Table 5.
TEAEs that occurred in ≥ 3 patients in any treatment arm overall after dosing with mogamulizumab (safety analysis set)
| Overall after dosing with mogamulizumab | ||||||
|---|---|---|---|---|---|---|
| Mogamulizumab arm | Placebo arm | Total | ||||
| Mogamulizumab n = 34 |
Mogamulizumab na = 31 |
Mogamulizumab na = 65 |
||||
| n | (%) | n | (%) | n | (%) | |
| Patients with any TEAE | 34 | (100.0) | 31 | (100.0) | 65 | (100.0) |
| Blood and lymphatic system disorders | 6 | (17.6) | 2 | (6.5) | 8 | (12.3) |
| Lymphopenia | 3 | (8.8) | 0 | (0.0) | 3 | (4.6) |
| Eye disorders | 12 | (35.3) | 9 | (29.0) | 21 | (32.3) |
| Cataract | 2 | (5.9) | 3 | (9.7) | 5 | (7.7) |
| Gastrointestinal disorders | 21 | (61.8) | 15 | (48.4) | 36 | (55.4) |
| Stomatitis | 7 | (20.6) | 5 | (16.1) | 12 | (18.5) |
| Dental caries | 3 | (8.8) | 3 | (9.7) | 6 | (9.2) |
| Diarrhea | 3 | (8.8) | 3 | (9.7) | 6 | (9.2) |
| General disorders and administration site conditions | 17 | (50.0) | 12 | (38.7) | 29 | (44.6) |
| Pyrexia | 9 | (26.5) | 5 | (16.1) | 14 | (21.5) |
| Infections and infestations | 25 | (73.5) | 26 | (83.9) | 51 | (78.5) |
| Nasopharyngitis | 13 | (38.2) | 12 | (38.7) | 25 | (38.5) |
| Cystitis | 5 | (14.7) | 5 | (16.1) | 10 | (15.4) |
| Otitis externa | 4 | (11.8) | 3 | (9.7) | 7 | (10.8) |
| Tinea pedis | 3 | (8.8) | 4 | (12.9) | 7 | (10.8) |
| Urinary tract infection | 4 | (11.8) | 1 | (3.2) | 5 | (7.7) |
| Bronchitis | 1 | (2.9) | 3 | (9.7) | 4 | (6.2) |
| Gingivitis | 3 | (8.8) | 1 | (3.2) | 4 | (6.2) |
| Influenza | 3 | (8.8) | 1 | (3.2) | 4 | (6.2) |
| Tinea infection | 3 | (8.8) | 1 | (3.2) | 4 | (6.2) |
| Herpes zoster | 0 | (0.0) | 3 | (9.7) | 3 | (4.6) |
| Sinusitis | 0 | (0.0) | 3 | (9.7) | 3 | (4.6) |
| Injury, poisoning, and procedural complications | 17 | (50.0) | 16 | (51.6) | 33 | (50.8) |
| Contusion | 8 | (23.5) | 2 | (6.5) | 10 | (15.4) |
| Thermal burn | 3 | (8.8) | 2 | (6.5) | 5 | (7.7) |
| Investigations | 20 | (58.8) | 15 | (48.4) | 35 | (53.8) |
| Lymphocyte count decreased | 11 | (32.4) | 9 | (29.0) | 20 | (30.8) |
| Blood lactate dehydrogenase increased | 4 | (11.8) | 2 | (6.5) | 6 | (9.2) |
| White blood cell count decreased | 4 | (11.8) | 1 | (3.2) | 5 | (7.7) |
| Musculoskeletal and connective tissue disorders | 20 | (58.8) | 12 | (38.7) | 32 | (49.2) |
| Back pain | 9 | (26.5) | 3 | (9.7) | 12 | (18.5) |
| Arthralgia | 8 | (23.5) | 3 | (9.7) | 11 | (16.9) |
| Myalgia | 3 | (8.8) | 1 | (3.2) | 4 | (6.2) |
| Neoplasms: benign, malignant, and unspecified (including cysts and polyps) | 5 | (14.7) | 2 | (6.5) | 7 | (10.8) |
| Skin papilloma | 3 | (8.8) | 1 | (3.2) | 4 | (6.2) |
| Nervous system disorders | 12 | (35.3) | 7 | (22.6) | 19 | (29.2) |
| Headache | 6 | (17.6) | 0 | (0.0) | 6 | (9.2) |
| Skin and subcutaneous tissue disorders | 31 | (91.2) | 30 | (96.8) | 61 | (93.8) |
| Rash | 20 | (58.8) | 25 | (80.6) | 45 | (69.2) |
| Alopecia | 6 | (17.6) | 7 | (22.6) | 13 | (20.0) |
| Dermatitis contact | 4 | (11.8) | 4 | (12.9) | 8 | (12.3) |
| Eczema | 4 | (11.8) | 4 | (12.9) | 8 | (12.3) |
| Dry skin | 6 | (17.6) | 1 | (3.2) | 7 | (10.8) |
| Seborrheic dermatitis | 2 | (5.9) | 5 | (16.1) | 7 | (10.8) |
| Dermatitis | 2 | (5.9) | 3 | (9.7) | 5 | (7.7) |
| Pruritus | 1 | (2.9) | 4 | (12.9) | 5 | (7.7) |
| Drug eruption | 3 | (8.8) | 0 | (0.0) | 3 | (4.6) |
| Miliaria | 0 | (0.0) | 3 | (9.7) | 3 | (4.6) |
| Rash maculo-papular | 3 | (8.8) | 0 | (0.0) | 3 | (4.6) |
| Vascular disorders | 5 | (14.7) | 1 | (3.2) | 6 | (9.2) |
| Hypertension | 3 | (8.8) | 0 | (0.0) | 3 | (4.6) |
an was calculated based on the patients who received at least one dose of mogamulizumab. One patient in the placebo arm withdrew from the study because of a TEAE during the double-blind period
TEAE treatment-emergent adverse event