Statistically conclusive or suggested result Inconclusive results Uncertain results Safety results

mCRC - 1st line (L1) metastatic/advanced - colorectal cancer (mCRC) mCRC - 1st line (L1)

versus Standard of Care (SoC)
pembrolizumab alone vs. Standard of Care (SoC) 1 noneinconclusive results for: DOR; objective responses (ORR); AE (any grade); AE leading to death (grade 5); TRAE leading to death (grade 5); Adrenal insufficiency TRAE (grade 3-4); Alopecia TRAE (grade 3-4); Anaemia TRAE (grade 3-4); Arthralgia TRAE (grade 3-4); Asthenia TRAE (grade 3-4); Colitis TRAE (grade 3-4); Decreased appetite TRAE (grade 3-4); Diabetes TRAE (grade 3-4); Dizziness TRAE (grade 3-4); Epistaxis TRAE (grade 3-4); Hepatitis TRAE (grade 3-4); Hyperthyroidism TRAE (grade 3-4); Hypophysitis TRAE (grade 3-4); Hypothyroidism TRAE (grade 3-4); Increase AST TRAE (grade 3-4); Increased ALT TRAE (grade 3-4); Infusion-related reactions TRAE (grade 3-4); Leucopenia TRAE (grade 3-4); Mucosal inflammation TRAE (grade 3-4); Myocarditis TRAE (grade 3-4); Myositis TRAE (grade 3-4); Nausea TRAE (grade 3-4); Nephritis TRAE (grade 3-4); Palmar-plantar erythrodysaesthesia syndrome TRAE (grade 3-4); Pancreatitis TRAE (grade 3-4); Peripheral neuropathy TRAE (grade 3-4); Peripheral sensory neuropathy TRAE (grade 3-4); Pneumonitis TRAE (grade 3-4); Pruritus TRAE (grade 3-4); Rash TRAE (grade 3-4); Severe skin reaction TRAE (grade 3-4); Stomatitis TRAE (grade 3-4); Thyroiditis TRAE (grade 3-4); Vomiting TRAE (grade 3-4); Abdominal pain AE (grade 3-4); Alopecia AE (grade 3-4); Anaemia AE (grade 3-4); Arthralgia AE (grade 3-4); Asthenia AE (grade 3-4); Back pain AE (grade 3-4); Constipation AE (grade 3-4); Cough AE (grade 3-4); Decreased appetite AE (grade 3-4); Diarrhoea AE (grade 3-4); Dizziness AE (grade 3-4); Dry skin AE (grade 3-4); Dyspepsia AE (grade 3-4); Dyspnoea AE (grade 3-4); Epistaxis AE (grade 3-4); Fatigue AE (grade 3-4); Headache AE (grade 3-4); Hypertension AE (grade 3-4); Hypothyroidism AE (grade 3-4); Increase AST AE (grade 3-4); Increased ALT AE (grade 3-4); Mucosal inflammation AE (grade 3-4); Nausea AE (grade 3-4); Palmar–plantar erythrodysesthesia syndrome AE (grade 3-4); Peripheral neuropathy AE (grade 3-4); Peripheral oedema AE (grade 3-4); Peripheral sensory neuropathy AE (grade 3-4); Pruritus AE (grade 3-4); Pyrexia AE (grade 3-4); Rash AE (grade 3-4); Stomatitis AE (grade 3-4); Vomiting AE (grade 3-4); Weight decreased AE (grade 3-4)

statistically conclusive 40 % decrease in progression or deaths (PFS) but the degree if certainty is unassessable

suggested 59 % decrease in AE (grade 3-4) but the degree if certainty is unassessable

suggested 86 % decrease in TRAE (grade 3-4) but the degree if certainty is unassessable

suggested 82 % decrease in Diarrhoea TRAE (grade 3-4) but the degree if certainty is unassessable

suggested 80 % decrease in Fatigue TRAE (grade 3-4) but the degree if certainty is unassessable

suggested 98 % decrease in Neutropenia TRAE (grade 3-4) but the degree if certainty is unassessable

suggested 98 % decrease in Neutropenia AE (grade 3-4) but the degree if certainty is unassessable

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