Table 3. Adverse Events and Serious Adverse Events Reported by Group.
| No. (%) of Events | ||
|---|---|---|
| Triple
Combination Pill Therapy (n = 349) |
Usual
Care (n = 351) |
|
| Total No. of adverse events | 230 | 189 |
| Had ≥1 adverse eventa | 133 (38.1) | 122 (34.8) |
| Type of adverse event | ||
| Musculoskeletal pain | 21 (6.0) | 28 (8.0) |
| Dizziness, syncope, or presyncope | 18 (5.2) | 10 (2.8) |
| Headache | 13 (3.7) | 11 (3.1) |
| Angina pectoris | 8 (2.3) | 6 (1.7) |
| Cough | 8 (2.3) | 18 (5.1) |
| Pyrexia | 6 (1.7) | 12 (3.4) |
| Edema peripheral | 6 (1.7) | 5 (1.4) |
| Upper respiratory tract infection | 6 (1.7) | 11 (3.1) |
| Hypoesthesia | 3 (0.9) | 5 (1.4) |
| All type hypotension | 2 (0.6) | 2 (0.6) |
| Chest pain | 3 (0.9) | 4 (1.1) |
| Had ≥1 serious adverse event | 27 (7.7) | 21 (6.0) |
| Type of serious adverse event | ||
| Infections and infestations | 8 (2.3) | 5 (1.4) |
| General disorders and administration site conditions | 3 (0.9) | 3 (0.9) |
| Renal and urinary disorders | 4 (1.1) | 1 (0.3) |
| Cardiac disorder | 2 (0.6) | 2 (0.6) |
| Nervous system disorder | 2 (0.6) | 2 (0.6) |
| Injury, poisoning, and procedural complications | 2 (0.6) | 1 (0.3) |
| Ear and labyrinth disorders | 0 | 2 (0.6) |
| Gastrointestinal disorder | 2 (0.6) | 0 |
| Immune system disorder | 1 (0.3) | 1 (0.3) |
| Neoplasms (benign, malignant, or unspecified) | 2 (0.6) | 0 |
| Respiratory, thoracic, and mediastinal disorders | 2 (0.6) | 0 |
| Endocrine disorder | 0 | 1 (0.3) |
| Gastrointestinal, renal, and urinary disorders | 1 (0.3) | 0 |
| Investigations | 0 | 1 (0.3) |
| Metabolism and nutrition disorders | 0 | 1 (0.3) |
| Metabolism and nutrition and vascular disorders | 1 (0.3) | 0 |
| Musculoskeletal and connective tissue disorders | 0 | 1 (0.3) |
| Reproductive system and breast disorders | 1 (0.3) | 0 |
| Surgical and medical procedures | 0 | 1 (0.3) |
| Vascular disorders | 0 | 1 (0.3) |
a
Adverse events occurring in fewer than 1% of all participants are not shown.