Table 3 Overall drug-related adverse events (a) and grade 3 or higher drug-related adverse events (b)
System organ class Preferred term | Arm A (N = 7) Aza + Pembro (%) | Arm B (N = 9) Romi + Pembro (%) | Arm C (N = 10) Aza + Romi + Pembro (%) | Total (N = 26) (%) |
|---|---|---|---|---|
(a) | ||||
Blood and Lymphatic disorders | 6 (86%) | 8 (89%) | 9 (90%) | 23 (88%) |
Anemia | 3 (43%) | 7 (78%) | 6 (60%) | 16 (62%) |
Lymphocyte count decreased | 2 (29%) | 5 (56%) | 7 (70%) | 14 (54%) |
Neutrophil count decreased | 3 (43%) | 1 (11%) | 2 (20%) | 6 (23%) |
Platelet count decreased | 0 (0%) | 4 (44%) | 5 (50%) | 9 (35%) |
White blood cell decreased | 3 (43%) | 0 (0%) | 2 (20%) | 5 (19%) |
Endocrine disorders | 0 (0%) | 1 (11%) | 2 (20%) | 3 (12%) |
Hyperthyroidism | 0 (0%) | 0 (0%) | 2 (20%) | 2 (8%) |
Hypothyroidism | 0 (0%) | 1 (11%) | 1 (10%) | 2 (8%) |
Gastrointestinal disorders | 7 (100%) | 8 (89%) | 10 (100%) | 25 (96%) |
Abdominal pain | 0 (0%) | 0 (0%) | 3 (30%) | 3 (12%) |
Anorexia | 5 (71%) | 5 (56%) | 7 (70%) | 17 (65%) |
Ascites | 1 (14%) | 0 (0%) | 1 (10%) | 2 (8%) |
Bloating | 2 (29%) | 1 (11%) | 0 (0%) | 3 (12%) |
Constipation | 1 (14%) | 2 (22%) | 0 (0%) | 3 (12%) |
Diarrhea | 6 (86%) | 1 (11%) | 4 (40%) | 11 (42%) |
Dry heaves | 0 (0%) | 2 (22%) | 1 (10%) | 3 (12%) |
Dry mouth | 2 (29%) | 0 (0%) | 0 (0%) | 2 (8%) |
Dyspepsia | 1 (14%) | 2 (22%) | 0 (0%) | 3 (12%) |
Dysphagia | 1 (14%) | 0 (0%) | 0 (0%) | 1 (4%) |
Flatulence | 1 (14%) | 0 (0%) | 0 (0%) | 1 (4%) |
Gastrointestinal reflux disease | 0 (0%) | 0 (0%) | 1 (10%) | 1 (4%) |
Gastroparesis | 1 (14%) | 0 (0%) | 0 (0%) | 1 (4%) |
Mouth pain | 0 (0%) | 0 (0%) | 1 (10%) | 1 (4%) |
Mucositis oral | 0 (0%) | 1 (11%) | 1 (10%) | 2 (8%) |
Nausea | 6 (86%) | 4 (44%) | 10 (100%) | 20 (77%) |
Vomiting | 4 (57%) | 5 (56%) | 10 (100%) | 19 (73%) |
Weight loss | 2 (29%) | 4 (44%) | 3 (30%) | 9 (35%) |
General disorders | 6 (86%) | 9 (100%) | 8 (80%) | 23 (88%) |
Chills | 0 (0%) | 3 (33%) | 1 (10%) | 4 (15%) |
Edema limbs | 1 (14%) | 2 (22%) | 2 (20%) | 5 (19%) |
Fatigue | 5 (71%) | 6 (67%) | 8 (80%) | 19 (73%) |
Fever | 2 (29%) | 3 (33%) | 4 (40%) | 9 (35%) |
Infections | 2 (29%) | 1 (11%) | 2 (20%) | 5 (19%) |
Infection, tongue | 0 (0%) | 0 (0%) | 1 (10%) | 1 (4%) |
Mucosal infection | 0 (0%) | 1 (11%) | 0 (0%) | 1 (4%) |
