Trial Outcomes & Findings for A Study of AST-120 for Evaluating Prevention of Progression In Chronic Kidney Disease Including Assessment of Quality of Life (EPPIC-2) (NCT NCT00501046)

NCT ID: NCT00501046

Last Updated: 2026-01-08

Results Overview

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

1015 participants

Primary outcome timeframe

Beyond Week 48, a 12-week visit cycle continued until the end of the study or until individual patients reached an endpoint

Results posted on

2026-01-08

Participant Flow

Participant milestones

Participant milestones
Measure	AST-120 AST-120: 9g /day (3 times a day)	Placebo Placebo: 9g /day (3 times a day)
Overall Study STARTED	508	507
Overall Study COMPLETED	238	213
Overall Study NOT COMPLETED	270	294

Reasons for withdrawal

Reasons for withdrawal
Measure	AST-120 AST-120: 9g /day (3 times a day)	Placebo Placebo: 9g /day (3 times a day)
Overall Study Adverse Event	21	25
Overall Study Death	23	30
Overall Study Lost to Follow-up	14	13
Overall Study Physician Decision	7	2
Overall Study Pregnancy	0	3
Overall Study Protocol Violation	2	1
Overall Study Withdrawal by Subject	84	83
Overall Study Reaching endpoints,Noncompliance,etc	119	137

Baseline Characteristics

A Study of AST-120 for Evaluating Prevention of Progression In Chronic Kidney Disease Including Assessment of Quality of Life (EPPIC-2)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	AST-120 n=508 Participants AST-120: 9g /day (3 times a day)	Placebo n=507 Participants Placebo: 9g /day (3 times a day)	Total n=1015 Participants Total of all reporting groups
Age, Continuous	54.4 years STANDARD_DEVIATION 15.52 • n=18 Participants	55.7 years STANDARD_DEVIATION 14.66 • n=17 Participants	55.1 years STANDARD_DEVIATION 15.11 • n=35 Participants
Sex: Female, Male Female	229 Participants n=18 Participants	226 Participants n=17 Participants	455 Participants n=35 Participants
Sex: Female, Male Male	279 Participants n=18 Participants	281 Participants n=17 Participants	560 Participants n=35 Participants

PRIMARY outcome

Timeframe: Beyond Week 48, a 12-week visit cycle continued until the end of the study or until individual patients reached an endpoint

Population: ITT (censored at last contact)

Outcome measures

Outcome measures
Measure	AST-120 n=500 Participants AST-120: 9g /day (3 times a day)	Placebo n=497 Participants Placebo: 9g /day (3 times a day)
Composite of Dialysis Initiation, Kidney Transplantation, and Serum Creatinine Doubling. Number of Participants Meeting the Criteria Are Reported.	172 participants	183 participants

PRIMARY outcome

Timeframe: Approximately 42 months

Population: Safety population

Outcome measures

Outcome measures
Measure	AST-120 n=507 Participants AST-120: 9g /day (3 times a day)	Placebo n=505 Participants Placebo: 9g /day (3 times a day)
Number of Participants With Treatment-emergent Adverse Events and Treatment-emergent Serious Adverse Events Treatment-emergent AE	438 Participants	425 Participants
Number of Participants With Treatment-emergent Adverse Events and Treatment-emergent Serious Adverse Events Treatment-emergent SAE	156 Participants	178 Participants

SECONDARY outcome

Timeframe: approximately 42 months

Population: ITT (censored at last contact)

Outcome measures

Outcome measures
Measure	AST-120 n=500 Participants AST-120: 9g /day (3 times a day)	Placebo n=497 Participants Placebo: 9g /day (3 times a day)
Number of Participants Who Developed a Component of a Quadruple Composite Endpoint (Initiation of Dialysis, Kidney Transplant, Doubling of sCr, or Death)	204 Participants	217 Participants

SECONDARY outcome

Timeframe: Baseline, Week 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, Early Term/Discontinuation (Mean: 430.293 Days), Final Visit (Mean: 908.486 Days)

Population: Safety population. This analysis was performed using the data only from patients who had the data at each visit.

Outcome measures

Outcome measures
Measure	AST-120 n=507 Participants AST-120: 9g /day (3 times a day)	Placebo n=505 Participants Placebo: 9g /day (3 times a day)
Vitamin A Levels Baseline	1143.6 ng/mL Standard Deviation 398.42	1159.4 ng/mL Standard Deviation 404.85
Vitamin A Levels Week 12	1098.9 ng/mL Standard Deviation 376.33	1182.9 ng/mL Standard Deviation 411.38
Vitamin A Levels Week 24	1106.0 ng/mL Standard Deviation 371.04	1180.5 ng/mL Standard Deviation 385.83
Vitamin A Levels Week 36	1118.4 ng/mL Standard Deviation 382.22	1201.6 ng/mL Standard Deviation 401.03
Vitamin A Levels Week 48	1117.0 ng/mL Standard Deviation 380.72	1196.7 ng/mL Standard Deviation 399.97
Vitamin A Levels Week 60	1162.6 ng/mL Standard Deviation 373.49	1242.3 ng/mL Standard Deviation 421.19
Vitamin A Levels Week 72	1157.6 ng/mL Standard Deviation 397.82	1243.5 ng/mL Standard Deviation 416.84
Vitamin A Levels Week 84	1225.6 ng/mL Standard Deviation 418.23	1249.3 ng/mL Standard Deviation 379.41
Vitamin A Levels Week 96	1219.5 ng/mL Standard Deviation 419.49	1267.8 ng/mL Standard Deviation 376.38
Vitamin A Levels Week 108	1231.2 ng/mL Standard Deviation 397.68	1266.6 ng/mL Standard Deviation 427.25
Vitamin A Levels Week 120	1240.8 ng/mL Standard Deviation 387.79	1198.7 ng/mL Standard Deviation 388.77
Vitamin A Levels Week 132	1253.2 ng/mL Standard Deviation 376.03	1234.2 ng/mL Standard Deviation 365.55
Vitamin A Levels Week 144	1324.6 ng/mL Standard Deviation 567.01	1204.5 ng/mL Standard Deviation 414.34
Vitamin A Levels Week 156	1196.3 ng/mL Standard Deviation 456.16	1193.0 ng/mL Standard Deviation 389.27
Vitamin A Levels Week 168	1265.0 ng/mL Standard Deviation 478.26	1363.7 ng/mL Standard Deviation 348.93
Vitamin A Levels Week 180	1243.4 ng/mL Standard Deviation 454.73	1147.8 ng/mL Standard Deviation 254.30
Vitamin A Levels Early Term/ Discontinuation	1231.2 ng/mL Standard Deviation 442.79	1269.4 ng/mL Standard Deviation 425.09
Vitamin A Levels Final Visit	1223.3 ng/mL Standard Deviation 393.07	1274.5 ng/mL Standard Deviation 350.67

SECONDARY outcome

Timeframe: Baseline, Week 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, Early Term/Discontinuation (Mean: 425.112 Days), Final Visit (Mean: 910.988 Days)

Population: Safety population. This analysis was performed using the data only from patients who had the data at each visit.

