TABLE 3.
Drug-related adverse effects with an incidence of ≥1% in Phase II/III clinical studies.
| Drug-related AEs | NEMO-500 mg (n = 519) | NEMO-750 mg (n = 151) | NEMO total (n = 670) | LEVO-500 mg (n = 317) | RD [95%CI] | |
|---|---|---|---|---|---|---|
| NEMO-500 mg VS. LEVO-500 mg | NEMO-750 mg VS. LEVO-500 mg | |||||
| Investigations a | 59 (11.4) | 15 (9.9) | 74 (11.0) | 32 (10.1) | 1.3 [-3.0; 5.6] | 0.2 [-5.6; 6.0] |
| Alanine aminotransferase increased | 23 (4.4) | 0 | 23 (3.4) | 8 (2.5) | ||
| Aspartate aminotransferase increased | 10 (1.9) | 1 (0.7) | 11 (1.6) | 3 (0.9) | ||
| Gamma-glutamyltransferase increased | 7 (1.3) | 0 | 7 (1.0) | 4 (1.3) | ||
| Electrocardiogram - prolonged QT b | 4 (0.8) | 4 (2.6) | 8 (1.2) | 5 (1.5) | ||
| Gastrointestinal disorders a | 31 (6.0) | 16 (10.6) | 47 (7.0) | 14 (4.4) | 1.6 [-1.5; 4.6] | 6.2 [0.8; 11.6] |
| Abdominal discomfort | 5 (1.0) | 2 (1.3) | 7 (1.0) | 1 (0.3) | ||
| Upper abdominal pain | 0 | 2 (1.3) | 2 (0.3) | 0 | ||
| Diarrhea | 7 (1.3) | 2 (1.3) | 9 (1.3) | 2 (0.6) | ||
| Nausea | 13 (2.5) | 9 (6.0) | 22 (3.3) | 5 (1.6) | ||
| Vomiting | 6 (1.2) | 4 (2.6) | 10 (1.5) | 7 (2.2) | ||
| Nervous system disorders a | 14 (2.7) | 4 (2.6) | 18 (2.7) | 6 (1.9) | 0.8 [-1.2; 2.9] | 0.8 [-2.2; 3.7] |
| Dizziness | 10 (1.9) | 3 (2.0) | 13 (1.9) | 3 (0.9) | ||
| Headache | 5 (1.0) | 2 (1.3) | 7 (1.0) | 3 (0.9) | ||
| Blood and lymphatic system disorders a | 14 (2.7) | 13 (8.6) | 26 (3.9) | 16 (5.0) | 2.3 [-0.4; 5.1] | 3.6 [-1.5; 8.6] |
| Leukopenia c | 12 (2.3) | 7 (4.6) | 19 (2.8) | 10 (3.2) | ||
| Neutropenia d | 13 (2.5) | 13 (8.6) | 26 (3.9) | 14 (4.4) | ||
| Thrombocytosis e | 4 (0.8) | 4 (2.6) | 8 (1.2) | 2 (0.6) | ||
| Skin and subcutaneous tissue disorders a | 6 (1.2) | 1 (0.7) | 7 (1.0) | 5 (1.6) | 0.4 [-1.2; 2.1] | 0.9 [-1.0; 2.8] |
| Rash | 2 (0.4) | 0 | 2 (0.3) | 4 (1.3) | ||
a
List the total incidence.
b
Includes prolonged QT, and prolonged corrected QT, intervals.
c
Includes decreased white blood cells count and leukopenia.
d
Includes decreased neutrophil percentage or count and neutropenia.
e
Includes increased platelet count and thrombocytosis.
The AE incidence in bold is calculated as SOC and is the sum of the incidence of AE for the corresponding PT.