NCT01693562 · OUTCOME
Number of Participants With Abnormal Clinical Laboratory Parameters Reported as TEAEs in the Dose-escalation, Dose-exploration, and Dose-expansion Phase A Phase 1/2 Study to Evaluate MEDI4736 · Source last updated 2021-05-13
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
Measure COUNT_OF_PARTICIPANTS
Unit Participants
Interval / dispersion Not reported
Time frame From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years) What was measured Number of participants with abnormal clinical laboratory parameters reported as TEAEs are reported. Abnormal clinical laboratory parameters defined as any abnormal finding during analysis of coagulation, urine, hematology, and serum chemistry.
Analysis population: As-treated population included all participants who received any dose of study drug. Participants enrolled in the 10 mg/kg Q2W Expansion and Escalation Cohort have been summarized as a total only. This is because the safety profile of durvalumab monotherapy 10 mg/kg Q2W was manageable and generally consistent with the known safety profile of the anti-PD-L1/PD-1 drug class.
Groups in this outcome Escalation Cohort (MEDI4736 0.1 mg/kg Q2W) Participants received intravenous (IV) infusion of MEDI4736 (durvalumab) 0.1 mg/kg every 2 weeks (Q2W) in the dose-escalation phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.
Escalation Cohort (MEDI4736 0.3 mg/kg Q2W) Participants received IV infusion of MEDI4736 0.3 mg/kg Q2W in the dose-escalation phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation , whichever occurred first
Escalation Cohort (MEDI4736 1 mg/kg Q2W) Participants received IV infusion of MEDI4736 1 mg/kg Q2W in the dose-escalation phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.
Escalation Cohort (MEDI4736 3 mg/kg Q2W) Participants received IV infusion of MEDI4736 3 mg/kg Q2W in the dose-escalation phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation , whichever occurred first.
Escalation Cohort (MEDI4736 15 mg/kg Q3W) Participants received IV infusion of MEDI4736 15 mg/kg every 3 weeks (Q3W) in the dose-escalation phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.
Exploration Cohort (MEDI4736 20 mg/kg Q4W) Participants received IV infusion of MEDI4736 20 mg/kg every 4 weeks (Q4W) in the dose-exploration phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.
Escalation/Expansion Cohort (Total MEDI4736 10 mg/kg Q2W) Participants received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-escalation or dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation , whichever occurred first.
Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.
Analysis denominator · Participants
Group Source count Escalation Cohort (MEDI4736 0.1 mg/kg Q2W) 4 Escalation Cohort (MEDI4736 0.3 mg/kg Q2W) 4 Escalation Cohort (MEDI4736 1 mg/kg Q2W) 3 Escalation Cohort (MEDI4736 3 mg/kg Q2W) 3 Escalation Cohort (MEDI4736 15 mg/kg Q3W) 7 Exploration Cohort (MEDI4736 20 mg/kg Q4W) 21 Escalation/Expansion Cohort (Total MEDI4736 10 mg/kg Q2W) 980
Reported measurements Anaemia Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment Escalation Cohort (MEDI4736 0.1 mg/kg Q2W) 1 Not reported Not reported Not reported Not reported Escalation Cohort (MEDI4736 0.3 mg/kg Q2W) 0 Not reported Not reported Not reported Not reported Escalation Cohort (MEDI4736 1 mg/kg Q2W) 0 Not reported Not reported Not reported Not reported Escalation Cohort (MEDI4736 3 mg/kg Q2W) 0 Not reported Not reported Not reported Not reported Escalation Cohort (MEDI4736 15 mg/kg Q3W) 0 Not reported Not reported Not reported Not reported Exploration Cohort (MEDI4736 20 mg/kg Q4W) 0 Not reported Not reported Not reported Not reported Escalation/Expansion Cohort (Total MEDI4736 10 mg/kg Q2W) 166 Not reported Not reported Not reported Not reported
