • Number of events 2 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.00% 0/1302 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Gastrointestinal disorders Retroperitoneal haematoma	0.00% 0/1306 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.08% 1/1302 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Gastrointestinal disorders Umbilical hernia	0.08% 1/1306 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.00% 0/1302 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Gastrointestinal disorders Upper gastrointestinal haemorrhage	0.15% 2/1306 • Number of events 2 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.00% 0/1302 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Gastrointestinal disorders Varices oesophageal	0.08% 1/1306 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.00% 0/1302 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Gastrointestinal disorders Volvulus of small bowel	0.08% 1/1306 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.00% 0/1302 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Gastrointestinal disorders Vomiting	0.08% 1/1306 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.00% 0/1302 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
General disorders Adverse drug reaction	0.00% 0/1306 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.08% 1/1302 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
General disorders Asthenia	0.31% 4/1306 • Number of events 4 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.23% 3/1302 • Number of events 3 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
General disorders Cardiac death	1.6% 21/1306 • Number of events 21 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	1.7% 22/1302 • Number of events 22 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
General disorders Chest pain	0.38% 5/1306 • Number of events 5 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.31% 4/1302 • Number of events 4 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
General disorders Death	7.9% 103/1306 • Number of events 103 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	6.7% 87/1302 • Number of events 88 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
General disorders Gait disturbance	0.23% 3/1306 • Number of events 3 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.00% 0/1302 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
General disorders General physical health deterioration	0.15% 2/1306 • Number of events 3 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.00% 0/1302 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
General disorders Impaired healing	0.00% 0/1306 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.08% 1/1302 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
General disorders Multimorbidity	0.08% 1/1306 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.00% 0/1302 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
General disorders Multiple organ dysfunction syndrome	0.15% 2/1306 • Number of events 2 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.15% 2/1302 • Number of events 2 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
General disorders Non-cardiac chest pain	0.46% 6/1306 • Number of events 6 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.38% 5/1302 • Number of events 5 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
General disorders Oedema	0.00% 0/1306 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.08% 1/1302 • Number of events 2 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
General disorders Oedema peripheral	0.15% 2/1306 • Number of events 2 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.15% 2/1302 • Number of events 2 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
General disorders Pacemaker generated arrhythmia	0.00% 0/1306 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.08% 1/1302 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
General disorders Pain	0.08% 1/1306 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.08% 1/1302 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
General disorders Peripheral swelling	0.08% 1/1306 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.00% 0/1302 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
General disorders Puncture site haemorrhage	0.00% 0/1306 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.08% 1/1302 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
General disorders Pyrexia	0.38% 5/1306 • Number of events 5 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.31% 4/1302 • Number of events 4 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
General disorders Sudden cardiac death	1.4% 18/1306 • Number of events 18 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	1.2% 15/1302 • Number of events 15 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
General disorders Systemic inflammatory response syndrome	0.15% 2/1306 • Number of events 2 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.00% 0/1302 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
General disorders Ulcer	0.08% 1/1306 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.00% 0/1302 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Hepatobiliary disorders Bile duct stone	0.46% 6/1306 • Number of events 7 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.23% 3/1302 • Number of events 3 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Hepatobiliary disorders Biliary colic	0.08% 1/1306 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.00% 0/1302 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Hepatobiliary disorders Biliary tract disorder	0.15% 2/1306 • Number of events 2 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.00% 0/1302 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Hepatobiliary disorders Cholangitis	0.23% 3/1306 • Number of events 3 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.23% 3/1302 • Number of events 3 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Hepatobiliary disorders Cholecystitis acute	0.61% 8/1306 • Number of events 8 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.38% 5/1302 • Number of events 5 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Hepatobiliary disorders Cholelithiasis	0.38% 5/1306 • Number of events 5 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.23% 3/1302 • Number of events 3 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Hepatobiliary disorders Cholestasis	0.08% 1/1306 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.00% 0/1302 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Hepatobiliary disorders Hepatic cyst	0.00% 0/1306 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.08% 1/1302 • Number of events 2 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Hepatobiliary disorders Hepatic lesion	0.08% 1/1306 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.00% 0/1302 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Hepatobiliary disorders Jaundice	0.00% 0/1306 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.08% 1/1302 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Hepatobiliary disorders Jaundice cholestatic	0.15% 2/1306 • Number of events 2 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.00% 0/1302 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Hepatobiliary disorders Liver disorder	0.00% 0/1306 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.08% 1/1302 • Number of events 2 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Hepatobiliary disorders Post cholecystectomy syndrome	0.08% 1/1306 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.00% 0/1302 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Immune system disorders Hypersensitivity	0.08% 1/1306 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.00% 0/1302 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Infections and infestations Abdominal infection	0.00% 0/1306 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.08% 1/1302 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Infections and infestations Appendicitis	0.15% 2/1306 • Number of events 2 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.15% 2/1302 • Number of events 2 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Infections and infestations Arthritis infective	0.00% 0/1306 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.08% 1/1302 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Infections and infestations Bacteraemia	0.08% 1/1306 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.15% 2/1302 • Number of events 2 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Infections and infestations Biliary sepsis	0.08% 1/1306 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.00% 0/1302 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Infections and infestations Brain abscess	0.08% 1/1306 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.00% 0/1302 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Infections and infestations Bronchitis	0.31% 4/1306 • Number of events 4 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.08% 1/1302 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Infections and infestations Bronchitis viral	0.08% 1/1306 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.00% 0/1302 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Infections and infestations Cellulitis	0.08% 1/1306 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.23% 3/1302 • Number of events 3 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Infections and infestations Clostridium colitis	0.08% 1/1306 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.00% 0/1302 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Infections and infestations Clostridium difficile colitis	0.08% 1/1306 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.08% 1/1302 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Infections and infestations Clostridium difficile infection	0.08% 1/1306 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.00% 0/1302 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Infections and infestations Coronavirus infection	0.08% 1/1306 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.00% 0/1302 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Infections and infestations Cystitis	0.00% 0/1306 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.08% 1/1302 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Infections and infestations Device related infection	0.08% 1/1306 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.15% 2/1302 • Number of events 2 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Infections and infestations Diverticulitis	0.46% 6/1306 • Number of events 6 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.31% 4/1302 • Number of events 4 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Infections and infestations Emphysematous pyelonephritis	0.08% 1/1306 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.00% 0/1302 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Infections and infestations Empyema	0.08% 1/1306 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.08% 1/1302 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Infections and infestations Endocarditis	0.15% 2/1306 • Number of events 2 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.23% 3/1302 • Number of events 3 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Infections and infestations Enterococcal sepsis	0.08% 1/1306 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.00% 0/1302 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Infections and infestations Erysipelas	0.23% 3/1306 • Number of events 5 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.08% 1/1302 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Infections and infestations Fungal infection	0.00% 0/1306 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.08% 1/1302 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Infections and infestations Gastric ulcer helicobacter	0.00% 0/1306 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.08% 1/1302 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Infections and infestations Gastroenteritis	0.08% 1/1306 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.00% 0/1302 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Infections and infestations Gastroenteritis rotavirus	0.00% 0/1306 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.08% 1/1302 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Infections and infestations Gastrointestinal infection	0.23% 3/1306 • Number of events 3 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.00% 0/1302 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Infections and infestations Groin abscess	0.15% 2/1306 • Number of events 2 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.08% 1/1302 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Infections and infestations Hepatic cyst infection	0.00% 0/1306 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.08% 1/1302 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Infections and infestations Hepatitis E	0.00% 0/1306 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.08% 1/1302 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Infections and infestations Herpes zoster	0.15% 2/1306 • Number of events 2 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.00% 0/1302 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Infections and infestations Implant site infection	0.00% 0/1306 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.08% 1/1302 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Infections and infestations Infection	0.31% 4/1306 • Number of events 4 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.54% 7/1302 • Number of events 8 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Infections and infestations Influenza	0.08% 1/1306 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.08% 1/1302 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Infections and infestations Intervertebral discitis	0.08% 1/1306 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.08% 1/1302 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Infections and infestations Lower respiratory tract infection	0.31% 4/1306 • Number of events 4 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.38% 5/1302 • Number of events 5 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Infections and infestations Mediastinal abscess	0.00% 0/1306 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.08% 1/1302 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Infections and infestations Myelitis	0.00% 0/1306 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.08% 1/1302 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Infections and infestations Osteomyelitis	0.08% 1/1306 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.08% 1/1302 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Infections and infestations Otitis media chronic	0.08% 1/1306 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.00% 0/1302 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Infections and infestations Pancreatic abscess	0.08% 1/1306 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.00% 0/1302 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Infections and infestations Papilloma viral infection	0.00% 0/1306 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.08% 1/1302 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Infections and infestations Pneumonia	4.4% 58/1306 • Number of events 74 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	4.3% 56/1302 • Number of events 61 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Infections and infestations Pneumonia pneumococcal	0.08% 1/1306 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.00% 0/1302 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Infections and infestations Post procedural infection	0.08% 1/1306 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.08% 1/1302 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Infections and infestations Postoperative wound infection	0.00% 0/1306 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.08% 1/1302 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Infections and infestations Pyelonephritis	0.08% 1/1306 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.08% 1/1302 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Infections and infestations Respiratory tract infection	0.46% 6/1306 • Number of events 7 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.23% 3/1302 • Number of events 3 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Infections and infestations Rhinovirus infection	0.00% 0/1306 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.08% 1/1302 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Infections and infestations Sepsis	0.23% 3/1306 • Number of events 3 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.69% 9/1302 • Number of events 9 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Infections and infestations Septic shock	0.69% 9/1306 • Number of events 9 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.38% 5/1302 • Number of events 5 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Infections and infestations Streptococcal endocarditis	0.08% 1/1306 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.00% 0/1302 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Infections and infestations Subcutaneous abscess	0.08% 1/1306 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.00% 0/1302 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Infections and infestations Superinfection	0.08% 1/1306 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.00% 0/1302 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Infections and infestations Superinfection bacterial	0.08% 1/1306 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.00% 0/1302 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Infections and infestations Urinary tract infection	1.8% 23/1306 • Number of events 25 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	1.5% 19/1302 • Number of events 21 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Infections and infestations Urosepsis	0.23% 3/1306 • Number of events 3 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.54% 7/1302 • Number of events 7 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Infections and infestations Viral infection	0.00% 0/1306 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.08% 1/1302 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Infections and infestations Wound infection	0.08% 1/1306 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.08% 1/1302 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Injury, poisoning and procedural complications Accident at home	0.00% 0/1306 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.08% 1/1302 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Injury, poisoning and procedural complications Acetabulum fracture	0.00% 0/1306 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.08% 1/1302 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Injury, poisoning and procedural complications Arterial injury	0.00% 0/1306 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.08% 1/1302 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Injury, poisoning and procedural complications Arteriovenous fistula aneurysm	0.00% 0/1306 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.08% 1/1302 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Injury, poisoning and procedural complications Cardiac procedure complication	0.00% 0/1306 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.08% 1/1302 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Injury, poisoning and procedural complications Cervical vertebral fracture	0.00% 0/1306 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.08% 1/1302 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Injury, poisoning and procedural complications Complications of transplanted kidney	0.08% 1/1306 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.00% 0/1302 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Injury, poisoning and procedural complications Compression fracture	0.08% 1/1306 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.00% 0/1302 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Injury, poisoning and procedural complications Concussion	0.08% 1/1306 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.08% 1/1302 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Injury, poisoning and procedural complications Contusion	0.23% 3/1306 • Number of events 3 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.00% 0/1302 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Injury, poisoning and procedural complications Craniocerebral injury	0.00% 0/1306 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.15% 2/1302 • Number of events 2 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Injury, poisoning and procedural complications Craniofacial fracture	0.08% 1/1306 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.15% 2/1302 • Number of events 2 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Injury, poisoning and procedural complications Fall	1.2% 16/1306 • Number of events 17 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	1.5% 20/1302 • Number of events 23 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Injury, poisoning and procedural complications Femoral neck fracture	0.23% 3/1306 • Number of events 3 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.38% 5/1302 • Number of events 5 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Injury, poisoning and procedural complications Femur fracture	0.69% 9/1306 • Number of events 9 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.77% 10/1302 • Number of events 10 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Injury, poisoning and procedural complications Fibula fracture	0.00% 0/1306 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.08% 1/1302 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Injury, poisoning and procedural complications Forearm fracture	0.00% 0/1306 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.08% 1/1302 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Injury, poisoning and procedural complications Fractured sacrum	0.00% 0/1306 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.15% 2/1302 • Number of events 2 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Injury, poisoning and procedural complications Head injury	0.31% 4/1306 • Number of events 4 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.23% 3/1302 • Number of events 3 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Injury, poisoning and procedural complications Hip fracture	0.08% 1/1306 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.00% 0/1302 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Injury, poisoning and procedural complications Humerus fracture	0.00% 0/1306 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.08% 1/1302 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Injury, poisoning and procedural complications Immunisation reaction	0.08% 1/1306 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.00% 0/1302 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Injury, poisoning and procedural complications Injury	0.23% 3/1306 • Number of events 4 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.54% 7/1302 • Number of events 7 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Injury, poisoning and procedural complications Intentional overdose	0.08% 1/1306 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.00% 0/1302 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Injury, poisoning and procedural complications Jaw fracture	0.08% 1/1306 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.00% 0/1302 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Injury, poisoning and procedural complications Joint dislocation	0.08% 1/1306 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.08% 1/1302 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Injury, poisoning and procedural complications Joint injury	0.00% 0/1306 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.08% 1/1302 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Injury, poisoning and procedural complications Limb injury	0.23% 3/1306 • Number of events 3 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.08% 1/1302 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Injury, poisoning and procedural complications Lip injury	0.08% 1/1306 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.00% 0/1302 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Injury, poisoning and procedural complications Lumbar vertebral fracture	0.15% 2/1306 • Number of events 2 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.00% 0/1302 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Injury, poisoning and procedural complications Multiple fractures	0.00% 0/1306 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.15% 2/1302 • Number of events 2 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Injury, poisoning and procedural complications Multiple injuries	0.00% 0/1306 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.08% 1/1302 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Injury, poisoning and procedural complications Nasal injury	0.08% 1/1306 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.00% 0/1302 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Injury, poisoning and procedural complications Osteoradionecrosis	0.08% 1/1306 • Number of events 2 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.00% 0/1302 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Injury, poisoning and procedural complications Patella fracture	0.08% 1/1306 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.00% 0/1302 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Injury, poisoning and procedural complications Pelvic fracture	0.23% 3/1306 • Number of events 3 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.46% 6/1302 • Number of events 7 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Injury, poisoning and procedural complications Periorbital haematoma	0.08% 1/1306 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.00% 0/1302 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Injury, poisoning and procedural complications Post procedural haematoma	0.00% 0/1306 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.08% 1/1302 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Injury, poisoning and procedural complications Post procedural haemorrhage	0.15% 2/1306 • Number of events 3 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.08% 1/1302 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Injury, poisoning and procedural complications Procedural haemorrhage	0.00% 0/1306 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.08% 1/1302 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Injury, poisoning and procedural complications Radius fracture	0.23% 3/1306 • Number of events 3 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.23% 3/1302 • Number of events 3 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Injury, poisoning and procedural complications Reactive gastropathy	0.00% 0/1306 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.08% 1/1302 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Injury, poisoning and procedural complications Rib fracture	0.15% 2/1306 • Number of events 2 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.15% 2/1302 • Number of events 2 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Injury, poisoning and procedural complications Road traffic accident	0.38% 5/1306 • Number of events 5 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.15% 2/1302 • Number of events 2 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Injury, poisoning and procedural complications Scrotal haematoma	0.08% 1/1306 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.00% 0/1302 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Injury, poisoning and procedural complications Skin laceration	0.23% 3/1306 • Number of events 3 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.00% 0/1302 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Injury, poisoning and procedural complications Skull fracture	0.08% 1/1306 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.23% 3/1302 • Number of events 3 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Injury, poisoning and procedural complications Spinal column injury	0.00% 0/1306 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.08% 1/1302 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Injury, poisoning and procedural complications Spinal fracture	0.31% 4/1306 • Number of events 4 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.15% 2/1302 • Number of events 2 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Injury, poisoning and procedural complications Sternal fracture	0.08% 1/1306 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.00% 0/1302 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Injury, poisoning and procedural complications Stoma complication	0.08% 1/1306 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.00% 0/1302 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Injury, poisoning and procedural complications Subdural haematoma	0.08% 1/1306 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.23% 3/1302 • Number of events 3 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Injury, poisoning and procedural complications Subdural haemorrhage	0.08% 1/1306 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.23% 