Incidence of treatment-emergent signs and symptoms (TESS) and type TESS occurring in ≥2% of patients in either treatment group
| Ibodutant 1 mg N=141 n (%) | Ibodutant 3 mg N=142 n (%) | Ibodutant 10 mg N=139 n (%) | Placebo N=143 n (%) | Total N=565 n (%) | |
|---|---|---|---|---|---|
| Number of TESSs | 57 | 73 | 71 | 56 | 257 |
| Number of patients reporting at least one TESS | 42 (29.8) | 41 (28.9) | 43 (30.9) | 32 (22.4) | 158 (28.0) |
| Number of patients reporting at least one treatment-related* TESS | 13 (9.2) | 8 (5.6) | 10 (7.2) | 12 (8.4) | 43 (7.7) |
| Number of patients reporting at least one severe TESS† | 1 (2.4) | 2 (4.9) | 1 (2.3) | 3 (9.4) | 7 (4.4) |
| Number of patients reporting at least one TESS leading to study discontinuation† | 3 (7.1) | 4 (9.8) | 1 (2.3) | 0 (0.0) | 8 (5.1) |
| Number of patients reporting at least one SAE (serious TESS) | 0 (0.0) | 1 (0.7) | 1 (0.7) | 3 (2.1) | 5 (0.9) |
| Number of patients reporting at least one AE that resulted in death | 0 (0.0%) | 0 (0.0%) | 0 (0.0%) | 0 (0.0%) | 0 (0.0%) |
| System organ class preferred term | #—n (%) | #—n (%) | #—n (%) | #—n (%) | #—n (%) |
|---|---|---|---|---|---|
| GI disorders | 13—13 (9.2) | 11—11 (7.7) | 8—8 (5.8) | 12—11 (7.7) | 44—43 (7.6) |
| Abdominal pain | 1—1 (0.7) | 2—2 (1.4) | 0—0 (0.0) | 4—3 (2.1) | 7—6 (1.1) |
| Nausea | 1—1 (0.7) | 4—4 (2.8) | 5—5 (3.6) | 3—3 (2.1) | 16—16 (2.8) |
| Infections and infestations | 10—8 (5.7) | 22—22 (15.5) | 21—21 (15.1) | 14—14 (9.8) | 67—65 (11.5) |
| Gastroenteritis | 0—0 (0.0) | 2—2 (1.4) | 3—3 (2.2) | 0—0 (0.0) | 5—5 (0.9) |
| Influenza | 0—0 (0.0) | 2—2 (1.4) | 3—3 (2.2) | 5—5 (3.5) | 10—10 (1.8) |
| Nasopharyngitis | 6—5 (3.5) | 4—4 (2.8) | 5—5 (3.6) | 3—3 (2.1) | 18—17 (3.0) |
| Upper respiratory tract infection | 0—0 (0.0) | 0—0 (0.0) | 3—3 (2.2) | 1—1 (0.7) | 4—4 (0.7) |
| Investigations | 5—5 (3.5) | 4—3 (2.1) | 7—7 (5.0) | 2—2 (1.4) | 18—17 (3.0) |
| Blood creatine phosphokinase increased | 3—3 (2.1) | 0—0 (0.0) | 1—1 (0.7) | 1—1 (0.7) | 5—5 (0.9) |
| Nervous system disorders | 11—11 (7.8) | 6—6 (4.2) | 12—9 (6.5) | 8—7 (4.9) | 37—33 (5.8) |
| Dizziness | 3—3 (2.1) | 2—2 (1.4) | 1—1 (0.7) | 0—0 (0.0) | 6—6 (1.1) |
| Headache | 7—7 (5.0) | 3—3 (2.1) | 11—8 (5.8) | 4—4 (2.8) | 25—22 (3.9) |
*Treatment-related TESSs are those with a relationship to study treatment of ‘certain’, ‘probable’, ‘possible’ or ‘unassessable/unclassifiable’ on the adverse event page.
†Percentage calculated on the number of patients with at least one TESS.
#, number of events; n, number of patients; SAE, serious adverse event.