Table 3.
Summary of Treatment Emergent Adverse Events for ≥5% of all Subjects and ≥30 of All Subjects
| MedDRA System Organ Class Preferred term | GI-4000 + Gemcitabine N = 88 | Placebo + Gemcitabine N = 88 | Total N = 176 |
|---|---|---|---|
| Blood and lymphatic system disorders, n (%) | |||
| Anemia | 36 (40.9) | 39 (44.3) | 75 (42.6) |
| Neutropenia | 37 (42.0) | 36 (40.9) | 73 (41.5) |
| Thrombocytopenia | 15 (17.0) | 17 (19.3) | 32 (18.2) |
| Gastrointestinal disorders, n (%) | |||
| Abdominal pain | 33 (37.5) | 32 36.4) | 65 (36.9) |
| Constipation | 26 (29.5) | 27 (30.7) | 53 (30.1) |
| Diarrhea | 31 (35.2) | 44 (50.0) | 75 (42.6) |
| Nausea | 46 (52.3) | 45 (51.1) | 91 (51.7) |
| Vomiting | 25 (28.4) | 24 (27.3) | 49 (27.8) |
| General disorders and administration site conditions, n (%) | |||
| Fatigue | 47 (53.4) | 50 (56.8) | 97 (55.1) |
| Edema, peripheral | 29 (33.0) | 26 (29.5) | 55 (31.3) |
| Pyrexia | 25 (28.4) | 30 (34.1) | 55 (31.3) |
| Injection site reactionsa | 40 (45.5) | 8 (9.1) | 48 (27.3) |
| Metabolism and nutrition disorders, n (%) | |||
| Anorexia | 16 (18.2) | 16 (18.2) | 32 (18.2) |
| Musculoskeletal and connective tissue disorders, n (%) | |||
| Back pain | 22 (25.0) | 19 (21.6) | 41 (23.3) |
| Nervous system disorders, n (%) | |||
| Dizziness | 16 (18.2) | 17 (19.3) | 33 (18.8) |
| Headache | 20 (22.7) | 19 (21.6) | 39 (22.2) |
| Psychiatric disorders, n (%) | |||
| Depression | 10 (11.4) | 21 (23.9) | 31 (17.6) |
| Insomnia | 22 (25.0) | 15 (17.0) | 37 (21.0) |
a
includes injection site erythema, induration, and pain.