3/1302 • Number of events 3 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Injury, poisoning and procedural complications Tibia fracture	0.08% 1/1306 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.08% 1/1302 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Injury, poisoning and procedural complications Toxicity to various agents	0.08% 1/1306 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.08% 1/1302 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Injury, poisoning and procedural complications Traumatic haematoma	0.00% 0/1306 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.08% 1/1302 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Injury, poisoning and procedural complications Vascular pseudoaneurysm	0.08% 1/1306 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.00% 0/1302 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Investigations Angiocardiogram	1.5% 20/1306 • Number of events 22 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	2.0% 26/1302 • Number of events 26 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Investigations Angiogram	0.08% 1/1306 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.31% 4/1302 • Number of events 4 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Investigations Arteriogram carotid	0.00% 0/1306 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.08% 1/1302 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Investigations Aspiration joint	0.08% 1/1306 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.08% 1/1302 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Investigations Aspiration pleural cavity	0.00% 0/1306 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.08% 1/1302 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Investigations Biopsy	0.31% 4/1306 • Number of events 4 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.08% 1/1302 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Investigations Biopsy adrenal gland	0.08% 1/1306 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.00% 0/1302 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Investigations Biopsy bladder	0.08% 1/1306 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.08% 1/1302 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Investigations Biopsy heart	0.08% 1/1306 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.00% 0/1302 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Investigations Biopsy kidney	0.08% 1/1306 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.00% 0/1302 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Investigations Biopsy lung	0.15% 2/1306 • Number of events 2 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.00% 0/1302 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Investigations Biopsy lymph gland	0.08% 1/1306 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.08% 1/1302 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Investigations Biopsy pericardium	0.08% 1/1306 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.00% 0/1302 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Investigations Biopsy prostate	0.08% 1/1306 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.00% 0/1302 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Investigations Biopsy skin	0.00% 0/1306 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.08% 1/1302 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Investigations Capsule endoscopy	0.08% 1/1306 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.08% 1/1302 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Investigations Cardiac electrophysiologic study	0.08% 1/1306 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.00% 0/1302 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Investigations Cardiac pacemaker evaluation	0.00% 0/1306 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.08% 1/1302 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Investigations Catheterisation cardiac	0.15% 2/1306 • Number of events 2 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.00% 0/1302 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Investigations Colonoscopy	2.8% 37/1306 • Number of events 45 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	1.5% 20/1302 • Number of events 21 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Investigations Coronavirus test positive	2.6% 34/1306 • Number of events 41 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	2.8% 36/1302 • Number of events 37 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Investigations Cystoscopy	0.31% 4/1306 • Number of events 4 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.00% 0/1302 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Investigations Diagnostic procedure	3.1% 40/1306 • Number of events 48 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	1.2% 16/1302 • Number of events 18 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Investigations Electrocardiogram ambulatory	0.08% 1/1306 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.00% 0/1302 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Investigations Endoscopic retrograde cholangiopancreatography	1.1% 14/1306 • Number of events 17 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.46% 6/1302 • Number of events 6 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Investigations Endoscopy small intestine	0.08% 1/1306 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.00% 0/1302 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Investigations Endoscopy upper gastrointestinal tract	4.1% 54/1306 • Number of events 64 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	1.8% 23/1302 • Number of events 27 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Investigations Human rhinovirus test positive	0.08% 1/1306 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.00% 0/1302 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Investigations Mediastinoscopy	0.08% 1/1306 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.00% 0/1302 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Investigations Oesophageal manometry	0.00% 0/1306 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.08% 1/1302 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Investigations Oesophagogastroduodenoscopy	0.08% 1/1306 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.00% 0/1302 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Investigations Paranasal biopsy	0.08% 1/1306 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.00% 0/1302 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Investigations Pneumovirus test positive	0.08% 1/1306 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.00% 0/1302 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Investigations Sleep study	0.08% 1/1306 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.00% 0/1302 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Investigations Ureteroscopy abnormal	0.00% 0/1306 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.08% 1/1302 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Investigations Venogram	0.08% 1/1306 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.00% 0/1302 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Investigations Viral test negative	7.3% 95/1306 • Number of events 130 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	7.1% 93/1302 • Number of events 122 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Investigations Weight decreased	0.08% 1/1306 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.00% 0/1302 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Metabolism and nutrition disorders Acidosis	0.08% 1/1306 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.00% 0/1302 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Metabolism and nutrition disorders Dehydration	0.46% 6/1306 • Number of events 7 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.54% 7/1302 • Number of events 8 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Metabolism and nutrition disorders Diabetes mellitus	0.31% 4/1306 • Number of events 5 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.15% 2/1302 • Number of events 3 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Metabolism and nutrition disorders Diabetes mellitus inadequate control	0.08% 1/1306 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.00% 0/1302 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Metabolism and nutrition disorders Diabetic ketoacidosis	0.08% 1/1306 • Number of events 2 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.00% 0/1302 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Metabolism and nutrition disorders Electrolyte imbalance	0.15% 2/1306 • Number of events 3 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.23% 3/1302 • Number of events 3 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Metabolism and nutrition disorders Gout	0.08% 1/1306 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.15% 2/1302 • Number of events 2 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Metabolism and nutrition disorders Hyperglycaemia	0.15% 2/1306 • Number of events 2 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.08% 1/1302 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Metabolism and nutrition disorders Hyperglycaemic hyperosmolar nonketotic syndrome	0.00% 0/1306 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.08% 1/1302 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Metabolism and nutrition disorders Hyperkalaemia	0.08% 1/1306 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.31% 4/1302 • Number of events 4 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Metabolism and nutrition disorders Hyperuricaemia	0.08% 1/1306 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.00% 0/1302 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Metabolism and nutrition disorders Hypoglycaemia	0.08% 1/1306 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.15% 2/1302 • Number of events 2 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Metabolism and nutrition disorders Hypokalaemia	0.15% 2/1306 • Number of events 2 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.15% 2/1302 • Number of events 2 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Metabolism and nutrition disorders Hyponatraemia	0.31% 4/1306 • Number of events 4 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.23% 3/1302 • Number of events 4 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Metabolism and nutrition disorders Iron deficiency	0.15% 2/1306 • Number of events 2 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.08% 1/1302 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Metabolism and nutrition disorders Metabolic acidosis	0.08% 1/1306 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.00% 0/1302 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Musculoskeletal and connective tissue disorders Arthralgia	0.08% 1/1306 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.23% 3/1302 • Number of events 4 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Musculoskeletal and connective tissue disorders Arthritis	0.15% 2/1306 • Number of events 2 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.08% 1/1302 • Number of events 2 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Musculoskeletal and connective tissue disorders Back pain	0.15% 2/1306 • Number of events 3 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.15% 2/1302 • Number of events 2 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Musculoskeletal and connective tissue disorders Bursitis	0.15% 2/1306 • Number of events 2 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.00% 0/1302 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Musculoskeletal and connective tissue disorders Cervical spinal stenosis	0.08% 1/1306 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.00% 0/1302 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Musculoskeletal and connective tissue disorders Haemarthrosis	0.23% 3/1306 • Number of events 3 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.00% 0/1302 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Musculoskeletal and connective tissue disorders Haematoma muscle	0.08% 1/1306 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.00% 0/1302 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Musculoskeletal and connective tissue disorders Intervertebral disc degeneration	0.00% 0/1306 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.08% 1/1302 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Musculoskeletal and connective tissue disorders Intervertebral disc protrusion	0.08% 1/1306 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.08% 1/1302 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Musculoskeletal and connective tissue disorders Joint effusion	0.00% 0/1306 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.08% 1/1302 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Musculoskeletal and connective tissue disorders Lumbar spinal stenosis	0.46% 6/1306 • Number of events 6 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.15% 2/1302 • Number of events 2 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Musculoskeletal and connective tissue disorders Myalgia	0.08% 1/1306 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.00% 0/1302 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Musculoskeletal and connective tissue disorders Neck pain	0.08% 1/1306 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.08% 1/1302 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Musculoskeletal and connective tissue disorders Osteoarthritis	0.61% 8/1306 • Number of events 8 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.77% 10/1302 • Number of events 10 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Musculoskeletal and connective tissue disorders Pain in extremity	0.08% 1/1306 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.00% 0/1302 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Musculoskeletal and connective tissue disorders Pseudarthrosis	0.08% 1/1306 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.00% 0/1302 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Musculoskeletal and connective tissue disorders Rhabdomyolysis	0.00% 0/1306 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.08% 1/1302 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Musculoskeletal and connective tissue disorders Rheumatoid arthritis	0.08% 1/1306 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.00% 0/1302 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Musculoskeletal and connective tissue disorders Sacroiliitis	0.00% 0/1306 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.08% 1/1302 • Number of events 2 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Abdominal neoplasm	0.08% 1/1306 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.00% 0/1302 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Acute myeloid leukaemia	0.08% 1/1306 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.00% 0/1302 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Adenocarcinoma gastric	0.23% 3/1306 • Number of events 4 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.08% 1/1302 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Adenocarcinoma of colon	0.08% 1/1306 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.00% 0/1302 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Basal cell carcinoma	0.08% 1/1306 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.08% 1/1302 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Benign neoplasm of bladder	0.00% 0/1306 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.08% 1/1302 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bladder cancer	0.23% 3/1306 • Number of events 4 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.00% 0/1302 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bladder transitional cell carcinoma recurrent	0.08% 1/1306 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.00% 0/1302 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bone cancer metastatic	0.08% 1/1306 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.00% 0/1302 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bowen's disease	0.08% 1/1306 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.00% 0/1302 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast cancer	0.08% 1/1306 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.31% 4/1302 • Number of events 4 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bronchial carcinoma	0.08% 1/1306 • Number of events 3 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.15% 2/1302 • Number of events 4 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Carcinoma in situ of skin	0.00% 0/1306 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.08% 1/1302 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Cholangiocarcinoma	0.08% 1/1306 • Number of events 2 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.00% 0/1302 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Chronic lymphocytic leukaemia	0.15% 2/1306 • Number of events 3 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.00% 0/1302 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colon cancer	0.77% 10/1306 • Number of events 14 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.15% 2/1302 • Number of events 2 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colon neoplasm	0.08% 1/1306 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.00% 0/1302 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colorectal adenoma	0.08% 1/1306 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.00% 0/1302 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Endometrial cancer	0.08% 1/1306 • Number of events 2 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.00% 0/1302 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Gammopathy	0.08% 1/1306 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.00% 0/1302 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Gastric cancer	0.23% 3/1306 • Number of events 6 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.00% 0/1302 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Gastric neoplasm	0.08% 1/1306 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.00% 0/1302 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Gastrointestinal carcinoma	0.08% 1/1306 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.00% 0/1302 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Hypergammaglobulinaemia benign monoclonal	0.00% 0/1306 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.08% 1/1302 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Laryngeal cancer	0.15% 2/1306 • Number of events 5 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.08% 1/1302 • Number of events 2 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lipoma	0.00% 0/1306 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.08% 1/1302 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung cancer metastatic	0.15% 2/1306 • Number of events 2 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.00% 0/1302 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung neoplasm malignant	0.61% 8/1306 • Number of events 11 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.46% 6/1302 • Number of events 9 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lymphoma	0.08% 1/1306 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.00% 0/1302 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Meningioma	0.08% 1/1306 • Number of events 2 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.00% 0/1302 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Mesothelioma malignant	0.08% 1/1306 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.00% 0/1302 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to bone	0.15% 2/1306 • Number of events 2 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.15% 2/1302 • Number of events 2 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to central nervous system	0.00% 0/1306 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.08% 1/1302 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to liver	0.00% 0/1306 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.15% 2/1302 • Number of events 2 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to lung	0.08% 1/1306 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.08% 1/1302 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to lymph nodes	0.08% 1/1306 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.08% 1/1302 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to pancreas	0.08% 1/1306 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.00% 0/1302 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to pleura	0.00% 0/1306 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.08% 1/1302 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to the mediastinum	0.00% 0/1306 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.08% 1/1302 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastasis	0.54% 7/1306 • Number of events 7 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.15% 2/1302 • Number of events 2 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Myelodysplastic syndrome	0.08% 1/1306 • Number of events 2 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.00% 0/1302 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Myelofibrosis	0.08% 1/1306 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.00% 0/1302 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Nasal sinus cancer	0.08% 1/1306 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.00% 0/1302 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasm	0.08% 1/1306 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.00% 0/1302 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasm malignant	0.08% 1/1306 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.23% 3/1302 • Number of events 3 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Non-Hodgkin's lymphoma	0.00% 0/1306 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.08% 1/1302 • Number of events 2 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Oesophageal adenocarcinoma	0.00% 0/1306 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.08% 1/1302 • Number of events 2 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Oesophageal carcinoma	0.00% 0/1306 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.15% 2/1302 • Number of events 2 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Ovarian adenoma	0.08% 1/1306 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.00% 0/1302 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Ovarian cancer	0.08% 1/1306 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.00% 0/1302 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Pancreatic carcinoma	0.38% 5/1306 • Number of events 7 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.08% 1/1302 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Pancreatic carcinoma metastatic	0.15% 2/1306 • Number of events 2 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.00% 0/1302 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Pancreatic neoplasm	0.31% 4/1306 • Number of events 4 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.00% 0/1302 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Pharyngeal cancer	0.00% 0/1306 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.08% 1/1302 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Plasma cell myeloma	0.00% 0/1306 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.08% 1/1302 • Number of events 4 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Pleural mesothelioma	0.00% 0/1306 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.08% 1/1302 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Pleural mesothelioma malignant	0.08% 1/1306 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.00% 0/1302 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate cancer	0.69% 9/1306 • Number of events 9 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.23% 3/1302 • Number of events 4 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate cancer metastatic	0.15% 2/1306 • Number of events 2 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.08% 1/1302 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Rectal adenocarcinoma	0.08% 1/1306 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.08% 1/1302 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Rectal cancer	0.15% 2/1306 • Number of events 2 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.00% 0/1302 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Rectal neoplasm	0.08% 1/1306 • Number of events 3 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.00% 0/1302 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Rectosigmoid cancer	0.00% 0/1306 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.15% 2/1302 • Number of events 2 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Renal cancer	0.15% 2/1306 • Number of events 2 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.00% 0/1302 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Renal cancer stage IV	0.00% 0/1306 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.08% 1/1302 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Renal neoplasm	0.08% 1/1306 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.00% 0/1302 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Salivary gland cancer	0.00% 0/1306 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.08% 1/1302 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Salivary gland neoplasm	0.08% 1/1306 • Number of events 2 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.08% 1/1302 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous cell carcinoma	0.23% 3/1306 • Number of events 4 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.15% 2/1302 • Number of events 3 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous cell carcinoma of head and neck	0.08% 1/1306 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.00% 0/1302 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous cell carcinoma of lung	0.08% 1/1306 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.00% 0/1302 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous cell carcinoma of skin	0.00% 0/1306 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.08% 1/1302 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous cell carcinoma of the oral cavity	0.08% 1/1306 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.00% 0/1302 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tongue neoplasm malignant stage unspecified	0.08% 1/1306 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.00% 0/1302 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tonsil cancer	0.08% 1/1306 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.08% 1/1302 • Number of events 4 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Transitional cell carcinoma	0.15% 2/1306 • Number of events 4 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.08% 1/1302 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumour haemorrhage	0.00% 0/1306 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.08% 1/1302 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Vaginal cancer	0.08% 1/1306 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.00% 0/1302 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Nervous system disorders Amnesia	0.00% 0/1306 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.08% 1/1302 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Nervous system disorders Carotid artery aneurysm	0.00% 0/1306 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.08% 1/1302 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Nervous system disorders Carotid artery stenosis	0.08% 1/1306 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.15% 2/1302 • Number of events 2 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Nervous system disorders Carpal tunnel syndrome	0.08% 1/1306 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.08% 1/1302 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Nervous system disorders Cauda equina syndrome	0.00% 0/1306 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.08% 1/1302 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Nervous system disorders Cerebellar haemorrhage	0.08% 1/1306 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.08% 1/1302 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Nervous system disorders Cerebral haematoma	0.08% 1/1306 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.00% 0/1302 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Nervous system disorders Cerebral haemorrhage	0.15% 2/1306 • Number of events 2 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.23% 3/1302 • Number of events 3 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Nervous system disorders Cerebral small vessel ischaemic disease	0.15% 2/1306 • Number of events 2 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.08% 1/1302 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Nervous system disorders Cerebrovascular accident	0.00% 0/1306 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.08% 1/1302 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Nervous system disorders Cervicobrachial syndrome	0.00% 0/1306 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.08% 1/1302 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Nervous system disorders Cognitive disorder	0.08% 1/1306 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.00% 0/1302 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Nervous system disorders Dementia	0.08% 1/1306 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.15% 