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Table 3 Treatment-emergent adverse events

From: Phase IB part of LOC-R01, a LOC network non-comparative randomized phase IB/II study testing R-MPV in combination with escalating doses of lenalidomide or ibrutinib for newly diagnosed primary central nervous system lymphoma (PCNSL) patients

 

Lenalidomide (N = 13)

N (%)

Ibrutinib (N = 12)

N (%)

Total (N = 25)

N (%)

Type of toxicity

Grade 1–2

Grade 3

Grade 4

Grade 5

Grade 1–2

Grade 3

Grade 4

Grade 5

Grade 1–2

Grade 3

Grade 4

Grade 5

Highest toxicity

2 (15.4%)

5 (38.5%)

5 (38.5%)

-

3 (25%)

5 (41.7%)

3 (25%)

1 (8.3%)

5 (20%)

10 (40%)

8 (32%)

1 (4%)

Investigations (highest toxicity)

2 (15.4%)

5 (38.5%)

1 (7.7%)

-

4 (33.3%)

3 (25%)

1 (8.3%)

-

6 (24%)

8 (32%)

2 (8%)

-

Cholestasis

2 (15.4%)

-

-

-

2 (16.7%)

-

-

-

4 (16%)

-

-

-

Creatinine increased

-

1 (7.7%)

-

-

2 (16.7%)

1 (8.3%)

-

-

2 (8%)

2 (8%)

-

-

Hepatic cytolysis

3 (23.1%)

4 (30.8%)

1 (7.7%)

-

2 (16.7%)

3 (25%)

1 (8.3%)

-

5 (20%)

7 (28%)

2 (8%)

-

Gastrointestinal disorders (highest toxicity)

5 (38.5%)

-

-

-

5 (41.7%)

1 (8.3%)

-

-

10 (40%)

1 (4%)

-

-

Abdominal pain

1 (7.7%)

-

-

-

1 (8.3%)

1 (8.3%)

-

-

2 (8%)

1 (4%)

-

-

Colitis

-

-

-

-

1 (8.3%)

-

-

-

1 (4%)

-

-

-

Constipation

5 (38.5%)

-

-

-

2 (16.7%)

-

-

-

7 (28%)

-

-

-

Diarrhea

2 (15.4%)

-

-

-

4 (33.3%)

-

-

-

6 (24%)

-

-

-

Nausea

1 (7.7%)

-

-

-

4 (33.3%)

-

-

-

5 (20%)

-

-

-

Vomiting

-

-

-

-

2 (16.7%)

-

-

-

2 (8%)

-

-

-

Metabolism and nutrition disorders (highest toxicity)

3 (23.1%)

1 (7.7%)

-

-

2 (16.7%)

1 (8.3%)

-

-

5 (20%)

2 (8%)

-

-

Anorexia

-

-

-

-

1 (8.3%)

-

-

-

1 (4%)

-

-

-

Hyperkalemia

-

-

-

-

1 (8.3%)

-

-

-

1 (4%)

-

-

-

Hypernatremia

1 (7.7%)

-

-

-

1 (8.3%)

1 (8.3%)

-

-

2 (8%)

1 (4%)

-

-

Hypokalemia

1 (7.7%)

1 (7.7%)

-

-

1 (8.3%)

-

-

-

2 (8%)

1 (4%)

-

-

Hypomagnesemia

1 (7.7%)

-

-

-

-

-

-

-

1 (4%)

-

-

-

Hyponatremia

2 (15.4%)

-

-

-

-

1 (8.3%)

-

-

2 (8%)

1 (4%)

-

-

Hypophosphatemia

1 (7.7%)

-

-

-

-

-

-

-

1 (4%)

-

-

-

Blood and lymphatic system disorders (highest toxicity)

3 (23.1%)

3 (23.1%)

1 (7.7%)

-

2 (16.7%)

2 (16.7%)

2 (16.7%)

-

5 (20%)

5 (20%)

3 (12%)

-

Anemia

5 (38.5%)

-

-

-

3 (25%)

2 (16.7%)

-

-

8 (32%)

2 (8%)

-

-

Lymphocyte count decreased

-

2 (15.4%)

-

-

-

-

-

-

-

2 (8%)

-

-

Neutrophil count decreased

1 (7.7%)

2 (15.4%)

1 (7.7%)

-

-

1 (8.3%)

2 (16.7%)

-

1 (4%)

3 (12%)

3 (12%)

-

Platelet count decreased

-

-

-

-

3 (25%)

1 (8.3%)

-

-

3 (12%)

1 (4%)

-

-

White blood cell decreased

-

1 (7.7%)

-

-

-

-

-

-

-

1 (4%)

-

-

Nervous system disorders (highest toxicity)

6 (46.2%)

1 (7.7%)

-

-

7 (58.3%)

1 (8.3%)

-

-

13 (52%)

2 (8%)

-

-

Headache

2 (15.4%)

-

-

-

3 (25%)

-

-

-

5 (20%)

-

-

-

Peripheral sensory neuropathy

6 (46.2%)

1 (7.7%)

-

-

5 (41.7%)

1 (8.3%)

-

-

11 (44%)

2 (8%)

-

-

Post-lumbar puncture syndrome

1 (7.7%)

-

-

-

1 (8.3%)

-

-

-

2 (8%)

-

-

-

Infections and infestations (highest toxicity)

2 (15.4%)

1 (7.7%)

2 (15.4%)

-

3 (25%)

2 (16.7%)

-

1 (8.3%)

5 (20%)

3 (12%)

2 (8%)

1 (4%)

Aspergillosis infection

-

-

-

-

-

-

-

1 (8.3%)

-

-

-

1 (4%)

Bacteremia

1 (7.7%)

