AESI by system organ class in the all-treated population
| AESI,∗ n (%) . | N = 117 . | |||||
|---|---|---|---|---|---|---|
| Grade 1 . | Grade 2 . | Grade 3 . | Grade 4 . | Grade 5 . | Total . | |
| Patients with any AESI | 6 (5.1) | 17 (14.5) | 9 (7.7) | 6 (5.1) | 1 (0.9) | 39 (33.3) |
| Endocrine disorders | 8 (6.8) | 16 (13.7) | 0 | 0 | 0 | 24 (20.5) |
| Hypothyroidism | 6 (5.1) | 8 (6.8) | 0 | 0 | 0 | 14 (12.0) |
| Hyperthyroidism | 5 (4.3) | 4 (3.4) | 0 | 0 | 0 | 9 (7.7) |
| Thyroiditis | 3 (2.6) | 5 (4.3) | 0 | 0 | 0 | 8 (6.8) |
| Autoimmune thyroiditis | 0 | 3 (2.6) | 0 | 0 | 0 | 3 (2.6) |
| Nervous system disorders | 0 | 3 (2.6) | 4 (3.4) | 2 (1.7) | 0 | 9 (7.7) |
| GBS | 0 | 1 (0.9) | 3 (2.6) | 2 (1.7) | 0 | 6 (5.1) |
| Facial paralysis | 0 | 0 | 1 (0.9) | 0 | 0 | 1 (0.9) |
| Myelitis transverse | 0 | 1 (0.9) | 0 | 0 | 0 | 1 (0.9) |
| Polyneuropathy | 0 | 0 | 1 (0.9) | 0 | 0 | 1 (0.9) |
| Radiculopathy | 0 | 1 (0.9) | 0 | 0 | 0 | 1 (0.9) |
| Respiratory, thoracic, and mediastinal disorders | 1 (0.9) | 3 (2.6) | 1 (0.9) | 0 | 0 | 5 (4.3) |
| Pneumonitis | 1 (0.9) | 3 (2.6) | 0 | 0 | 0 | 4 (3.4) |
| Interstitial lung disease | 0 | 0 | 1 (0.9) | 0 | 0 | 1 (0.9) |
| Hepatobiliary disorders | 0 | 0 | 2 (1.7) | 1 (0.9) | 0 | 3 (2.6) |
| Drug-induced liver injury | 0 | 0 | 2 (1.7) | 0 | 0 | 2 (1.7) |
| Autoimmune hepatitis | 0 | 0 | 0 | 1 (0.9) | 0 | 1 (0.9) |
| Blood and lymphatic system disorders | 0 | 0 | 1 (0.9) | 0 | 1 (0.9) | 2 (1.7) |
| Aplastic anemia | 0 | 0 | 0 | 0 | 1 (0.9) | 1 (0.9) |
| Autoimmune hemolytic anemia | 0 | 0 | 1 (0.9) | 0 | 0 | 1 (0.9) |
| Metabolism and nutrition disorders | 0 | 0 | 0 | 2 (1.7) | 0 | 2 (1.7) |
| Diabetic ketoacidosis | 0 | 0 | 0 | 2 (1.7) | 0 | 2 (1.7) |
| Type 1 diabetes mellitus | 0 | 0 | 0 | 1 (0.9) | 0 | 1 (0.9) |
| Renal and urinary disorders | 0 | 0 | 2 (1.7) | 0 | 0 | 2 (1.7) |
| Tubulointerstitial nephritis | 0 | 0 | 2 (1.7) | 0 | 0 | 2 (1.7) |
| Eye disorders | 1 (0.9) | 0 | 0 | 0 | 0 | 1 (0.9) |
| Blepharitis | 1 (0.9) | 0 | 0 | 0 | 0 | 1 (0.9) |
| Infections and infestations | 0 | 0 | 1 (0.9) | 0 | 0 | 1 (0.9) |
| Meningitis aseptic | 0 | 0 | 1 (0.9) | 0 | 0 | 1 (0.9) |
| Musculoskeletal and connective tissue disorders | 0 | 1 (0.9) | 0 | 0 | 0 | 1 (0.9) |
| Myositis | 0 | 1 (0.9) | 0 | 0 | 0 | 1 (0.9) |
| Skin and subcutaneous tissue disorders | 0 | 0 | 0 | 1 (0.9) | 0 | 1 (0.9) |
| Generalized dermatitis exfoliative | 0 | 0 | 0 | 1 (0.9) | 0 | 1 (0.9) |
| Lichenoid keratosis | 0 | 0 | 0 | 1 (0.9) | 0 | 1 (0.9) |
| AESI,∗ n (%) . | N = 117 . | |||||
|---|---|---|---|---|---|---|
