Table 2.
Adverse Events coded by Common Terminology Criteria for Adverse Events version 3.0 body system. Frequency of adverse events shown in N=absolute numbers of adverse events; Pts(%)= number and percent of participants who experienced at least one adverse event; AE= Adverse Events; SAE= Serious Adverse Events; Cntl=Control diet; HC/HC=high-carbohydrate/hypercaloric diet; HF/HC= high-fat/hypercaloric diet. Specific AEs listed parenthetically under the CTCAE body systems are a selection from all CTCAE terms reported.
| Adverse Events by Body Sytem |
Cntl | HC/HC | HF/HC | p values (events) | p values (% Pts) | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Type | N | Pts (%) |
N | Pts (%) |
N | Pts (%) |
Overall | HC/HC vs. Cntl |
HF/HC vs. Cntl |
Overall | HC/HC vs. Cntl |
HF/HC vs. Cntl |
|
| Allergy/Immunology (Allergic rhinitis) | AE | 0 | 0 (0) | 1 | 1 (13) | 0 | 0 (0) | 0•81 | 0•69 | >0•99 | >0•99 | >0•99 | >0•99 |
| SAE | 0 | 0 (0) | 0 | 0 (0) | 0 | 0 (0) | >0•99 | >0•99 | >0•99 | >0•99 | >0•99 | >0•99 | |
| Cardiac (Atrial fibrillation, elevated troponin) | AE | 2 | 1 (17) | 0 | 0 (0) | 0 | 0 (0) | >0•99 | 0•97 | 0•97 | 0•6 | 0•43 | >0•99 |
| SAE | 0 | 0(0) | 0 | 0 (0) | 0 | 0 (0) | >0•99 | >0•99 | >0•99 | >0•99 | >0•99 | >0•99 | |
| Constitutional Symptoms (Fatigue, weight change) | AE | 7 | 2 (33) | 2 | 2 (25) | 5 | 2 (33) | 0•41 | 0•2 | 0•78 | >0•99 | >0•99 | >0•99 |
| SAE | 0 | 0 (0) | 0 | 0 (0) | 0 | 0 (0) | >0•99 | >0•99 | >0•99 | >0•99 | >0•99 | >0•99 | |
| Dermatology (Abration) | AE | 0 | 0 (0) | 0 | 0 (0) | 1 | 1 (17) | 0•71 | >0•99 | 0•51 | 0•6 | >0•99 | >0•99 |
| SAE | 0 | 0 (0) | 0 | 0 (0) | 0 | 0 (0) | >0•99 | >0•99 | >0•99 | >0•99 | >0•99 | >0•99 | |
| Gastrointestinal (detached feeding tube, bloating, dyspepsia, diarrhea) | AE | 13 | 6 (100) | 8 | 4 (50) | 21 | 6 (100) | 0•04 | 0•11 | 0•21 | 0•02 | 0•09 | >0•99 |
| SAE | 0 | 0 (0) | 0 | 0 (0) | 0 | 0 (0) | >0•99 | >0•99 | >0•99 | >0•99 | >0•99 | >0•99 | |
| Hematology/Coagulation (Thrombocytopenia) | AE | 1 | 1 (17) | 0 | 0 (0) | 0 | 0 (0) | >0•99 | 0•97 | 0•64 | 0•6 | 0•43 | >0•99 |
| SAE | 0 | 0 (0) | 0 | 0 (0) | 0 | 0 (0) | >0•99 | >0•99 | >0•99 | >0•99 | >0•99 | >0•99 | |
| Infection (Urinary tract, pneumonia) | AE | 5 | 2 (33) | 3 | 3 (38) | 6 | 4 (67) | 0•46 | 0•41 | 0•82 | 0•62 | >0•99 | 0•57 |
| SAE | 1 | 1 (17) | 0 | 0 (0) | 0 | 0 (0) | 0•6 | 0•43 | >0•99 | 0•6 | 0•43 | >0•99 | |
| Metabolic/Laboratory (Elevated alkaline phosphatase, hypokalemia) | AE | 2 | 1 (17) | 0 | 0 (0) | 0 | 0 (0) | >0•99 | 0•97 | 0•97 | 0•6 | 0•43 | >0•99 |
| SAE | 0 | 0 (0) | 0 | 0 (0) | 0 | 0 (0) | >0•99 | >0•99 | >0•99 | >0•99 | >0•99 | >0•99 | |
| Musculoskeletal (Falls, weakness) | AE | 0 | 0 (0) | 5 | 1 (13) | 4 | 2 (33) | >0•99 | 0•97 | 0•97 | 0•45 | >0•99 | 0•45 |
| SAE | 0 | 0 (0) | 0 | 0 (0) | 0 | 0 (0) | >0•99 | >0•99 | >0•99 | >0•99 | >0•99 | >0•99 | |
| Neurology/Psychiatry (Dizziness, depression) | AE | 1 | 1 (17) | 1 | 1 (13) | 1 | 1 (17) | 0•97 | 0•9 | 0•99 | >0•99 | >0•99 | >0•99 |
| SAE | 0 | 0 (0) | 0 | 0 (0) | 1 | 1 (17) | 0•6 | >0•99 | >0•99 | 0•6 | >0•99 | >0•99 | |
| Pain (Abdomin, neck, limb) | AE | 3 | 2 (33) | 2 | 2 (25) | 4 | 3 (50) | 0•58 | 0•46 | 0•72 | 0•84 | >0•99 | >0•99 |
| SAE | 2 | 1 (17) | 0 | 0 (0) | 0 | 0 (0) | 0•18 | 0•18 | 0•5 | 0•6 | 0•43 | >0•99 | |
| Pulmonary/Upper Respiratory (Dyspnea, hypoxia, aspiration, cough) | AE | 8 | 3 (50) | 1 | 1 (13) | 6 | 3 (50) | 0•16 | 0•075 | 0•72 | 0•28 | 0•24 | >0•99 |
| SAE | 6 | 3 (50) | 0 | 0 (0) | 2 | 2 (33) | 0•007 | 0•006 | 0•29 | 0•07 | 0•06 | >0•99 | |
| Total | AE | 42 | 6 (100) | 23 | 8 (100) | 48 | 6 (100) | 0•06 | 0•06 | 0•73 | >0•99 | >0•99 | >0•99 |
| SAE | 9 | 4 (67) | 0 | 0 (0) | 3 | 3 (50) | <0•001 | <0•001 | 0•15 | 0•03 | 0•015 | >0•99 | |