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Table 2 Drug-related adverse events reported during the entire treatment period (All patients, N = 28)

From: Once weekly paclitaxel associated with a fixed dose of oral metronomic cyclophosphamide: a dose-finding phase 1 trial

AE category G 0 G 1 G 2 G 3 G 4 Total G ≥ 1 Total G ≥ 3
Blood And Lymphatic System Disorders 0 4 9 12 3 28 100.00% 15 53.57%
 Anemia 24 1 3 0 0 4 14.30% 0 0.00%
 Platelet Count Decreased 27 0 0 1 0 1 3.60% 1 3.60%
 Neutropenia 16 3 6 3 0 12 43.86% 3 10.71%
 Febrile Neutropenia 26 0 0 1 1 2 7.10% 2 7.10%
 Lymphocyte Count Decreased 0 6 10 10 2 28 100.00% 12 43.86%
Gastrointestinal Disorders 15 7 6 0 0 13 46.40% 0 0.00%
 Abdominal Pain 26 1 1 0 0 2 7.10% 0 0.00%
 Diarrhea 23 2 3 0 0 5 17.90% 0 0.00%
 Nausea 21 5 2 0 0 7 25.00% 0 0.00%
 Stomatitis 27 1 0 0 0 1 3.60% 0 0.00%
 Vomiting 26 2 0 0 0 2 7.10% 0 0.00%
General Disorders 13 7 6 2 0 15 53.60% 2 7.10%
 Fatigue 13 7 6 2 0 15 53.60% 2 7.10%
Metabolism And Nutrition Disorders 23 3 2 0 0 5 17.90% 0 0.00%
 Anorexia 25 2 1 0 0 3 10.70% 0 0.00%
 Hypoalbuminemia 27 0 1 0 0 1 3.60% 0 0.00%
 Weight Loss 27 1 0 0 0 1 3.60% 0 0.00%
Nervous System Disorders 15 9 3 1 0 13 46.43% 1 3.60%
 Dizziness 27 0 1 0 0 1 3.60% 0 0.00%
 Dysgeusia 26 2 0 0 0 2 7.10% 0 0.00%
 Peripheral Sensory/Motor Neuropathy* 16 8 3 1 0 12 43.86% 1 3.60%
Renal And Urinary Disorders 26 1 1 0 0 2 7.10% 0 0.00%
 Hematuria 26 1 1 0 0 2 7.10% 0 0.00%
Respiratory, Thoracic And Mediastinal Disorders 24 3 1 0 0 4 14.30% 0 0.00%
 Dyspnea 26 1 1 0 0 2 7.10% 0 0.00%
 Epistaxis 26 2 0 0 0 2 7.10% 0 0.00%
Skin And Subcutaneous Tissue Disorders 14 7 7 0 0 14 50.00% 0 0.00%
 Alopecia 14 7 7 0 0 14 50.00% 0 0.00%
 Dry Skin 26 2 0 0 0 2 7.10% 0 0.00%
  1. G 0: no AE; G 1: Grade 1 AE, G 2: Grade 2 AE, G 3: Grade 3 AE, G 4: Grade 4 AE, G 5: lethal AE
  2. For each category type, we considered the maximum grade per patient observed over the entire treatment duration
  3. All adverse events, classified as drug-related or not, are summarized in (Additional file 1: Table S1)
  4. *Myalgia has been pooled with peripheral sensory neuropathy because this symptom reflects more a peripheral neurotoxicity than a musculoskeletal disorder in the study setting
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BMC Cancer

ISSN: 1471-2407

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