Outcome measures

Outcome measures
Measure	AST-120 n=507 Participants AST-120: 9g /day (3 times a day)	Placebo n=505 Participants Placebo: 9g /day (3 times a day)
Vitamin B12 Levels Baseline	651.7 pg/mL Standard Deviation 1961.13	747.9 pg/mL Standard Deviation 2521.02
Vitamin B12 Levels Week 12	497.6 pg/mL Standard Deviation 1466.88	464.3 pg/mL Standard Deviation 650.01
Vitamin B12 Levels Week 24	608.4 pg/mL Standard Deviation 2016.76	681.0 pg/mL Standard Deviation 2127.01
Vitamin B12 Levels Week 36	631.8 pg/mL Standard Deviation 2079.77	618.7 pg/mL Standard Deviation 2031.35
Vitamin B12 Levels Week 48	455.2 pg/mL Standard Deviation 371.17	728.4 pg/mL Standard Deviation 2412.07
Vitamin B12 Levels Week 60	444.4 pg/mL Standard Deviation 332.65	637.8 pg/mL Standard Deviation 1911.72
Vitamin B12 Levels Week 72	601.6 pg/mL Standard Deviation 1882.39	741.3 pg/mL Standard Deviation 2281.81
Vitamin B12 Levels Week 84	465.2 pg/mL Standard Deviation 637.01	740.9 pg/mL Standard Deviation 2492.87
Vitamin B12 Levels Week 96	444.8 pg/mL Standard Deviation 364.90	459.5 pg/mL Standard Deviation 548.84
Vitamin B12 Levels Week 108	700.2 pg/mL Standard Deviation 2110.74	505.6 pg/mL Standard Deviation 771.70
Vitamin B12 Levels Week 120	509.9 pg/mL Standard Deviation 726.72	689.1 pg/mL Standard Deviation 1864.40
Vitamin B12 Levels Week 132	657.7 pg/mL Standard Deviation 1428.09	476.9 pg/mL Standard Deviation 483.88
Vitamin B12 Levels Week 144	416.3 pg/mL Standard Deviation 211.52	721.3 pg/mL Standard Deviation 1543.37
Vitamin B12 Levels Week 156	601.5 pg/mL Standard Deviation 744.06	1046.6 pg/mL Standard Deviation 3595.42
Vitamin B12 Levels Week 168	552.7 pg/mL Standard Deviation 570.85	750.2 pg/mL Standard Deviation 1385.54
Vitamin B12 Levels Week 180	494.5 pg/mL Standard Deviation 389.57	1062.7 pg/mL Standard Deviation 2386.40
Vitamin B12 Levels Early Term/ Discontinuation	1186.2 pg/mL Standard Deviation 4148.50	1174.8 pg/mL Standard Deviation 3403.80
Vitamin B12 Levels Final Visit	764.2 pg/mL Standard Deviation 2392.88	505.5 pg/mL Standard Deviation 1063.91

SECONDARY outcome

Timeframe: Baseline, Week 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, Early Term/Discontinuation (Mean: 429.695 Days), Final Visit (Mean: 908.601 Days)

Population: Safety population. This analysis was performed using the data only from patients who had the data at each visit.

Outcome measures

Outcome measures
Measure	AST-120 n=507 Participants AST-120: 9g /day (3 times a day)	Placebo n=505 Participants Placebo: 9g /day (3 times a day)
25-Hydroxyvitamin D Levels Week 60	21.39 ng/mL Standard Deviation 10.139	20.36 ng/mL Standard Deviation 10.250
25-Hydroxyvitamin D Levels Week 72	22.56 ng/mL Standard Deviation 11.326	21.58 ng/mL Standard Deviation 11.225
25-Hydroxyvitamin D Levels Week 84	22.29 ng/mL Standard Deviation 9.967	22.30 ng/mL Standard Deviation 10.728
25-Hydroxyvitamin D Levels Baseline	21.09 ng/mL Standard Deviation 10.391	20.36 ng/mL Standard Deviation 10.063
25-Hydroxyvitamin D Levels Week 12	21.64 ng/mL Standard Deviation 9.981	21.08 ng/mL Standard Deviation 10.246
25-Hydroxyvitamin D Levels Week 24	21.70 ng/mL Standard Deviation 10.166	21.28 ng/mL Standard Deviation 10.100
25-Hydroxyvitamin D Levels Week 36	21.72 ng/mL Standard Deviation 10.441	21.00 ng/mL Standard Deviation 9.766
25-Hydroxyvitamin D Levels Week 48	21.10 ng/mL Standard Deviation 10.195	20.57 ng/mL Standard Deviation 10.489
25-Hydroxyvitamin D Levels Week 96	22.63 ng/mL Standard Deviation 10.563	21.83 ng/mL Standard Deviation 10.463
25-Hydroxyvitamin D Levels Week 108	22.97 ng/mL Standard Deviation 10.305	22.17 ng/mL Standard Deviation 11.535
25-Hydroxyvitamin D Levels Week 120	24.45 ng/mL Standard Deviation 11.315	22.55 ng/mL Standard Deviation 12.332
25-Hydroxyvitamin D Levels Week 132	25.50 ng/mL Standard Deviation 11.083	22.33 ng/mL Standard Deviation 11.377
25-Hydroxyvitamin D Levels Week 144	25.02 ng/mL Standard Deviation 10.830	21.06 ng/mL Standard Deviation 9.960
25-Hydroxyvitamin D Levels Week 156	27.30 ng/mL Standard Deviation 14.396	21.46 ng/mL Standard Deviation 10.506
25-Hydroxyvitamin D Levels Week 168	28.87 ng/mL Standard Deviation 12.654	23.91 ng/mL Standard Deviation 11.704
25-Hydroxyvitamin D Levels Week 180	33.63 ng/mL Standard Deviation 15.515	25.72 ng/mL Standard Deviation 8.827
25-Hydroxyvitamin D Levels Early Term/ Discontinuation	22.18 ng/mL Standard Deviation 13.112	21.32 ng/mL Standard Deviation 10.752
25-Hydroxyvitamin D Levels Final Visit	24.62 ng/mL Standard Deviation 11.311	24.03 ng/mL Standard Deviation 11.099

SECONDARY outcome

Timeframe: Baseline, Week 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, Early Term/Discontinuation (Mean: 427.067 Days), Final Visit (Mean: 908.715 Days)

Population: Safety population. This analysis was performed using the data only from patients who had the data at each visit.

