Trial Outcomes & Findings for A Study of AST-120 for Evaluating Prevention of Progression In Chronic Kidney Disease (EPPIC-1) (NCT NCT00500682)

NCT ID: NCT00500682

Last Updated: 2026-01-08

Results Overview

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

1020 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	510	510
Overall Study COMPLETED	204	223
Overall Study NOT COMPLETED	306	287

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	37	29
Overall Study Death	25	16
Overall Study Lost to Follow-up	11	11
Overall Study Physician Decision	6	10
Overall Study Pregnancy	2	0
Overall Study Protocol Violation	1	3
Overall Study Withdrawal by Subject	80	74
Overall Study Reaching endpoints, Noncompliance, etc	144	144

Baseline Characteristics

A Study of AST-120 for Evaluating Prevention of Progression In Chronic Kidney Disease (EPPIC-1)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	AST-120 n=510 Participants AST-120: 9g /day (3 times a day)	Placebo n=510 Participants Placebo: 9g /day (3 times a day)	Total n=1020 Participants Total of all reporting groups
Age, Continuous	56.5 years STANDARD_DEVIATION 14.93 • n=18 Participants	55.8 years STANDARD_DEVIATION 14.99 • n=17 Participants	56.1 years STANDARD_DEVIATION 14.95 • n=35 Participants
Sex: Female, Male Female	195 Participants n=18 Participants	179 Participants n=17 Participants	374 Participants n=35 Participants
Sex: Female, Male Male	315 Participants n=18 Participants	331 Participants n=17 Participants	646 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=502 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.	178 participants	177 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=509 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	436 Participants	448 Participants
Number of Participants With Treatment-emergent Adverse Events and Treatment-emergent Serious Adverse Events Treatment-emergent SAE	195 Participants	184 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=502 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)	213 Participants	201 Participants

SECONDARY outcome

Timeframe: Baseline, Week 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, Early Term/Discontinuation (Mean: 428.615 Days), Final Visit (Mean: 947.354 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=509 Participants Placebo: 9g /day (3 times a day)
Vitamin A Levels Baseline	1145.3 ng/mL Standard Deviation 356.67	1164.2 ng/mL Standard Deviation 387.08
Vitamin A Levels Week 12	1142.4 ng/mL Standard Deviation 374.14	1177.9 ng/mL Standard Deviation 404.21
Vitamin A Levels Week 24	1151.5 ng/mL Standard Deviation 382.40	1193.6 ng/mL Standard Deviation 363.36
Vitamin A Levels Week 36	1148.1 ng/mL Standard Deviation 385.90	1215.1 ng/mL Standard Deviation 406.78
Vitamin A Levels Week 48	1156.2 ng/mL Standard Deviation 367.71	1210.1 ng/mL Standard Deviation 396.91
Vitamin A Levels Week 60	1199.2 ng/mL Standard Deviation 388.36	1232.1 ng/mL Standard Deviation 419.86
Vitamin A Levels Week 72	1216.0 ng/mL Standard Deviation 368.58	1265.5 ng/mL Standard Deviation 428.28
Vitamin A Levels Week 84	1252.1 ng/mL Standard Deviation 406.11	1292.8 ng/mL Standard Deviation 435.80
Vitamin A Levels Week 96	1240.2 ng/mL Standard Deviation 367.21	1314.8 ng/mL Standard Deviation 433.70
Vitamin A Levels Week 108	1222.1 ng/mL Standard Deviation 367.46	1305.7 ng/mL Standard Deviation 421.64
Vitamin A Levels Week 120	1188.8 ng/mL Standard Deviation 357.58	1234.7 ng/mL Standard Deviation 397.81
Vitamin A Levels Week 132	1273.5 ng/mL Standard Deviation 416.43	1284.1 ng/mL Standard Deviation 411.37
Vitamin A Levels Week 144	1305.0 ng/mL Standard Deviation 379.81	1277.9 ng/mL Standard Deviation 336.23
Vitamin A Levels Week 156	1255.6 ng/mL Standard Deviation 323.72	1174.8 ng/mL Standard Deviation 347.46
Vitamin A Levels Week 168	1244.6 ng/mL Standard Deviation 275.57	1185.9 ng/mL Standard Deviation 402.00
Vitamin A Levels Week 180	1176.5 ng/mL Standard Deviation 342.14	1203.5 ng/mL Standard Deviation 271.98
Vitamin A Levels Week 192	1253.0 ng/mL Standard Deviation 340.63	1189.3 ng/mL Standard Deviation 152.33
Vitamin A Levels Early Term/Discontinuation	1167.2 ng/mL Standard Deviation 401.08	1191.4 ng/mL Standard Deviation 457.79
Vitamin A Levels Final Visit	1266.9 ng/mL Standard Deviation 357.06	1320.1 ng/mL Standard Deviation 444.09