Thrombocytopenia Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment Escalation Cohort (MEDI4736 0.1 mg/kg Q2W) 0 Not reported Not reported Not reported Not reported Escalation Cohort (MEDI4736 0.3 mg/kg Q2W) 0 Not reported Not reported Not reported Not reported Escalation Cohort (MEDI4736 1 mg/kg Q2W) 0 Not reported Not reported Not reported Not reported Escalation Cohort (MEDI4736 3 mg/kg Q2W) 0 Not reported Not reported Not reported Not reported Escalation Cohort (MEDI4736 15 mg/kg Q3W) 0 Not reported Not reported Not reported Not reported Exploration Cohort (MEDI4736 20 mg/kg Q4W) 1 Not reported Not reported Not reported Not reported Escalation/Expansion Cohort (Total MEDI4736 10 mg/kg Q2W) 24 Not reported Not reported Not reported Not reported
White blood cell count increased Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment Escalation Cohort (MEDI4736 0.1 mg/kg Q2W) 0 Not reported Not reported Not reported Not reported Escalation Cohort (MEDI4736 0.3 mg/kg Q2W) 0 Not reported Not reported Not reported Not reported Escalation Cohort (MEDI4736 1 mg/kg Q2W) 0 Not reported Not reported Not reported Not reported Escalation Cohort (MEDI4736 3 mg/kg Q2W) 0 Not reported Not reported Not reported Not reported Escalation Cohort (MEDI4736 15 mg/kg Q3W) 0 Not reported Not reported Not reported Not reported Exploration Cohort (MEDI4736 20 mg/kg Q4W) 1 Not reported Not reported Not reported Not reported Escalation/Expansion Cohort (Total MEDI4736 10 mg/kg Q2W) 3 Not reported Not reported Not reported Not reported
Leukocytosis Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment Escalation Cohort (MEDI4736 0.1 mg/kg Q2W) 0 Not reported Not reported Not reported Not reported Escalation Cohort (MEDI4736 0.3 mg/kg Q2W) 0 Not reported Not reported Not reported Not reported Escalation Cohort (MEDI4736 1 mg/kg Q2W) 0 Not reported Not reported Not reported Not reported Escalation Cohort (MEDI4736 3 mg/kg Q2W) 0 Not reported Not reported Not reported Not reported Escalation Cohort (MEDI4736 15 mg/kg Q3W) 0 Not reported Not reported Not reported Not reported Exploration Cohort (MEDI4736 20 mg/kg Q4W) 0 Not reported Not reported Not reported Not reported Escalation/Expansion Cohort (Total MEDI4736 10 mg/kg Q2W) 20 Not reported Not reported Not reported Not reported
Lymphocyte count decreased Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment Escalation Cohort (MEDI4736 0.1 mg/kg Q2W) 0 Not reported Not reported Not reported Not reported Escalation Cohort (MEDI4736 0.3 mg/kg Q2W) 0 Not reported Not reported Not reported Not reported Escalation Cohort (MEDI4736 1 mg/kg Q2W) 0 Not reported Not reported Not reported Not reported Escalation Cohort (MEDI4736 3 mg/kg Q2W) 0 Not reported Not reported Not reported Not reported Escalation Cohort (MEDI4736 15 mg/kg Q3W) 0 Not reported Not reported Not reported Not reported Exploration Cohort (MEDI4736 20 mg/kg Q4W) 0 Not reported Not reported Not reported Not reported Escalation/Expansion Cohort (Total MEDI4736 10 mg/kg Q2W) 12 Not reported Not reported Not reported Not reported