2/1302 • Number of events 2 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Nervous system disorders Dementia Alzheimer's type	0.08% 1/1306 • Number of events 2 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.08% 1/1302 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Nervous system disorders Diabetic neuropathy	0.08% 1/1306 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.00% 0/1302 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Nervous system disorders Disturbance in attention	0.00% 0/1306 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.08% 1/1302 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Nervous system disorders Dizziness	0.31% 4/1306 • Number of events 4 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.08% 1/1302 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Nervous system disorders Embolic stroke	0.54% 7/1306 • Number of events 7 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.69% 9/1302 • Number of events 9 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Nervous system disorders Epilepsy	0.31% 4/1306 • Number of events 4 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.08% 1/1302 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Nervous system disorders Guillain-Barre syndrome	0.08% 1/1306 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.00% 0/1302 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Nervous system disorders Haemorrhage intracranial	0.08% 1/1306 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.00% 0/1302 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Nervous system disorders Haemorrhagic stroke	0.00% 0/1306 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.08% 1/1302 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Nervous system disorders Haemorrhagic transformation stroke	0.00% 0/1306 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.08% 1/1302 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Nervous system disorders Headache	0.08% 1/1306 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.15% 2/1302 • Number of events 3 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Nervous system disorders Ischaemic stroke	1.9% 25/1306 • Number of events 25 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	2.2% 29/1302 • Number of events 30 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Nervous system disorders Lacunar stroke	0.00% 0/1306 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.08% 1/1302 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Nervous system disorders Loss of consciousness	0.00% 0/1306 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.15% 2/1302 • Number of events 2 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Nervous system disorders Memory impairment	0.08% 1/1306 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.00% 0/1302 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Nervous system disorders Metabolic encephalopathy	0.00% 0/1306 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.08% 1/1302 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Nervous system disorders Nervous system disorder	0.08% 1/1306 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.00% 0/1302 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Nervous system disorders Nystagmus	0.08% 1/1306 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.00% 0/1302 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Nervous system disorders Paraplegia	0.00% 0/1306 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.08% 1/1302 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Nervous system disorders Parkinson's disease	0.15% 2/1306 • Number of events 2 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.15% 2/1302 • Number of events 2 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Nervous system disorders Parkinsonism	0.08% 1/1306 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.00% 0/1302 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Nervous system disorders Polyneuropathy	0.15% 2/1306 • Number of events 3 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.00% 0/1302 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Nervous system disorders Presyncope	0.15% 2/1306 • Number of events 2 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.08% 1/1302 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Nervous system disorders Restless legs syndrome	0.00% 0/1306 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.08% 1/1302 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Nervous system disorders Sciatica	0.23% 3/1306 • Number of events 3 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.31% 4/1302 • Number of events 4 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Nervous system disorders Seizure	0.08% 1/1306 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.08% 1/1302 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Nervous system disorders Speech disorder	0.08% 1/1306 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.00% 0/1302 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Nervous system disorders Subarachnoid haemorrhage	0.15% 2/1306 • Number of events 2 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.31% 4/1302 • Number of events 4 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Nervous system disorders Syncope	0.69% 9/1306 • Number of events 11 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.69% 9/1302 • Number of events 9 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Nervous system disorders Transient global amnesia	0.08% 1/1306 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.00% 0/1302 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Nervous system disorders Transient ischaemic attack	0.46% 6/1306 • Number of events 7 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.38% 5/1302 • Number of events 5 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Product Issues Device dislocation	0.08% 1/1306 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.00% 0/1302 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Product Issues Device inappropriate shock delivery	0.08% 1/1306 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.00% 0/1302 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Product Issues Device lead issue	0.23% 3/1306 • Number of events 3 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.31% 4/1302 • Number of events 4 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Product Issues Device malfunction	0.08% 1/1306 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.00% 0/1302 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Product Issues Device occlusion	0.08% 1/1306 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.00% 0/1302 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Product Issues Lead dislodgement	0.08% 1/1306 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.31% 4/1302 • Number of events 4 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Product Issues Undersensing	0.00% 0/1306 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.08% 1/1302 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Psychiatric disorders Aggression	0.08% 1/1306 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.00% 0/1302 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Psychiatric disorders Agitation	0.15% 2/1306 • Number of events 2 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.00% 0/1302 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Psychiatric disorders Chronic idiopathic pain syndrome	0.00% 0/1306 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.08% 1/1302 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Psychiatric disorders Completed suicide	0.08% 1/1306 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.00% 0/1302 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Psychiatric disorders Confusional state	0.08% 1/1306 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.00% 0/1302 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Psychiatric disorders Delirium	0.00% 0/1306 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.15% 2/1302 • Number of events 2 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Psychiatric disorders Depression	0.00% 0/1306 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.15% 2/1302 • Number of events 2 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Psychiatric disorders Disorientation	0.08% 1/1306 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.00% 0/1302 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Psychiatric disorders Disturbance in social behaviour	0.08% 1/1306 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.00% 0/1302 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Psychiatric disorders Drug abuse	0.08% 1/1306 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.00% 0/1302 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Psychiatric disorders Drug dependence	0.08% 1/1306 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.00% 0/1302 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Psychiatric disorders Insomnia	0.08% 1/1306 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.00% 0/1302 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Psychiatric disorders Mental disorder	0.00% 0/1306 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.15% 2/1302 • Number of events 2 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Psychiatric disorders Suicide attempt	0.08% 1/1306 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.15% 2/1302 • Number of events 2 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Renal and urinary disorders Acute kidney injury	1.1% 14/1306 • Number of events 14 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	1.00% 13/1302 • Number of events 14 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Renal and urinary disorders Bladder disorder	0.08% 1/1306 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.00% 0/1302 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Renal and urinary disorders Calculus urinary	0.08% 1/1306 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.00% 0/1302 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Renal and urinary disorders Chronic kidney disease	0.15% 2/1306 • Number of events 2 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.46% 6/1302 • Number of events 7 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Renal and urinary disorders Dysuria	0.08% 1/1306 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.00% 0/1302 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Renal and urinary disorders Haematuria	0.69% 9/1306 • Number of events 13 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.61% 8/1302 • Number of events 10 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Renal and urinary disorders Hydronephrosis	0.08% 1/1306 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.00% 0/1302 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Renal and urinary disorders Nephrolithiasis	0.08% 1/1306 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.08% 1/1302 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Renal and urinary disorders Nephropathy toxic	0.08% 1/1306 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.00% 0/1302 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Renal and urinary disorders Nocturia	0.08% 1/1306 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.00% 0/1302 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Renal and urinary disorders Prerenal failure	0.00% 0/1306 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.08% 1/1302 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Renal and urinary disorders Renal failure	0.46% 6/1306 • Number of events 6 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.38% 5/1302 • Number of events 6 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Renal and urinary disorders Renal impairment	0.00% 0/1306 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.08% 1/1302 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Renal and urinary disorders Renal pelvis fistula	0.08% 1/1306 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.00% 0/1302 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Renal and urinary disorders Ureteric stenosis	0.08% 1/1306 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.00% 0/1302 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Renal and urinary disorders Ureterolithiasis	0.08% 1/1306 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.08% 1/1302 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Renal and urinary disorders Urethral haemorrhage	0.08% 1/1306 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.00% 0/1302 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Renal and urinary disorders Urinary bladder haemorrhage	0.15% 2/1306 • Number of events 2 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.15% 2/1302 • Number of events 2 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Renal and urinary disorders Urinary retention	0.31% 4/1306 • Number of events 4 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.00% 0/1302 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Reproductive system and breast disorders Benign prostatic hyperplasia	0.23% 3/1306 • Number of events 3 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.00% 0/1302 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Reproductive system and breast disorders Genital lesion	0.00% 0/1306 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.08% 1/1302 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Reproductive system and breast disorders Prostatitis	0.15% 2/1306 • Number of events 2 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.08% 1/1302 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Reproductive system and breast disorders Uterine prolapse	0.08% 1/1306 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.00% 0/1302 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Reproductive system and breast disorders Vaginal haemorrhage	0.08% 1/1306 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.00% 0/1302 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Reproductive system and breast disorders Vaginal prolapse	0.08% 1/1306 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.00% 0/1302 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Respiratory, thoracic and mediastinal disorders Acute respiratory distress syndrome	0.00% 0/1306 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.08% 1/1302 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Respiratory, thoracic and mediastinal disorders Aspiration	0.15% 2/1306 • Number of events 2 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.15% 2/1302 • Number of events 2 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Respiratory, thoracic and mediastinal disorders Asthma	0.15% 2/1306 • Number of events 2 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.15% 2/1302 • Number of events 2 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	0.61% 8/1306 • Number of events 9 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.61% 8/1302 • Number of events 10 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Respiratory, thoracic and mediastinal disorders Cough	0.08% 1/1306 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.00% 0/1302 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Respiratory, thoracic and mediastinal disorders Cystic lung disease	0.08% 1/1306 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.00% 0/1302 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.61% 8/1306 • Number of events 9 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.61% 8/1302 • Number of events 8 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Respiratory, thoracic and mediastinal disorders Emphysema	0.15% 2/1306 • Number of events 2 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.00% 0/1302 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Respiratory, thoracic and mediastinal disorders Epistaxis	0.38% 5/1306 • Number of events 5 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.15% 2/1302 • Number of events 2 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Respiratory, thoracic and mediastinal disorders Haemoptysis	0.15% 2/1306 • Number of events 2 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.08% 1/1302 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Respiratory, thoracic and mediastinal disorders Haemothorax	0.15% 2/1306 • Number of events 3 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.00% 0/1302 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Respiratory, thoracic and mediastinal disorders Interstitial lung disease	0.08% 1/1306 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.00% 0/1302 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Respiratory, thoracic and mediastinal disorders Nasal septum deviation	0.00% 0/1306 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.08% 1/1302 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Respiratory, thoracic and mediastinal disorders Obstructive sleep apnoea syndrome	0.08% 1/1306 • Number of events 2 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.00% 0/1302 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.61% 8/1306 • Number of events 8 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.61% 8/1302 • Number of events 10 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Respiratory, thoracic and mediastinal disorders Pneumonitis	0.08% 1/1306 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.08% 1/1302 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Respiratory, thoracic and mediastinal disorders Pneumothorax	0.15% 2/1306 • Number of events 2 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.00% 0/1302 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.23% 3/1306 • Number of events 3 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.77% 10/1302 • Number of events 10 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Respiratory, thoracic and mediastinal disorders Pulmonary fibrosis	0.08% 1/1306 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.08% 1/1302 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Respiratory, thoracic and mediastinal disorders Pulmonary hypertension	0.08% 1/1306 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.08% 1/1302 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Respiratory, thoracic and mediastinal disorders Pulmonary mass	0.08% 1/1306 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.00% 0/1302 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Respiratory, thoracic and mediastinal disorders Pulmonary oedema	0.15% 2/1306 • Number of events 2 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.00% 0/1302 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Respiratory, thoracic and mediastinal disorders Respiratory acidosis	0.08% 1/1306 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.00% 0/1302 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Respiratory, thoracic and mediastinal disorders Respiratory failure	0.84% 11/1306 • Number of events 11 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.54% 7/1302 • Number of events 7 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Respiratory, thoracic and mediastinal disorders Restrictive pulmonary disease	0.08% 1/1306 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.00% 0/1302 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Respiratory, thoracic and mediastinal disorders Sleep apnoea syndrome	0.15% 2/1306 • Number of events 3 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.08% 1/1302 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Respiratory, thoracic and mediastinal disorders Thoracic haemorrhage	0.00% 0/1306 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.08% 1/1302 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Skin and subcutaneous tissue disorders Actinic keratosis	0.08% 1/1306 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.08% 1/1302 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Skin and subcutaneous tissue disorders Diabetic foot	0.31% 4/1306 • Number of events 6 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.08% 1/1302 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Skin and subcutaneous tissue disorders Erythema	0.00% 0/1306 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.08% 1/1302 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Skin and subcutaneous tissue disorders Haemorrhage subcutaneous	0.00% 0/1306 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.08% 1/1302 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Skin and subcutaneous tissue disorders Hyperkeratosis	0.00% 0/1306 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.08% 1/1302 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Skin and subcutaneous tissue disorders Rash	0.00% 0/1306 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.08% 1/1302 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Skin and subcutaneous tissue disorders Skin ulcer	0.15% 2/1306 • Number of events 2 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.08% 1/1302 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Surgical and medical procedures Abdominal cavity drainage	0.00% 0/1306 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.08% 1/1302 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Surgical and medical procedures Abdominal wall operation	0.08% 1/1306 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.00% 0/1302 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Surgical and medical procedures Abscess drainage	0.08% 1/1306 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.08% 1/1302 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Surgical and medical procedures Amputation	0.08% 1/1306 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.00% 0/1302 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Surgical and medical procedures Anal lesion excision	0.08% 1/1306 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.00% 0/1302 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Surgical and medical procedures Aneurysm repair	0.08% 1/1306 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.08% 1/1302 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Surgical and medical procedures Angioplasty	0.38% 5/1306 • Number of events 7 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.38% 5/1302 • Number of events 5 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Surgical and medical procedures Aortic aneurysm repair	0.31% 4/1306 • Number of events 4 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.00% 0/1302 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Surgical and medical procedures Aortic bypass	0.00% 0/1306 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.08% 1/1302 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Surgical and medical procedures Aortic stent insertion	0.08% 1/1306 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.00% 0/1302 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Surgical and medical procedures Aortic valve replacement	0.23% 3/1306 • Number of events 3 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.15% 2/1302 • Number of events 2 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Surgical and medical procedures Appendicectomy	0.15% 2/1306 • Number of events 2 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.23% 3/1302 • Number of events 3 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Surgical and medical procedures Arterial aneurysm repair	0.00% 0/1306 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.08% 1/1302 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Surgical and medical procedures Arterial stent insertion	0.08% 1/1306 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.00% 0/1302 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Surgical and medical procedures Arteriovenous fistula operation	0.00% 0/1306 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.08% 1/1302 • Number of events 2 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Surgical and medical procedures Arthrodesis	0.00% 0/1306 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.08% 1/1302 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Surgical and medical procedures Atrial appendage closure	0.31% 4/1306 • Number of events 4 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.08% 1/1302 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Surgical and medical procedures Bile duct stent insertion	0.08% 1/1306 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.08% 1/1302 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Surgical and medical procedures Bile duct stent removal	0.08% 1/1306 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.08% 1/1302 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Surgical and medical procedures Biliary catheter insertion	0.08% 1/1306 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.00% 0/1302 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Surgical and medical procedures Bladder catheter removal	0.15% 2/1306 • Number of events 2 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.00% 0/1302 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Surgical and medical procedures Bladder catheter temporary	0.08% 1/1306 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.08% 1/1302 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Surgical and medical procedures Bladder catheterisation	0.23% 3/1306 • Number of events 3 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.08% 1/1302 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Surgical and medical procedures Bladder neoplasm surgery	0.23% 3/1306 • Number of events 3 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.00% 0/1302 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Surgical and medical procedures Bladder polypectomy	0.08% 1/1306 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.00% 0/1302 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Surgical and medical procedures Brachytherapy	0.08% 1/1306 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.08% 1/1302 • Number of events 2 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Surgical and medical procedures Breast conserving surgery	0.00% 0/1306 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.15% 2/1302 • Number of events 2 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Surgical and medical procedures Breast prosthesis removal	0.08% 1/1306 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.00% 0/1302 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Surgical and medical procedures Bunion operation	0.08% 1/1306 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.00% 0/1302 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Surgical and medical procedures Bursa removal	0.08% 1/1306 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.00% 0/1302 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Surgical and medical procedures Cancer surgery	0.23% 3/1306 • Number of events 3 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.23% 3/1302 • Number of events 3 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Surgical and medical procedures Cardiac ablation	1.1% 15/1306 • Number of events 16 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	1.2% 15/1302 • Number of events 15 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Surgical and medical procedures Cardiac pacemaker adjustment	0.08% 1/1306 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.23% 3/1302 • Number of events 3 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Surgical and medical procedures Cardiac pacemaker insertion	0.23% 3/1306 • Number of events 3 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.08% 1/1302 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Surgical and medical procedures Cardiac pacemaker removal	0.15% 2/1306 • Number of events 2 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.31% 4/1302 • Number of events 4 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Surgical and medical procedures Cardiac pacemaker replacement	2.9% 38/1306 • Number of events 39 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	4.4% 57/1302 • Number of events 58 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Surgical and medical procedures Cardiac resynchronisation therapy	1.5% 19/1306 • Number of events 20 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	1.00% 13/1302 • Number of events 14 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Surgical and medical procedures Cardioversion	1.6% 21/1306 • Number of events 29 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	1.6% 21/1302 • Number of events 22 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Surgical and medical procedures Carotid endarterectomy	0.08% 1/1306 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.08% 1/1302 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Surgical and medical procedures Cataract operation	0.00% 0/1306 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.15% 2/1302 • Number of events 2 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Surgical and medical procedures Central venous catheter removal	0.00% 0/1306 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.08% 1/1302 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Surgical and medical procedures Central venous catheterisation	0.08% 1/1306 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.08% 1/1302 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Surgical and medical procedures Chemotherapy	0.08% 1/1306 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.00% 0/1302 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Surgical