Table 2.
Summary of TEAEs in >1% of Subjects—Safety Analysis Set
| All TEAEs | Drug‐Related TEAEs | |||||||
|---|---|---|---|---|---|---|---|---|
| S + P 235 mg Fosnetupitant (N = 30) | Overall IV (N = 148) | Overall Oral (N = 134) | Total (N = 158) | S + P 235 mg Fosnetupitant (N = 30) | Overall IV (N = 148) | Overall Oral (N = 134) | Total (N = 158) | |
| Subjects with ≥1 TEAE, n (%) | 10 (33.3) | 46 (31.1) | 57 (42.5) | 80 (50.6) | 9 (30.0) | 34 (23.0) | 37 (27.6) | 59 (37.3) |
| Number of TEAEs | 20 | 83 | 86 | 169 | 14 | 55 | 53 | 108 |
| MedDRA System Organ Class Preferred Term, n (%) | ||||||||
| Gastrointestinal disorders | ||||||||
| Abdominal pain | 0 (0) | 0 (0) | 4 (3.0) | 4 (2.5) | 0 (0) | 0 (0) | 2 (1.5) | 2 (1.3) |
| Abdominal pain upper | 0 (0) | 3 (2.0) | 5 (3.7) | 7 (4.4) | 0 (0) | 3 (2.0) | 5 (3.7) | 7 (4.4) |
| Constipation | 0 (0) | 2 (1.4) | 10 (7.5) | 12 (7.6) | 0 (0) | 2 (1.4) | 10 (7.5) | 12 (7.6) |
| Nausea | 0 (0) | 2 (1.4) | 4 (3.0) | 4 (2.5) | 0 (0) | 2 (1.4) | 4 (3.0) | 4 (2.5) |
| General disorders and administration‐site conditions | ||||||||
| Fatigue | 0 (0) | 6 (4.1) | 3 (2.2) | 9 (5.7) | 0 (0) | 6 (4.1) | 3 (2.2) | 9 (5.7) |
| Feeling hot | 0 (0) | 2 (1.4) | 0 (0) | 2 (1.3) | 0 (0) | 0 (0) | 0 (0) | 0 (0) |
| Infusion‐site thrombosis | 4 (13.3) | 8 (5.4) | 2 (1.5) | 10 (6.3) | 4 (13.3) | 8 (5.4) | 2 (1.5) | 10 (6.3) |
| Vessel puncture‐site thrombosis | 5 (16.7) | 14 (9.5) | 14 (10.4) | 25 (15.8) | 0 (0) | 0 (0) | 0 (0) | 0 (0) |
| Infections and infestations | ||||||||
| Nasopharyngitis | 0 (0) | 1 (0.7) | 3 (2.2) | 4 (2.5) | 0 (0) | 0 (0) | 0 (0) | 0 (0) |
| Musculoskeletal and connective tissue disorders | ||||||||
| Muscle spasms | 0 (0) | 1 (0.7) | 1 (0.7) | 2 (1.3) | 0 (0) | 0 (0) | 0 (0) | 0 (0) |
| Nervous system disorders | ||||||||
| Dizziness | 2 (6.7) | 3 (2.0) | 5 (3.7) | 8 (5.1) | 2 (6.7) | 3 (2.0) | 3 (2.2) | 6 (3.8) |
| Headache | 2 (6.7) | 12 (8.1) | 21 (15.7) | 28 (17.7) | 2 (6.7) | 12 (8.1) | 17 (12.7) | 25 (15.8) |
| Vascular disorders | ||||||||
| Phlebosclerosis | 0 (0) | 1 (0.7) | 1 (0.7) | 2 (1.3) | 0 (0) | 0 (0) | 0 (0) | 0 (0) |
IV, infusion of 17.6 to 353 mg fosnetupitant and administration of placebo capsule; Oral, oral NEPA (netupitant 300 mg/palonosetron 0.5 mg) administration and placebo infusion; MedDRA, Medical Dictionary for Regulatory Activities; P, pilot crossover part; S, single‐ascending‐dose/single‐ascending‐dose crossover part; TEAE, treatment‐emergent adverse event.