Mucositis oral | 2 (29%) | 0 (0%) | 1 (10%) | 3 (12%) |
Investigations | 5 (71%) | 6 (67%) | 6 (60%) | 17 (65%) |
Alkaline phosphatase increased | 3 (43%) | 4 (44%) | 5 (50%) | 12 (46%) |
ALT increased | 3 (43%) | 3 (33%) | 2 (20%) | 8 (31%) |
AST increased | 3 (43%) | 1 (11%) | 1 (10%) | 5 (19%) |
Blood bilirubin increased | 2 (29%) | 0 (0%) | 0 (0%) | 2 (8%) |
Creatinine increased | 1 (14%) | 0 (0%) | 3 (30%) | 4 (15%) |
INR increased | 0 (0%) | 1 (11%) | 0 (0%) | 1 (4%) |
Prolonged QTC | 1 (14%) | 0 (0%) | 0 (0%) | 1 (4%) |
Metabolism and nutrition disorders | 4 (57%) | 5 (56%) | 8 (80%) | 17 (65%) |
Dehydration | 0 (0%) | 0 (0%) | 1 (10%) | 1 (4%) |
Hyperglycemia | 1 (14%) | 4 (44%) | 4 (40%) | 9 (35%) |
Hypermagnesemia | 1 (14%) | 1 (11%) | 0 (0%) | 2 (8%) |
Hypernatremia | 0 (0%) | 0 (0%) | 1 (10%) | 1 (4%) |
Hypoalbuminemia | 0 (0%) | 3 (33%) | 3 (30%) | 6 (23%) |
Hypocalcemia | 0 (0%) | 2 (22%) | 5 (50%) | 7 (27%) |
Hypokalemia | 0 (0%) | 1 (11%) | 1 (10%) | 2 (8%) |
Hypomagnesemia | 0 (0%) | 0 (0%) | 2 (20%) | 2 (8%) |
Hyponatremia | 1 (14%) | 2 (22%) | 3 (30%) | 6 (23%) |
Hypophosphatemia | 1 (14%) | 4 (44%) | 3 (30%) | 8 (31%) |
Musculoskeletal disorders | 2 (29%) | 2 (22%) | 5 (50%) | 9 (35%) |
arthralgia | 2 (29%) | 0 (0%) | 3 (30%) | 5 (19%) |
Arthritis | 0 (0%) | 0 (0%) | 1 (10%) | 1 (4%) |
Back pain | 2 (29%) | 0 (0%) | 0 (0%) | 2 (8%) |
Body aches | 0 (0%) | 0 (0%) | 1 (10%) | 1 (4%) |
Myalgia | 0 (0%) | 0 (0%) | 2 (20%) | 2 (8%) |
Pain in extremity | 0 (0%) | 2 (22%) | 0 (0%) | 2 (8%) |
Nervous system disorders | 1 (14%) | 7 (78%) | 6 (60%) | 14 (54%) |
Cognitive disturbance | 0 (0%) | 0 (0%) | 1 (10%) | 1 (4%) |
Dizziness | 0 (0%) | 1 (11%) | 1 (10%) | 2 (8%) |
Dysgeusia | 1 (14%) | 6 (67%) | 4 (40%) | 11 (42%) |
Dysphasia | 1 (14%) | 0 (0%) | 0 (0%) | 1 (4%) |
Headache | 0 (0%) | 2 (22%) | 1 (10%) | 3 (12%) |
Paresthesia | 0 (0%) | 0 (0%) | 1 (10%) | 1 (4%) |
Tremor | 0 (0%) | 0 (0%) | 1 (10%) | 1 (4%) |
Psychiatric disorders | 0 (0%) | 1 (11%) | 2 (20%) | 3 (12%) |
Anxiety | 0 (0%) | 0 (0%) | 1 (10%) | 1 (4%) |
Insomnia | 0 (0%) | 0 (0%) | 1 (10%) | 1 (4%) |
Irritability | 0 (0%) | 1 (11%) | 0 (0%) | 1 (4%) |
Renal and urinary disorders | 0 (0%) | 1 (11%) | 1 (10%) | 2 (8%) |
Chronic kidney disease | 0 (0%) | 0 (0%) | 1 (10%) | 1 (4%) |
Proteinuria | 0 (0%) | 1 (11%) | 0 (0%) | 1 (4%) |