and medical procedures Cholecystectomy	0.84% 11/1306 • Number of events 11 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.46% 6/1302 • Number of events 6 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Surgical and medical procedures Cholelithotomy	0.08% 1/1306 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.00% 0/1302 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Surgical and medical procedures Circumcision	0.08% 1/1306 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.00% 0/1302 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Surgical and medical procedures Colectomy	0.61% 8/1306 • Number of events 9 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.23% 3/1302 • Number of events 3 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Surgical and medical procedures Colostomy	0.08% 1/1306 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.08% 1/1302 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Surgical and medical procedures Coronary angioplasty	0.23% 3/1306 • Number of events 3 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.15% 2/1302 • Number of events 3 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Surgical and medical procedures Coronary arterial stent insertion	2.2% 29/1306 • Number of events 32 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	2.1% 27/1302 • Number of events 30 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Surgical and medical procedures Coronary artery bypass	0.38% 5/1306 • Number of events 5 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.31% 4/1302 • Number of events 4 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Surgical and medical procedures Corpora cavernosa surgery	0.08% 1/1306 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.00% 0/1302 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Surgical and medical procedures Craniectomy	0.08% 1/1306 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.00% 0/1302 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Surgical and medical procedures Cyst drainage	0.00% 0/1306 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.08% 1/1302 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Surgical and medical procedures Cytoreductive surgery	0.00% 0/1306 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.15% 2/1302 • Number of events 2 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Surgical and medical procedures Debridement	0.08% 1/1306 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.08% 1/1302 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Surgical and medical procedures Duodenal sphincterotomy	0.15% 2/1306 • Number of events 2 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.00% 0/1302 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Surgical and medical procedures Duodenectomy	0.08% 1/1306 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.00% 0/1302 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Surgical and medical procedures Ear tube insertion	0.08% 1/1306 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.00% 0/1302 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Surgical and medical procedures Electrocoagulation	0.08% 1/1306 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.00% 0/1302 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Surgical and medical procedures Endarterectomy	0.23% 3/1306 • Number of events 3 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.08% 1/1302 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Surgical and medical procedures Eventration repair	0.00% 0/1306 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.08% 1/1302 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Surgical and medical procedures Eyelid operation	0.08% 1/1306 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.00% 0/1302 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Surgical and medical procedures Foot amputation	0.08% 1/1306 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.08% 1/1302 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Surgical and medical procedures Gastrectomy	0.15% 2/1306 • Number of events 3 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.08% 1/1302 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Surgical and medical procedures Gastrointestinal endoscopic therapy	0.08% 1/1306 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.00% 0/1302 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Surgical and medical procedures Gastrostomy	0.00% 0/1306 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.08% 1/1302 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Surgical and medical procedures Glossectomy	0.08% 1/1306 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.00% 0/1302 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Surgical and medical procedures Haematoma evacuation	0.00% 0/1306 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.08% 1/1302 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Surgical and medical procedures Haemodialysis	0.08% 1/1306 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.08% 1/1302 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Surgical and medical procedures Haemorrhoid operation	0.15% 2/1306 • Number of events 2 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.08% 1/1302 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Surgical and medical procedures Hernia repair	0.08% 1/1306 • Number of events 2 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.23% 3/1302 • Number of events 3 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Surgical and medical procedures High frequency ablation	0.15% 2/1306 • Number of events 2 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.00% 0/1302 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Surgical and medical procedures Hip arthroplasty	1.2% 16/1306 • Number of events 17 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.84% 11/1302 • Number of events 11 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Surgical and medical procedures Hip surgery	0.15% 2/1306 • Number of events 2 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.00% 0/1302 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Surgical and medical procedures Hospitalisation	0.23% 3/1306 • Number of events 3 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.15% 2/1302 • Number of events 2 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Surgical and medical procedures Ileostomy	0.00% 0/1306 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.08% 1/1302 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Surgical and medical procedures Immunochemotherapy	0.08% 1/1306 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.00% 0/1302 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Surgical and medical procedures Infiltration anaesthesia	0.00% 0/1306 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.08% 1/1302 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Surgical and medical procedures Inguinal hernia repair	0.23% 3/1306 • Number of events 3 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.31% 4/1302 • Number of events 4 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Surgical and medical procedures Internal fixation of fracture	0.69% 9/1306 • Number of events 10 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.69% 9/1302 • Number of events 9 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Surgical and medical procedures Intestinal operation	0.00% 0/1306 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.08% 1/1302 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Surgical and medical procedures Intra-aortic balloon placement	0.08% 1/1306 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.00% 0/1302 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Surgical and medical procedures Intraocular lens implant	0.00% 0/1306 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.08% 1/1302 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Surgical and medical procedures Jejunectomy	0.08% 1/1306 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.00% 0/1302 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Surgical and medical procedures Joint fluid drainage	0.08% 1/1306 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.00% 0/1302 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Surgical and medical procedures Knee arthroplasty	0.46% 6/1306 • Number of events 6 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.46% 6/1302 • Number of events 6 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Surgical and medical procedures Knee operation	0.08% 1/1306 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.31% 4/1302 • Number of events 4 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Surgical and medical procedures Laparoscopic surgery	0.15% 2/1306 • Number of events 2 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.08% 1/1302 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Surgical and medical procedures Laparotomy	0.38% 5/1306 • Number of events 5 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.08% 1/1302 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Surgical and medical procedures Large intestinal polypectomy	0.23% 3/1306 • Number of events 3 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.15% 2/1302 • Number of events 2 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Surgical and medical procedures Laryngeal operation	0.08% 1/1306 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.08% 1/1302 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Surgical and medical procedures Laryngeal prosthesis placement	0.00% 0/1306 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.08% 1/1302 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Surgical and medical procedures Laryngectomy	0.15% 2/1306 • Number of events 2 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.08% 1/1302 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Surgical and medical procedures Lesion excision	0.00% 0/1306 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.08% 1/1302 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Surgical and medical procedures Limb amputation	0.15% 2/1306 • Number of events 2 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.08% 1/1302 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Surgical and medical procedures Lithotripsy	0.00% 0/1306 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.08% 1/1302 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Surgical and medical procedures Liver ablation	0.08% 1/1306 • Number of events 3 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.00% 0/1302 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Surgical and medical procedures Liver operation	0.00% 0/1306 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.08% 1/1302 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Surgical and medical procedures Lung lobectomy	0.23% 3/1306 • Number of events 3 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.00% 0/1302 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Surgical and medical procedures Lymphadenectomy	0.08% 1/1306 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.23% 3/1302 • Number of events 3 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Surgical and medical procedures Mammoplasty	0.08% 1/1306 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.00% 0/1302 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Surgical and medical procedures Medical device implantation	0.08% 1/1306 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.00% 0/1302 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Surgical and medical procedures Meningioma surgery	0.08% 1/1306 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.00% 0/1302 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Surgical and medical procedures Mitral valve repair	0.23% 3/1306 • Number of events 4 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.23% 3/1302 • Number of events 3 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Surgical and medical procedures Neck dissection	0.00% 0/1306 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.08% 1/1302 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Surgical and medical procedures Nephrectomy	0.08% 1/1306 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.08% 1/1302 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Surgical and medical procedures Nephrostomy	0.08% 1/1306 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.00% 0/1302 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Surgical and medical procedures Oesophageal dilation procedure	0.00% 0/1306 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.08% 1/1302 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Surgical and medical procedures Oesophageal prosthesis insertion	0.00% 0/1306 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.08% 1/1302 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Surgical and medical procedures Orthopaedic procedure	0.00% 0/1306 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.08% 1/1302 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Surgical and medical procedures Pancreaticoduodenectomy	0.08% 1/1306 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.00% 0/1302 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Surgical and medical procedures Paracentesis	0.08% 1/1306 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.00% 0/1302 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Surgical and medical procedures Parathyroidectomy	0.08% 1/1306 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.00% 0/1302 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Surgical and medical procedures Parotidectomy	0.08% 1/1306 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.08% 1/1302 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Surgical and medical procedures Pelvic operation	0.00% 0/1306 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.08% 1/1302 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Surgical and medical procedures Percutaneous coronary intervention	2.1% 28/1306 • Number of events 33 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	2.8% 36/1302 • Number of events 39 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Surgical and medical procedures Pericardial drainage	0.08% 1/1306 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.00% 0/1302 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Surgical and medical procedures Peripheral artery angioplasty	0.31% 4/1306 • Number of events 4 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.23% 3/1302 • Number of events 3 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Surgical and medical procedures Peripheral artery bypass	0.08% 1/1306 • Number of events 2 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.08% 1/1302 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Surgical and medical procedures Peripheral artery stent insertion	0.23% 3/1306 • Number of events 3 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.31% 4/1302 • Number of events 4 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Surgical and medical procedures Peripheral nerve destruction	0.08% 1/1306 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.00% 0/1302 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Surgical and medical procedures Pharyngeal fistula repair	0.08% 1/1306 • Number of events 2 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.00% 0/1302 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Surgical and medical procedures Pharyngeal operation	0.08% 1/1306 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.00% 0/1302 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Surgical and medical procedures Pleurectomy	0.08% 1/1306 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.00% 0/1302 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Surgical and medical procedures Polypectomy	0.15% 2/1306 • Number of events 2 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.08% 1/1302 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Surgical and medical procedures Positive airway pressure therapy	0.08% 1/1306 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.00% 0/1302 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Surgical and medical procedures Proctectomy	0.38% 5/1306 • Number of events 5 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.00% 0/1302 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Surgical and medical procedures Prostatectomy	0.08% 1/1306 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.15% 2/1302 • Number of events 2 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Surgical and medical procedures Ptosis repair	0.00% 0/1306 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.08% 1/1302 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Surgical and medical procedures Radiotherapy	0.15% 2/1306 • Number of events 2 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.00% 0/1302 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Surgical and medical procedures Radiotherapy to lung	0.00% 0/1306 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.08% 1/1302 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Surgical and medical procedures Radiotherapy to rectum	0.08% 1/1306 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.00% 0/1302 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Surgical and medical procedures Rectal prolapse repair	0.15% 2/1306 • Number of events 2 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.00% 0/1302 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Surgical and medical procedures Removal of internal fixation	0.08% 1/1306 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.00% 0/1302 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Surgical and medical procedures Renal stone removal	0.08% 1/1306 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.08% 1/1302 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Surgical and medical procedures Resuscitation	0.08% 1/1306 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.38% 5/1302 • Number of events 5 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Surgical and medical procedures Shoulder operation	0.00% 0/1306 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.08% 1/1302 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Surgical and medical procedures Skin neoplasm excision	0.31% 4/1306 • Number of events 4 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.23% 3/1302 • Number of events 3 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Surgical and medical procedures Small intestinal resection	0.08% 1/1306 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.00% 0/1302 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Surgical and medical procedures Spinal decompression	0.23% 3/1306 • Number of events 3 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.00% 0/1302 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Surgical and medical procedures Spinal laminectomy	0.00% 0/1306 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.08% 1/1302 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Surgical and medical procedures Spinal operation	0.23% 3/1306 • Number of events 3 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.31% 4/1302 • Number of events 5 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Surgical and medical procedures Surgery	0.15% 2/1306 • Number of events 2 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.08% 1/1302 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Surgical and medical procedures Therapeutic procedure	1.2% 16/1306 • Number of events 22 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.46% 6/1302 • Number of events 7 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Surgical and medical procedures Thoracic cavity drainage	0.15% 2/1306 • Number of events 2 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.15% 2/1302 • Number of events 3 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Surgical and medical procedures Thrombectomy	0.15% 2/1306 • Number of events 2 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.38% 5/1302 • Number of events 5 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Surgical and medical procedures Thrombolysis	0.00% 0/1306 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.31% 4/1302 • Number of events 4 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Surgical and medical procedures Thyroidectomy	0.08% 1/1306 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.00% 0/1302 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Surgical and medical procedures Toe amputation	0.00% 0/1306 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.08% 1/1302 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Surgical and medical procedures Tracheostomy	0.00% 0/1306 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.08% 1/1302 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Surgical and medical procedures Transcatheter aortic valve implantation	0.46% 6/1306 • Number of events 6 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.38% 5/1302 • Number of events 5 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Surgical and medical procedures Transfusion	4.4% 58/1306 • Number of events 78 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	2.2% 28/1302 • Number of events 37 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Surgical and medical procedures Transurethral bladder resection	0.69% 9/1306 • Number of events 11 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.31% 4/1302 • Number of events 5 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Surgical and medical procedures Transurethral prostatectomy	0.38% 5/1306 • Number of events 5 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.15% 2/1302 • Number of events 3 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Surgical and medical procedures Tumour excision	0.08% 1/1306 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.00% 0/1302 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Surgical and medical procedures Umbilical hernia repair	0.08% 1/1306 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.00% 0/1302 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Surgical and medical procedures Ureteral stent insertion	0.31% 4/1306 • Number of events 4 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.15% 2/1302 • Number of events 2 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Surgical and medical procedures Ureteral stent removal	0.00% 0/1306 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.08% 1/1302 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Surgical and medical procedures Urethrotomy	0.08% 1/1306 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.00% 0/1302 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Surgical and medical procedures Urinary cystectomy	0.15% 2/1306 • Number of events 2 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.00% 0/1302 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Surgical and medical procedures Urinary incontinence surgery	0.08% 1/1306 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.00% 0/1302 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Surgical and medical procedures Uterine prolapse repair	0.08% 1/1306 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.00% 0/1302 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Surgical and medical procedures Vaginal prolapse repair	0.08% 1/1306 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.00% 0/1302 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Surgical and medical procedures Varicose vein operation	0.23% 3/1306 • Number of events 3 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.00% 0/1302 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Surgical and medical procedures Vascular operation	0.15% 2/1306 • Number of events 2 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.31% 4/1302 • Number of events 5 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Surgical and medical procedures Vitrectomy	0.08% 1/1306 • Number of events 2 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.00% 0/1302 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Surgical and medical procedures Vocal cord operation	0.08% 1/1306 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.00% 0/1302 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Vascular disorders Angiodysplasia	0.38% 5/1306 • Number of events 6 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.00% 0/1302 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Vascular disorders Aortic aneurysm	0.31% 4/1306 • Number of events 5 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.00% 0/1302 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Vascular disorders Aortic stenosis	0.23% 3/1306 • Number of events 3 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.15% 2/1302 • Number of events 2 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Vascular disorders Arterial haemorrhage	0.08% 1/1306 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.00% 0/1302 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Vascular disorders Bleeding varicose vein	0.08% 1/1306 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.00% 0/1302 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Vascular disorders Circulatory collapse	0.00% 0/1306 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.08% 1/1302 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Vascular disorders Deep vein thrombosis	0.23% 3/1306 • Number of events 3 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.31% 4/1302 • Number of events 4 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Vascular disorders Embolism arterial	0.00% 0/1306 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.08% 1/1302 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Vascular disorders Giant cell arteritis	0.08% 1/1306 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.08% 1/1302 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Vascular disorders Haematoma	0.31% 4/1306 • Number of events 4 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.23% 3/1302 • Number of events 3 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Vascular disorders Haemorrhage	1.4% 18/1306 • Number of events 20 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.77% 10/1302 • Number of events 10 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Vascular disorders Hypertension	0.23% 3/1306 • Number of events 3 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.31% 4/1302 • Number of events 4 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Vascular disorders Hypertensive crisis	0.23% 3/1306 • Number of events 4 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.23% 3/1302 • Number of events 3 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Vascular disorders Hypertensive emergency	0.08% 1/1306 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.08% 1/1302 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Vascular disorders Hypotension	0.23% 3/1306 • Number of events 6 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.31% 4/1302 • Number of events 4 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Vascular disorders Lymphoedema	0.08% 1/1306 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.00% 0/1302 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Vascular disorders Orthostatic hypotension	0.31% 4/1306 • Number of events 4 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.15% 2/1302 • Number of events 2 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Vascular disorders Peripheral arterial occlusive disease	0.54% 7/1306 • Number of events 7 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.46% 6/1302 • Number of events 8 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Vascular disorders Peripheral artery occlusion	0.15% 2/1306 • Number of events 3 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.15% 2/1302 • Number of events 2 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Vascular disorders Peripheral artery stenosis	0.08% 1/1306 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.15% 2/1302 • Number of events 2 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Vascular disorders Peripheral embolism	0.08% 1/1306 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.23% 3/1302 • Number of events 3 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Vascular disorders Peripheral ischaemia	0.15% 2/1306 • Number of events 2 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.00% 0/1302 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Vascular disorders Superficial vein thrombosis	0.00% 0/1306 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.15% 2/1302 • Number of events 2 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Vascular disorders Thrombophlebitis	0.15% 2/1306 • Number of events 2 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.08% 1/1302 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Vascular disorders Thrombosis	0.00% 0/1306 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.08% 1/1302 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Vascular disorders Vasculitis	0.08% 1/1306 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.00% 0/1302 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Vascular disorders Venous stenosis	0.08% 1/1306 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.00% 0/1302 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Vascular disorders Venous thrombosis	0.00% 0/1306 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.08% 1/1302 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.