Outcome measures

Outcome measures
Measure	AST-120 n=507 Participants AST-120: 9g /day (3 times a day)	Placebo n=505 Participants Placebo: 9g /day (3 times a day)
Vitamin E Levels Week 60	16.60 ug/mL Standard Deviation 5.787	17.14 ug/mL Standard Deviation 6.267
Vitamin E Levels Week 72	16.79 ug/mL Standard Deviation 6.188	17.10 ug/mL Standard Deviation 6.242
Vitamin E Levels Week 84	17.13 ug/mL Standard Deviation 6.978	16.82 ug/mL Standard Deviation 5.847
Vitamin E Levels Baseline	16.55 ug/mL Standard Deviation 6.204	16.29 ug/mL Standard Deviation 6.188
Vitamin E Levels Week 12	16.59 ug/mL Standard Deviation 6.152	16.94 ug/mL Standard Deviation 6.756
Vitamin E Levels Week 24	16.87 ug/mL Standard Deviation 6.146	16.82 ug/mL Standard Deviation 6.275
Vitamin E Levels Week 36	17.32 ug/mL Standard Deviation 7.280	16.82 ug/mL Standard Deviation 6.046
Vitamin E Levels Week 48	17.12 ug/mL Standard Deviation 6.653	16.95 ug/mL Standard Deviation 6.204
Vitamin E Levels Week 96	17.42 ug/mL Standard Deviation 6.987	17.21 ug/mL Standard Deviation 6.007
Vitamin E Levels Week 108	17.27 ug/mL Standard Deviation 6.403	17.03 ug/mL Standard Deviation 5.986
Vitamin E Levels Week 120	16.95 ug/mL Standard Deviation 5.217	16.79 ug/mL Standard Deviation 5.870
Vitamin E Levels Week 132	16.81 ug/mL Standard Deviation 5.533	16.42 ug/mL Standard Deviation 6.081
Vitamin E Levels Week 144	17.11 ug/mL Standard Deviation 6.970	17.06 ug/mL Standard Deviation 6.607
Vitamin E Levels Week 156	16.64 ug/mL Standard Deviation 6.016	16.70 ug/mL Standard Deviation 6.491
Vitamin E Levels Week 168	16.64 ug/mL Standard Deviation 6.435	18.02 ug/mL Standard Deviation 6.865
Vitamin E Levels Week 180	15.57 ug/mL Standard Deviation 4.474	17.58 ug/mL Standard Deviation 5.239
Vitamin E Levels Early Term/ Discontinuation	16.32 ug/mL Standard Deviation 5.047	16.25 ug/mL Standard Deviation 6.334
Vitamin E Levels Final Visit	15.60 ug/mL Standard Deviation 5.731	15.92 ug/mL Standard Deviation 6.211

SECONDARY outcome

Timeframe: Baseline, Week 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, Early Term/Discontinuation (Mean: 432.942 Days), Final Visit (Mean: 910.448 Days)

Population: Safety population. This analysis was performed using the data only from patients who had the data at each visit.

Outcome measures

Outcome measures
Measure	AST-120 n=507 Participants AST-120: 9g /day (3 times a day)	Placebo n=505 Participants Placebo: 9g /day (3 times a day)
Vitamin K Levels Baseline	0.663 ng/mL Standard Deviation 0.6138	0.628 ng/mL Standard Deviation 0.6023
Vitamin K Levels Week 12	0.651 ng/mL Standard Deviation 0.6296	0.653 ng/mL Standard Deviation 0.6060
Vitamin K Levels Week 24	0.655 ng/mL Standard Deviation 0.5999	0.658 ng/mL Standard Deviation 0.6364
Vitamin K Levels Week 36	0.730 ng/mL Standard Deviation 0.6616	0.640 ng/mL Standard Deviation 0.6120
Vitamin K Levels Week 48	0.626 ng/mL Standard Deviation 0.5746	0.649 ng/mL Standard Deviation 0.6211
Vitamin K Levels Week 60	0.695 ng/mL Standard Deviation 0.6458	0.732 ng/mL Standard Deviation 0.6640
Vitamin K Levels Week 72	0.703 ng/mL Standard Deviation 0.6295	0.703 ng/mL Standard Deviation 0.6668
Vitamin K Levels Week 84	0.775 ng/mL Standard Deviation 0.7309	0.717 ng/mL Standard Deviation 0.6631
Vitamin K Levels Week 96	0.723 ng/mL Standard Deviation 0.6386	0.682 ng/mL Standard Deviation 0.6382
Vitamin K Levels Week 108	0.801 ng/mL Standard Deviation 0.7190	0.737 ng/mL Standard Deviation 0.7428
Vitamin K Levels Week 120	0.688 ng/mL Standard Deviation 0.7177	0.717 ng/mL Standard Deviation 0.6918
Vitamin K Levels Week 132	0.782 ng/mL Standard Deviation 0.7253	0.650 ng/mL Standard Deviation 0.6832
Vitamin K Levels Week 144	0.661 ng/mL Standard Deviation 0.6658	0.662 ng/mL Standard Deviation 0.5824
Vitamin K Levels Week 156	0.685 ng/mL Standard Deviation 0.6300	0.724 ng/mL Standard Deviation 0.6570
Vitamin K Levels Week 168	0.822 ng/mL Standard Deviation 0.7662	0.862 ng/mL Standard Deviation 0.7611
Vitamin K Levels Week 180	0.879 ng/mL Standard Deviation 0.8268	1.020 ng/mL Standard Deviation 1.0008
Vitamin K Levels Early Term / Discontinuation	0.761 ng/mL Standard Deviation 0.6920	0.679 ng/mL Standard Deviation 0.6541
Vitamin K Levels Final Visit	0.843 ng/mL Standard Deviation 0.7197	0.814 ng/mL Standard Deviation 0.6982

SECONDARY outcome

Timeframe: Baseline, Week 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, Early Term/Discontinuation (Mean: 420.569 Days), Final Visit (Mean: 909.848 Days)

Population: Safety population. This analysis was performed using the data only from patients who had the data at each visit.

Outcome measures

Outcome measures
Measure	AST-120 n=507 Participants AST-120: 9g /day (3 times a day)	Placebo n=505 Participants Placebo: 9g /day (3 times a day)
Serum Folate Levels Week 36	13.35 ng/mL Standard Deviation 24.059	16.61 ng/mL Standard Deviation 34.428
Serum Folate Levels Week 48	13.84 ng/mL Standard Deviation 24.193	18.16 ng/mL Standard Deviation 40.329
Serum Folate Levels Week 60	13.25 ng/mL Standard Deviation 20.655	17.57 ng/mL Standard Deviation 40.427
Serum Folate Levels Week 84	12.67 ng/mL Standard Deviation 19.767	14.34 ng/mL Standard Deviation 26.514
Serum Folate Levels Week 96	13.27 ng/mL Standard Deviation 18.484	17.20 ng/mL Standard Deviation 37.621
Serum Folate Levels Week 108	12.76 ng/mL Standard Deviation 18.758	17.10 ng/mL Standard Deviation 42.133
Serum Folate Levels Baseline	15.51 ng/mL Standard Deviation 28.300	18.87 ng/mL Standard Deviation 37.577
Serum Folate Levels Week 12	13.46 ng/mL Standard Deviation 23.247	18.57 ng/mL Standard Deviation 38.500
Serum Folate Levels Week 24	13.79 ng/mL Standard Deviation 28.539	17.44 ng/mL Standard Deviation 39.950
Serum Folate Levels Week 72	12.78 ng/mL Standard Deviation 21.370	17.76 ng/mL Standard Deviation 38.679
Serum Folate Levels Week 120	12.34 ng/mL Standard Deviation 13.152	18.93 ng/mL Standard Deviation 46.884
Serum Folate Levels Week 132	12.13 ng/mL Standard Deviation 12.813	14.08 ng/mL Standard Deviation 36.549
Serum Folate Levels Week 144	14.26 ng/mL Standard Deviation 31.355	9.93 ng/mL Standard Deviation 9.423
Serum Folate Levels Week 156	12.12 ng/mL Standard Deviation 12.259	10.04 ng/mL Standard Deviation 10.910
Serum Folate Levels Week 168	13.90 ng/mL Standard Deviation 16.225	17.62 ng/mL Standard Deviation 31.941
Serum Folate Levels Week 180	16.63 ng/mL Standard Deviation 17.402	13.45 ng/mL Standard Deviation 14.884
Serum Folate Levels Early Term/ Discontinuation	12.28 ng/mL Standard Deviation 18.101	23.21 ng/mL Standard Deviation 35.035
Serum Folate Levels Final Visit	13.62 ng/mL Standard Deviation 24.370	18.36 ng/mL Standard Deviation 42.611