SECONDARY outcome

Timeframe: Baseline, Week 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, Early Term/Discontinuation (Mean: 428.114 Days), Final Visit (Mean: 947.239 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=509 Participants Placebo: 9g /day (3 times a day)
Vitamin B12 Levels Week 120	590.0 pg/mL Standard Deviation 1968.53	638.4 pg/mL Standard Deviation 1993.90
Vitamin B12 Levels Week 132	923.7 pg/mL Standard Deviation 3358.51	714.2 pg/mL Standard Deviation 2262.71
Vitamin B12 Levels Week 144	460.5 pg/mL Standard Deviation 291.19	472.6 pg/mL Standard Deviation 283.43
Vitamin B12 Levels Baseline	688.1 pg/mL Standard Deviation 1881.58	620.5 pg/mL Standard Deviation 1630.87
Vitamin B12 Levels Week 12	597.3 pg/mL Standard Deviation 1824.74	570.0 pg/mL Standard Deviation 1347.75
Vitamin B12 Levels Week 24	554.2 pg/mL Standard Deviation 1654.52	483.7 pg/mL Standard Deviation 536.30
Vitamin B12 Levels Week 36	500.6 pg/mL Standard Deviation 568.44	581.6 pg/mL Standard Deviation 1316.46
Vitamin B12 Levels Week 48	530.6 pg/mL Standard Deviation 759.54	500.2 pg/mL Standard Deviation 940.36
Vitamin B12 Levels Week 60	494.2 pg/mL Standard Deviation 534.92	704.9 pg/mL Standard Deviation 2338.15
Vitamin B12 Levels Week 72	545.9 pg/mL Standard Deviation 1268.50	661.8 pg/mL Standard Deviation 2014.14
Vitamin B12 Levels Week 84	497.6 pg/mL Standard Deviation 923.15	543.1 pg/mL Standard Deviation 1246.14
Vitamin B12 Levels Week 96	646.6 pg/mL Standard Deviation 2012.14	799.6 pg/mL Standard Deviation 2767.12
Vitamin B12 Levels Week 108	544.1 pg/mL Standard Deviation 1564.38	682.2 pg/mL Standard Deviation 1947.45
Vitamin B12 Levels Week 156	476.3 pg/mL Standard Deviation 285.02	586.3 pg/mL Standard Deviation 811.97
Vitamin B12 Levels Week 168	563.9 pg/mL Standard Deviation 528.25	493.7 pg/mL Standard Deviation 342.53
Vitamin B12 Levels Week 180	564.2 pg/mL Standard Deviation 254.57	653.8 pg/mL Standard Deviation 694.69
Vitamin B12 Levels Week 192	489.0 pg/mL Standard Deviation 306.00	974.0 pg/mL Standard Deviation 898.28
Vitamin B12 Levels Early Term/Discontinuation	935.7 pg/mL Standard Deviation 2400.94	953.5 pg/mL Standard Deviation 2914.40
Vitamin B12 Levels Final Visit	626.7 pg/mL Standard Deviation 1464.99	747.1 pg/mL Standard Deviation 2495.49