Neutropenia Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment Escalation Cohort (MEDI4736 0.1 mg/kg Q2W) 0 Not reported Not reported Not reported Not reported Escalation Cohort (MEDI4736 0.3 mg/kg Q2W) 0 Not reported Not reported Not reported Not reported Escalation Cohort (MEDI4736 1 mg/kg Q2W) 0 Not reported Not reported Not reported Not reported Escalation Cohort (MEDI4736 3 mg/kg Q2W) 0 Not reported Not reported Not reported Not reported Escalation Cohort (MEDI4736 15 mg/kg Q3W) 0 Not reported Not reported Not reported Not reported Exploration Cohort (MEDI4736 20 mg/kg Q4W) 0 Not reported Not reported Not reported Not reported Escalation/Expansion Cohort (Total MEDI4736 10 mg/kg Q2W) 8 Not reported Not reported Not reported Not reported
Leukopenia Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment Escalation Cohort (MEDI4736 0.1 mg/kg Q2W) 0 Not reported Not reported Not reported Not reported Escalation Cohort (MEDI4736 0.3 mg/kg Q2W) 0 Not reported Not reported Not reported Not reported Escalation Cohort (MEDI4736 1 mg/kg Q2W) 0 Not reported Not reported Not reported Not reported Escalation Cohort (MEDI4736 3 mg/kg Q2W) 0 Not reported Not reported Not reported Not reported Escalation Cohort (MEDI4736 15 mg/kg Q3W) 0 Not reported Not reported Not reported Not reported Exploration Cohort (MEDI4736 20 mg/kg Q4W) 0 Not reported Not reported Not reported Not reported Escalation/Expansion Cohort (Total MEDI4736 10 mg/kg Q2W) 7 Not reported Not reported Not reported Not reported
Thrombocytosis Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment Escalation Cohort (MEDI4736 0.1 mg/kg Q2W) 0 Not reported Not reported Not reported Not reported Escalation Cohort (MEDI4736 0.3 mg/kg Q2W) 0 Not reported Not reported Not reported Not reported Escalation Cohort (MEDI4736 1 mg/kg Q2W) 0 Not reported Not reported Not reported Not reported Escalation Cohort (MEDI4736 3 mg/kg Q2W) 0 Not reported Not reported Not reported Not reported Escalation Cohort (MEDI4736 15 mg/kg Q3W) 0 Not reported Not reported Not reported Not reported Exploration Cohort (MEDI4736 20 mg/kg Q4W) 0 Not reported Not reported Not reported Not reported Escalation/Expansion Cohort (Total MEDI4736 10 mg/kg Q2W) 5 Not reported Not reported Not reported Not reported
Iron deficiency anaemia Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment Escalation Cohort (MEDI4736 0.1 mg/kg Q2W) 0 Not reported Not reported Not reported Not reported Escalation Cohort (MEDI4736 0.3 mg/kg Q2W) 0 Not reported Not reported Not reported Not reported Escalation Cohort (MEDI4736 1 mg/kg Q2W) 0 Not reported Not reported Not reported Not reported Escalation Cohort (MEDI4736 3 mg/kg Q2W) 0 Not reported Not reported Not reported Not reported Escalation Cohort (MEDI4736 15 mg/kg Q3W) 0 Not reported Not reported Not reported Not reported Exploration Cohort (MEDI4736 20 mg/kg Q4W) 0 Not reported Not reported Not reported Not reported Escalation/Expansion Cohort (Total MEDI4736 10 mg/kg Q2W) 3 Not reported Not reported Not reported Not reported
Haemoglobin decreased Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment Escalation Cohort (MEDI4736 0.1 mg/kg Q2W) 0 Not reported Not reported Not reported Not reported Escalation Cohort (MEDI4736 0.3 mg/kg Q2W) 0 Not reported Not reported Not reported Not reported Escalation Cohort (MEDI4736 1 mg/kg Q2W) 0 Not reported Not reported Not reported Not reported Escalation Cohort (MEDI4736 3 mg/kg Q2W) 0 Not reported Not reported Not reported Not reported Escalation Cohort (MEDI4736 15 mg/kg Q3W) 0 Not reported Not reported Not reported Not reported Exploration Cohort (MEDI4736 20 mg/kg Q4W) 0 Not reported Not reported Not reported Not reported Escalation/Expansion Cohort (Total MEDI4736 10 mg/kg Q2W) 2 Not reported Not reported Not reported Not reported