Other adverse events

Measure	Edoxaban n=1306 participants at risk Edoxaban will be applied in NOAH at the therapeutic dose approved for stroke prevention in non-valvular AF, i.e. 60 mg OD with a reduction of dose to 30 mg OD in patients with one of the following characteristics: Impaired renal function (CrCl 15-50 ml/min), or low body weight (≤60 kg), or patients receiving the glycoprotein-P inhibitors cyclosporin, dronedarone, erythromycin, or ketoconazole. Edoxaban: Edoxaban will be applied at the therapeutic dose approved for stroke prevention in non-valvular AF, i.e. 60 mg OD with a reduction of dose to 30 mg OD in patients with one of the following characteristics: Impaired renal function (CrCl 15-50 ml/min), or low body weight (≤60 kg), or patients receiving the glycoprotein-P inhibitors cyclosporin, dronedarone, erythromycin, or ketoconazole.	ASA or Placebo n=1302 participants at risk Either one tablet of ASA 100 mg plus one placebo tablet matching in colour, form and size to edoxaban 60 mg or one placebo tablet matching in colour, weight, form and size to ASA 100 mg plus one placebo tablet matching in colour, form and size to edoxaban 60 mg will be administered per day depending on the indication for use of antiplatelet therapy as assessed by the responsible investigator ASA: ASA 100 mg tablets or Placebo, based on accepted indication for the latter, including peripherial or coronary artery disease, a prior myocardial infarction, or a prior stroke.
Blood and lymphatic system disorders Anaemia	0.92% 12/1306 • Number of events 13 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.61% 8/1302 • Number of events 8 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Blood and lymphatic system disorders Blood disorder	0.00% 0/1306 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.08% 1/1302 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Blood and lymphatic system disorders Iron deficiency anaemia	0.23% 3/1306 • Number of events 4 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.15% 2/1302 • Number of events 2 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Blood and lymphatic system disorders Lymph node calcification	0.08% 1/1306 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.00% 0/1302 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Blood and lymphatic system disorders Lymphadenopathy	0.00% 0/1306 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.15% 2/1302 • Number of events 2 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Blood and lymphatic system disorders Microcytic anaemia	0.08% 1/1306 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.00% 0/1302 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Blood and lymphatic system disorders Nephrogenic anaemia	0.08% 1/1306 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.00% 0/1302 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Blood and lymphatic system disorders Normochromic anaemia	0.08% 1/1306 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.00% 0/1302 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Blood and lymphatic system disorders Normocytic anaemia	0.15% 2/1306 • Number of events 2 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.00% 0/1302 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Blood and lymphatic system disorders Thrombocytopenia	0.08% 1/1306 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.23% 3/1302 • Number of events 3 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Cardiac disorders Angina pectoris	0.92% 12/1306 • Number of events 13 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.61% 8/1302 • Number of events 10 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Cardiac disorders Angina unstable	0.08% 1/1306 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.00% 0/1302 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Cardiac disorders Aortic valve stenosis	0.00% 0/1306 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.08% 1/1302 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Cardiac disorders Arrhythmia	0.08% 1/1306 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.08% 1/1302 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Cardiac disorders Arteriosclerosis coronary artery	0.00% 0/1306 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.08% 1/1302 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Cardiac disorders Atrial fibrillation	0.31% 4/1306 • Number of events 6 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.84% 11/1302 • Number of events 11 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Cardiac disorders Atrial flutter	0.69% 9/1306 • Number of events 10 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.31% 4/1302 • Number of events 4 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Cardiac disorders Atrial tachycardia	0.08% 1/1306 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.00% 0/1302 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Cardiac disorders Bradycardia	0.08% 1/1306 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.08% 1/1302 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Cardiac disorders Cardiac failure	1.5% 20/1306 • Number of events 29 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	1.4% 18/1302 • Number of events 18 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Cardiac disorders Cardiac failure chronic	0.08% 1/1306 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.08% 1/1302 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Cardiac disorders Cardiac failure congestive	0.00% 0/1306 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.08% 1/1302 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Cardiac disorders Cardiovascular insufficiency	0.00% 0/1306 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.15% 2/1302 • Number of events 2 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Cardiac disorders Coronary artery disease	0.08% 1/1306 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.15% 2/1302 • Number of events 2 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Cardiac disorders Coronary artery stenosis	0.00% 0/1306 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.08% 1/1302 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Cardiac disorders Left ventricular dysfunction	0.08% 1/1306 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.00% 0/1302 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Cardiac disorders Mitral valve stenosis	0.00% 0/1306 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.08% 1/1302 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Cardiac disorders Myocardial fibrosis	0.00% 0/1306 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.08% 1/1302 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Cardiac disorders Myocardial ischaemia	0.00% 0/1306 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.08% 1/1302 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Cardiac disorders Palpitations	1.5% 20/1306 • Number of events 20 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.54% 7/1302 • Number of events 7 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Cardiac disorders Supraventricular tachycardia	0.00% 0/1306 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.08% 1/1302 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Cardiac disorders Tachyarrhythmia	0.08% 1/1306 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.00% 0/1302 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Cardiac disorders Tachycardia	0.15% 2/1306 • Number of events 2 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.15% 2/1302 • Number of events 2 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Cardiac disorders Ventricular extrasystoles	0.15% 2/1306 • Number of events 3 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.08% 1/1302 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Cardiac disorders Ventricular fibrillation	0.00% 0/1306 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.08% 1/1302 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Cardiac disorders Ventricular tachycardia	0.46% 6/1306 • Number of events 7 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.23% 3/1302 • Number of events 3 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Ear and labyrinth disorders Auricular swelling	0.08% 1/1306 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.00% 0/1302 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Ear and labyrinth disorders Ear pain	0.15% 2/1306 • Number of events 2 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.00% 0/1302 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Ear and labyrinth disorders Meniere's disease	0.08% 1/1306 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.00% 0/1302 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Ear and labyrinth disorders Tinnitus	0.08% 1/1306 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.08% 1/1302 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Ear and labyrinth disorders Tympanic membrane perforation	0.00% 0/1306 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.08% 1/1302 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Ear and labyrinth disorders Vertigo	0.61% 8/1306 • Number of events 9 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.54% 7/1302 • Number of events 8 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Endocrine disorders Graves' disease	0.00% 0/1306 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.08% 1/1302 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Endocrine disorders Hyperthyroidism	0.00% 0/1306 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.08% 1/1302 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Endocrine disorders Hypothyroidism	0.31% 4/1306 • Number of events 4 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.23% 3/1302 • Number of events 3 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Eye disorders Age-related macular degeneration	0.08% 1/1306 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.08% 1/1302 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Eye disorders Amaurosis fugax	0.08% 1/1306 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.00% 0/1302 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Eye disorders Blepharitis	0.00% 0/1306 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.08% 1/1302 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Eye disorders Cataract	0.69% 9/1306 • Number of events 11 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.54% 7/1302 • Number of events 8 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Eye disorders Cataract nuclear	0.00% 0/1306 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.08% 1/1302 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Eye disorders Charles Bonnet syndrome	0.00% 0/1306 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.08% 1/1302 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Eye disorders Choroidal haemorrhage	0.15% 2/1306 • Number of events 2 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.00% 0/1302 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Eye disorders Conjunctival haemorrhage	0.15% 2/1306 • Number of events 2 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.15% 2/1302 • Number of events 2 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Eye disorders Conjunctival hyperaemia	0.08% 1/1306 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.00% 0/1302 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Eye disorders Conjunctival irritation	0.08% 1/1306 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.00% 0/1302 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Eye disorders Dacryostenosis acquired	0.08% 1/1306 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.00% 0/1302 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Eye disorders Dermatochalasis	0.00% 0/1306 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.08% 1/1302 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Eye disorders Eye haemorrhage	0.23% 3/1306 • Number of events 3 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.23% 3/1302 • Number of events 3 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Eye disorders Eye inflammation	0.00% 0/1306 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.08% 1/1302 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Eye disorders Eye pain	0.23% 3/1306 • Number of events 3 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.00% 0/1302 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Eye disorders Eyelid bleeding	0.00% 0/1306 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.08% 1/1302 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Eye disorders Lacrimation increased	0.00% 0/1306 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.15% 2/1302 • Number of events 3 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Eye disorders Macular degeneration	0.08% 1/1306 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.08% 1/1302 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Eye disorders Maculopathy	0.08% 1/1306 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.00% 0/1302 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Eye disorders Ocular hyperaemia	0.15% 2/1306 • Number of events 2 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.08% 1/1302 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Eye disorders Optic disc haemorrhage	0.08% 1/1306 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.00% 0/1302 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Eye disorders Retinal detachment	0.08% 1/1306 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.00% 0/1302 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Eye disorders Retinal haemorrhage	0.08% 1/1306 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.00% 0/1302 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Eye disorders Retinal tear	0.08% 1/1306 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.00% 0/1302 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Eye disorders Retinal vein occlusion	0.00% 0/1306 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.08% 1/1302 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Eye disorders Uveitis	0.08% 1/1306 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.00% 0/1302 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Eye disorders Vision blurred	0.15% 2/1306 • Number of events 2 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.08% 1/1302 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Eye disorders Visual acuity reduced	0.15% 2/1306 • Number of events 2 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.00% 0/1302 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Eye disorders Visual impairment	0.23% 3/1306 • Number of events 8 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.38% 5/1302 • Number of events 5 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Eye disorders Vitreous floaters	0.00% 0/1306 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.08% 1/1302 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Eye disorders Vitreous haemorrhage	0.00% 0/1306 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.08% 1/1302 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Gastrointestinal disorders Abdominal discomfort	0.00% 0/1306 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.08% 1/1302 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Gastrointestinal disorders Abdominal distension	0.08% 1/1306 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.00% 0/1302 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Gastrointestinal disorders Abdominal hernia	0.08% 1/1306 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.00% 0/1302 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Gastrointestinal disorders Abdominal pain	0.69% 9/1306 • Number of events 9 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	1.2% 16/1302 • Number of events 19 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Gastrointestinal disorders Abdominal pain upper	0.77% 10/1306 • Number of events 10 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.23% 3/1302 • Number of events 3 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Gastrointestinal disorders Anal fissure	0.08% 1/1306 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.00% 0/1302 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Gastrointestinal disorders Anal haemorrhage	0.08% 1/1306 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.00% 0/1302 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Gastrointestinal disorders Aphthous ulcer	0.00% 0/1306 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.08% 1/1302 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Gastrointestinal disorders Colitis	0.00% 0/1306 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.08% 1/1302 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Gastrointestinal disorders Constipation	0.31% 4/1306 • Number of events 5 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.61% 8/1302 • Number of events 8 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Gastrointestinal disorders Diaphragmatic hernia	0.00% 0/1306 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.08% 1/1302 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Gastrointestinal disorders Diarrhoea	1.5% 19/1306 • Number of events 20 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	1.5% 20/1302 • Number of events 21 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Gastrointestinal disorders Diverticulum	0.08% 1/1306 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.08% 1/1302 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Gastrointestinal disorders Diverticulum intestinal	0.08% 1/1306 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.00% 0/1302 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Gastrointestinal disorders Dry mouth	0.08% 1/1306 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.00% 0/1302 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Gastrointestinal disorders Duodenitis	0.08% 1/1306 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.00% 0/1302 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Gastrointestinal disorders Dyspepsia	0.23% 3/1306 • Number of events 3 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.38% 5/1302 • Number of events 5 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Gastrointestinal disorders Dysphagia	0.31% 4/1306 • Number of events 4 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.23% 3/1302 • Number of events 3 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Gastrointestinal disorders Flatulence	0.08% 1/1306 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.15% 2/1302 • Number of events 2 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Gastrointestinal disorders Frequent bowel movements	0.08% 1/1306 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.00% 0/1302 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Gastrointestinal disorders Gastritis	0.54% 7/1306 • Number of events 7 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.61% 8/1302 • Number of events 8 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Gastrointestinal disorders Gastritis erosive	0.08% 1/1306 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.00% 0/1302 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Gastrointestinal disorders Gastrointestinal disorder	0.08% 1/1306 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.00% 0/1302 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Gastrointestinal disorders Gastrointestinal haemorrhage	0.15% 2/1306 • Number of events 2 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.15% 2/1302 • Number of events 2 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Gastrointestinal disorders Gastrointestinal pain	0.00% 0/1306 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.08% 1/1302 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Gastrointestinal disorders Gastrooesophageal reflux disease	0.15% 2/1306 • Number of events 2 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.00% 0/1302 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Gastrointestinal disorders Gingival bleeding	0.54% 7/1306 • Number of events 7 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.15% 2/1302 • Number of events 2 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Gastrointestinal disorders Haematochezia	0.15% 2/1306 • Number of events 2 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.15% 2/1302 • Number of events 2 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Gastrointestinal disorders Haemorrhoidal haemorrhage	0.15% 2/1306 • Number of events 3 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.00% 0/1302 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Gastrointestinal disorders Haemorrhoids	0.23% 3/1306 • Number of events 5 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.15% 2/1302 • Number of events 2 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Gastrointestinal disorders Inguinal hernia	0.00% 0/1306 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.15% 2/1302 • Number of events 2 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Gastrointestinal disorders Intestinal haemorrhage	0.08% 1/1306 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.00% 0/1302 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Gastrointestinal disorders Intestinal obstruction	0.08% 1/1306 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.00% 0/1302 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Gastrointestinal disorders Large intestine polyp	0.08% 1/1306 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.08% 1/1302 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Gastrointestinal disorders Lip haemorrhage	0.08% 1/1306 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.00% 0/1302 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Gastrointestinal disorders Lower gastrointestinal haemorrhage	0.08% 1/1306 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.00% 0/1302 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Gastrointestinal disorders Melaena	0.15% 2/1306 • Number of events 2 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.15% 2/1302 • Number of events 2 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Gastrointestinal disorders Mouth haemorrhage	0.15% 2/1306 • Number of events 2 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.08% 1/1302 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Gastrointestinal disorders Nausea	1.6% 21/1306 • Number of events 21 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.84% 11/1302 • Number of events 11 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Gastrointestinal disorders Oesophageal stenosis	0.00% 0/1306 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.08% 1/1302 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Gastrointestinal disorders Oesophagitis	0.08% 1/1306 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.00% 0/1302 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Gastrointestinal disorders Pancreatitis	0.00% 0/1306 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.08% 1/1302 • Number of events 2 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Gastrointestinal disorders Peritoneal cyst	0.00% 0/1306 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.08% 1/1302 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Gastrointestinal disorders Rectal haemorrhage	0.69% 9/1306 • Number of events 9 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.38% 5/1302 • Number of events 6 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Gastrointestinal disorders Rectal prolapse	0.08% 1/1306 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.00% 0/1302 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Gastrointestinal disorders Rectal tenesmus	0.08% 1/1306 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.00% 0/1302 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Gastrointestinal disorders Reflux gastritis	0.00% 0/1306 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.08% 1/1302 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Gastrointestinal disorders Toothache	0.15% 2/1306 • Number of events 2 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.15% 2/1302 • Number of events 2 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Gastrointestinal disorders Trichoglossia	0.00% 0/1306 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.08% 1/1302 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Gastrointestinal disorders Varices oesophageal	0.08% 1/1306 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.00% 0/1302 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Gastrointestinal disorders Vomiting	0.23% 3/1306 • Number of events 3 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.38% 5/1302 • Number of events 5 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
General disorders Adverse drug reaction	0.08% 1/1306 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.00% 0/1302 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
General disorders Asthenia	1.4% 18/1306 • Number of events 20 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	1.2% 15/1302 • Number of events 17 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
General disorders Chest discomfort	0.15% 2/1306 • Number of events 2 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.08% 1/1302 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
General disorders Chest pain	1.5% 20/1306 • Number of events 21 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	1.5% 19/1302 • Number of events 20 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
General disorders Complication associated with device	0.15% 2/1306 • Number of events 2 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.00% 0/1302 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
General disorders Facial pain	0.00% 0/1306 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.08% 1/1302 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
General disorders Fatigue	0.61% 8/1306 • Number of events 8 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.84% 11/1302 • Number of events 11 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
General disorders Gait disturbance	0.15% 2/1306 • Number of events 2 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.31% 4/1302 • Number of events 4 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
General disorders General physical health deterioration	0.23% 3/1306 • Number of events 3 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.15% 2/1302 • Number of events 2 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
General disorders Illness	0.00% 0/1306 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.08% 1/1302 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
General disorders Inflammation	0.00% 0/1306 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.08% 1/1302 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
General disorders Infusion site extravasation	0.08% 1/1306 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.00% 0/1302 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
General disorders Malaise	0.77% 10/1306 • Number of events 10 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.31% 4/1302 • Number of events 4 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
General disorders Non-cardiac chest pain	0.54% 7/1306 • Number of events 13 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.54% 7/1302 • Number of events 7 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
General disorders Oedema	0.46% 6/1306 • Number of events 6 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.23% 3/1302 • Number of events 3 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
General disorders Oedema peripheral	1.2% 16/1306 • Number of events 20 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	1.5% 19/1302 • Number of events 19 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
General disorders Pain	0.23% 3/1306 • Number of events 3 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.00% 0/1302 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
General disorders Peripheral swelling	0.54% 7/1306 • Number of events 7 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.54% 7/1302 • Number of events 7 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