SECONDARY outcome

Timeframe: Baseline, Week 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, Early Term/Discontinuation (Mean: 427.270 Days), Final Visit (Mean: 946.762 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=509 Participants Placebo: 9g /day (3 times a day)
25-Hydroxyvitamin D Levels Early Term/Discontinuation	20.57 ng/mL Standard Deviation 9.958	22.52 ng/mL Standard Deviation 11.803
25-Hydroxyvitamin D Levels Final Visit	25.20 ng/mL Standard Deviation 10.847	25.69 ng/mL Standard Deviation 9.937
25-Hydroxyvitamin D Levels Baseline	22.08 ng/mL Standard Deviation 10.361	22.06 ng/mL Standard Deviation 10.400
25-Hydroxyvitamin D Levels Week 12	21.55 ng/mL Standard Deviation 9.988	22.15 ng/mL Standard Deviation 10.162
25-Hydroxyvitamin D Levels Week 24	21.41 ng/mL Standard Deviation 9.823	22.13 ng/mL Standard Deviation 9.648
25-Hydroxyvitamin D Levels Week 36	21.70 ng/mL Standard Deviation 10.539	21.70 ng/mL Standard Deviation 9.926
25-Hydroxyvitamin D Levels Week 48	21.83 ng/mL Standard Deviation 10.963	22.06 ng/mL Standard Deviation 10.644
25-Hydroxyvitamin D Levels Week 60	21.78 ng/mL Standard Deviation 11.076	21.56 ng/mL Standard Deviation 10.425
25-Hydroxyvitamin D Levels Week 72	22.23 ng/mL Standard Deviation 10.988	22.29 ng/mL Standard Deviation 9.617
25-Hydroxyvitamin D Levels Week 84	21.79 ng/mL Standard Deviation 10.759	22.75 ng/mL Standard Deviation 10.528
25-Hydroxyvitamin D Levels Week 96	22.18 ng/mL Standard Deviation 11.563	22.53 ng/mL Standard Deviation 10.833
25-Hydroxyvitamin D Levels Week 108	21.85 ng/mL Standard Deviation 11.324	21.62 ng/mL Standard Deviation 10.679
25-Hydroxyvitamin D Levels Week 120	22.15 ng/mL Standard Deviation 11.189	22.45 ng/mL Standard Deviation 9.344
25-Hydroxyvitamin D Levels Week 132	22.04 ng/mL Standard Deviation 10.581	21.83 ng/mL Standard Deviation 10.285
25-Hydroxyvitamin D Levels Week 144	23.29 ng/mL Standard Deviation 11.051	22.95 ng/mL Standard Deviation 11.046
25-Hydroxyvitamin D Levels Week 156	23.23 ng/mL Standard Deviation 9.857	23.01 ng/mL Standard Deviation 12.943
25-Hydroxyvitamin D Levels Week 168	25.45 ng/mL Standard Deviation 12.045	24.44 ng/mL Standard Deviation 11.403
25-Hydroxyvitamin D Levels Week 180	29.58 ng/mL Standard Deviation 12.985	28.10 ng/mL Standard Deviation 10.929
25-Hydroxyvitamin D Levels Week 192	33.10 ng/mL Standard Deviation 6.651	31.38 ng/mL Standard Deviation 9.606