Adverse Events

AST-120

Serious events: 156 serious events

Other events: 393 other events

Deaths: 0 deaths

Placebo

Serious events: 178 serious events

Other events: 377 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Additional Information

Clinical Trials, Information Desk

Tanabe Pharma Corporation

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: OTHER

Serious adverse events
Measure	AST-120 n=507 participants at risk AST-120: 9g /day (3 times a day)	Placebo n=505 participants at risk Placebo: 9g /day (3 times a day)
Blood and lymphatic system disorders Anaemia	1.4% 7/507 The AE analysis is based on the Safety Population. The Safety Population included all patients who were randomized and received at least 1 dose of study drug. The start number of Participant Flow included all patients who were randomized.	1.2% 6/505 The AE analysis is based on the Safety Population. The Safety Population included all patients who were randomized and received at least 1 dose of study drug. The start number of Participant Flow included all patients who were randomized.
Blood and lymphatic system disorders Haemolytic anaemia	0.20% 1/507 The AE analysis is based on the Safety Population. The Safety Population included all patients who were randomized and received at least 1 dose of study drug. The start number of Participant Flow included all patients who were randomized.	0.00% 0/505 The AE analysis is based on the Safety Population. The Safety Population included all patients who were randomized and received at least 1 dose of study drug. The start number of Participant Flow included all patients who were randomized.
Blood and lymphatic system disorders Iron deficiency anaemia	0.00% 0/507 The AE analysis is based on the Safety Population. The Safety Population included all patients who were randomized and received at least 1 dose of study drug. The start number of Participant Flow included all patients who were randomized.	0.20% 1/505 The AE analysis is based on the Safety Population. The Safety Population included all patients who were randomized and received at least 1 dose of study drug. The start number of Participant Flow included all patients who were randomized.
Cardiac disorders Acute coronary syndrome	0.39% 2/507 The AE analysis is based on the Safety Population. The Safety Population included all patients who were randomized and received at least 1 dose of study drug. The start number of Participant Flow included all patients who were randomized.	0.00% 0/505 The AE analysis is based on the Safety Population. The Safety Population included all patients who were randomized and received at least 1 dose of study drug. The start number of Participant Flow included all patients who were randomized.
Cardiac disorders Acute left ventricular failure	0.20% 1/507 The AE analysis is based on the Safety Population. The Safety Population included all patients who were randomized and received at least 1 dose of study drug. The start number of Participant Flow included all patients who were randomized.	0.00% 0/505 The AE analysis is based on the Safety Population. The Safety Population included all patients who were randomized and received at least 1 dose of study drug. The start number of Participant Flow included all patients who were randomized.
Cardiac disorders Acute myocardial infarction	1.6% 8/507 The AE analysis is based on the Safety Population. The Safety Population included all patients who were randomized and received at least 1 dose of study drug. The start number of Participant Flow included all patients who were randomized.	1.2% 6/505 The AE analysis is based on the Safety Population. The Safety Population included all patients who were randomized and received at least 1 dose of study drug. The start number of Participant Flow included all patients who were randomized.
Cardiac disorders Angina pectoris	0.39% 2/507 The AE analysis is based on the Safety Population. The Safety Population included all patients who were randomized and received at least 1 dose of study drug. The start number of Participant Flow included all patients who were randomized.	0.99% 5/505 The AE analysis is based on the Safety Population. The Safety Population included all patients who were randomized and received at least 1 dose of study drug. The start number of Participant Flow included all patients who were randomized.
Cardiac disorders Angina unstable	0.99% 5/507 The AE analysis is based on the Safety Population. The Safety Population included all patients who were randomized and received at least 1 dose of study drug. The start number of Participant Flow included all patients who were randomized.	0.79% 4/505 The AE analysis is based on the Safety Population. The Safety Population included all patients who were randomized and received at least 1 dose of study drug. The start number of Participant Flow included all patients who were randomized.
Cardiac disorders Arrhythmia	0.20% 1/507 The AE analysis is based on the Safety Population. The Safety Population included all patients who were randomized and received at least 1 dose of study drug. The start number of Participant Flow included all patients who were randomized.	0.00% 0/505 The AE analysis is based on the Safety Population. The Safety Population included all patients who were randomized and received at least 1 dose of study drug. The start number of Participant Flow included all patients who were randomized.
Cardiac disorders Arteriosclerosis coronary artery	0.20% 1/507 The AE analysis is based on the Safety Population. The Safety Population included all patients who were randomized and received at least 1 dose of study drug. The start number of Participant Flow included all patients who were randomized.	0.40% 2/505 The AE analysis is based on the Safety Population. The Safety Population included all patients who were randomized and received at least 1 dose of study drug. The start number of Participant Flow included all patients who were randomized.
Cardiac disorders Atrial fibrillation	0.79% 4/507 The AE analysis is based on the Safety Population. The Safety Population included all patients who were randomized and received at least 1 dose of study drug. The start number of Participant Flow included all patients who were randomized.	0.20% 1/505 The AE analysis is based on the Safety Population. The Safety Population included all patients who were randomized and received at least 1 dose of study drug. The start number of Participant Flow included all patients who were randomized.
Cardiac disorders Atrial flutter	0.39% 2/507 The AE analysis is based on the Safety Population. The Safety Population included all patients who were randomized and received at least 1 dose of study drug. The start number of Participant Flow included all patients who were randomized.	0.20% 1/505 The AE analysis is based on the Safety Population. The Safety Population included all patients who were randomized and received at least 1 dose of study drug. The start number of Participant Flow included all patients who were randomized.
Cardiac disorders Atrioventricular block	0.20% 1/507 The AE analysis is based on the Safety Population. The Safety Population included all patients who were randomized and received at least 1 dose of study drug. The start number of Participant Flow included all patients who were randomized.	0.00% 0/505 The AE analysis is based on the Safety Population. The Safety Population included all patients who were randomized and received at least 1 dose of study drug. The start number of Participant Flow included all patients who were randomized.