General disorders Pyrexia	0.31% 4/1306 • Number of events 4 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.38% 5/1302 • Number of events 5 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
General disorders Swelling face	0.08% 1/1306 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.00% 0/1302 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
General disorders Ulcer	0.08% 1/1306 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.00% 0/1302 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
General disorders Vaccination site haematoma	0.08% 1/1306 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.00% 0/1302 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Hepatobiliary disorders Biliary colic	0.00% 0/1306 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.15% 2/1302 • Number of events 2 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Hepatobiliary disorders Cholelithiasis	0.15% 2/1306 • Number of events 2 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.00% 0/1302 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Hepatobiliary disorders Congestive hepatopathy	0.00% 0/1306 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.08% 1/1302 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Hepatobiliary disorders Hepatic cirrhosis	0.08% 1/1306 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.00% 0/1302 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Hepatobiliary disorders Hepatic cyst	0.00% 0/1306 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.08% 1/1302 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Hepatobiliary disorders Hepatic pain	0.08% 1/1306 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.00% 0/1302 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Hepatobiliary disorders Non-alcoholic steatohepatitis	0.08% 1/1306 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.00% 0/1302 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Hepatobiliary disorders Primary biliary cholangitis	0.00% 0/1306 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.08% 1/1302 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Immune system disorders Hypersensitivity	0.15% 2/1306 • Number of events 2 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.00% 0/1302 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Infections and infestations Bacteriuria	0.00% 0/1306 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.08% 1/1302 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Infections and infestations Bronchitis	0.38% 5/1306 • Number of events 5 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.54% 7/1302 • Number of events 7 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Infections and infestations Candida infection	0.08% 1/1306 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.00% 0/1302 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Infections and infestations Cellulitis	0.15% 2/1306 • Number of events 3 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.08% 1/1302 • Number of events 2 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Infections and infestations Chronic sinusitis	0.08% 1/1306 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.00% 0/1302 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Infections and infestations Conjunctivitis	0.46% 6/1306 • Number of events 6 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.15% 2/1302 • Number of events 2 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Infections and infestations Cystitis	0.38% 5/1306 • Number of events 6 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.15% 2/1302 • Number of events 2 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Infections and infestations Dacryocystitis	0.08% 1/1306 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.00% 0/1302 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Infections and infestations Diverticulitis	0.15% 2/1306 • Number of events 2 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.08% 1/1302 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Infections and infestations Ear infection	0.23% 3/1306 • Number of events 4 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.00% 0/1302 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Infections and infestations Ear infection fungal	0.08% 1/1306 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.00% 0/1302 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Infections and infestations Endocarditis	0.00% 0/1306 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.08% 1/1302 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Infections and infestations Erysipelas	0.15% 2/1306 • Number of events 2 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.15% 2/1302 • Number of events 2 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Infections and infestations Eye infection	0.00% 0/1306 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.08% 1/1302 • Number of events 2 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Infections and infestations Folliculitis	0.08% 1/1306 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.00% 0/1302 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Infections and infestations Fungal infection	0.08% 1/1306 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.15% 2/1302 • Number of events 2 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Infections and infestations Fungal skin infection	0.00% 0/1306 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.08% 1/1302 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Infections and infestations Gastroenteritis	0.08% 1/1306 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.23% 3/1302 • Number of events 3 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Infections and infestations Gastroenteritis viral	0.00% 0/1306 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.08% 1/1302 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Infections and infestations Gastrointestinal infection	0.00% 0/1306 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.08% 1/1302 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Infections and infestations Herpes zoster	0.15% 2/1306 • Number of events 2 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.23% 3/1302 • Number of events 3 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Infections and infestations Impetigo	0.08% 1/1306 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.00% 0/1302 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Infections and infestations Implant site infection	0.15% 2/1306 • Number of events 2 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.00% 0/1302 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Infections and infestations Infected dermal cyst	0.00% 0/1306 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.08% 1/1302 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Infections and infestations Influenza	0.08% 1/1306 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.08% 1/1302 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Infections and infestations Liver abscess	0.08% 1/1306 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.00% 0/1302 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Infections and infestations Localised infection	0.08% 1/1306 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.00% 0/1302 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Infections and infestations Lower respiratory tract infection	0.23% 3/1306 • Number of events 3 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.46% 6/1302 • Number of events 8 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Infections and infestations Lyme disease	0.00% 0/1306 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.08% 1/1302 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Infections and infestations Nasopharyngitis	0.46% 6/1306 • Number of events 6 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.84% 11/1302 • Number of events 11 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Infections and infestations Orchitis	0.00% 0/1306 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.08% 1/1302 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Infections and infestations Pharyngitis	0.08% 1/1306 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.00% 0/1302 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Infections and infestations Pneumonia	0.38% 5/1306 • Number of events 5 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.31% 4/1302 • Number of events 4 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Infections and infestations Pulpitis dental	0.08% 1/1306 • Number of events 4 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.00% 0/1302 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Infections and infestations Pyelonephritis	0.08% 1/1306 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.00% 0/1302 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Infections and infestations Respiratory tract infection	0.46% 6/1306 • Number of events 6 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.61% 8/1302 • Number of events 11 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Infections and infestations Rhinitis	0.08% 1/1306 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.00% 0/1302 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Infections and infestations Sinusitis	0.08% 1/1306 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.00% 0/1302 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Infections and infestations Tinea pedis	0.00% 0/1306 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.08% 1/1302 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Infections and infestations Tooth abscess	0.00% 0/1306 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.08% 1/1302 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Infections and infestations Tooth infection	0.15% 2/1306 • Number of events 2 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.23% 3/1302 • Number of events 3 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Infections and infestations Upper respiratory tract infection	0.08% 1/1306 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.38% 5/1302 • Number of events 5 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Infections and infestations Urinary tract infection	1.4% 18/1306 • Number of events 33 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	1.5% 19/1302 • Number of events 24 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Infections and infestations Urosepsis	0.00% 0/1306 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.08% 1/1302 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Infections and infestations Vestibular neuronitis	0.00% 0/1306 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.08% 1/1302 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Infections and infestations Viral infection	0.08% 1/1306 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.00% 0/1302 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Infections and infestations Wound infection	0.08% 1/1306 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.15% 2/1302 • Number of events 3 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Injury, poisoning and procedural complications Accidental overdose	0.31% 4/1306 • Number of events 5 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.08% 1/1302 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Injury, poisoning and procedural complications Animal bite	0.08% 1/1306 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.23% 3/1302 • Number of events 3 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Injury, poisoning and procedural complications Ankle fracture	0.08% 1/1306 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.00% 0/1302 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Injury, poisoning and procedural complications Arthropod bite	0.23% 3/1306 • Number of events 3 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.15% 2/1302 • Number of events 2 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Injury, poisoning and procedural complications Bone fissure	0.00% 0/1306 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.08% 1/1302 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Injury, poisoning and procedural complications Chest injury	0.00% 0/1306 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.15% 2/1302 • Number of events 3 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Injury, poisoning and procedural complications Clavicle fracture	0.08% 1/1306 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.00% 0/1302 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Injury, poisoning and procedural complications Contusion	0.61% 8/1306 • Number of events 8 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.31% 4/1302 • Number of events 4 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Injury, poisoning and procedural complications Craniofacial fracture	0.08% 1/1306 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.00% 0/1302 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Injury, poisoning and procedural complications Epicondylitis	0.00% 0/1306 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.08% 1/1302 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Injury, poisoning and procedural complications Eye injury	0.00% 0/1306 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.08% 1/1302 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Injury, poisoning and procedural complications Eyelid injury	0.00% 0/1306 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.08% 1/1302 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Injury, poisoning and procedural complications Face injury	0.00% 0/1306 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.08% 1/1302 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Injury, poisoning and procedural complications Fall	2.5% 32/1306 • Number of events 37 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	2.4% 31/1302 • Number of events 35 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Injury, poisoning and procedural complications Femur fracture	0.15% 2/1306 • Number of events 2 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.00% 0/1302 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Injury, poisoning and procedural complications Hand fracture	0.08% 1/1306 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.00% 0/1302 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Injury, poisoning and procedural complications Head injury	0.31% 4/1306 • Number of events 5 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	1.00% 13/1302 • Number of events 13 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Injury, poisoning and procedural complications Heat exhaustion	0.00% 0/1306 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.08% 1/1302 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Injury, poisoning and procedural complications Humerus fracture	0.08% 1/1306 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.46% 6/1302 • Number of events 6 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Injury, poisoning and procedural complications Implantation complication	0.08% 1/1306 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.00% 0/1302 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Injury, poisoning and procedural complications Injury	0.00% 0/1306 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.08% 1/1302 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Injury, poisoning and procedural complications Joint dislocation	0.15% 2/1306 • Number of events 2 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.08% 1/1302 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Injury, poisoning and procedural complications Joint injury	0.23% 3/1306 • Number of events 3 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.15% 2/1302 • Number of events 2 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Injury, poisoning and procedural complications Ligament sprain	0.15% 2/1306 • Number of events 2 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.15% 2/1302 • Number of events 2 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Injury, poisoning and procedural complications Limb injury	0.38% 5/1306 • Number of events 7 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.54% 7/1302 • Number of events 8 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Injury, poisoning and procedural complications Lower limb fracture	0.15% 2/1306 • Number of events 2 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.00% 0/1302 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Injury, poisoning and procedural complications Lumbar vertebral fracture	0.08% 1/1306 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.00% 0/1302 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Injury, poisoning and procedural complications Muscle strain	0.00% 0/1306 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.08% 1/1302 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Injury, poisoning and procedural complications Pelvic fracture	0.00% 0/1306 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.08% 1/1302 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Injury, poisoning and procedural complications Periorbital haematoma	0.08% 1/1306 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.00% 0/1302 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Injury, poisoning and procedural complications Periorbital haemorrhage	0.08% 1/1306 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.00% 0/1302 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Injury, poisoning and procedural complications Post procedural haematoma	0.08% 1/1306 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.00% 0/1302 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Injury, poisoning and procedural complications Post procedural haemorrhage	0.08% 1/1306 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.00% 0/1302 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Injury, poisoning and procedural complications Radius fracture	0.15% 2/1306 • Number of events 2 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.15% 2/1302 • Number of events 2 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Injury, poisoning and procedural complications Rib fracture	0.15% 2/1306 • Number of events 2 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.08% 1/1302 • Number of events 2 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Injury, poisoning and procedural complications Road traffic accident	0.00% 0/1306 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.08% 1/1302 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Injury, poisoning and procedural complications Scar	0.00% 0/1306 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.08% 1/1302 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Injury, poisoning and procedural complications Shoulder fracture	0.00% 0/1306 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.08% 1/1302 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Injury, poisoning and procedural complications Silicosis	0.08% 1/1306 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.00% 0/1302 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Injury, poisoning and procedural complications Skin abrasion	0.15% 2/1306 • Number of events 2 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.23% 3/1302 • Number of events 3 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Injury, poisoning and procedural complications Skin laceration	0.23% 3/1306 • Number of events 3 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.31% 4/1302 • Number of events 4 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Injury, poisoning and procedural complications Soft tissue injury	0.08% 1/1306 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.00% 0/1302 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Injury, poisoning and procedural complications Spinal compression fracture	0.00% 0/1306 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.08% 1/1302 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Injury, poisoning and procedural complications Synovial rupture	0.00% 0/1306 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.08% 1/1302 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Injury, poisoning and procedural complications Wound haemorrhage	0.00% 0/1306 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.08% 1/1302 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Injury, poisoning and procedural complications Wrist fracture	0.15% 2/1306 • Number of events 2 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.00% 0/1302 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Investigations Angiocardiogram	0.15% 2/1306 • Number of events 2 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.08% 1/1302 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Investigations Angiogram	0.15% 2/1306 • Number of events 2 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.00% 0/1302 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Investigations Arthroscopy	0.00% 0/1306 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.08% 1/1302 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Investigations Biopsy intestine	0.08% 1/1306 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.00% 0/1302 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Investigations Biopsy lymph gland	0.00% 0/1306 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.15% 2/1302 • Number of events 2 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Investigations Biopsy prostate	0.15% 2/1306 • Number of events 2 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.08% 1/1302 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Investigations Bleeding time prolonged	0.31% 4/1306 • Number of events 4 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.08% 1/1302 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Investigations Blood cholesterol increased	0.00% 0/1306 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.08% 1/1302 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Investigations Blood creatinine increased	0.08% 1/1306 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.08% 1/1302 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Investigations Blood magnesium decreased	0.00% 0/1306 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.08% 1/1302 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Investigations Body temperature increased	0.08% 1/1306 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.08% 1/1302 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Investigations Bronchial aspiration procedure	0.08% 1/1306 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.00% 0/1302 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Investigations Bronchoscopy abnormal	0.00% 0/1306 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.08% 1/1302 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Investigations Catheterisation cardiac	0.23% 3/1306 • Number of events 3 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.08% 1/1302 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Investigations Colonoscopy	0.38% 5/1306 • Number of events 5 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.15% 2/1302 • Number of events 2 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Investigations Coronavirus test positive	3.7% 48/1306 • Number of events 49 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	2.3% 30/1302 • Number of events 30 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Investigations Cystoscopy	0.00% 0/1306 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.08% 1/1302 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Investigations Dental examination	0.00% 0/1306 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.08% 1/1302 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Investigations Diagnostic procedure	0.08% 1/1306 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.00% 0/1302 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Investigations Echocardiogram	0.00% 0/1306 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.08% 1/1302 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Investigations Echocardiogram abnormal	0.00% 0/1306 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.08% 1/1302 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Investigations Ejection fraction decreased	0.00% 0/1306 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.15% 2/1302 • Number of events 2 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Investigations Endoscopy	0.08% 1/1306 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.00% 0/1302 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Investigations Endoscopy upper gastrointestinal tract	0.15% 2/1306 • Number of events 2 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.08% 1/1302 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Investigations Glomerular filtration rate decreased	0.08% 1/1306 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.00% 0/1302 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Investigations Glomerular filtration rate increased	0.00% 0/1306 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.08% 1/1302 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Investigations Haemoglobin decreased	0.08% 1/1306 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.00% 0/1302 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Investigations Haemoglobin increased	0.00% 0/1306 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.08% 1/1302 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Investigations Heart rate decreased	0.00% 0/1306 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.08% 1/1302 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Investigations Heart rate increased	0.08% 1/1306 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.00% 0/1302 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Investigations Hepatic enzyme increased	0.08% 1/1306 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.23% 3/1302 • Number of events 3 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Investigations International normalised ratio abnormal	0.00% 0/1306 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.08% 1/1302 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Investigations Low density lipoprotein increased	0.00% 0/1306 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.08% 1/1302 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Investigations Magnetic resonance imaging	0.00% 0/1306 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.08% 1/1302 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Investigations Platelet count decreased	0.08% 1/1306 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.00% 0/1302 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Investigations Prostatic specific antigen increased	0.08% 1/1306 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.08% 1/1302 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Investigations Radioisotope scan	0.00% 0/1306 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.08% 1/1302 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Investigations Rectal ultrasound	0.00% 0/1306 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.08% 1/1302 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Investigations Serum ferritin decreased	0.00% 0/1306 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.08% 1/1302 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Investigations Sleep study	0.08% 1/1306 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.00% 0/1302 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Investigations Spirometry	0.08% 1/1306 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.00% 0/1302 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Investigations Troponin increased	0.00% 0/1306 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.08% 1/1302 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Investigations Vitamin D decreased	0.08% 1/1306 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.08% 1/1302 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Investigations Weight decreased	0.38% 5/1306 • Number of events 5 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.54% 7/1302 • Number of events 8 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Investigations Weight increased	0.15% 2/1306 • Number of events 2 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.08% 