Respiratory disorders | 3 (43%) | 2 (22%) | 2 (20%) | 7 (27%) |
Cough | 3 (43%) | 1 (11%) | 1 (10%) | 5 (19%) |
Dyspnea | 0 (0%) | 1 (11%) | 1 (10%) | 2 (8%) |
Pleuritic pain | 0 (0%) | 1 (11%) | 0 (0%) | 1 (4%) |
Rhinorrhea | 0 (0%) | 0 (0%) | 1 (10%) | 1 (4%) |
Sore throat | 0 (0%) | 0 (0%) | 1 (10%) | 1 (4%) |
Skin and subcutaneous disorders | 3 (43%) | 1 (11%) | 1 (10%) | 5 (19%) |
Discoloration, hands | 0 (0%) | 0 (0%) | 1 (10%) | 1 (4%) |
Erythema | 0 (0%) | 0 (0%) | 1 (10%) | 1 (4%) |
Pruritus | 1 (14%) | 0 (0%) | 1 (10%) | 2 (8%) |
Rash | 3 (43%) | 0 (0%) | 1 (10%) | 4 (15%) |
Skin peeling | 0 (0%) | 1 (11%) | 0 (0%) | 1 (4%) |
Vascular disorders | 0 (0%) | 2 (22%) | 3 (30%) | 5 (19%) |
Diaphoresis | 0 (0%) | 0 (0%) | 1 (10%) | 1 (4%) |
Hot flash | 0 (0%) | 1 (11%) | 0 (0%) | 1 (4%) |
Hypertension | 0 (0%) | 0 (0%) | 1 (10%) | 1 (4%) |
Hypotension | 0 (0%) | 0 (0%) | 1 (10%) | 1 (4%) |
Night sweats | 0 (0%) | 1 (11%) | 0 (0%) | 1 (4%) |
(b) | ||||
Any grade3 + related AE | 4 (57%) | 7 (78%) | 4 (40%) | 15 (58%) |
Blood and lymphatic disorders | 4 (57%) | 5 (56%) | 2 (20%) | 11 (42%) |
Anemia | 1 (14%) | 4 (44%) | 0 (0%) | 5 (19%) |
Lymphocyte count decreased | 2 (29%) | 2 (22%) | 1 (10%) | 5 (19%) |
Neutrophil count decreased | 2 (29%) | 0 (0%) | 1 (10%) | 3 (12%) |
Gastrointestinal disorders | 0 (0%) | 1 (11%) | 2 (20%) | 3 (12%) |
Abdominal pain | 0 (0%) | 0 (0%) | 1 (10%) | 1 (4%) |
Ascites | 0 (0%) | 0 (0%) | 1 (10%) | 1 (4%) |
Diarrhea | 0 (0%) | 1 (11%) | 0 (0%) | 1 (4%) |
Nausea | 0 (0%) | 0 (0%) | 1 (10%) | 1 (4%) |
Vomiting | 0 (0%) | 0 (0%) | 2 (20%) | 2 (8%) |
General disorders | 0 (0%) | 3 (33%) | 0 (0%) | 3 (12%) |
Fatigue | 0 (0%) | 2 (22%) | 0 (0%) | 2 (8%) |
Fever | 0 (0%) | 1 (11%) | 0 (0%) | 1 (4%) |
Investigations | 2 (29%) | 1 (11%) | 1 (10%) | 4 (15%) |
Alkaline phosphatase increased | 1 (14%) | 1 (11%) | 1 (10%) | 3 (12%) |
ALT increased | 1 (14%) | 0 (0%) | 0 (0%) | 1 (4%) |
AST increased | 2 (29%) | 0 (0%) | 0 (0%) | 2 (8%) |
Blood bilirubin increased | 1 (14%) | 0 (0%) | 0 (0%) | 1 (4%) |
Metabolism and nutrition disorders | 0 (0%) | 2 (22%) | 1 (10%) | 3 (12%) |
Hyponatremia | 0 (0%) | 0 (0%) | 1 (10%) | 1 (4%) |
Hypophosphatemia | 0 (0%) | 2 (22%) | 0 (0%) | 2 (8%) |
Musculoskeletal disorders | 0 (0%) | 0 (0%) | 1 (10%) | 1 (4%) |
Arthritis | 0 (0%) | 0 (0%) | 1 (10%) | 1 (4%) |