Table 3.
Number (percentage) of participants allocated to usual care or total diet replacement (TDR) programme reporting an adverse event
| Adverse events* | Usual care group (n=140)† | TDR group (n=138)† | Total |
|---|---|---|---|
| Gastrointestinal disorders: | |||
| Abdominal discomfort | 3 (2) | 3 (2) | 6 (2) |
| Upper abdominal pain | 0 (0) | 3 (2) | 3 (1) |
| Breath odour | 0 (0) | 3 (2) | 3 (1) |
| Constipation | 0 (0) | 20 (15) | 20 (7) |
| Dry mouth | 0 (0) | 4 (4) | 4 (1) |
| Nausea | 0 (0) | 3 (2) | 3 (1) |
| Painful defaecation | 0 (0) | 4 (3) | 4 (1) |
| General disorders: | |||
| Asthenia | 0 (0) | 3 (2) | 3 (1) |
| Fatigue | 1 (1) | 12 (9) | 13 (5) |
| Influenza-like illness | 4 (3) | 3 (2) | 7 (3) |
| Thirst | 0 (0) | 3 (2) | 3 (1) |
| Infections: | |||
| Lower respiratory tract infection | 0 (0) | 3 (2) | 3 (1) |
| Nasopharyngitis | 7 (5) | 4 (3) | 11 (4) |
| Investigations: Scan | 3 (2) | 0 (0) | 3 (1) |
| Nervous system disorders: | |||
| Dizziness | 2 (1) | 6 (4) | 8 (3) |
| Headache | 3 (2) | 11 (8) | 14 (5) |
| Psychiatric disorders: | |||
| Irritability | 0 (0) | 3 (2) | 3 (1) |
| Respiratory, thoracic, and mediastinal disorders: | |||
| Oropharyngeal pain | 2 (1) | 2 (1) | 4 (1) |
*
Events of any severity that occurred in more than 2% of the sample.
†
Two people in the usual care group and four in the TDR group withdrew consent for use of data after randomisation.