| Treatment-emergent AE . | RTX + LEF (n = 93) . | PL + LEF (n = 47) . |
|---|---|---|
| Any AE | 66 (71.0) | 33 (70.2) |
| AEs occurring in ≥5% of subjects in either group | ||
| Infections and infestations | 37 (39.8) | 16 (34.0) |
| Nasopharyngitis | 11 (11.8) | 6 (12.8) |
| Urinary tract infection | 8 (8.6) | 2 (4.3) |
| Musculoskeletal and connective tissue disorders | 20 (21.5) | 11 (23.4) |
| RA | 6 (6.5) | 2 (4.3) |
| Vascular disorders | 15 (16.1) | 7 (14.9) |
| Hypertension | 11 (11.8) | 5 (10.6) |
| Gastrointestinal disorders | 12 (12.9) | 5 (10.6) |
| Diarrhoea | 7 (5.3) | 5 (10.6) |
| Investigations | 11 (11.8) | 3 (6.4) |
| Nervous system disorders | 6 (6.5) | 8 (17.0) |
| General disorders and administration site conditions | 7 (7.5) | 5 (10.6) |
| Injury, poisoning and procedural complications | 9 (9.7) | 2 (4.3) |
| Skin and s.c. tissue disorders | 7 (7.5) | 4 (8.5) |
| Blood and lymphatic system disorders | 5 (5.4) | 2 (4.3) |
| Metabolism and nutrition disorders | 3 (3.2) | 4 (8.5) |
| Respiratory, thoracic and mediastinal disorders | 5 (5.4) | 2 (4.3) |
| Reproductive system and breast disorders | 1 (1.1) | 3 (6.4) |
| Cardiac disorders | – | 3 (6.4) |
| Any SAE | 19 (20.4) | 1 (2.1) |
| SAE by system organ class | ||
| Infections and infestations | 5 (5.4) | – |
| Musculoskeletal and connective tissue disorders | 5 (5.4) | – |
| Gastrointestinal disorders | 3 (3.2) | 1 (2.1) |
| Investigations | 3 (3.2) | – |
| Surgical and medical procedures | 3 (3.2) | – |
| General disorders and administration site conditions | 2 (2.2) | – |
| Injury, poisoning and procedural complications | 1 (1.1) | – |
| Neoplasms benign, malignant and unspecified | 1 (1.1) | – |
| Nervous system disorders | 1 (1.1) | – |
| Respiratory, thoracic and mediastinal disorders | 1 (1.1) | – |
| Treatment-emergent AE . | RTX + LEF (n = 93) . | PL + LEF (n = 47) . |
|---|---|---|
| Any AE | 66 (71.0) | 33 (70.2) |
| AEs occurring in ≥5% of subjects in either group | ||
| Infections and infestations | 37 (39.8) | 16 (34.0) |
| Nasopharyngitis | 11 (11.8) | 6 (12.8) |
| Urinary tract infection | 8 (8.6) | 2 (4.3) |
| Musculoskeletal and connective tissue disorders | 20 (21.5) | 11 (23.4) |
| RA | 6 (6.5) | 2 (4.3) |
| Vascular disorders | 15 (16.1) | 7 (14.9) |
| Hypertension | 11 (11.8) | 5 (10.6) |
| Gastrointestinal disorders | 12 (12.9) | 5 (10.6) |
| Diarrhoea | 7 (5.3) | 5 (10.6) |
| Investigations | 11 (11.8) | 3 (6.4) |
| Nervous system disorders | 6 (6.5) | 8 (17.0) |
| General disorders and administration site conditions | 7 (7.5) | 5 (10.6) |
| Injury, poisoning and procedural complications | 9 (9.7) | 2 (4.3) |
| Skin and s.c. tissue disorders | 7 (7.5) | 4 (8.5) |
| Blood and lymphatic system disorders | 5 (5.4) | 2 (4.3) |
| Metabolism and nutrition disorders | 3 (3.2) | 4 (8.5) |
| Respiratory, thoracic and mediastinal disorders | 5 (5.4) | 2 (4.3) |
| Reproductive system and breast disorders | 1 (1.1) | 3 (6.4) |
| Cardiac disorders | – | 3 (6.4) |
| Any SAE | 19 (20.4) | 1 (2.1) |
| SAE by system organ class | ||
| Infections and infestations | 5 (5.4) | – |
| Musculoskeletal and connective tissue disorders | 5 (5.4) | – |
| Gastrointestinal disorders | 3 (3.2) | 1 (2.1) |
| Investigations | 3 (3.2) | – |
| Surgical and medical procedures | 3 (3.2) | – |
| General disorders and administration site conditions | 2 (2.2) | – |
| Injury, poisoning and procedural complications | 1 (1.1) | – |
| Neoplasms benign, malignant and unspecified | 1 (1.1) | – |
| Nervous system disorders | 1 (1.1) | – |
| Respiratory, thoracic and mediastinal disorders | 1 (1.1) | – |
Data are presented as n (%). aSubjects could have more than one AE or SAE. AE: adverse event; PL: placebo; RTX: rituximab; SAE: serious adverse event.