| Grade 1 . | Grade 2 . | Grade 3 . | Grade 4 . | Grade 5 . | Total . | |
| Patients with any AESI | 6 (5.1) | 17 (14.5) | 9 (7.7) | 6 (5.1) | 1 (0.9) | 39 (33.3) |
| Endocrine disorders | 8 (6.8) | 16 (13.7) | 0 | 0 | 0 | 24 (20.5) |
| Hypothyroidism | 6 (5.1) | 8 (6.8) | 0 | 0 | 0 | 14 (12.0) |
| Hyperthyroidism | 5 (4.3) | 4 (3.4) | 0 | 0 | 0 | 9 (7.7) |
| Thyroiditis | 3 (2.6) | 5 (4.3) | 0 | 0 | 0 | 8 (6.8) |
| Autoimmune thyroiditis | 0 | 3 (2.6) | 0 | 0 | 0 | 3 (2.6) |
| Nervous system disorders | 0 | 3 (2.6) | 4 (3.4) | 2 (1.7) | 0 | 9 (7.7) |
| GBS | 0 | 1 (0.9) | 3 (2.6) | 2 (1.7) | 0 | 6 (5.1) |
| Facial paralysis | 0 | 0 | 1 (0.9) | 0 | 0 | 1 (0.9) |
| Myelitis transverse | 0 | 1 (0.9) | 0 | 0 | 0 | 1 (0.9) |
| Polyneuropathy | 0 | 0 | 1 (0.9) | 0 | 0 | 1 (0.9) |
| Radiculopathy | 0 | 1 (0.9) | 0 | 0 | 0 | 1 (0.9) |
| Respiratory, thoracic, and mediastinal disorders | 1 (0.9) | 3 (2.6) | 1 (0.9) | 0 | 0 | 5 (4.3) |
| Pneumonitis | 1 (0.9) | 3 (2.6) | 0 | 0 | 0 | 4 (3.4) |
| Interstitial lung disease | 0 | 0 | 1 (0.9) | 0 | 0 | 1 (0.9) |
| Hepatobiliary disorders | 0 | 0 | 2 (1.7) | 1 (0.9) | 0 | 3 (2.6) |
| Drug-induced liver injury | 0 | 0 | 2 (1.7) | 0 | 0 | 2 (1.7) |
| Autoimmune hepatitis | 0 | 0 | 0 | 1 (0.9) | 0 | 1 (0.9) |
| Blood and lymphatic system disorders | 0 | 0 | 1 (0.9) | 0 | 1 (0.9) | 2 (1.7) |
| Aplastic anemia | 0 | 0 | 0 | 0 | 1 (0.9) | 1 (0.9) |
| Autoimmune hemolytic anemia | 0 | 0 | 1 (0.9) | 0 | 0 | 1 (0.9) |
| Metabolism and nutrition disorders | 0 | 0 | 0 | 2 (1.7) | 0 | 2 (1.7) |
| Diabetic ketoacidosis | 0 | 0 | 0 | 2 (1.7) | 0 | 2 (1.7) |
| Type 1 diabetes mellitus | 0 | 0 | 0 | 1 (0.9) | 0 | 1 (0.9) |
| Renal and urinary disorders | 0 | 0 | 2 (1.7) | 0 | 0 | 2 (1.7) |
| Tubulointerstitial nephritis | 0 | 0 | 2 (1.7) | 0 | 0 | 2 (1.7) |
| Eye disorders | 1 (0.9) | 0 | 0 | 0 | 0 | 1 (0.9) |
| Blepharitis | 1 (0.9) | 0 | 0 | 0 | 0 | 1 (0.9) |
| Infections and infestations | 0 | 0 | 1 (0.9) | 0 | 0 | 1 (0.9) |
| Meningitis aseptic | 0 | 0 | 1 (0.9) | 0 | 0 | 1 (0.9) |
| Musculoskeletal and connective tissue disorders | 0 | 1 (0.9) | 0 | 0 | 0 | 1 (0.9) |
| Myositis | 0 | 1 (0.9) | 0 | 0 | 0 | 1 (0.9) |
| Skin and subcutaneous tissue disorders | 0 | 0 | 0 | 1 (0.9) | 0 | 1 (0.9) |
| Generalized dermatitis exfoliative | 0 | 0 | 0 | 1 (0.9) | 0 | 1 (0.9) |
| Lichenoid keratosis | 0 | 0 | 0 | 1 (0.9) | 0 | 1 (0.9) |
AE, adverse event; AESI, adverse events of special interest; GBS, Guillain-Barré syndrome; MedDRA, Medical Dictionary for Regulatory Activities.
AEs coded using MedDRA version 22.0.