Table 3:
Treatment-related adverse events
| Gemcitabine (n=36) |
Gemcitabine plus berzosertib (n=34) |
|||||
|---|---|---|---|---|---|---|
| Grades 1–2 | Grade 3 | Grade 4 | Grades 1–2 | Grade 3 | Grade 4 | |
| Blood and lymphatic system disorders | ||||||
| Anaemia | 21 (58%) | 4 (11%) | 0 | 18 (53%) | 5 (15%) | 0 |
| Febrile neutropenia | 1 (3%) | 1 (3%) | 0 | 0 | 1 (3%) | 0 |
| Haemolytic uraemic syndrome | 0 | 1 (3%) | 0 | 0 | 0 | 0 |
| Thrombocytosis | 0 | 0 | 0 | 1 (3%) | 1 (3%) | 0 |
| Lymphocyte count decreased | 5 (14%) | 1 (3%) | 0 | 0 | 1 (3%) | 0 |
| Neutrophil count decreased | 7 (19%) | 10 (28%) | 4 (11%) | 8 (24%) | 12 (35%) | 4 (12%) |
| Platelet count decreased | 4 (11%) | 0 | 2 (6%) | 9 (26%) | 2 (6%) | 6 (18%) |
| White blood cell decreased | 4 (11%) | 4 (11%) | 0 | 5 (15%) | 3 (9%) | 0 |
| Cardiac disorders | ||||||
| Myocardial infarction | 0 | 1 (3%) | 0 | 0 | 0 | 0 |
| Endocrine disorders | ||||||
| Addisonian crisis | 0 | 0 | 0 | 0 | 1 (3%) | 0 |
| Gastrointestinal disorders | ||||||
| Abdominal pain | 1 (3%) | 0 | 0 | 0 | 1 (3%) | 0 |
| Constipation | 4 (11%) | 0 | 0 | 6 (18%) | 0 | 0 |
| Diarrhoea | 6 (17%) | 0 | 0 | 8 (24%) | 1 (3%) | 0 |
| Gastric haemorrhage | 0 | 1 (3%) | 0 | 0 | 0 | 0 |
| Mucositis oral | 1 (3%) | 0 | 0 | 6 (18%) | 0 | 0 |
| Nausea | 17 (47%) | 1 (3%) | 0 | 19 (56%) | 1 (3%) | 0 |
| Vomiting | 7 (19%) | 0 | 0 | 12 (35%) | 1 (3%) | 0 |
| General disorders and administration site conditions | ||||||
| Chills | 2 (6%) | 0 | 0 | 6 (18%) | 0 | 0 |
| Oedema limbs | 6 (17%) | 1 (3%) | 0 | 1 (3%) | 0 | 0 |
| Fatigue | 18 (50%) | 3 (8%) | 0 | 19 (56%) | 3 (9%) | 0 |
| Fever | 3 (8%) | 0 | 0 | 8 (24%) | 0 | 0 |
| Flu-like symptoms | 4 (11%) | 0 | 0 | 4 (12%) | 0 | 0 |
| Injury, poisoning, and procedural complications | ||||||
| Fall | 0 | 1 (3%) | 0 | 0 | 0 | 0 |
| Investigations | ||||||
| Alanine aminotransferase increased | 7 (19%) | 0 | 0 | 10 (29%) | 0 | 0 |
| Aspartate aminotransferase increased | 8 (22%) | 0 | 0 | 12 (35%) | 0 | 0 |
| Cardiac troponin T increased | 0 | 1 (3%) | 0 | 0 | 0 | 0 |
| Metabolism and nutrition disorders | ||||||
| Anorexia | 5 (14%) | 0 | 0 | 7 (21%) | 0 | 0 |
| Musculoskeletal and connective tissue disorders | ||||||
| Generalised muscle weakness | 1 (3%) | 0 | 0 | 2 (6%) | 1 (3%) | 0 |
| Myalgia | 3 (8%) | 0 | 0 | 5 (15%) | 0 | 0 |
| Nervous system disorders | ||||||
| Headache | 3 (8%) | 0 | 0 | 7 (21%) | 1 (3%) | 0 |
| Respiratory, thoracic, and mediastinal disorders | ||||||
| Dyspnoea | 2 (6%) | 1 (3%) | 0 | 5 (15%) | 0 | 0 |
| Skin and subcutaneous tissue disorders | ||||||
| Maculopapular rash | 5 (14%) | 0 | 0 | 4 (12%) | 0 | 0 |
| Vascular disorders | ||||||
| Capillary leak syndrome | 0 | 1 (3%) | 0 | 0 | 0 | 0 |
Grade 1 and 2 adverse events occurring in at least 10% of patients and all grade 3 and 4 adverse events are shown. There was one treatment-related death in the gemcitabine alone group due to sepsis and one treatment-related death in the gemcitabine plus berzosertib group due to pneumonitis. There were no other deaths due to adverse events.