Table 2.
TEAEs for M3541 + RT (N = 15; safety analysis set). a Overview of TEAEs. b Incidence of TEAEs by System Organ Class and Preferred Term reported for ≥ three patients (20%) overall at the Preferred Term Level (N = 15; safety analysis set)
| Patients with any: n (%) | Any grade | Grade ≥ 3a | |||
|---|---|---|---|---|---|
| TEAE | 15 (100.0) | 4 (26.7) | |||
| M3541-related TEAE | 10 (66.7) | 1 (6.7) | |||
| RT-related TEAE | 10 (66.7) | 2 (13.3) | |||
| Serious TEAE | 2 (13.3) | 2 (13.3) | |||
| M3541-related serious TEAE | 0 | 0 | |||
| RT-related serious TEAE | 1 (6.7) | 1 (6.7) | |||
| TEAE leading to study discontinuation | 0 | 0 | |||
| TEAE leading to death | 0 | 0 | |||
| M3541 dose cohort | |||||
| System Organ Class Preferred Termb |
50 mg/FD n = 3 n (%) |
100 mg/FD n = 4 n (%) |
200 mg/FD n = 5 n (%) |
300 mg/FD n = 3 n (%) |
Overall N = 15 n (%) |
| Patients with ≥ 1 TEAEc | 3 (100.0) | 4 (100.0) | 5 (100.0) | 3 (100.0) | 15 (100.0) |
| Gastrointestinal disorders | 3 (100.0) | 1 (25.0) | 3 (60.0) | 1 (33.3) | 8 (53.3) |
| Diarrhea | 0 | 1 (25.0) | 3 (60.0) | 1 (33.3) | 5 (33.3) |
| Nausea | 1 (33.3) | 0 | 2 (40.0) | 0 | 3 (20.0) |
| General disorders and administration site conditions | 3 (100.0) | 3 (75.0) | 2 (40.0) | 1 (33.3) | 9 (60.0) |
| Fatigue | 2 (66.7) | 0 | 2 (40.0) | 1 (33.3) | 5 (33.3) |
| Infections and infestations | 1 (33.3) | 1 (25.0) | 2 (40.0) | 0 | 4 (26.7) |
| UTI | 0 | 1 (25.0) | 2 (40.0) | 0 | 3 (20.0) |
| Musculoskeletal and connective tissue disorders | 2 (66.7) | 3 (75.0) | 2 (40.0) | 1 (33.3) | 8 (53.3) |
| Muscular weakness | 0 | 2 (50.0) | 1 (20.0) | 0 | 3 (20.0) |
| Respiratory, thoracic and mediastinal disorders | 1 (33.3) | 1 (25.0) | 1 (20.0) | 1 (33.3) | 4 (26.7) |
| Oropharyngeal pain | 1 (33.3) | 1 (25.0) | 1 (20.0) | 0 | 3 (20.0) |
| Skin and subcutaneous tissue disorders | 0 | 2 (50.0) | 3 (60.0) | 2 (66.7) | 7 (46.7) |
| Dry skin | 0 | 1 (25.0) | 1 (20.0) | 1 (33.3) | 3 (20.0) |
| Pruritus | 0 | 1 (25.0) | 1 (20.0) | 2 (66.7) | 4 (26.7) |
FD, fraction day, RT radiotherapy, MedDRA Medical Dictionary for Regulatory Activities, N/n number of patients, TEAE treatment-emergent adverse event, UTI urinary tract infection
aNo grade 4 TEAEs were reported
bAll TEAEs were coded using the MedDRA Version 22.1
cIf a patient had more than one event within a primary System Organ Class or Preferred Term, the patient was counted only once within that System Organ Class or Preferred Term