AE grade | Exercise (160 adverse events, 670 participants) Total number of adverse eventsa - exercise-related adverse events | Usual care (98 adverse events, 623 participants) Total number of adverse eventsa - exercise-related adverse events | ||
---|---|---|---|---|
1 | Grade 1 adverse events: 127–1 | Grade 1 adverse events: 73–0 | ||
Low-severity musculoskeletal symptoms (pain, stiffness, soreness, tendonitis, cramp or arthritis) (65–1) Fatigue (7–0) Flu-like symptoms (6–0) Palpitations (5–0) Bruising (5–0) Dizziness/vertigo (5–0) Headache (4–0) Diarrhea (3–0) Dry mouth (3–0) Toothache (3–0) | Otitis media (3–0) Fall (3–0) Sinus pain (3–0) External ear inflammation (2–0) Shortness of breath (2–0) Neuralgia (2–0) Mouth pain (1–0) Non-cardiac chest pain (1–0) Upper-respiratory infection (1–0) Constipation (1–0) Vomiting (1–0) Lymph node pain (1–0) | Low-severity musculoskeletal symptoms (pain, stiffness, soreness, tendonitis, cramp or arthritis) (41–0) Fatigue (10–0) Shortness of breath (2–0) Diarrhea (2–0) Flu-like symptoms (2–0) Bruising (2–0) Dizziness (2–0) Dry eye (1–0) Dry mouth (1–0) | Palpitations (1–0) Edema in limbs (1–0) Non-cardiac chest pain (1–0) Fall (1–0) Arthritis (1–0) Headache (1–0) Neuralgia (1–0) Sinus pain (1–0) Vomiting (1–0) Chills (1–0) | |
2 | Grade 2 adverse events: 14–6 | Grade 2 adverse events: 4–0 | ||
Musculoskeletal pain (6–6) Chest pain (2–0) Wound infection at the site of surgery (1–0) Blurred vision (1–0) | Gastroesophageal reflux disease (1–0) Edema limbs (1–0) Hyperglycaemia (1–0) Peripheral neuropathy (preventing exercise) (1–0) | Postoperative ileus (1–0) Hyperthyroidism (1–0) Gastroesophageal reflux disease (1–0) Chest pain (1–0) | ||
3b | Grade 3 adverse events: 12–0 | Grade 3 adverse events: 14–0 | ||
Unspecified medical problem leading to withdrawal (5–0) Postoperative ventral hernias (2–0) | Fatigue and malaise (led to withdrawal) (2–0) Stroke (2–0) Acute illness (1–0) | Unspecified medical reasons (6–0) Mental reasons/depression (3–0) Postoperative ventral hernias (1–0) Microhaematuria (1–0) | Acute illness (1–0) Progressive disease with cough (1–0) Psychological reasons leading to withdrawal (1–0) | |
4 | Grade 4 adverse events: 5–0 | Grade 4 adverse events: 5–0 | ||
Cancer recurrence (1–0) Emergency surgery required (1–0) Pneumonia (1–0) | Metastasis (1–0) Diagnosed with lung cancer (1–0) | Metastasis (3–0) Cancer recurrence (2–0) | ||
5 | Grade 5 adverse events: 2–0 | Grade 5 adverse events: 2–0 | ||
Death (2–0; n = 1 due to perforated cholecystitis; n = 1 unspecified) | Death (2–0; n = 1 was due to sepsis; n = 1 unspecified) |