Serious adverse events (SAEs)5 by system organ class and preferred term in patients with pemphigus vulgaris up to month 24
| System organ class, preferred term | Rituximab + prednisone (n = 38) | Prednisone alone (n = 36) |
| Patients with at least one SAE, n (%) | 11 (29) | 16 (44) |
| Total number of SAEs | 26 | 24 |
| Musculoskeletal and connective tissue disorders, patients, n (%) | 5 (13) | 4 (11) |
| Myopathy | 1 (3) | 2 (6) |
| Lumbar spinal stenosis | 0 | 1 (3) |
| Osteonecrosis | 0 | 1 (3) |
| Tendonitis | 0 | 1 (3) |
| Arthralgia | 1 (3) | 0 |
| Myalgia | 1 (3) | 0 |
| Osteoporotic fracture | 1 (3) | 0 |
| Psoriatic arthropathy | 1 (3) | 0 |
| Total number of events | 5 | 5 |
| Respiratory, thoracic and mediastinal disorders, patients n (%) | 3 (8) | 3 (8) |
| Pulmonary embolism | 2 (5) | 2 (6) |
| Dyspnoea | 0 | 1 (3) |
| Nasal septum perforation | 1 (3) | 0 |
| Total number of events | 3 | 3 |
| Infections and infestations, patients, n (%) | 3 (8) | 1 (3) |
| Pneumocystis jirovecii pneumonia | 1 (3) | 1 (3) |
| Infective thrombosis | 1 (3) | 0 |
| Intervertebral discitis | 1 (3) | 0 |
| Lung infection | 1 (3) | 0 |
| Staphylococcal sepsis | 1 (3) | 0 |
| Total number of events | 5 | 1 |
| Nervous system disorders, patients, n (%) | 2 (5) | 3 (8) |
| Cerebrovascular accident | 0 | 1 (3) |
| Motor dysfunction | 0 | 1 (3) |
| Sciatica | 0 | 1 (3) |
| Headache | 1 (3) | 0 |
| Neuropathy peripheral | 1 (3) | 0 |
| Total number of events | 2 | 3 |
| Vascular disorders, patients, n (%) | 2 (5) | 3 (8) |
| Deep vein thrombosis | 0 | 1 (3) |
| Hypertension | 0 | 1 (3) |
| Phlebitis | 0 | 1 (3) |
| Hypotension | 1 (3) | 0 |
| Venous thrombosis limb | 1 (3) | 0 |
| Total number of events | 2 | 3 |
| System organ class, preferred term | Rituximab + prednisone (n = 38) | Prednisone alone (n = 36) |
| Patients with at least one SAE, n (%) | 11 (29) | 16 (44) |
| Total number of SAEs | 26 | 24 |
| Musculoskeletal and connective tissue disorders, patients, n (%) | 5 (13) | 4 (11) |
| Myopathy | 1 (3) | 2 (6) |
| Lumbar spinal stenosis | 0 | 1 (3) |
| Osteonecrosis | 0 | 1 (3) |
| Tendonitis | 0 | 1 (3) |
| Arthralgia | 1 (3) | 0 |
| Myalgia | 1 (3) | 0 |
| Osteoporotic fracture | 1 (3) | 0 |
| Psoriatic arthropathy | 1 (3) | 0 |
| Total number of events | 5 | 5 |
| Respiratory, thoracic and mediastinal disorders, patients n (%) | 3 (8) | 3 (8) |
| Pulmonary embolism | 2 (5) | 2 (6) |
| Dyspnoea | 0 | 1 (3) |
| Nasal septum perforation | 1 (3) | 0 |
| Total number of events | 3 | 3 |
| Infections and infestations, patients, n (%) | 3 (8) | 1 (3) |
| Pneumocystis jirovecii pneumonia | 1 (3) | 1 (3) |
| Infective thrombosis | 1 (3) | 0 |
| Intervertebral discitis | 1 (3) | 0 |
| Lung infection | 1 (3) | 0 |
| Staphylococcal sepsis | 1 (3) | 0 |
| Total number of events | 5 | 1 |
| Nervous system disorders, patients, n (%) | 2 (5) | 3 (8) |
| Cerebrovascular accident | 0 | 1 (3) |
| Motor dysfunction | 0 | 1 (3) |
| Sciatica | 0 | 1 (3) |
| Headache | 1 (3) | 0 |
| Neuropathy peripheral | 1 (3) | 0 |
| Total number of events | 2 | 3 |
| Vascular disorders, patients, n (%) | 2 (5) | 3 (8) |
| Deep vein thrombosis | 0 | 1 (3) |
| Hypertension | 0 | 1 (3) |
| Phlebitis | 0 | 1 (3) |
| Hypotension | 1 (3) | 0 |
| Venous thrombosis limb | 1 (3) | 0 |
| Total number of events | 2 | 3 |
Only those SAEs in a system organ class with at least two patients overall are listed. An SAE is any adverse event that results in the death of a patient, is potentially life‐threatening, requires hospitalization (> 24 h) or a prolongation of initial hospitalization, results in a disability or significant prolonged incapacitation, leads to a congenital abnormality or birth defect, or is any other adverse effect judged to be medically significant by the investigator reporting the event.