-

-

-

-

-

-

-

1 (4%)

-

-

-

Catheter related infection

-

-

2 (15.4%)

-

-

-

-

-

-

-

2 (8%)

-

COVID-19 Infection

1 (7.7%)

-

-

-

1 (8.3%)

-

-

-

2 (8%)

-

-

-

Endocarditis

-

1 (7.7%)

-

-

-

-

-

-

-

1 (4%)

-

-

Lung infection

-

-

-

-

-

-

-

1 (8.3%)

-

-

-

1 (4%)

Pharyngitis

-

-

-

-

1 (8.3%)

-

-

-

1 (4%)

-

-

-

Sepsis

-

1 (7.7%)

-

-

-

2 (16.7%)

-

1 (8.3%)

-

3 (12%)

-

1 (4%)

Stye

-

-

-

-

1 (8.3%)

-

-

-

1 (4%)

-

-

-

Tooth infection

2 (15.4%)

-

-

-

-

-

-

-

2 (8%)

-

-

-

Urinary tract infection

1 (7.7%)

-

-

-

1 (8.3%)

1 (8.3%)

-

-

2 (8%)

1 (4%)

-

-

General disorders and administration site conditions (highest toxicity)

3 (23.1%)

-

-

-

4 (33.3%)

-

-

-

7 (28%)

-

-

-

Edema limbs

-

-

-

-

1 (8.3%)

-

-

-

1 (4%)

-

-

-

Fatigue

3 (23.1%)

-

-

-

3 (25%)

-

-

-

6 (24%)

-

-

-

Fever

1 (7.7%)

-

-

-

1 (8.3%)

-

-

-

2 (8%)

-

-

-

Malaise

1 (7.7%)

-

-

-

-

-

-

-

1 (4%)

-

-

-

Odynophagia

1 (7.7%)

-

-

-

-

-

-

-

1 (4%)

-

-

-

Skin and subcutaneous tissue disorders (highest toxicity)

2 (15.4%)

1 (7.7%)

1 (7.7%)

-

4 (33.3%)

-

-

-

6 (24%)

1 (4%)

1 (4%)

-

Dry skin

1 (7.7%)

-

-

-

-

-

-

-

1 (4%)

-

-

-

Erythema multiforme

1 (7.7%)

-

-

-

1 (8.3%)

-

-

-

2 (8%)

-

-

-

Hyperhidrosis

1 (7.7%)

-

-

-

1 (8.3%)

-

-

-

2 (8%)

-

-

-

Lyell’s syndrome

-

-

1 (7.7%)

-

-

-

-

-

-

-

1 (4%)

-

PAC inflammation

-

-

-

-

1 (8.3%)

-

-

-

1 (4%)

-

-

-

Pruritus

-

-

-

-

1 (8.3%)

-

-

-

1 (4%)

-

-

-

Rash maculo-papular

2 (15.4%)

1 (7.7%)

-

-

1 (8.3%)

-

-

-

3 (12%)

1 (4%)

-

-

Respiratory, thoracic and mediastinal disorders (highest toxicity)

3 (23.1%)

-

-

-

-

-

-

-

3 (12%)

-

-

-

Cough

1 (7.7%)

-

-

-

-

-

-

-

1 (4%)

-

-

-

Dyspnea

3 (23.1%)

-

-

-

-

-

-

-

3 (12%)

-

-

-

Oxygen desaturation

1 (7.7%)

-

-

-

-

-

-

-

1 (4%)

-

-

-

Rhinorrhea

1 (7.7%)

-

-

-

    

1 (4%)

-

-

-

Cardiac disorders (highest toxicity)

1 (7.7%)

-

-

-

1 (8.3%)

-

-

-

2 (8%)

-

-

-

Atrial fibrillation

-

-

-

-

1 (8.3%)

-

-

-

1 (4%)

-

-

-

Chest pain - cardiac

1 (7.7%)

-

-

-

-

-

-

-

1 (4%)

-

-

-

Musculoskeletal and connective tissue disorders (highest toxicity)

2 (15.4%)

-

-

-

-

-

-

-

2 (8%)

-

-

-

Back pain

1 (7.7%)

-

-

-

-

-

-

-

1 (4%)

-

-

-

Muscle cramp

1 (7.7%)

-

-

-

-

-

-

-

1 (4%)

-

-

-

Vascular disorders (highest toxicity)

3 (23.1%)

-

-

-

-

1 (8.3%)

-

-

3 (12%)

1 (4%)

-

-

Hypertension

-

-

-

-

-

1 (8.3%)

-

-

-

1 (4%)

-

-

Thromboembolic event

3 (23.1%)

-

-

-

-

-

-

-

3 (12%)

-

-

-

Ear and labyrinth disorders (highest toxicity)

-

-

-

-

1 (8.3%)

-

-

-

1 (4%)

-

-

-

Vertigo

-

-

-

-

1 (8.3%)

-

-

-

1 (4%)

-

-

-

Endocrine disorders (highest toxicity)

1 (7.7%)

-

-

-

-

-

-

-

1 (4%)

-

-

-

Hypopituitarism

1 (7.7%)

-

-

-

-

-

-

-

1 (4%)

-

-

-

  1. TEAEs were defined as AEs occurring after the first dose of lenalidomide or ibrutinib, in combination with R-MPV, and through the whole induction phase; i.e. four evaluable cycles of lenalidomide or ibrutinib + R-MPV. TEAEs were classified according to the system organ class (SOC) of the common terminology criteria for adverse events (CTCAE) v5.0 and summarized by considering the highest grade achieved per patient. The term “highest toxicity” refers to the most severe grade observed within each SOC and overall
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Journal of Hematology & Oncology

ISSN: 1756-8722

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