| Treatment-emergent AE . | RTX + LEF (n = 93) . | PL + LEF (n = 47) . |
|---|---|---|
| Any AE | 66 (71.0) | 33 (70.2) |
| AEs occurring in ≥5% of subjects in either group | ||
| Infections and infestations | 37 (39.8) | 16 (34.0) |
| Nasopharyngitis | 11 (11.8) | 6 (12.8) |
| Urinary tract infection | 8 (8.6) | 2 (4.3) |
| Musculoskeletal and connective tissue disorders | 20 (21.5) | 11 (23.4) |
| RA | 6 (6.5) | 2 (4.3) |
| Vascular disorders | 15 (16.1) | 7 (14.9) |
| Hypertension | 11 (11.8) | 5 (10.6) |
| Gastrointestinal disorders | 12 (12.9) | 5 (10.6) |
| Diarrhoea | 7 (5.3) | 5 (10.6) |
| Investigations | 11 (11.8) | 3 (6.4) |
| Nervous system disorders | 6 (6.5) | 8 (17.0) |
| General disorders and administration site conditions | 7 (7.5) | 5 (10.6) |
| Injury, poisoning and procedural complications | 9 (9.7) | 2 (4.3) |
| Skin and s.c. tissue disorders | 7 (7.5) | 4 (8.5) |
| Blood and lymphatic system disorders | 5 (5.4) | 2 (4.3) |
| Metabolism and nutrition disorders | 3 (3.2) | 4 (8.5) |
| Respiratory, thoracic and mediastinal disorders | 5 (5.4) | 2 (4.3) |
| Reproductive system and breast disorders | 1 (1.1) | 3 (6.4) |
| Cardiac disorders | – | 3 (6.4) |
| Any SAE | 19 (20.4) | 1 (2.1) |
| SAE by system organ class | ||
| Infections and infestations | 5 (5.4) | – |
| Musculoskeletal and connective tissue disorders | 5 (5.4) | – |
| Gastrointestinal disorders | 3 (3.2) | 1 (2.1) |
| Investigations | 3 (3.2) | – |
| Surgical and medical procedures | 3 (3.2) | – |
| General disorders and administration site conditions | 2 (2.2) | – |
| Injury, poisoning and procedural complications | 1 (1.1) | – |
| Neoplasms benign, malignant and unspecified | 1 (1.1) | – |
| Nervous system disorders | 1 (1.1) | – |
| Respiratory, thoracic and mediastinal disorders | 1 (1.1) | – |
| Treatment-emergent AE . | RTX + LEF (n = 93) . | PL + LEF (n = 47) . |
|---|---|---|
| Any AE | 66 (71.0) | 33 (70.2) |
| AEs occurring in ≥5% of subjects in either group | ||
| Infections and infestations | 37 (39.8) | 16 (34.0) |
| Nasopharyngitis | 11 (11.8) | 6 (12.8) |
| Urinary tract infection | 8 (8.6) | 2 (4.3) |
| Musculoskeletal and connective tissue disorders | 20 (21.5) | 11 (23.4) |
| RA | 6 (6.5) | 2 (4.3) |
| Vascular disorders | 15 (16.1) | 7 (14.9) |
| Hypertension | 11 (11.8) | 5 (10.6) |
| Gastrointestinal disorders | 12 (12.9) | 5 (10.6) |
| Diarrhoea | 7 (5.3) | 5 (10.6) |
| Investigations | 11 (11.8) | 3 (6.4) |
| Nervous system disorders | 6 (6.5) | 8 (17.0) |
| General disorders and administration site conditions | 7 (7.5) | 5 (10.6) |
| Injury, poisoning and procedural complications | 9 (9.7) | 2 (4.3) |
| Skin and s.c. tissue disorders | 7 (7.5) | 4 (8.5) |
| Blood and lymphatic system disorders | 5 (5.4) | 2 (4.3) |
| Metabolism and nutrition disorders | 3 (3.2) | 4 (8.5) |
| Respiratory, thoracic and mediastinal disorders | 5 (5.4) | 2 (4.3) |
| Reproductive system and breast disorders | 1 (1.1) | 3 (6.4) |
| Cardiac disorders | – | 3 (6.4) |
| Any SAE | 19 (20.4) | 1 (2.1) |
| SAE by system organ class | ||
| Infections and infestations | 5 (5.4) | – |
| Musculoskeletal and connective tissue disorders | 5 (5.4) | – |
| Gastrointestinal disorders | 3 (3.2) | 1 (2.1) |
| Investigations | 3 (3.2) | – |
| Surgical and medical procedures | 3 (3.2) | – |
| General disorders and administration site conditions | 2 (2.2) | – |
| Injury, poisoning and procedural complications | 1 (1.1) | – |
| Neoplasms benign, malignant and unspecified | 1 (1.1) | – |
| Nervous system disorders | 1 (1.1) | – |
| Respiratory, thoracic and mediastinal disorders | 1 (1.1) | – |
Data are presented as n (%). aSubjects could have more than one AE or SAE. AE: adverse event; PL: placebo; RTX: rituximab; SAE: serious adverse event.
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