Table 15: Very Common and Common Adverse Drug Reactions NCI-CTC Grade 3-5 Reactions All Grade Reactions* (≥ 2% difference between the study arms in at least (≥ 10% difference between the one clinical trial) study arms in at least one System Organ Class clinical trial) (SOC) Very common Common Very Common Sepsis Infections and Abscess infestations Infection Febrile neutropenia Anaemia Blood and the Leucopenia lymphatic systems Neutropenia disorders Thrombocytopenia Dehydration Anorexia Metabolism and nutrition disorders Peripheral sensory Cerebrovascular accident Dysgeusia Nervous system neuropathy Syncope Headache disorders Somnolence Dysarthria Headache **Peripheral sensory neuropathy Eye disorder Eye disorders Lacrimation increased Cardiac failure congestive Cardiac disorders Supraventricular tachycardia Hypertension Thromboembolism Hypertension Vascular disorders (arterial) Deep vein thrombosis Haemorrhage Pulmonary embolism Dyspnoea Respiratory, thoracic Dyspnoea Epistaxis and mediastinal Hypoxia Rhinitis disorders Epistaxis Diarrhoea Intestinal Perforation Ileus Constipation Gastrointestinal Nausea Intestinal obstruction Stomatitis disorders Vomiting Abdominal pain Rectal haemorrhage Gastrointestinal disorder Diarrhoea Stomatitis Ovarian failure Endocrine disorders Palmar-plantar Exfoliative dermatitis Skin and subcutaneous erythrodysaesthesia Dry skin tissue disorders syndrome Skin discolouration Muscular weakness Arthralgia Musculoskeletal, connective tissue and Myalgia Arthralgia bone disorders Proteinuria Proteinuria Renal and urinary Urinary Tract Infection disorders Asthenia Pain Pyrexia General disorders and Fatigue Lethargy Asthenia administration site Mucosal inflammation Pain conditions General physical health Mucosal inflammation deterioration *Only Grade 2-5 adverse events were collected in study MO22224 **Difference of 10% was observed in study MO22224 ≥ Laboratory Abnormalities
Table 15: Very Common and Common Adverse Drug Reactions System Organ Class (SOC) NCI-CTC Grade 3-5 Reactions (≥ 2% difference between the study arms in at least one clinical trial) All Grade Reactions* (≥ 10% difference between the study arms in at least one clinical trial) Very common Common Very Common Infections and infestations Sepsis Abscess Infection Blood and the lymphatic systems disorders Febrile neutropenia Leucopenia Neutropenia Thrombocytopenia Anaemia Metabolism and nutrition disorders Dehydration Anorexia Nervous system disorders Peripheral sensory neuropathy Cerebrovascular accident Syncope Somnolence Headache Dysgeusia Headache Dysarthria **Peripheral sensory neuropathy Eye disorders Eye disorder Lacrimation increased Cardiac disorders Cardiac failure congestive Supraventricular tachycardia Vascular disorders Hypertension Thromboembolism (arterial) Deep vein thrombosis Haemorrhage Hypertension Respiratory, thoracic and mediastinal disorders Pulmonary embolism Dyspnoea Hypoxia Epistaxis Dyspnoea Epistaxis Rhinitis Gastrointestinal disorders Diarrhoea Nausea Vomiting Intestinal Perforation Ileus Intestinal obstruction Abdominal pain Gastrointestinal disorder Stomatitis Constipation Stomatitis Rectal haemorrhage Diarrhoea Endocrine disorders Ovarian failure Skin and subcutaneous tissue disorders Palmar-plantar erythrodysaesthesia syndrome Exfoliative dermatitis Dry skin Skin discolouration Musculoskeletal, connective tissue and bone disorders Muscular weakness Myalgia Arthralgia Arthralgia Renal and urinary disorders Proteinuria Urinary Tract Infection Proteinuria General disorders and administration site conditions Asthenia Fatigue Pain Lethargy Mucosal inflammation General physical health deterioration Pyrexia Asthenia Pain Mucosal inflammation *Only Grade 2-5 adverse events were collected in study MO22224 **Difference of ≥ 10% was observed in study MO22224 Laboratory Abnormalities
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