1/1302 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Metabolism and nutrition disorders Cachexia	0.08% 1/1306 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.15% 2/1302 • Number of events 2 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Metabolism and nutrition disorders Decreased appetite	0.00% 0/1306 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.15% 2/1302 • Number of events 2 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Metabolism and nutrition disorders Dehydration	0.00% 0/1306 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.15% 2/1302 • Number of events 2 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Metabolism and nutrition disorders Diabetes mellitus	0.54% 7/1306 • Number of events 7 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.31% 4/1302 • Number of events 4 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Metabolism and nutrition disorders Folate deficiency	0.00% 0/1306 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.08% 1/1302 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Metabolism and nutrition disorders Gout	0.23% 3/1306 • Number of events 3 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.31% 4/1302 • Number of events 4 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Metabolism and nutrition disorders Hypercholesterolaemia	0.08% 1/1306 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.00% 0/1302 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Metabolism and nutrition disorders Hyperglycaemia	0.15% 2/1306 • Number of events 4 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.08% 1/1302 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Metabolism and nutrition disorders Hyperkalaemia	0.08% 1/1306 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.00% 0/1302 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Metabolism and nutrition disorders Hyperlipidaemia	0.08% 1/1306 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.00% 0/1302 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Metabolism and nutrition disorders Hypertriglyceridaemia	0.08% 1/1306 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.00% 0/1302 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Metabolism and nutrition disorders Hyperuricaemia	0.23% 3/1306 • Number of events 3 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.23% 3/1302 • Number of events 3 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Metabolism and nutrition disorders Hypoglycaemia	0.15% 2/1306 • Number of events 2 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.00% 0/1302 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Metabolism and nutrition disorders Hypokalaemia	0.08% 1/1306 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.00% 0/1302 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Metabolism and nutrition disorders Impaired fasting glucose	0.00% 0/1306 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.08% 1/1302 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Metabolism and nutrition disorders Iron deficiency	0.23% 3/1306 • Number of events 4 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.08% 1/1302 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Metabolism and nutrition disorders Type 2 diabetes mellitus	0.00% 0/1306 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.15% 2/1302 • Number of events 2 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Musculoskeletal and connective tissue disorders Arthralgia	1.4% 18/1306 • Number of events 23 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	1.8% 24/1302 • Number of events 27 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Musculoskeletal and connective tissue disorders Arthritis	0.00% 0/1306 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.23% 3/1302 • Number of events 3 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Musculoskeletal and connective tissue disorders Back pain	0.84% 11/1306 • Number of events 11 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	1.5% 19/1302 • Number of events 25 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Musculoskeletal and connective tissue disorders Bone pain	0.08% 1/1306 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.08% 1/1302 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Musculoskeletal and connective tissue disorders Bursitis	0.00% 0/1306 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.15% 2/1302 • Number of events 2 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Musculoskeletal and connective tissue disorders Chondrocalcinosis	0.15% 2/1306 • Number of events 2 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.00% 0/1302 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Musculoskeletal and connective tissue disorders Groin pain	0.08% 1/1306 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.08% 1/1302 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Musculoskeletal and connective tissue disorders Haematoma muscle	0.08% 1/1306 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.00% 0/1302 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Musculoskeletal and connective tissue disorders Intervertebral disc protrusion	0.08% 1/1306 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.00% 0/1302 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Musculoskeletal and connective tissue disorders Joint microhaemorrhage	0.00% 0/1306 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.08% 1/1302 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Musculoskeletal and connective tissue disorders Joint swelling	0.08% 1/1306 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.00% 0/1302 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Musculoskeletal and connective tissue disorders Lumbar spinal stenosis	0.15% 2/1306 • Number of events 3 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.08% 1/1302 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Musculoskeletal and connective tissue disorders Mobility decreased	0.08% 1/1306 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.15% 2/1302 • Number of events 2 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Musculoskeletal and connective tissue disorders Muscle fatigue	0.08% 1/1306 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.00% 0/1302 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Musculoskeletal and connective tissue disorders Muscle spasms	0.46% 6/1306 • Number of events 6 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.00% 0/1302 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Musculoskeletal and connective tissue disorders Muscle twitching	0.15% 2/1306 • Number of events 2 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.08% 1/1302 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Musculoskeletal and connective tissue disorders Muscular weakness	0.15% 2/1306 • Number of events 2 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.00% 0/1302 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Musculoskeletal and connective tissue disorders Musculoskeletal chest pain	0.08% 1/1306 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.08% 1/1302 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Musculoskeletal and connective tissue disorders Musculoskeletal stiffness	0.00% 0/1306 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.08% 1/1302 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Musculoskeletal and connective tissue disorders Myalgia	0.31% 4/1306 • Number of events 4 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.08% 1/1302 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Musculoskeletal and connective tissue disorders Myopathy	0.08% 1/1306 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.00% 0/1302 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Musculoskeletal and connective tissue disorders Neck pain	0.08% 1/1306 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.15% 2/1302 • Number of events 2 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Musculoskeletal and connective tissue disorders Osteoarthritis	0.69% 9/1306 • Number of events 10 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.23% 3/1302 • Number of events 4 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Musculoskeletal and connective tissue disorders Osteochondrosis	0.00% 0/1306 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.08% 1/1302 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Musculoskeletal and connective tissue disorders Osteonecrosis	0.00% 0/1306 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.08% 1/1302 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Musculoskeletal and connective tissue disorders Osteopenia	0.00% 0/1306 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.08% 1/1302 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Musculoskeletal and connective tissue disorders Osteoporosis	0.08% 1/1306 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.08% 1/1302 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Musculoskeletal and connective tissue disorders Pain in extremity	0.69% 9/1306 • Number of events 9 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	1.2% 15/1302 • Number of events 16 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Musculoskeletal and connective tissue disorders Periarthritis	0.00% 0/1306 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.08% 1/1302 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Musculoskeletal and connective tissue disorders Polymyalgia rheumatica	0.08% 1/1306 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.08% 1/1302 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Musculoskeletal and connective tissue disorders Rheumatic disorder	0.08% 1/1306 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.08% 1/1302 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Musculoskeletal and connective tissue disorders Spinal osteoarthritis	0.00% 0/1306 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.08% 1/1302 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Musculoskeletal and connective tissue disorders Spondylolisthesis	0.00% 0/1306 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.15% 2/1302 • Number of events 2 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Musculoskeletal and connective tissue disorders Tendonitis	0.08% 1/1306 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.08% 1/1302 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Musculoskeletal and connective tissue disorders Vertebral lesion	0.08% 1/1306 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.00% 0/1302 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Adenocarcinoma of colon	0.08% 1/1306 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.00% 0/1302 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Basal cell carcinoma	0.23% 3/1306 • Number of events 3 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.15% 2/1302 • Number of events 3 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bladder cancer	0.00% 0/1306 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.08% 1/1302 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast cancer	0.08% 1/1306 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.23% 3/1302 • Number of events 3 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Carcinoma in situ of skin	0.00% 0/1306 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.08% 1/1302 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colon cancer	0.15% 2/1306 • Number of events 2 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.15% 2/1302 • Number of events 2 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colorectal cancer recurrent	0.08% 1/1306 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.00% 0/1302 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Hypergammaglobulinaemia benign monoclonal	0.08% 1/1306 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.00% 0/1302 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Laryngeal cancer	0.08% 1/1306 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.00% 0/1302 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung neoplasm malignant	0.00% 0/1306 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.08% 1/1302 • Number of events 2 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lymphoma	0.08% 1/1306 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.00% 0/1302 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant melanoma	0.08% 1/1306 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.08% 1/1302 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant melanoma in situ	0.08% 1/1306 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.00% 0/1302 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to kidney	0.00% 0/1306 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.08% 1/1302 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to liver	0.00% 0/1306 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.15% 2/1302 • Number of events 2 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to lung	0.00% 0/1306 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.08% 1/1302 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Myeloproliferative neoplasm	0.00% 0/1306 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.08% 1/1302 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasm	0.08% 1/1306 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.00% 0/1302 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Plasma cell myeloma	0.00% 0/1306 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.08% 1/1302 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Plasmacytoma	0.00% 0/1306 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.08% 1/1302 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate cancer	0.54% 7/1306 • Number of events 7 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.38% 5/1302 • Number of events 5 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate cancer metastatic	0.00% 0/1306 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.08% 1/1302 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Rectal adenocarcinoma	0.15% 2/1306 • Number of events 2 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.08% 1/1302 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Skin cancer	0.15% 2/1306 • Number of events 2 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.15% 2/1302 • Number of events 3 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous cell carcinoma	0.15% 2/1306 • Number of events 2 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.00% 0/1302 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous cell carcinoma of skin	0.00% 0/1306 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.08% 1/1302 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Nervous system disorders Ataxia	0.08% 1/1306 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.00% 0/1302 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Nervous system disorders Axonal neuropathy	0.08% 1/1306 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.00% 0/1302 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Nervous system disorders Balance disorder	0.08% 1/1306 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.15% 2/1302 • Number of events 2 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Nervous system disorders Carotid arteriosclerosis	0.00% 0/1306 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.08% 1/1302 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Nervous system disorders Carotid artery stenosis	0.00% 0/1306 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.08% 1/1302 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Nervous system disorders Carpal tunnel syndrome	0.00% 0/1306 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.15% 2/1302 • Number of events 2 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Nervous system disorders Cerebral ischaemia	0.08% 1/1306 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.00% 0/1302 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Nervous system disorders Cerebral small vessel ischaemic disease	0.00% 0/1306 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.08% 1/1302 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Nervous system disorders Cognitive disorder	0.23% 3/1306 • Number of events 3 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.38% 5/1302 • Number of events 5 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Nervous system disorders Dementia	0.23% 3/1306 • Number of events 3 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.46% 6/1302 • Number of events 6 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Nervous system disorders Dementia Alzheimer's type	0.00% 0/1306 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.08% 1/1302 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Nervous system disorders Depressed level of consciousness	0.08% 1/1306 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.00% 0/1302 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Nervous system disorders Dizziness	3.6% 47/1306 • Number of events 57 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	3.5% 46/1302 • Number of events 52 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Nervous system disorders Dizziness postural	0.08% 1/1306 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.15% 2/1302 • Number of events 2 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Nervous system disorders Dysarthria	0.00% 0/1306 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.15% 2/1302 • Number of events 2 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Nervous system disorders Facial paralysis	0.08% 1/1306 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.00% 0/1302 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Nervous system disorders Facial paresis	0.08% 1/1306 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.00% 0/1302 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Nervous system disorders Headache	1.5% 20/1306 • Number of events 21 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	1.5% 19/1302 • Number of events 21 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Nervous system disorders Hemiparesis	0.08% 1/1306 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.00% 0/1302 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Nervous system disorders Hypoaesthesia	0.08% 1/1306 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.00% 0/1302 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Nervous system disorders Intracranial aneurysm	0.00% 0/1306 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.08% 1/1302 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Nervous system disorders Ischaemic stroke	0.00% 0/1306 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.08% 1/1302 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Nervous system disorders Lethargy	0.08% 1/1306 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.00% 0/1302 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Nervous system disorders Loss of consciousness	0.08% 1/1306 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.15% 2/1302 • Number of events 2 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Nervous system disorders Memory impairment	0.08% 1/1306 • Number of events 2 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.08% 1/1302 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Nervous system disorders Neuralgia	0.08% 1/1306 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.00% 0/1302 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Nervous system disorders Ophthalmic migraine	0.00% 0/1306 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.08% 1/1302 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Nervous system disorders Paraesthesia	0.46% 6/1306 • Number of events 6 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.15% 2/1302 • Number of events 2 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Nervous system disorders Parkinson's disease	0.08% 1/1306 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.23% 3/1302 • Number of events 3 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Nervous system disorders Polyneuropathy	0.08% 1/1306 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.08% 1/1302 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Nervous system disorders Presyncope	0.00% 0/1306 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.08% 1/1302 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Nervous system disorders Sciatica	0.23% 3/1306 • Number of events 3 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.38% 5/1302 • Number of events 5 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Nervous system disorders Seizure	0.08% 1/1306 • Number of events 2 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.00% 0/1302 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Nervous system disorders Somnolence	0.00% 0/1306 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.15% 2/1302 • Number of events 2 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Nervous system disorders Speech disorder	0.08% 1/1306 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.00% 0/1302 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Nervous system disorders Syncope	1.1% 15/1306 • Number of events 16 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.84% 11/1302 • Number of events 14 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Nervous system disorders Tremor	0.08% 1/1306 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.15% 2/1302 • Number of events 2 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Nervous system disorders Vascular dementia	0.00% 0/1306 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.15% 2/1302 • Number of events 3 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Product Issues Device electrical impedance issue	0.00% 0/1306 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.08% 1/1302 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Product Issues Device inappropriate shock delivery	0.00% 0/1306 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.08% 1/1302 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Product Issues Device lead damage	0.00% 0/1306 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.08% 1/1302 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Product Issues Device lead issue	0.08% 1/1306 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.00% 0/1302 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Product Issues Device malfunction	0.00% 0/1306 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.08% 1/1302 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Product Issues Device occlusion	0.08% 1/1306 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.00% 0/1302 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Product Issues Device stimulation issue	0.08% 1/1306 • Number of events 2 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.00% 0/1302 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Product Issues Lead dislodgement	0.00% 0/1306 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.08% 1/1302 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Product Issues Thrombosis in device	0.00% 0/1306 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.08% 1/1302 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Psychiatric disorders Abnormal behaviour	0.00% 0/1306 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.08% 1/1302 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Psychiatric disorders Anxiety	0.31% 4/1306 • Number of events 4 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.31% 4/1302 • Number of events 4 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Psychiatric disorders Anxiety disorder	0.00% 0/1306 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.08% 1/1302 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Psychiatric disorders Apathy	0.08% 1/1306 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.00% 0/1302 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Psychiatric disorders Confusional state	0.00% 0/1306 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.23% 3/1302 • Number of events 3 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Psychiatric disorders Depressed mood	0.08% 1/1306 • Number of events 2 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.00% 0/1302 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Psychiatric disorders Depression	0.08% 1/1306 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.15% 2/1302 • Number of events 2 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Psychiatric disorders Disorientation	0.00% 0/1306 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.08% 1/1302 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Psychiatric disorders Insomnia	0.15% 2/1306 • Number of events 2 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.23% 3/1302 • Number of events 3 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Psychiatric disorders Mental disorder	0.08% 1/1306 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.00% 0/1302 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Psychiatric disorders Panic attack	0.00% 0/1306 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.08% 1/1302 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Psychiatric disorders Restlessness	0.00% 0/1306 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.08% 1/1302 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Psychiatric disorders Sleep disorder	0.31% 4/1306 • Number of events 4 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.00% 0/1302 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Renal and urinary disorders Acute kidney injury	0.23% 3/1306 • Number of events 3 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.08% 1/1302 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Renal and urinary disorders Bladder wall calcification	0.00% 0/1306 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.08% 1/1302 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Renal and urinary disorders Chronic kidney disease	0.38% 5/1306 • Number of events 6 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.00% 0/1302 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Renal and urinary disorders Dysuria	0.15% 2/1306 • Number of events 4 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.08% 1/1302 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Renal and urinary disorders Haematuria	2.4% 31/1306 • Number of events 41 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.61% 8/1302 • Number of events 10 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Renal and urinary disorders Nocturia	0.08% 1/1306 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.08% 1/1302 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Renal and urinary disorders Oliguria	0.08% 1/1306 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.00% 0/1302 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Renal and urinary disorders Polyuria	0.00% 0/1306 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.08% 1/1302 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Renal and urinary disorders Proteinuria	0.00% 0/1306 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.08% 1/1302 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Renal and urinary disorders Renal colic	0.00% 0/1306 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.08% 1/1302 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Renal and urinary disorders Renal failure	0.23% 3/1306 • Number of events 3 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.15% 2/1302 • Number of events 2 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Renal and urinary disorders Renal impairment	0.08% 1/1306 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.08% 1/1302 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Renal and urinary disorders Renal pain	0.08% 1/1306 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.00% 0/1302 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Renal and urinary disorders Urinary bladder haemorrhage	0.08% 1/1306 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.08% 1/1302 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Renal and urinary disorders Urinary incontinence	0.00% 0/1306 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.08% 1/1302 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Renal and urinary disorders Urinary retention	0.08% 1/1306 