(A) Number (%) of patients with at least one adverse event by system organ class reported in the double-blind maintenance phase and (B) suspected adverse drug reactions (ie, side effects) by system organ class and preferred term reported in the open-label induction and in the double-blind maintenance phase
| (A) | ||
|---|---|---|
| System organ class | Number (%) of patients with at least one adverse event in double-blind phase | |
| Budesonide (n=44) | Placebo (n=48) | |
| Cardiac disorders | 1 (2.3) | 0 (0) |
| Ear and labyrinth disorders | 0 (0) | 1 (2.1) |
| Eye disorders | 2 (4.5) | 0 (0) |
| Gastrointestinal disorders | 4 (9.1) | 11 (22.9) |
| General disorders and administration site conditions | 1 (2.3) | 2 (4.2) |
| Hepatobiliary disorders | 1 (2.3) | 0 (0) |
| Infections and infestations | 12 (27.3) | 9 (18.8) |
| Injury, poisoning and procedural complications | 4 (9.1) | 1 (2.1) |
| Investigations | 3 (6.8) | 0 (0) |
| Metabolism and nutrition disorders | 0 (0) | 1 (2.1) |
| Musculoskeletal and connective tissue disorders | 13 (29.5) | 4 (8.3) |
| Arthralgia | 2 (4.5) | 3 (6.3) |
| Arthritis | 2 (4.5) | 0 (0) |
| Back pain | 2 (4.5) | 0 (0) |
| Muscle spasms | 2 (4.5) | 0 (0) |
| Other | 7 (5.9) | 1 (2.1) |
| Neoplasms benign, malignant and unspecified (including cysts and polyps) | 2 (4.5) | 0 (0) |
| Nervous system disorders | 3 (6.8) | 0 (0) |
| Psychiatric disorders | 3 (6.8) | 2 (4.2) |
| Reproductive system and breast disorders | 1 (2.3) | 0 (0) |
| Respiratory, thoracic and mediastinal disorders | 3 (6.8) | 2 (4.2) |
| Skin and subcutaneous tissue disorders | 7 (15.9) | 4 (8.3) |
| Hyperhidrosis | 2 (4.5) | 0 (0) |
| Eczema | 1 (2.3) | 1 (2.1) |
| Other | 6 (13.6) | 3 (6.3) |
| Surgical and medical procedures | 2 (4.5) | 1 (2.1) |
| Vascular disorders | 2 (4.5) | 1 (2.1) |
| (B) | ||
|---|---|---|
| System organ class Preferred term | Number of suspected adverse drug reactions related to budesonide | |
| 8-week open-label induction phase | 52-week double-blind maintenance phase | |
| Cardiac disorders | ||
| Palpitations | 1 | 0 |
| Ear and labyrinth disorders | ||
| Vertigo | 1 | 0 |
| Eye disorders | ||
| Eye swelling | 1 | 0 |
| Glaucoma | 0 | 1 |
| Gastrointestinal disorders | ||
| Abdominal discomfort | 1 | 0 |
| Constipation | 3 | 0 |
| Flatulence | 1 | 0 |
| Nausea | 0 | 1 |
| General disorders and administration site conditions | ||
| Sensation of pressure | 1 | 0 |
| Infections and infestations | ||
| Vulvovaginal mycotic infection | 0 | 1 |
| Investigations | ||
| Alanine aminotransferase increased | 0 | 1 |
| Aspartate aminotransferase increased | 0 | 1 |
| Urinalysis abnormal | 1 | 0 |
| Weight increased | 0 | 2 |
| Metabolism and nutrition disorders | ||
| Diabetes mellitus | 2 | 0 |
| Increased appetite | 1 | 0 |
| Musculoskeletal and connective tissue disorders | ||
| Muscle spasms | 3 | 1 |
| Nervous system disorders | ||
| Dizziness | 1 | 0 |
| Headache | 1 | 0 |
| Psychiatric disorders | ||
| Depression | 1 | 0 |
| Mood swings | 1 | 0 |
| Sleep disorder | 1 | 0 |
| Skin and subcutaneous tissue disorders | ||
| Ecchymosis | 2 | 1 |
| Erythema | 2 | 0 |
| Subcutaneous haemorrhage | 0 | 1 |
| Hyperhidrosis | 0 | 1 |
| Increased tendency to bruise | 0 | 1 |
| Night sweats | 1 | 1 |
| Pruritus | 2 | 0 |
| Skin haemorrhage | 1 | 0 |
| Swelling face | 1 | 1 |
| Vascular disorders | ||
| Hypertension | 2 | 1 |
| Total | 32 | 15 |