Cardiac disorders Atrioventricular block complete	0.20% 1/507 The AE analysis is based on the Safety Population. The Safety Population included all patients who were randomized and received at least 1 dose of study drug. The start number of Participant Flow included all patients who were randomized.	0.00% 0/505 The AE analysis is based on the Safety Population. The Safety Population included all patients who were randomized and received at least 1 dose of study drug. The start number of Participant Flow included all patients who were randomized.
Cardiac disorders Atrioventricular block first degree	0.39% 2/507 The AE analysis is based on the Safety Population. The Safety Population included all patients who were randomized and received at least 1 dose of study drug. The start number of Participant Flow included all patients who were randomized.	0.00% 0/505 The AE analysis is based on the Safety Population. The Safety Population included all patients who were randomized and received at least 1 dose of study drug. The start number of Participant Flow included all patients who were randomized.
Cardiac disorders Atrioventricular block second degree	0.00% 0/507 The AE analysis is based on the Safety Population. The Safety Population included all patients who were randomized and received at least 1 dose of study drug. The start number of Participant Flow included all patients who were randomized.	0.20% 1/505 The AE analysis is based on the Safety Population. The Safety Population included all patients who were randomized and received at least 1 dose of study drug. The start number of Participant Flow included all patients who were randomized.
Cardiac disorders Bradycardia	0.20% 1/507 The AE analysis is based on the Safety Population. The Safety Population included all patients who were randomized and received at least 1 dose of study drug. The start number of Participant Flow included all patients who were randomized.	0.79% 4/505 The AE analysis is based on the Safety Population. The Safety Population included all patients who were randomized and received at least 1 dose of study drug. The start number of Participant Flow included all patients who were randomized.
Cardiac disorders Cardiac arrest	0.59% 3/507 The AE analysis is based on the Safety Population. The Safety Population included all patients who were randomized and received at least 1 dose of study drug. The start number of Participant Flow included all patients who were randomized.	0.59% 3/505 The AE analysis is based on the Safety Population. The Safety Population included all patients who were randomized and received at least 1 dose of study drug. The start number of Participant Flow included all patients who were randomized.
Cardiac disorders Cardiac failure	0.79% 4/507 The AE analysis is based on the Safety Population. The Safety Population included all patients who were randomized and received at least 1 dose of study drug. The start number of Participant Flow included all patients who were randomized.	0.79% 4/505 The AE analysis is based on the Safety Population. The Safety Population included all patients who were randomized and received at least 1 dose of study drug. The start number of Participant Flow included all patients who were randomized.
Cardiac disorders Cardiac failure acute	0.20% 1/507 The AE analysis is based on the Safety Population. The Safety Population included all patients who were randomized and received at least 1 dose of study drug. The start number of Participant Flow included all patients who were randomized.	0.00% 0/505 The AE analysis is based on the Safety Population. The Safety Population included all patients who were randomized and received at least 1 dose of study drug. The start number of Participant Flow included all patients who were randomized.
Cardiac disorders Cardiac failure chronic	0.00% 0/507 The AE analysis is based on the Safety Population. The Safety Population included all patients who were randomized and received at least 1 dose of study drug. The start number of Participant Flow included all patients who were randomized.	0.20% 1/505 The AE analysis is based on the Safety Population. The Safety Population included all patients who were randomized and received at least 1 dose of study drug. The start number of Participant Flow included all patients who were randomized.
Cardiac disorders Cardiac failure congestive	0.99% 5/507 The AE analysis is based on the Safety Population. The Safety Population included all patients who were randomized and received at least 1 dose of study drug. The start number of Participant Flow included all patients who were randomized.	2.2% 11/505 The AE analysis is based on the Safety Population. The Safety Population included all patients who were randomized and received at least 1 dose of study drug. The start number of Participant Flow included all patients who were randomized.
Cardiac disorders Cardiogenic shock	0.00% 0/507 The AE analysis is based on the Safety Population. The Safety Population included all patients who were randomized and received at least 1 dose of study drug. The start number of Participant Flow included all patients who were randomized.	0.40% 2/505 The AE analysis is based on the Safety Population. The Safety Population included all patients who were randomized and received at least 1 dose of study drug. The start number of Participant Flow included all patients who were randomized.
Cardiac disorders Cardiomyopathy	0.20% 1/507 The AE analysis is based on the Safety Population. The Safety Population included all patients who were randomized and received at least 1 dose of study drug. The start number of Participant Flow included all patients who were randomized.	0.00% 0/505 The AE analysis is based on the Safety Population. The Safety Population included all patients who were randomized and received at least 1 dose of study drug. The start number of Participant Flow included all patients who were randomized.
Cardiac disorders Cardiomyopathy alcoholic	0.20% 1/507 The AE analysis is based on the Safety Population. The Safety Population included all patients who were randomized and received at least 1 dose of study drug. The start number of Participant Flow included all patients who were randomized.	0.00% 0/505 The AE analysis is based on the Safety Population. The Safety Population included all patients who were randomized and received at least 1 dose of study drug. The start number of Participant Flow included all patients who were randomized.
Cardiac disorders Cardiopulmonary failure	0.20% 1/507 The AE analysis is based on the Safety Population. The Safety Population included all patients who were randomized and received at least 1 dose of study drug. The start number of Participant Flow included all patients who were randomized.	0.00% 0/505 The AE analysis is based on the Safety Population. The Safety Population included all patients who were randomized and received at least 1 dose of study drug. The start number of Participant Flow included all patients who were randomized.