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.15% 2/1302 • Number of events 2 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Reproductive system and breast disorders Benign prostatic hyperplasia	0.15% 2/1306 • Number of events 2 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.15% 2/1302 • Number of events 2 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Reproductive system and breast disorders Breast mass	0.00% 0/1306 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.15% 2/1302 • Number of events 2 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Reproductive system and breast disorders Erectile dysfunction	0.08% 1/1306 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.00% 0/1302 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Reproductive system and breast disorders Gynaecomastia	0.00% 0/1306 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.08% 1/1302 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Reproductive system and breast disorders Prostatitis	0.08% 1/1306 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.08% 1/1302 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Reproductive system and breast disorders Vaginal haemorrhage	0.15% 2/1306 • Number of events 2 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.00% 0/1302 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Respiratory, thoracic and mediastinal disorders Asthma	0.08% 1/1306 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.08% 1/1302 • Number of events 2 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Respiratory, thoracic and mediastinal disorders Bronchial hyperreactivity	0.08% 1/1306 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.00% 0/1302 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Respiratory, thoracic and mediastinal disorders Bronchitis chronic	0.08% 1/1306 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.00% 0/1302 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Respiratory, thoracic and mediastinal disorders Bronchospasm	0.00% 0/1306 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.08% 1/1302 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	0.00% 0/1306 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.31% 4/1302 • Number of events 4 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Respiratory, thoracic and mediastinal disorders Cough	0.69% 9/1306 • Number of events 10 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.61% 8/1302 • Number of events 8 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Respiratory, thoracic and mediastinal disorders Diaphragmatic spasm	0.08% 1/1306 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.08% 1/1302 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Respiratory, thoracic and mediastinal disorders Dyspnoea	3.3% 43/1306 • Number of events 46 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	3.2% 42/1302 • Number of events 50 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Respiratory, thoracic and mediastinal disorders Dyspnoea exertional	0.77% 10/1306 • Number of events 11 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.46% 6/1302 • Number of events 6 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Respiratory, thoracic and mediastinal disorders Epistaxis	3.7% 48/1306 • Number of events 54 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	1.6% 21/1302 • Number of events 22 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Respiratory, thoracic and mediastinal disorders Haemoptysis	0.15% 2/1306 • Number of events 2 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.08% 1/1302 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Respiratory, thoracic and mediastinal disorders Hiccups	0.08% 1/1306 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.00% 0/1302 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Respiratory, thoracic and mediastinal disorders Hydrothorax	0.08% 1/1306 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.00% 0/1302 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Respiratory, thoracic and mediastinal disorders Hypoxia	0.08% 1/1306 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.00% 0/1302 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Respiratory, thoracic and mediastinal disorders Nasal polyps	0.08% 1/1306 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.00% 0/1302 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Respiratory, thoracic and mediastinal disorders Nocturnal dyspnoea	0.08% 1/1306 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.00% 0/1302 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Respiratory, thoracic and mediastinal disorders Orthopnoea	0.00% 0/1306 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.08% 1/1302 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.15% 2/1306 • Number of events 3 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.08% 1/1302 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Respiratory, thoracic and mediastinal disorders Pulmonary fibrosis	0.15% 2/1306 • Number of events 2 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.15% 2/1302 • Number of events 2 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Respiratory, thoracic and mediastinal disorders Respiratory failure	0.08% 1/1306 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.00% 0/1302 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Respiratory, thoracic and mediastinal disorders Respiratory tract congestion	0.00% 0/1306 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.08% 1/1302 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Respiratory, thoracic and mediastinal disorders Restrictive pulmonary disease	0.08% 1/1306 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.00% 0/1302 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Respiratory, thoracic and mediastinal disorders Rhinitis allergic	0.08% 1/1306 • Number of events 2 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.00% 0/1302 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Respiratory, thoracic and mediastinal disorders Rhinorrhoea	0.08% 1/1306 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.00% 0/1302 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Respiratory, thoracic and mediastinal disorders Sleep apnoea syndrome	0.00% 0/1306 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.08% 1/1302 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Skin and subcutaneous tissue disorders Actinic keratosis	0.23% 3/1306 • Number of events 3 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.00% 0/1302 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Skin and subcutaneous tissue disorders Alopecia	0.00% 0/1306 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.15% 2/1302 • Number of events 3 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Skin and subcutaneous tissue disorders Blister	0.08% 1/1306 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.00% 0/1302 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Skin and subcutaneous tissue disorders Chronic papillomatous dermatitis	0.08% 1/1306 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.00% 0/1302 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Skin and subcutaneous tissue disorders Decubitus ulcer	0.23% 3/1306 • Number of events 3 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.00% 0/1302 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Skin and subcutaneous tissue disorders Dermal cyst	0.00% 0/1306 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.08% 1/1302 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Skin and subcutaneous tissue disorders Dermatitis	0.08% 1/1306 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.08% 1/1302 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Skin and subcutaneous tissue disorders Dermatitis contact	0.00% 0/1306 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.08% 1/1302 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Skin and subcutaneous tissue disorders Dermatosis	0.08% 1/1306 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.00% 0/1302 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Skin and subcutaneous tissue disorders Eczema	0.08% 1/1306 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.00% 0/1302 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Skin and subcutaneous tissue disorders Erythema	0.08% 1/1306 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.23% 3/1302 • Number of events 3 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Skin and subcutaneous tissue disorders Hirsutism	0.08% 1/1306 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.00% 0/1302 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Skin and subcutaneous tissue disorders Hyperhidrosis	0.00% 0/1306 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.15% 2/1302 • Number of events 2 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Skin and subcutaneous tissue disorders Hyperkeratosis	0.08% 1/1306 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.00% 0/1302 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Skin and subcutaneous tissue disorders Ingrowing nail	0.08% 1/1306 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.00% 0/1302 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Skin and subcutaneous tissue disorders Lichen planus	0.08% 1/1306 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.00% 0/1302 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Skin and subcutaneous tissue disorders Petechiae	0.08% 1/1306 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.00% 0/1302 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Skin and subcutaneous tissue disorders Pruritus	1.00% 13/1306 • Number of events 13 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.61% 8/1302 • Number of events 8 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Skin and subcutaneous tissue disorders Psoriasis	0.08% 1/1306 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.00% 0/1302 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Skin and subcutaneous tissue disorders Purpura	0.15% 2/1306 • Number of events 2 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.00% 0/1302 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Skin and subcutaneous tissue disorders Rash	0.77% 10/1306 • Number of events 11 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.69% 9/1302 • Number of events 12 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Skin and subcutaneous tissue disorders Rash pruritic	0.15% 2/1306 • Number of events 4 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.08% 1/1302 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Skin and subcutaneous tissue disorders Skin haemorrhage	0.15% 2/1306 • Number of events 2 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.08% 1/1302 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Skin and subcutaneous tissue disorders Skin lesion	0.15% 2/1306 • Number of events 2 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.08% 1/1302 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Skin and subcutaneous tissue disorders Skin ulcer	0.31% 4/1306 • Number of events 4 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.15% 2/1302 • Number of events 2 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Skin and subcutaneous tissue disorders Stasis dermatitis	0.08% 1/1306 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.00% 0/1302 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Skin and subcutaneous tissue disorders Telangiectasia	0.08% 1/1306 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.00% 0/1302 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Skin and subcutaneous tissue disorders Urticaria	0.08% 1/1306 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.08% 1/1302 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Skin and subcutaneous tissue disorders Xeroderma	0.08% 1/1306 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.00% 0/1302 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Social circumstances Breast prosthesis user	0.08% 1/1306 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.00% 0/1302 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Social circumstances Living in residential institution	0.00% 0/1306 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.08% 1/1302 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Surgical and medical procedures Arthrodesis	0.08% 1/1306 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.00% 0/1302 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Surgical and medical procedures Bladder neoplasm surgery	0.08% 1/1306 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.00% 0/1302 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Surgical and medical procedures Blepharoplasty	0.00% 0/1306 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.15% 2/1302 • Number of events 2 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Surgical and medical procedures Bunion operation	0.00% 0/1306 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.08% 1/1302 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Surgical and medical procedures Cancer surgery	0.08% 1/1306 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.23% 3/1302 • Number of events 3 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Surgical and medical procedures Cardiac pacemaker insertion	0.00% 0/1306 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.08% 1/1302 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Surgical and medical procedures Cardiac pacemaker removal	0.08% 1/1306 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.08% 1/1302 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Surgical and medical procedures Cardiac pacemaker replacement	2.8% 36/1306 • Number of events 36 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	3.0% 39/1302 • Number of events 40 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Surgical and medical procedures Cardiac resynchronisation therapy	0.46% 6/1306 • Number of events 6 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.23% 3/1302 • Number of events 3 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Surgical and medical procedures Cardioversion	0.46% 6/1306 • Number of events 7 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.69% 9/1302 • Number of events 11 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Surgical and medical procedures Carpal tunnel decompression	0.23% 3/1306 • Number of events 3 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.23% 3/1302 • Number of events 3 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Surgical and medical procedures Cataract operation	0.84% 11/1306 • Number of events 15 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.92% 12/1302 • Number of events 15 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Surgical and medical procedures Catheter management	0.00% 0/1306 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.15% 2/1302 • Number of events 3 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Surgical and medical procedures Cholelithotomy	0.00% 0/1306 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.08% 1/1302 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Surgical and medical procedures Coronary arterial stent insertion	0.00% 0/1306 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.08% 1/1302 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Surgical and medical procedures Dental implantation	0.08% 1/1306 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.00% 0/1302 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Surgical and medical procedures Electrocauterisation	0.00% 0/1306 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.08% 1/1302 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Surgical and medical procedures Endodontic procedure	0.00% 0/1306 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.08% 1/1302 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Surgical and medical procedures Eye operation	0.00% 0/1306 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.08% 1/1302 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Surgical and medical procedures Eyelid operation	0.15% 2/1306 • Number of events 4 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.00% 0/1302 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Surgical and medical procedures Finger amputation	0.00% 0/1306 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.08% 1/1302 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Surgical and medical procedures Gastric polypectomy	0.08% 1/1306 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.00% 0/1302 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Surgical and medical procedures Haematoma evacuation	0.00% 0/1306 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.08% 1/1302 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Surgical and medical procedures Hernia repair	0.08% 1/1306 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.00% 0/1302 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Surgical and medical procedures Hydrocele operation	0.08% 1/1306 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.00% 0/1302 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Surgical and medical procedures Inguinal hernia repair	0.08% 1/1306 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.00% 0/1302 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Surgical and medical procedures Internal fixation of fracture	0.00% 0/1306 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.08% 1/1302 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Surgical and medical procedures Jaw operation	0.08% 1/1306 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.00% 0/1302 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Surgical and medical procedures Knee arthroplasty	0.08% 1/1306 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.00% 0/1302 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Surgical and medical procedures Knee operation	0.08% 1/1306 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.15% 2/1302 • Number of events 3 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Surgical and medical procedures Large intestinal polypectomy	0.38% 5/1306 • Number of events 5 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.00% 0/1302 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Surgical and medical procedures Liver operation	0.00% 0/1306 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.08% 1/1302 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Surgical and medical procedures Medical device removal	0.08% 1/1306 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.00% 0/1302 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Surgical and medical procedures Mole excision	0.00% 0/1306 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.08% 1/1302 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Surgical and medical procedures Papilloma excision	0.08% 1/1306 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.00% 0/1302 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Surgical and medical procedures Percutaneous coronary intervention	0.08% 1/1306 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.08% 1/1302 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Surgical and medical procedures Peripheral artery angioplasty	0.00% 0/1306 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.08% 1/1302 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Surgical and medical procedures Prostatic operation	0.08% 1/1306 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.00% 0/1302 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Surgical and medical procedures Radiotherapy to prostate	0.08% 1/1306 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.08% 1/1302 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Surgical and medical procedures Rhinoplasty	0.08% 1/1306 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.00% 0/1302 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Surgical and medical procedures Rhizolysis	0.08% 1/1306 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.00% 0/1302 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Surgical and medical procedures Sclerotherapy	0.08% 1/1306 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.00% 0/1302 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Surgical and medical procedures Shoulder operation	0.00% 0/1306 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.08% 1/1302 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Surgical and medical procedures Skin lesion removal	0.00% 0/1306 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.08% 1/1302 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Surgical and medical procedures Skin neoplasm excision	0.61% 8/1306 • Number of events 10 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.38% 5/1302 • Number of events 6 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Surgical and medical procedures Skin operation	0.00% 0/1306 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.08% 1/1302 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Surgical and medical procedures Toe amputation	0.08% 1/1306 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.00% 0/1302 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Surgical and medical procedures Tooth extraction	0.84% 11/1306 • Number of events 12 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.31% 4/1302 • Number of events 4 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Surgical and medical procedures Transurethral bladder resection	0.00% 0/1306 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.08% 1/1302 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Vascular disorders Angiodysplasia	0.08% 1/1306 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.00% 0/1302 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Vascular disorders Aortic aneurysm	0.23% 3/1306 • Number of events 3 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.15% 2/1302 • Number of events 2 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Vascular disorders Aortic arteriosclerosis	0.00% 0/1306 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.08% 1/1302 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Vascular disorders Aortic dilatation	0.08% 1/1306 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.00% 0/1302 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Vascular disorders Aortic stenosis	0.00% 0/1306 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.08% 1/1302 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Vascular disorders Aortic thrombosis	0.00% 0/1306 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.08% 1/1302 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Vascular disorders Arteriosclerosis	0.00% 0/1306 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.08% 1/1302 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Vascular disorders Bleeding varicose vein	0.15% 2/1306 • Number of events 2 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.00% 0/1302 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Vascular disorders Blood pressure fluctuation	0.08% 1/1306 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.15% 2/1302 • Number of events 2 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Vascular disorders Circulatory collapse	0.15% 2/1306 • Number of events 2 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.08% 1/1302 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Vascular disorders Deep vein thrombosis	0.08% 1/1306 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.08% 1/1302 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Vascular disorders Haematoma	1.6% 21/1306 • Number of events 24 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	1.3% 17/1302 • Number of events 17 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Vascular disorders Haemorrhage	0.31% 4/1306 • Number of events 6 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.15% 2/1302 • Number of events 2 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Vascular disorders Hot flush	0.08% 1/1306 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.08% 1/1302 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Vascular disorders Hypertension	0.61% 8/1306 • Number of events 8 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.77% 10/1302 • Number of events 11 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Vascular disorders Hypertensive crisis	0.31% 4/1306 • Number of events 4 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.31% 4/1302 • Number of events 4 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Vascular disorders Hypertensive emergency	0.00% 0/1306 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.23% 3/1302 • Number of events 3 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Vascular disorders Hypertensive urgency	0.08% 1/1306 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.00% 0/1302 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Vascular disorders Hypotension	1.00% 13/1306 • Number of events 14 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.84% 11/1302 • Number of events 12 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Vascular disorders Intermittent claudication	0.15% 2/1306 • Number of events 2 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.00% 0/1302 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Vascular disorders Orthostatic hypotension	0.31% 4/1306 • Number of events 4 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.08% 1/1302 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Vascular disorders Peripheral arterial occlusive disease	0.15% 2/1306 • Number of events 2 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.15% 2/1302 • Number of events 2 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Vascular disorders Peripheral artery occlusion	0.08% 1/1306 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.00% 0/1302 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Vascular disorders Peripheral venous disease	0.15% 2/1306 • Number of events 3 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.00% 0/1302 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Vascular disorders Phlebitis	0.08% 1/1306 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.00% 0/1302 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Vascular disorders Raynaud's phenomenon	0.00% 0/1306 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.08% 1/1302 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Vascular disorders Subgaleal haematoma	0.00% 0/1306 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.08% 1/1302 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Vascular disorders Superficial vein thrombosis	0.00% 0/1306 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.15% 2/1302 • Number of events 2 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Vascular disorders Thrombophlebitis	0.08% 1/1306 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.15% 2/1302 • Number of events 2 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Vascular disorders Thrombosis	0.00% 0/1306 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.08% 1/1302 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Vascular disorders Varicose ulceration	0.08% 1/1306 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.08% 1/1302 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Vascular disorders Varicose vein	0.08% 1/1306 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.00% 0/1302 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.
Vascular disorders Venous thrombosis	0.08% 1/1306 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.	0.08% 1/1302 • Number of events 1 • (S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment. Following the patient's randomisation in the study, all AEs, whether related or not related to study drug, had to be collected. However, within the context of the NOAH - AFNET 6 trial, no specific AEs and/or laboratory abnormalities are being considered as critical to safety evaluations. Thus, reporting of AEs not fulfilling any criteria of seriousness is not time critical. All-cause mortality was only assessed for mITT population, other AEs in ITT population.

Additional Information

Prof. Dr. Paulus Kirchhof

Universitätsklinikum Hamburg-Eppendorf

Phone: +49 (0)40 7410-52438

Email: p.kirchhof@uke.de

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place