Neutrophil count increased Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment Escalation Cohort (MEDI4736 0.1 mg/kg Q2W) 0 Not reported Not reported Not reported Not reported Escalation Cohort (MEDI4736 0.3 mg/kg Q2W) 0 Not reported Not reported Not reported Not reported Escalation Cohort (MEDI4736 1 mg/kg Q2W) 0 Not reported Not reported Not reported Not reported Escalation Cohort (MEDI4736 3 mg/kg Q2W) 0 Not reported Not reported Not reported Not reported Escalation Cohort (MEDI4736 15 mg/kg Q3W) 0 Not reported Not reported Not reported Not reported Exploration Cohort (MEDI4736 20 mg/kg Q4W) 0 Not reported Not reported Not reported Not reported Escalation/Expansion Cohort (Total MEDI4736 10 mg/kg Q2W) 2 Not reported Not reported Not reported Not reported
Red blood cell count decreased Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment Escalation Cohort (MEDI4736 0.1 mg/kg Q2W) 0 Not reported Not reported Not reported Not reported Escalation Cohort (MEDI4736 0.3 mg/kg Q2W) 0 Not reported Not reported Not reported Not reported Escalation Cohort (MEDI4736 1 mg/kg Q2W) 0 Not reported Not reported Not reported Not reported Escalation Cohort (MEDI4736 3 mg/kg Q2W) 0 Not reported Not reported Not reported Not reported Escalation Cohort (MEDI4736 15 mg/kg Q3W) 0 Not reported Not reported Not reported Not reported Exploration Cohort (MEDI4736 20 mg/kg Q4W) 0 Not reported Not reported Not reported Not reported Escalation/Expansion Cohort (Total MEDI4736 10 mg/kg Q2W) 1 Not reported Not reported Not reported Not reported
Anaemia of chronic disease Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment Escalation Cohort (MEDI4736 0.1 mg/kg Q2W) 0 Not reported Not reported Not reported Not reported Escalation Cohort (MEDI4736 0.3 mg/kg Q2W) 0 Not reported Not reported Not reported Not reported Escalation Cohort (MEDI4736 1 mg/kg Q2W) 0 Not reported Not reported Not reported Not reported Escalation Cohort (MEDI4736 3 mg/kg Q2W) 0 Not reported Not reported Not reported Not reported Escalation Cohort (MEDI4736 15 mg/kg Q3W) 0 Not reported Not reported Not reported Not reported Exploration Cohort (MEDI4736 20 mg/kg Q4W) 0 Not reported Not reported Not reported Not reported Escalation/Expansion Cohort (Total MEDI4736 10 mg/kg Q2W) 1 Not reported Not reported Not reported Not reported
Eosinophilia Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment Escalation Cohort (MEDI4736 0.1 mg/kg Q2W) 0 Not reported Not reported Not reported Not reported Escalation Cohort (MEDI4736 0.3 mg/kg Q2W) 0 Not reported Not reported Not reported Not reported Escalation Cohort (MEDI4736 1 mg/kg Q2W) 0 Not reported Not reported Not reported Not reported Escalation Cohort (MEDI4736 3 mg/kg Q2W) 0 Not reported Not reported Not reported Not reported Escalation Cohort (MEDI4736 15 mg/kg Q3W) 0 Not reported Not reported Not reported Not reported Exploration Cohort (MEDI4736 20 mg/kg Q4W) 0 Not reported Not reported Not reported Not reported Escalation/Expansion Cohort (Total MEDI4736 10 mg/kg Q2W) 1 Not reported Not reported Not reported Not reported