SECONDARY outcome

Timeframe: Baseline, Week 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, Early Term/Discontinuation (Mean: 428.056 Days), Final Visit (Mean: 946.525 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=509 Participants Placebo: 9g /day (3 times a day)
Vitamin E Levels Baseline	17.49 ug/mL Standard Deviation 7.554	16.95 ug/mL Standard Deviation 6.923
Vitamin E Levels Week 12	17.30 ug/mL Standard Deviation 6.880	16.44 ug/mL Standard Deviation 6.080
Vitamin E Levels Week 24	17.55 ug/mL Standard Deviation 7.237	17.08 ug/mL Standard Deviation 6.560
Vitamin E Levels Week 36	17.42 ug/mL Standard Deviation 6.474	17.22 ug/mL Standard Deviation 6.445
Vitamin E Levels Week 48	17.58 ug/mL Standard Deviation 7.040	17.31 ug/mL Standard Deviation 6.544
Vitamin E Levels Week 60	17.77 ug/mL Standard Deviation 7.376	17.70 ug/mL Standard Deviation 6.880
Vitamin E Levels Week 72	17.50 ug/mL Standard Deviation 6.683	17.07 ug/mL Standard Deviation 6.119
Vitamin E Levels Week 84	17.70 ug/mL Standard Deviation 6.779	17.27 ug/mL Standard Deviation 6.440
Vitamin E Levels Week 96	17.24 ug/mL Standard Deviation 6.510	17.28 ug/mL Standard Deviation 6.480
Vitamin E Levels Week 108	17.60 ug/mL Standard Deviation 6.580	17.07 ug/mL Standard Deviation 6.126
Vitamin E Levels Week 120	18.18 ug/mL Standard Deviation 7.293	17.17 ug/mL Standard Deviation 6.416
Vitamin E Levels Week 132	18.71 ug/mL Standard Deviation 7.926	16.52 ug/mL Standard Deviation 5.407
Vitamin E Levels Week 144	18.02 ug/mL Standard Deviation 6.653	16.47 ug/mL Standard Deviation 6.805
Vitamin E Levels Week 156	17.59 ug/mL Standard Deviation 5.937	17.21 ug/mL Standard Deviation 7.081
Vitamin E Levels Week 168	16.60 ug/mL Standard Deviation 5.946	18.00 ug/mL Standard Deviation 8.052
Vitamin E Levels Week 180	15.52 ug/mL Standard Deviation 4.696	15.17 ug/mL Standard Deviation 7.808
Vitamin E Levels Week 192	14.00 ug/mL Standard Deviation 3.568	16.45 ug/mL Standard Deviation 5.341
Vitamin E Levels Early Term/Discontinuation	15.72 ug/mL Standard Deviation 5.512	15.58 ug/mL Standard Deviation 6.200
Vitamin E Levels Final Visit	17.14 ug/mL Standard Deviation 7.356	16.03 ug/mL Standard Deviation 5.606

SECONDARY outcome

Timeframe: Baseline, Week 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, Early Term/Discontinuation (Mean: 441.826 Days), Final Visit (Mean: 946.463 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=509 Participants Placebo: 9g /day (3 times a day)
Vitamin K Levels Week 12	0.752 ng/mL Standard Deviation 0.6601	0.769 ng/mL Standard Deviation 0.6887
Vitamin K Levels Week 24	0.705 ng/mL Standard Deviation 0.6006	0.706 ng/mL Standard Deviation 0.6238
Vitamin K Levels Baseline	0.711 ng/mL Standard Deviation 0.6276	0.721 ng/mL Standard Deviation 0.6308
Vitamin K Levels Week 36	0.739 ng/mL Standard Deviation 0.6726	0.748 ng/mL Standard Deviation 0.6630
Vitamin K Levels Week 48	0.763 ng/mL Standard Deviation 0.6630	0.704 ng/mL Standard Deviation 0.6491
Vitamin K Levels Week 60	0.761 ng/mL Standard Deviation 0.6868	0.778 ng/mL Standard Deviation 0.7247
Vitamin K Levels Week 72	0.823 ng/mL Standard Deviation 0.7291	0.722 ng/mL Standard Deviation 0.6489
Vitamin K Levels Week 84	0.780 ng/mL Standard Deviation 0.7174	0.725 ng/mL Standard Deviation 0.6869
Vitamin K Levels Week 96	0.809 ng/mL Standard Deviation 0.7156	0.768 ng/mL Standard Deviation 0.6867
Vitamin K Levels Week 108	0.802 ng/mL Standard Deviation 0.6797	0.768 ng/mL Standard Deviation 0.7119
Vitamin K Levels Week 120	0.768 ng/mL Standard Deviation 0.6708	0.814 ng/mL Standard Deviation 0.7119
Vitamin K Levels Week 132	0.824 ng/mL Standard Deviation 0.7655	0.760 ng/mL Standard Deviation 0.5740
Vitamin K Levels Week 144	0.882 ng/mL Standard Deviation 0.7630	0.780 ng/mL Standard Deviation 0.6052
Vitamin K Levels Week 156	0.754 ng/mL Standard Deviation 0.6129	0.816 ng/mL Standard Deviation 0.6822
Vitamin K Levels Week 168	0.858 ng/mL Standard Deviation 0.6494	1.031 ng/mL Standard Deviation 0.8805
Vitamin K Levels Week 180	0.850 ng/mL Standard Deviation 0.7162	0.970 ng/mL Standard Deviation 0.9033
Vitamin K Levels Early Term/Discontinuation	0.735 ng/mL Standard Deviation 0.7523	0.686 ng/mL Standard Deviation 0.5772
Vitamin K Levels Final Visit	0.971 ng/mL Standard Deviation 0.7657	0.844 ng/mL Standard Deviation 0.6784