Serious adverse events (SAEs)5 by system organ class and preferred term in patients with pemphigus vulgaris up to month 24
| System organ class, preferred term | Rituximab + prednisone (n = 38) | Prednisone alone (n = 36) |
| Patients with at least one SAE, n (%) | 11 (29) | 16 (44) |
| Total number of SAEs | 26 | 24 |
| Musculoskeletal and connective tissue disorders, patients, n (%) | 5 (13) | 4 (11) |
| Myopathy | 1 (3) | 2 (6) |
| Lumbar spinal stenosis | 0 | 1 (3) |
| Osteonecrosis | 0 | 1 (3) |
| Tendonitis | 0 | 1 (3) |
| Arthralgia | 1 (3) | 0 |
| Myalgia | 1 (3) | 0 |
| Osteoporotic fracture | 1 (3) | 0 |
| Psoriatic arthropathy | 1 (3) | 0 |
| Total number of events | 5 | 5 |
| Respiratory, thoracic and mediastinal disorders, patients n (%) | 3 (8) | 3 (8) |
| Pulmonary embolism | 2 (5) | 2 (6) |
| Dyspnoea | 0 | 1 (3) |
| Nasal septum perforation | 1 (3) | 0 |
| Total number of events | 3 | 3 |
| Infections and infestations, patients, n (%) | 3 (8) | 1 (3) |
| Pneumocystis jirovecii pneumonia | 1 (3) | 1 (3) |
| Infective thrombosis | 1 (3) | 0 |
| Intervertebral discitis | 1 (3) | 0 |
| Lung infection | 1 (3) | 0 |
| Staphylococcal sepsis | 1 (3) | 0 |
| Total number of events | 5 | 1 |
| Nervous system disorders, patients, n (%) | 2 (5) | 3 (8) |
| Cerebrovascular accident | 0 | 1 (3) |
| Motor dysfunction | 0 | 1 (3) |
| Sciatica | 0 | 1 (3) |
| Headache | 1 (3) | 0 |
| Neuropathy peripheral | 1 (3) | 0 |
| Total number of events | 2 | 3 |
| Vascular disorders, patients, n (%) | 2 (5) | 3 (8) |
| Deep vein thrombosis | 0 | 1 (3) |
| Hypertension | 0 | 1 (3) |
| Phlebitis | 0 | 1 (3) |
| Hypotension | 1 (3) | 0 |
| Venous thrombosis limb | 1 (3) | 0 |
| Total number of events | 2 | 3 |
| System organ class, preferred term | Rituximab + prednisone (n = 38) | Prednisone alone (n = 36) |
| Patients with at least one SAE, n (%) | 11 (29) | 16 (44) |
| Total number of SAEs | 26 | 24 |
| Musculoskeletal and connective tissue disorders, patients, n (%) | 5 (13) | 4 (11) |
| Myopathy | 1 (3) | 2 (6) |
| Lumbar spinal stenosis | 0 | 1 (3) |
| Osteonecrosis | 0 | 1 (3) |
| Tendonitis | 0 | 1 (3) |
| Arthralgia | 1 (3) | 0 |
| Myalgia | 1 (3) | 0 |
| Osteoporotic fracture | 1 (3) | 0 |
| Psoriatic arthropathy | 1 (3) | 0 |
| Total number of events | 5 | 5 |
| Respiratory, thoracic and mediastinal disorders, patients n (%) | 3 (8) | 3 (8) |
| Pulmonary embolism | 2 (5) | 2 (6) |
| Dyspnoea | 0 | 1 (3) |
| Nasal septum perforation | 1 (3) | 0 |
| Total number of events | 3 | 3 |
| Infections and infestations, patients, n (%) | 3 (8) | 1 (3) |
| Pneumocystis jirovecii pneumonia | 1 (3) | 1 (3) |
| Infective thrombosis | 1 (3) | 0 |
| Intervertebral discitis | 1 (3) | 0 |
| Lung infection | 1 (3) | 0 |
| Staphylococcal sepsis | 1 (3) | 0 |
| Total number of events | 5 | 1 |
| Nervous system disorders, patients, n (%) | 2 (5) | 3 (8) |
| Cerebrovascular accident | 0 | 1 (3) |
| Motor dysfunction | 0 | 1 (3) |
| Sciatica | 0 | 1 (3) |
| Headache | 1 (3) | 0 |
| Neuropathy peripheral | 1 (3) | 0 |
| Total number of events | 2 | 3 |
| Vascular disorders, patients, n (%) | 2 (5) | 3 (8) |
| Deep vein thrombosis | 0 | 1 (3) |
| Hypertension | 0 | 1 (3) |
| Phlebitis | 0 | 1 (3) |
| Hypotension | 1 (3) | 0 |
| Venous thrombosis limb | 1 (3) | 0 |
| Total number of events | 2 | 3 |
Only those SAEs in a system organ class with at least two patients overall are listed. An SAE is any adverse event that results in the death of a patient, is potentially life‐threatening, requires hospitalization (> 24 h) or a prolongation of initial hospitalization, results in a disability or significant prolonged incapacitation, leads to a congenital abnormality or birth defect, or is any other adverse effect judged to be medically significant by the investigator reporting the event.
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