Haemolysis Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment Escalation Cohort (MEDI4736 0.1 mg/kg Q2W) 0 Not reported Not reported Not reported Not reported Escalation Cohort (MEDI4736 0.3 mg/kg Q2W) 0 Not reported Not reported Not reported Not reported Escalation Cohort (MEDI4736 1 mg/kg Q2W) 0 Not reported Not reported Not reported Not reported Escalation Cohort (MEDI4736 3 mg/kg Q2W) 0 Not reported Not reported Not reported Not reported Escalation Cohort (MEDI4736 15 mg/kg Q3W) 0 Not reported Not reported Not reported Not reported Exploration Cohort (MEDI4736 20 mg/kg Q4W) 0 Not reported Not reported Not reported Not reported Escalation/Expansion Cohort (Total MEDI4736 10 mg/kg Q2W) 1 Not reported Not reported Not reported Not reported
Leukostasis syndrome Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment Escalation Cohort (MEDI4736 0.1 mg/kg Q2W) 0 Not reported Not reported Not reported Not reported Escalation Cohort (MEDI4736 0.3 mg/kg Q2W) 0 Not reported Not reported Not reported Not reported Escalation Cohort (MEDI4736 1 mg/kg Q2W) 0 Not reported Not reported Not reported Not reported Escalation Cohort (MEDI4736 3 mg/kg Q2W) 0 Not reported Not reported Not reported Not reported Escalation Cohort (MEDI4736 15 mg/kg Q3W) 0 Not reported Not reported Not reported Not reported Exploration Cohort (MEDI4736 20 mg/kg Q4W) 0 Not reported Not reported Not reported Not reported Escalation/Expansion Cohort (Total MEDI4736 10 mg/kg Q2W) 1 Not reported Not reported Not reported Not reported
Immune thrombocytopenic purpura Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment Escalation Cohort (MEDI4736 0.1 mg/kg Q2W) 0 Not reported Not reported Not reported Not reported Escalation Cohort (MEDI4736 0.3 mg/kg Q2W) 0 Not reported Not reported Not reported Not reported Escalation Cohort (MEDI4736 1 mg/kg Q2W) 0 Not reported Not reported Not reported Not reported Escalation Cohort (MEDI4736 3 mg/kg Q2W) 0 Not reported Not reported Not reported Not reported Escalation Cohort (MEDI4736 15 mg/kg Q3W) 0 Not reported Not reported Not reported Not reported Exploration Cohort (MEDI4736 20 mg/kg Q4W) 0 Not reported Not reported Not reported Not reported Escalation/Expansion Cohort (Total MEDI4736 10 mg/kg Q2W) 1 Not reported Not reported Not reported Not reported
International normalised ratio increased Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment Escalation Cohort (MEDI4736 0.1 mg/kg Q2W) 0 Not reported Not reported Not reported Not reported Escalation Cohort (MEDI4736 0.3 mg/kg Q2W) 0 Not reported Not reported Not reported Not reported Escalation Cohort (MEDI4736 1 mg/kg Q2W) 0 Not reported Not reported Not reported Not reported Escalation Cohort (MEDI4736 3 mg/kg Q2W) 0 Not reported Not reported Not reported Not reported Escalation Cohort (MEDI4736 15 mg/kg Q3W) 0 Not reported Not reported Not reported Not reported Exploration Cohort (MEDI4736 20 mg/kg Q4W) 0 Not reported Not reported Not reported Not reported Escalation/Expansion Cohort (Total MEDI4736 10 mg/kg Q2W) 16 Not reported Not reported Not reported Not reported
Activated partial thromboplastin time prolonged Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment Escalation Cohort (MEDI4736 0.1 mg/kg Q2W) 0 Not reported Not reported Not reported Not reported Escalation Cohort (MEDI4736 0.3 mg/kg Q2W) 0 Not reported Not reported Not reported Not reported Escalation Cohort (MEDI4736 1 mg/kg Q2W) 0 Not reported Not reported Not reported Not reported Escalation Cohort (MEDI4736 3 mg/kg Q2W) 0 Not reported Not reported Not reported Not reported Escalation Cohort (MEDI4736 15 mg/kg Q3W) 0 Not reported Not reported Not reported Not reported Exploration Cohort (MEDI4736 20 mg/kg Q4W) 0 Not reported Not reported Not reported Not reported Escalation/Expansion Cohort (Total MEDI4736 10 mg/kg Q2W) 15 Not reported Not reported Not reported Not reported