SECONDARY outcome

Timeframe: Baseline, Week 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, Early Term/Discontinuation (Mean: 423.024 Days), Final Visit (Mean: 946.074 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=509 Participants Placebo: 9g /day (3 times a day)
Serum Folate Levels Week 60	19.06 ng/mL Standard Deviation 41.799	19.72 ng/mL Standard Deviation 45.119
Serum Folate Levels Week 72	16.12 ng/mL Standard Deviation 32.761	19.96 ng/mL Standard Deviation 43.951
Serum Folate Levels Week 180	33.10 ng/mL Standard Deviation 19.021	22.23 ng/mL Standard Deviation 25.137
Serum Folate Levels Week 24	18.16 ng/mL Standard Deviation 34.095	19.46 ng/mL Standard Deviation 45.178
Serum Folate Levels Week 36	20.95 ng/mL Standard Deviation 47.528	18.54 ng/mL Standard Deviation 41.653
Serum Folate Levels Week 48	19.30 ng/mL Standard Deviation 44.798	21.50 ng/mL Standard Deviation 49.944
Serum Folate Levels Week 84	17.00 ng/mL Standard Deviation 30.020	20.95 ng/mL Standard Deviation 46.184
Serum Folate Levels Week 96	14.47 ng/mL Standard Deviation 25.918	18.17 ng/mL Standard Deviation 36.846
Serum Folate Levels Week 108	13.50 ng/mL Standard Deviation 18.491	19.22 ng/mL Standard Deviation 39.625
Serum Folate Levels Week 120	12.52 ng/mL Standard Deviation 16.033	17.01 ng/mL Standard Deviation 36.733
Serum Folate Levels Week 132	17.09 ng/mL Standard Deviation 45.645	18.85 ng/mL Standard Deviation 44.240
Serum Folate Levels Week 144	18.13 ng/mL Standard Deviation 41.386	18.09 ng/mL Standard Deviation 39.002
Serum Folate Levels Week 156	13.08 ng/mL Standard Deviation 13.098	15.13 ng/mL Standard Deviation 20.162
Serum Folate Levels Week 168	15.13 ng/mL Standard Deviation 12.776	16.26 ng/mL Standard Deviation 19.734
Serum Folate Levels Early Term/Discontinuation	24.43 ng/mL Standard Deviation 49.342	17.14 ng/mL Standard Deviation 24.122
Serum Folate Levels Final Visit	15.52 ng/mL Standard Deviation 26.263	22.66 ng/mL Standard Deviation 50.498
Serum Folate Levels Baseline	21.70 ng/mL Standard Deviation 44.420	21.78 ng/mL Standard Deviation 47.064
Serum Folate Levels Week 12	21.47 ng/mL Standard Deviation 46.801	20.94 ng/mL Standard Deviation 45.093

