Table 2B:
Number of Events and Number of Subject for each Adverse Effect Type by Treatment Group
| Adverse Effect Category | Imatinib N= 45 | Placebo N = 22 | ||
|---|---|---|---|---|
| No. of events | No. of subjects (%) | No. of events | No. of subjects (%) | |
| Infections and infestations | 26 | 12 (26.7) | 9 | 4 (18.2) |
| Eye disorders | 2 | 2 (4.4) | 0 | 0 (0.0) |
| Musculoskeletal and connective tissue disorders | 4 | 3 (6.7) | 1 | 1 (4.5) |
| Nervous system disorders | 4 | 4 (8.9) | 0 | 0 (0.0) |
| Gastrointestinal disorders | 13 | 6 (13.3) | 0 | 0 (0.0) |
| Metabolism and nutrition disorders | 11 | 5 (11.1) | 2 | 2 (9.1) |
| Reproductive system and breast disorders | 1 | 1 (2.2) | 0 | 0 (0.0) |
| Psychiatric disorders | 9 | 5 (11.1) | 0 | 0 (0.0) |
| Respiratory, thoracic and mediastinal disorders | 6 | 6 (13.3) | 1 | 1 (4.5) |
| Skin and subcutaneous tissue disorders | 6 | 5 (11.1) | 3 | 2 (9.1) |
| Ear and labyrinth disorders | 1 | 1 (2.2) | 0 | 0 (0.0) |
| Cardiac disorders | 6 | 4 (8.9) | 0 | 0 (0.0) |
| General disorders/Administration site conditions | 2 | 2 (4.4) | 0 | 0 (0.0) |
| Laboratory Investigations | 18 | 10 (22.2) | 4 | 2 (9.1) |
| Pregnancy, puerperium and perinatal conditions | 0 | 0 (0.0) | 1 | 1 (4.5) |
| Injury, poisoning and procedural complications | 4 | 2 (4.4) | 0 | 0 (0.0) |
| Immune system disorders | 0 | 0 (0.0) | 1 | 1 (4.5) |
| Hepatobiliary disorders | 5 | 3 (6.7) | 2 | 2 (9.1) |
| Surgical and medical procedures | 0 | 0 (0.0) | 2 | 2 (9.1) |
| Blood and lymphatic system disorders | 7 | 4 (8.9) | 0 | 0 (0.0) |
| Endocrine disorders | 45 | 4 (8.9) | 2 | 1 (4.5) |
| Renal and urinary disorders | 2 | 1 (2.2) | 0 | 0 (0.0) |
| Total Events | 172 | --- | 28 | --- |