Table 3.
Number (%) of patients with at least one adverse event (AE) according to treatment arm by MedDRA System Organ Classification (SOC).
| Standard diet plus Lemon Juice (n = 100) | Standard Diet alone (n = 103) | P value | |
|---|---|---|---|
| Any adverse event | 64 (64·0%) | 54 (52·4%) | 0·118 |
| Cardiac disorders | 0 (0·0%) | 2 (1·9%) | 0·498 |
| Congenital, familial and genetic disorders | 1 (1·0%) | 0 (0·0%) | 0·493 |
| Endocrine disorders | 2 (2·0%) | 1 (1·0%) | 0·618 |
| Gastrointestinal disorders | 37 (37·0%) | 8 (7·8%) | <0·001 |
| - Nausea | 2 (2·0%) | 1 (1·0%) | 0·618 |
| - Epigastralgia | 8 (8·0%) | 3 (2·9%) | 0·130 |
| - Gastric pyrosis/heartburn | 21 (21·0%) | 1 (1·0%) | <0·001 |
| - Constipation/diarrhoea | 4 (4·0%) | 0 (0·0%) | 0·058 |
| - Dental erosion, hypersensitivity | 2 (2·0%) | 0 (0·0%) | 0·241 |
| - Other | 8 (8·0%) | 3 (2·9%) | 0·130 |
| Infections and infestations | 3 (3·0%) | 6 (5·8%) | 0·498 |
| Injury, poisoning and procedural complications | 2 (2·0%) | 1 (1·0%) | 0·618 |
| Metabolism and nutrition disorders | 1 (1·0%) | 2 (1·9%) | 1·000 |
| Musculoskeletal and connective tissue disorders | 2 (2·0%) | 4 (3·9%) | 0·683 |
| Neoplasms benign, malignant and unspecified# | 1 (1·0%) | 3 (2·9%) | 0·621 |
| Nervous system disorders° | 1 (1·0%) | 2 (1·9%) | 1·000 |
| Psychiatric disorders | 1 (1·0%) | 0 (0·0%) | 0.493 |
| Renal and urinary disorders | 28 (28·0%) | 41 (39·8%) | 0·103 |
| - Renal colic* | 24 (24·0%) | 26 (25·2%) | 0·872 |
| - Pyelic stones | 7 (7·0%) | 10 (9·7%) | 0·614 |
| - Macrohematuria | 3 (3·0%) | 6 (5·8%) | 0·498 |
| - Dysuria | 1 (1·0%) | 4 (3·9%) | 0·369 |
| - Renal/parapyelic cyst | 1 (1·0%) | 5 (4·9%) | 0·212 |
| - Endoscopic ureterolithotripsy | 3 (3·0%) | 2 (1·9%) | 0·680 |
| - Shock wave litotripsy | 2 (2·0%) | 2 (1·9%) | 1·000 |
| - Other | 4 (4·0%) | 2 (1·9%) | 0·440 |
| Reproductive system and breast disorders | 1 (1·0%) | 2 (1·9%) | 1·000 |
| Respiratory, thoracic and mediastinal disorders | 1 (1·0%) | 0 (0·0%) | 0·493 |
Chi-square test. Including two serious adverse events: Dorsal Melanoma# and Cerebral Aneurysm Rupture°. *with or without stone expulsion.