Adverse Events

AST-120

Serious events: 195 serious events

Other events: 376 other events

Deaths: 0 deaths

Placebo

Serious events: 184 serious events

Other events: 382 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=509 participants at risk Placebo: 9g /day (3 times a day)
Cardiac disorders Bradycardia	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% 1/509 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	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.	1.4% 7/509 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 of chronic disease	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% 0/509 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% 1/509 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 Lymphadenopathy	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% 0/509 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 Nephrogenic 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% 0/509 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 Thrombocytopenia	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% 0/509 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	0.99% 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.	0.59% 3/509 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	1.4% 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.	0.98% 5/509 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	0.99% 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.	0.39% 2/509 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	0.00% 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% 1/509 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 Aortic valve incompetence	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% 0/509 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	0.39% 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% 0/509 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	0.20% 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.	0.39% 2/509 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.	0.00% 0/509 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.	0.20% 1/509 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 Bundle branch block left	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% 1/509 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	0.59% 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.	0.79% 4/509 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.	0.59% 3/509 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	0.20% 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% 0/509 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	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.	1.8% 9/509 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 valve disease	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% 0/509 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 Cardio-respiratory arrest	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% 0/509 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.	0.20% 1/509 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.	0.98% 5/509 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 stenosis	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% 1/509 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	0.00% 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% 1/509 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	0.99% 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.	0.20% 1/509 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	0.20% 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% 0/509 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 Pericarditis	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% 0/509 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 Right ventricular failure	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% 0/509 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 Sick sinus syndrome	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% 1/509 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 Supraventricular 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% 0/509 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% 0/509 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 tachyarrhythmia	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% 0/509 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 tachycardia	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% 1/509 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	0.20% 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% 0/509 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 Blindness	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% 1/509 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	0.39% 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% 0/509 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 Conjunctival haemorrhage	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% 1/509 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=509 participants at risk Placebo: 9g /day (3 times a day)
Blood and lymphatic system disorders Anaemia	11.4% 58/507 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.	15.9% 81/509 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	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.	0.98% 5/509 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	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.	0.39% 2/509 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	0.79% 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.	1.6% 8/509 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	1.8% 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.	2.0% 10/509 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	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.	3.3% 17/509 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	2.8% 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.	1.8% 9/509 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	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.	2.0% 10/509 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	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.	2.9% 15/509 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	2.6% 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.	1.2% 6/509 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	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.	7.3% 37/509 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	5.7% 29/507 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.	7.3% 37/509 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	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.	2.8% 14/509 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	0.20% 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.	1.2% 6/509 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	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.	2.4% 12/509 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	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.	2.8% 14/509 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	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.	1.6% 8/509 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	9.3% 47/507 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.	8.3% 42/509 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	4.5% 23/507 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.	4.1% 21/509 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 Asthenia	3.4% 17/507 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% 11/509 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	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.	4.7% 24/509 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.	1.8% 9/509 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	11.2% 57/507 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.	9.8% 50/509 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	1.2% 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.	1.6% 8/509 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.
Immune system disorders Seasonal allergy	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% 6/509 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	4.5% 23/507 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.	3.1% 16/509 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.	0.39% 2/509 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 Erysipelas	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% 1/509 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	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.	1.8% 9/509 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	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.	1.2% 6/509 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	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.	4.1% 21/509 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	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.	3.3% 17/509 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	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% 9/509 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	0.79% 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.	1.8% 9/509 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 Pyelonephritis chronic	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.	1.6% 8/509 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	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.	2.4% 12/509 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 Rhinitis	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% 6/509 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	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.	2.4% 12/509 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	4.7% 24/507 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.	6.1% 31/509 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 Urinary tract infection	7.3% 37/507 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.	3.7% 19/509 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.