Summary of the safety profile Columvi monotherapy The most common adverse reactions (≥ 20%) were cytokine release syndrome, neutropenia, anaemia, thrombocytopenia, and rash. 1%). 5% of patients. 4%). Columvi in combination with gemcitabine and oxaliplatin The most common adverse reactions (≥ 20%) were thrombocytopenia, cytokine release syndrome, neutropenia, anaemia, nausea, peripheral neuropathy, diarrhoea, aspartate aminotransferase increased, alanine aminotransferase increased, rash, lymphopenia, pyrexia, and vomiting.
3%). 9% of patients. 2%). Tabulated list of adverse reactions Adverse reactions occurring in relapsed or refractory DLBCL patients treated with Columvi monotherapy (n=145) in study NP30179 are listed in Table 6. Patients received a median of 5 cycles of Columvi treatment (range: 1 to 13 cycles).
Adverse reactions occurring in relapsed or refractory DLBCL patients treated with Columvi in combination with gemcitabine and oxaliplatin (n=172) in study GO41944 (STARGLO) are listed in Table 7. Patients received a median of 11 cycles of Columvi treatment (range: 1 to 13 cycles).
The adverse reactions are listed by MedDRA system organ class and categories of frequency. The following categories of frequency have been used: very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1 000 to < 1/100), rare (≥ 1/10 000 to < 1/1 000), very rare (< 1/10 000).
Within each frequency grouping, adverse reactions are presented in the order of decreasing seriousness. 16 Table 6. Adverse reactions reported in patients with relapsed or refractory DLBCL treated with Columvi monotherapy System organ class Adverse reaction All grades Grade 34 Infections and infestations Viral infections1 Very common Common* Bacterial infections2 Common Common Upper respiratory tract infections3 Common Very rare** Sepsis4 Common Common* Lower respiratory tract infections5 Common Very rare** Pneumonia Common Uncommon Urinary tract infection6 Common Uncommon Fungal infections7 Common Very rare** Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumour flare Very common Common Blood and lymphatic system disorders Neutropenia Very common Very Common Anaemia Very common Common Thrombocytopenia Very common Common Lymphopenia Common Common Febrile neutropenia8 Common Common Immune system disorders Cytokine release syndrome9 Very common Common Metabolism and nutrition disorders Hypophosphataemia Very common Common Hypomagnesaemia Very common Very rare** Hypocalcaemia Very common Very rare** Hypokalaemia Very common Uncommon Hyponatraemia Common Common Tumour lysis syndrome Common Common Psychiatric disorders Confusional state Common Very rare** Nervous system disorders Headache Very common Very rare** Immune effector cell-associated neurotoxicity syndrome10 Common Uncommon* Somnolence Common Uncommon Tremor Common Very rare** Myelitis11 Uncommon Uncommon Gastrointestinal disorders Constipation Very common Very rare** Diarrhoea Very common Very rare** Nausea Very common Very rare** Gastrointestinal haemorrhage12 Common Common Vomiting Common Very rare** Colitis Uncommon Uncommon Skin and subcutaneous tissue disorders Rash13 Very common Common General disorders and administration site conditions Pyrexia Very common Very rare** 17 System organ class Adverse reaction All grades Grade 34 Investigations Alanine aminotransferase increased Common Common Aspartate aminotransferase increased Common Common Blood alkaline phosphatase increased Common Common Gamma-glutamyltransferase increased Common Common Blood bilirubin increased Common Uncommon Hepatic enzyme increased Common Common * Grade 5 reactions reported.
See Description of selected adverse reactions. ** No Grade 3-4 events were reported. 1 Includes COVID-19, COVID-19 pneumonia, herpes zoster, influenza, and ophthalmic herpes zoster. 2 Includes vascular device infection, bacterial infection, Campylobacter infection, biliary tract infection bacterial, urinary tract infection bacterial, Clostridium difficile infection, Escherichia infection, and peritonitis.
3 Includes upper respiratory tract infection, sinusitis, nasopharyngitis, chronic sinusitis, and rhinitis. 4 Includes sepsis and septic shock. 5 Includes lower respiratory tract infection and bronchitis. 6 Includes urinary tract infection and Escherichia urinary tract infection.
7 Includes oesophageal candidiasis and oral candidiasis. 8 Includes febrile neutropenia and neutropenic infection. 9 Based on ASTCT consensus grading (Lee 2019). 10 ICANS based on Lee 2019 and includes somnolence, cognitive disorder, confusional state, delirium, and disorientation.
11 Myelitis occurred concurrently with CRS. 12 Includes gastrointestinal haemorrhage, large intestinal haemorrhage, and gastric haemorrhage. 13 Includes rash, rash pruritic, rash maculo-papular, dermatitis, dermatitis acneiform, dermatitis exfoliative, erythema, palmar erythema, pruritis, and rash erythematous.
18 Table 7. Adverse reactions reported in patients with relapsed or refractory DLBCL […]