Cardiac disorders Coronary artery disease	0.59% 3/507 The AE analysis is based on the Safety Population. The Safety Population included all patients who were randomized and received at least 1 dose of study drug. The start number of Participant Flow included all patients who were randomized.	0.59% 3/505 The AE analysis is based on the Safety Population. The Safety Population included all patients who were randomized and received at least 1 dose of study drug. The start number of Participant Flow included all patients who were randomized.
Cardiac disorders Coronary artery insufficiency	0.00% 0/507 The AE analysis is based on the Safety Population. The Safety Population included all patients who were randomized and received at least 1 dose of study drug. The start number of Participant Flow included all patients who were randomized.	0.20% 1/505 The AE analysis is based on the Safety Population. The Safety Population included all patients who were randomized and received at least 1 dose of study drug. The start number of Participant Flow included all patients who were randomized.
Cardiac disorders Ischaemic cardiomyopathy	0.20% 1/507 The AE analysis is based on the Safety Population. The Safety Population included all patients who were randomized and received at least 1 dose of study drug. The start number of Participant Flow included all patients who were randomized.	0.00% 0/505 The AE analysis is based on the Safety Population. The Safety Population included all patients who were randomized and received at least 1 dose of study drug. The start number of Participant Flow included all patients who were randomized.
Cardiac disorders Left ventricular dysfunction	0.20% 1/507 The AE analysis is based on the Safety Population. The Safety Population included all patients who were randomized and received at least 1 dose of study drug. The start number of Participant Flow included all patients who were randomized.	0.00% 0/505 The AE analysis is based on the Safety Population. The Safety Population included all patients who were randomized and received at least 1 dose of study drug. The start number of Participant Flow included all patients who were randomized.
Cardiac disorders Myocardial infarction	0.20% 1/507 The AE analysis is based on the Safety Population. The Safety Population included all patients who were randomized and received at least 1 dose of study drug. The start number of Participant Flow included all patients who were randomized.	0.79% 4/505 The AE analysis is based on the Safety Population. The Safety Population included all patients who were randomized and received at least 1 dose of study drug. The start number of Participant Flow included all patients who were randomized.
Cardiac disorders Myocardial ischaemia	0.00% 0/507 The AE analysis is based on the Safety Population. The Safety Population included all patients who were randomized and received at least 1 dose of study drug. The start number of Participant Flow included all patients who were randomized.	0.20% 1/505 The AE analysis is based on the Safety Population. The Safety Population included all patients who were randomized and received at least 1 dose of study drug. The start number of Participant Flow included all patients who were randomized.
Cardiac disorders Silent myocardial infarction	0.20% 1/507 The AE analysis is based on the Safety Population. The Safety Population included all patients who were randomized and received at least 1 dose of study drug. The start number of Participant Flow included all patients who were randomized.	0.00% 0/505 The AE analysis is based on the Safety Population. The Safety Population included all patients who were randomized and received at least 1 dose of study drug. The start number of Participant Flow included all patients who were randomized.
Cardiac disorders Sinus bradycardia	0.20% 1/507 The AE analysis is based on the Safety Population. The Safety Population included all patients who were randomized and received at least 1 dose of study drug. The start number of Participant Flow included all patients who were randomized.	0.20% 1/505 The AE analysis is based on the Safety Population. The Safety Population included all patients who were randomized and received at least 1 dose of study drug. The start number of Participant Flow included all patients who were randomized.
Cardiac disorders Tachycardia	0.20% 1/507 The AE analysis is based on the Safety Population. The Safety Population included all patients who were randomized and received at least 1 dose of study drug. The start number of Participant Flow included all patients who were randomized.	0.00% 0/505 The AE analysis is based on the Safety Population. The Safety Population included all patients who were randomized and received at least 1 dose of study drug. The start number of Participant Flow included all patients who were randomized.
Cardiac disorders Ventricular fibrillation	0.20% 1/507 The AE analysis is based on the Safety Population. The Safety Population included all patients who were randomized and received at least 1 dose of study drug. The start number of Participant Flow included all patients who were randomized.	0.20% 1/505 The AE analysis is based on the Safety Population. The Safety Population included all patients who were randomized and received at least 1 dose of study drug. The start number of Participant Flow included all patients who were randomized.
Endocrine disorders Hyperparathyroidism tertiary	0.00% 0/507 The AE analysis is based on the Safety Population. The Safety Population included all patients who were randomized and received at least 1 dose of study drug. The start number of Participant Flow included all patients who were randomized.	0.20% 1/505 The AE analysis is based on the Safety Population. The Safety Population included all patients who were randomized and received at least 1 dose of study drug. The start number of Participant Flow included all patients who were randomized.
Endocrine disorders Myxoedema	0.00% 0/507 The AE analysis is based on the Safety Population. The Safety Population included all patients who were randomized and received at least 1 dose of study drug. The start number of Participant Flow included all patients who were randomized.	0.20% 1/505 The AE analysis is based on the Safety Population. The Safety Population included all patients who were randomized and received at least 1 dose of study drug. The start number of Participant Flow included all patients who were randomized.
Eye disorders Cataract	0.20% 1/507 The AE analysis is based on the Safety Population. The Safety Population included all patients who were randomized and received at least 1 dose of study drug. The start number of Participant Flow included all patients who were randomized.	0.00% 0/505 The AE analysis is based on the Safety Population. The Safety Population included all patients who were randomized and received at least 1 dose of study drug. The start number of Participant Flow included all patients who were randomized.
Eye disorders Diabetic retinopathy	0.20% 1/507 The AE analysis is based on the Safety Population. The Safety Population included all patients who were randomized and received at least 1 dose of study drug. The start number of Participant Flow included all patients who were randomized.	0.00% 0/505 The AE analysis is based on the Safety Population. The Safety Population included all patients who were randomized and received at least 1 dose of study drug. The start number of Participant Flow included all patients who were randomized.

