Table 3 Overview of adverse events
Characteristics | FDC of MSP (N = 118) | MS (N = 118) | ||
|---|---|---|---|---|
n (%) | No. of events | n (%) | No of events | |
Adverse events | 15 (12.7%) | 17 | 10 (8.5%) | 10 |
Severe adverse events | 1 (0.8%) | 1 | 0 (0.0%) | 0 |
Death | 0 | 0 | 0 | 0 |
Common adverse events | ||||
Blood and lymphatic system disorders | 2 (1.7%) | 3 | 3 (2.5%) | 3 |
Anemia | 1 (0.8%) | 2 | 3 (2.5%) | 3 |
Thrombocytopenia | 1 (0.8%) | 1 | 0 (0.0%) | 0 |
Cardiac disorders | 1 (0.8%) | 1 | 0 (0.0%) | 0 |
Myocardial infarction | 1 (0.8%) | 1 | 0 (0.0%) | 0 |
Gastrointestinal | 4 (3.4%) | 4 | 2 (1.7%) | 2 |
Abdominal pain | 0 (0.0%) | 0 | 1 (0.8%) | 1 |
Flatulence | 2 (1.7%) | 2 | 0 (0.0%) | 0 |
Gastritis | 1 (0.8%) | 1 | 0 (0.0%) | 0 |
Hyperchlorhydria | 1 (0.8%) | 1 | 0 (0.0%) | 0 |
Vomiting | 0 (0.0%) | 0 | 1 (0.8%) | 1 |
Infections and infestations | 1 (0.8%) | 1 | 1 (0.8%) | 1 |
Nasopharyngitis | 1 (0.8%) | 1 | 1 (0.8%) | 1 |
Injury, poisoning and procedural complications | 1 (0.8%) | 1 | 0 (0.0%) | 0 |
Heat stroke | 1 (0.8%) | 1 | 0 (0.0%) | 0 |
Investigations | 1 (0.8%) | 1 | 1 (0.8%) | 1 |
Glomerular filtration rate decreased | 1 (0.8%) | 1 | 1 (0.8%) | 1 |
Metabolism and nutrition disorders | 2 (1.7%) | 2 | 0 (0.0%) | 0 |
Dehydration | 1 (0.8%) | 1 | 0 (0.0%) | 0 |
Hyperuricemia | 1 (0.8%) | 1 | 0 (0.0%) | 0 |
Musculoskeletal & connective tissue disorders | 1 (0.8%) | 1 | 0 (0.0%) | 0 |
Myalgia | 1 (0.8%) | 1 | 0 (0.0%) | 0 |
Nervous system disorder | 0 (0.0%) | 0 | 1 (0.8%) | 1 |
Headache | 0 (0.0%) | 0 | 1 (0.8%) | 1 |
Respiratory, thoracic and mediastinal disorders | 2 (1.7%) | 2 | 2 (1.7%) | 2 |
Cough | 2 (1.7%) | 2 | 2 (1.7%) | 2 |
Skin and subcutaneous tissue disorders | 1 (0.8%) | 1 | 0 (0.0%) | 0 |
Rash | 1 (0.8%) | 1 | 0 (0.0%) | 0 |