Other adverse events
Measure	AST-120 n=507 participants at risk AST-120: 9g /day (3 times a day)	Placebo n=505 participants at risk Placebo: 9g /day (3 times a day)
General disorders Asthenia	2.8% 14/507 The AE analysis is based on the Safety Population. The Safety Population included all patients who were randomized and received at least 1 dose of study drug. The start number of Participant Flow included all patients who were randomized.	4.0% 20/505 The AE analysis is based on the Safety Population. The Safety Population included all patients who were randomized and received at least 1 dose of study drug. The start number of Participant Flow included all patients who were randomized.
Blood and lymphatic system disorders Anaemia	14.8% 75/507 The AE analysis is based on the Safety Population. The Safety Population included all patients who were randomized and received at least 1 dose of study drug. The start number of Participant Flow included all patients who were randomized.	16.4% 83/505 The AE analysis is based on the Safety Population. The Safety Population included all patients who were randomized and received at least 1 dose of study drug. The start number of Participant Flow included all patients who were randomized.
Cardiac disorders Angina pectoris	0.20% 1/507 The AE analysis is based on the Safety Population. The Safety Population included all patients who were randomized and received at least 1 dose of study drug. The start number of Participant Flow included all patients who were randomized.	1.4% 7/505 The AE analysis is based on the Safety Population. The Safety Population included all patients who were randomized and received at least 1 dose of study drug. The start number of Participant Flow included all patients who were randomized.
Ear and labyrinth disorders Vertigo	0.39% 2/507 The AE analysis is based on the Safety Population. The Safety Population included all patients who were randomized and received at least 1 dose of study drug. The start number of Participant Flow included all patients who were randomized.	1.2% 6/505 The AE analysis is based on the Safety Population. The Safety Population included all patients who were randomized and received at least 1 dose of study drug. The start number of Participant Flow included all patients who were randomized.
Endocrine disorders Hyperparathyroidism	1.4% 7/507 The AE analysis is based on the Safety Population. The Safety Population included all patients who were randomized and received at least 1 dose of study drug. The start number of Participant Flow included all patients who were randomized.	0.79% 4/505 The AE analysis is based on the Safety Population. The Safety Population included all patients who were randomized and received at least 1 dose of study drug. The start number of Participant Flow included all patients who were randomized.
Endocrine disorders Hyperparathyroidism secondary	1.8% 9/507 The AE analysis is based on the Safety Population. The Safety Population included all patients who were randomized and received at least 1 dose of study drug. The start number of Participant Flow included all patients who were randomized.	1.6% 8/505 The AE analysis is based on the Safety Population. The Safety Population included all patients who were randomized and received at least 1 dose of study drug. The start number of Participant Flow included all patients who were randomized.
Eye disorders Cataract	2.4% 12/507 The AE analysis is based on the Safety Population. The Safety Population included all patients who were randomized and received at least 1 dose of study drug. The start number of Participant Flow included all patients who were randomized.	1.2% 6/505 The AE analysis is based on the Safety Population. The Safety Population included all patients who were randomized and received at least 1 dose of study drug. The start number of Participant Flow included all patients who were randomized.
Eye disorders Eye haemorrhage	1.4% 7/507 The AE analysis is based on the Safety Population. The Safety Population included all patients who were randomized and received at least 1 dose of study drug. The start number of Participant Flow included all patients who were randomized.	0.00% 0/505 The AE analysis is based on the Safety Population. The Safety Population included all patients who were randomized and received at least 1 dose of study drug. The start number of Participant Flow included all patients who were randomized.
Gastrointestinal disorders Abdominal discomfort	1.8% 9/507 The AE analysis is based on the Safety Population. The Safety Population included all patients who were randomized and received at least 1 dose of study drug. The start number of Participant Flow included all patients who were randomized.	0.00% 0/505 The AE analysis is based on the Safety Population. The Safety Population included all patients who were randomized and received at least 1 dose of study drug. The start number of Participant Flow included all patients who were randomized.
Gastrointestinal disorders Abdominal distension	3.2% 16/507 The AE analysis is based on the Safety Population. The Safety Population included all patients who were randomized and received at least 1 dose of study drug. The start number of Participant Flow included all patients who were randomized.	3.2% 16/505 The AE analysis is based on the Safety Population. The Safety Population included all patients who were randomized and received at least 1 dose of study drug. The start number of Participant Flow included all patients who were randomized.
Gastrointestinal disorders Abdominal pain	3.6% 18/507 The AE analysis is based on the Safety Population. The Safety Population included all patients who were randomized and received at least 1 dose of study drug. The start number of Participant Flow included all patients who were randomized.	3.8% 19/505 The AE analysis is based on the Safety Population. The Safety Population included all patients who were randomized and received at least 1 dose of study drug. The start number of Participant Flow included all patients who were randomized.
Gastrointestinal disorders Abdominal pain upper	2.8% 14/507 The AE analysis is based on the Safety Population. The Safety Population included all patients who were randomized and received at least 1 dose of study drug. The start number of Participant Flow included all patients who were randomized.	2.6% 13/505 The AE analysis is based on the Safety Population. The Safety Population included all patients who were randomized and received at least 1 dose of study drug. The start number of Participant Flow included all patients who were randomized.
Gastrointestinal disorders Constipation	10.8% 55/507 The AE analysis is based on the Safety Population. The Safety Population included all patients who were randomized and received at least 1 dose of study drug. The start number of Participant Flow included all patients who were randomized.	7.5% 38/505 The AE analysis is based on the Safety Population. The Safety Population included all patients who were randomized and received at least 1 dose of study drug. The start number of Participant Flow included all patients who were randomized.
Gastrointestinal disorders Diarrhoea	8.3% 42/507 The AE analysis is based on the Safety Population. The Safety Population included all patients who were randomized and received at least 1 dose of study drug. The start number of Participant Flow included all patients who were randomized.	8.1% 41/505 The AE analysis is based on the Safety Population. The Safety Population included all patients who were randomized and received at least 1 dose of study drug. The start number of Participant Flow included all patients who were randomized.
Gastrointestinal disorders Dyspepsia	3.2% 16/507 The AE analysis is based on the Safety Population. The Safety Population included all patients who were randomized and received at least 1 dose of study drug. The start number of Participant Flow included all patients who were randomized.	4.2% 21/505 The AE analysis is based on the Safety Population. The Safety Population included all patients who were randomized and received at least 1 dose of study drug. The start number of Participant Flow included all patients who were randomized.
Gastrointestinal disorders Faeces discoloured	0.79% 4/507 The AE analysis is based on the Safety Population. The Safety Population included all patients who were randomized and received at least 1 dose of study drug. The start number of Participant Flow included all patients who were randomized.	2.2% 11/505 The AE analysis is based on the Safety Population. The Safety Population included all patients who were randomized and received at least 1 dose of study drug. The start number of Participant Flow included all patients who were randomized.
Gastrointestinal disorders Flatulence	2.4% 12/507 The AE analysis is based on the Safety Population. The Safety Population included all patients who were randomized and received at least 1 dose of study drug. The start number of Participant Flow included all patients who were randomized.	3.0% 15/505 The AE analysis is based on the Safety Population. The Safety Population included all patients who were randomized and received at least 1 dose of study drug. The start number of Participant Flow included all patients who were randomized.
Gastrointestinal disorders Gastritis	3.9% 20/507 The AE analysis is based on the Safety Population. The Safety Population included all patients who were randomized and received at least 1 dose of study drug. The start number of Participant Flow included all patients who were randomized.	4.4% 22/505 The AE analysis is based on the Safety Population. The Safety Population included all patients who were randomized and received at least 1 dose of study drug. The start number of Participant Flow included all patients who were randomized.
Gastrointestinal disorders Gastrooesophageal reflux disease	2.2% 11/507 The AE analysis is based on the Safety Population. The Safety Population included all patients who were randomized and received at least 1 dose of study drug. The start number of Participant Flow included all patients who were randomized.	0.40% 2/505 The AE analysis is based on the Safety Population. The Safety Population included all patients who were randomized and received at least 1 dose of study drug. The start number of Participant Flow included all patients who were randomized.
Gastrointestinal disorders Nausea	8.9% 45/507 The AE analysis is based on the Safety Population. The Safety Population included all patients who were randomized and received at least 1 dose of study drug. The start number of Participant Flow included all patients who were randomized.	8.9% 45/505 The AE analysis is based on the Safety Population. The Safety Population included all patients who were randomized and received at least 1 dose of study drug. The start number of Participant Flow included all patients who were randomized.
Gastrointestinal disorders Vomiting	5.5% 28/507 The AE analysis is based on the Safety Population. The Safety Population included all patients who were randomized and received at least 1 dose of study drug. The start number of Participant Flow included all patients who were randomized.	7.1% 36/505 The AE analysis is based on the Safety Population. The Safety Population included all patients who were randomized and received at least 1 dose of study drug. The start number of Participant Flow included all patients who were randomized.
General disorders Chest pain	1.4% 7/507 The AE analysis is based on the Safety Population. The Safety Population included all patients who were randomized and received at least 1 dose of study drug. The start number of Participant Flow included all patients who were randomized.	1.2% 6/505 The AE analysis is based on the Safety Population. The Safety Population included all patients who were randomized and received at least 1 dose of study drug. The start number of Participant Flow included all patients who were randomized.
General disorders Chills	1.2% 6/507 The AE analysis is based on the Safety Population. The Safety Population included all patients who were randomized and received at least 1 dose of study drug. The start number of Participant Flow included all patients who were randomized.	0.20% 1/505 The AE analysis is based on the Safety Population. The Safety Population included all patients who were randomized and received at least 1 dose of study drug. The start number of Participant Flow included all patients who were randomized.
General disorders Fatigue	4.3% 22/507 The AE analysis is based on the Safety Population. The Safety Population included all patients who were randomized and received at least 1 dose of study drug. The start number of Participant Flow included all patients who were randomized.	2.8% 14/505 The AE analysis is based on the Safety Population. The Safety Population included all patients who were randomized and received at least 1 dose of study drug. The start number of Participant Flow included all patients who were randomized.
General disorders Oedema	2.6% 13/507 The AE analysis is based on the Safety Population. The Safety Population included all patients who were randomized and received at least 1 dose of study drug. The start number of Participant Flow included all patients who were randomized.	2.6% 13/505 The AE analysis is based on the Safety Population. The Safety Population included all patients who were randomized and received at least 1 dose of study drug. The start number of Participant Flow included all patients who were randomized.
General disorders Oedema peripheral	9.1% 46/507 The AE analysis is based on the Safety Population. The Safety Population included all patients who were randomized and received at least 1 dose of study drug. The start number of Participant Flow included all patients who were randomized.	11.3% 57/505 The AE analysis is based on the Safety Population. The Safety Population included all patients who were randomized and received at least 1 dose of study drug. The start number of Participant Flow included all patients who were randomized.
General disorders Pyrexia	1.6% 8/507 The AE analysis is based on the Safety Population. The Safety Population included all patients who were randomized and received at least 1 dose of study drug. The start number of Participant Flow included all patients who were randomized.	1.8% 9/505 The AE analysis is based on the Safety Population. The Safety Population included all patients who were randomized and received at least 1 dose of study drug. The start number of Participant Flow included all patients who were randomized.
Infections and infestations Bronchitis	2.8% 14/507 The AE analysis is based on the Safety Population. The Safety Population included all patients who were randomized and received at least 1 dose of study drug. The start number of Participant Flow included all patients who were randomized.	3.8% 19/505 The AE analysis is based on the Safety Population. The Safety Population included all patients who were randomized and received at least 1 dose of study drug. The start number of Participant Flow included all patients who were randomized.
Infections and infestations Cellulitis	1.4% 7/507 The AE analysis is based on the Safety Population. The Safety Population included all patients who were randomized and received at least 1 dose of study drug. The start number of Participant Flow included all patients who were randomized.	0.99% 5/505 The AE analysis is based on the Safety Population. The Safety Population included all patients who were randomized and received at least 1 dose of study drug. The start number of Participant Flow included all patients who were randomized.
Infections and infestations Cystitis	1.2% 6/507 The AE analysis is based on the Safety Population. The Safety Population included all patients who were randomized and received at least 1 dose of study drug. The start number of Participant Flow included all patients who were randomized.	0.79% 4/505 The AE analysis is based on the Safety Population. The Safety Population included all patients who were randomized and received at least 1 dose of study drug. The start number of Participant Flow included all patients who were randomized.
Infections and infestations Gastroenteritis	1.8% 9/507 The AE analysis is based on the Safety Population. The Safety Population included all patients who were randomized and received at least 1 dose of study drug. The start number of Participant Flow included all patients who were randomized.	1.2% 6/505 The AE analysis is based on the Safety Population. The Safety Population included all patients who were randomized and received at least 1 dose of study drug. The start number of Participant Flow included all patients who were randomized.
Infections and infestations Herpes zoster	1.4% 7/507 The AE analysis is based on the Safety Population. The Safety Population included all patients who were randomized and received at least 1 dose of study drug. The start number of Participant Flow included all patients who were randomized.	0.59% 3/505 The AE analysis is based on the Safety Population. The Safety Population included all patients who were randomized and received at least 1 dose of study drug. The start number of Participant Flow included all patients who were randomized.
Infections and infestations Influenza	5.1% 26/507 The AE analysis is based on the Safety Population. The Safety Population included all patients who were randomized and received at least 1 dose of study drug. The start number of Participant Flow included all patients who were randomized.	4.2% 21/505 The AE analysis is based on the Safety Population. The Safety Population included all patients who were randomized and received at least 1 dose of study drug. The start number of Participant Flow included all patients who were randomized.
Infections and infestations Nasopharyngitis	4.1% 21/507 The AE analysis is based on the Safety Population. The Safety Population included all patients who were randomized and received at least 1 dose of study drug. The start number of Participant Flow included all patients who were randomized.	2.8% 14/505 The AE analysis is based on the Safety Population. The Safety Population included all patients who were randomized and received at least 1 dose of study drug. The start number of Participant Flow included all patients who were randomized.
Infections and infestations Pharyngitis	2.2% 11/507 The AE analysis is based on the Safety Population. The Safety Population included all patients who were randomized and received at least 1 dose of study drug. The start number of Participant Flow included all patients who were randomized.	1.6% 8/505 The AE analysis is based on the Safety Population. The Safety Population included all patients who were randomized and received at least 1 dose of study drug. The start number of Participant Flow included all patients who were randomized.
Infections and infestations Pneumonia	0.99% 5/507 The AE analysis is based on the Safety Population. The Safety Population included all patients who were randomized and received at least 1 dose of study drug. The start number of Participant Flow included all patients who were randomized.	1.2% 6/505 The AE analysis is based on the Safety Population. The Safety Population included all patients who were randomized and received at least 1 dose of study drug. The start number of Participant Flow included all patients who were randomized.
Infections and infestations Respiratory tract infection	1.8% 9/507 The AE analysis is based on the Safety Population. The Safety Population included all patients who were randomized and received at least 1 dose of study drug. The start number of Participant Flow included all patients who were randomized.	1.8% 9/505 The AE analysis is based on the Safety Population. The Safety Population included all patients who were randomized and received at least 1 dose of study drug. The start number of Participant Flow included all patients who were randomized.
Infections and infestations Respiratory tract infection viral	0.79% 4/507 The AE analysis is based on the Safety Population. The Safety Population included all patients who were randomized and received at least 1 dose of study drug. The start number of Participant Flow included all patients who were randomized.	1.2% 6/505 The AE analysis is based on the Safety Population. The Safety Population included all patients who were randomized and received at least 1 dose of study drug. The start number of Participant Flow included all patients who were randomized.
Infections and infestations Sinusitis	2.8% 14/507 The AE analysis is based on the Safety Population. The Safety Population included all patients who were randomized and received at least 1 dose of study drug. The start number of Participant Flow included all patients who were randomized.	0.99% 5/505 The AE analysis is based on the Safety Population. The Safety Population included all patients who were randomized and received at least 1 dose of study drug. The start number of Participant Flow included all patients who were randomized.
Infections and infestations Upper respiratory tract infection	4.9% 25/507 The AE analysis is based on the Safety Population. The Safety Population included all patients who were randomized and received at least 1 dose of study drug. The start number of Participant Flow included all patients who were randomized.	3.8% 19/505 The AE analysis is based on the Safety Population. The Safety Population included all patients who were randomized and received at least 1 dose of study drug. The start number of Participant Flow included all patients who were randomized.