Blood fibrinogen increased Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment Escalation Cohort (MEDI4736 0.1 mg/kg Q2W) 0 Not reported Not reported Not reported Not reported Escalation Cohort (MEDI4736 0.3 mg/kg Q2W) 0 Not reported Not reported Not reported Not reported Escalation Cohort (MEDI4736 1 mg/kg Q2W) 0 Not reported Not reported Not reported Not reported Escalation Cohort (MEDI4736 3 mg/kg Q2W) 0 Not reported Not reported Not reported Not reported Escalation Cohort (MEDI4736 15 mg/kg Q3W) 0 Not reported Not reported Not reported Not reported Exploration Cohort (MEDI4736 20 mg/kg Q4W) 0 Not reported Not reported Not reported Not reported Escalation/Expansion Cohort (Total MEDI4736 10 mg/kg Q2W) 8 Not reported Not reported Not reported Not reported
Platelet count decreased Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment Escalation Cohort (MEDI4736 0.1 mg/kg Q2W) 0 Not reported Not reported Not reported Not reported Escalation Cohort (MEDI4736 0.3 mg/kg Q2W) 0 Not reported Not reported Not reported Not reported Escalation Cohort (MEDI4736 1 mg/kg Q2W) 0 Not reported Not reported Not reported Not reported Escalation Cohort (MEDI4736 3 mg/kg Q2W) 0 Not reported Not reported Not reported Not reported Escalation Cohort (MEDI4736 15 mg/kg Q3W) 0 Not reported Not reported Not reported Not reported Exploration Cohort (MEDI4736 20 mg/kg Q4W) 0 Not reported Not reported Not reported Not reported Escalation/Expansion Cohort (Total MEDI4736 10 mg/kg Q2W) 5 Not reported Not reported Not reported Not reported
Disseminated intravascular coagulation Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment Escalation Cohort (MEDI4736 0.1 mg/kg Q2W) 0 Not reported Not reported Not reported Not reported Escalation Cohort (MEDI4736 0.3 mg/kg Q2W) 0 Not reported Not reported Not reported Not reported Escalation Cohort (MEDI4736 1 mg/kg Q2W) 0 Not reported Not reported Not reported Not reported Escalation Cohort (MEDI4736 3 mg/kg Q2W) 0 Not reported Not reported Not reported Not reported Escalation Cohort (MEDI4736 15 mg/kg Q3W) 0 Not reported Not reported Not reported Not reported Exploration Cohort (MEDI4736 20 mg/kg Q4W) 0 Not reported Not reported Not reported Not reported Escalation/Expansion Cohort (Total MEDI4736 10 mg/kg Q2W) 2 Not reported Not reported Not reported Not reported
Prothrombin time prolonged Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment Escalation Cohort (MEDI4736 0.1 mg/kg Q2W) 0 Not reported Not reported Not reported Not reported Escalation Cohort (MEDI4736 0.3 mg/kg Q2W) 0 Not reported Not reported Not reported Not reported Escalation Cohort (MEDI4736 1 mg/kg Q2W) 0 Not reported Not reported Not reported Not reported Escalation Cohort (MEDI4736 3 mg/kg Q2W) 0 Not reported Not reported Not reported Not reported Escalation Cohort (MEDI4736 15 mg/kg Q3W) 0 Not reported Not reported Not reported Not reported Exploration Cohort (MEDI4736 20 mg/kg Q4W) 0 Not reported Not reported Not reported Not reported Escalation/Expansion Cohort (Total MEDI4736 10 mg/kg Q2W) 2 Not reported Not reported Not reported Not reported
Activated partial thromboplastin time shortened Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment Escalation Cohort (MEDI4736 0.1 mg/kg Q2W) 0 Not reported Not reported Not reported Not reported Escalation Cohort (MEDI4736 0.3 mg/kg Q2W) 0 Not reported Not reported Not reported Not reported Escalation Cohort (MEDI4736 1 mg/kg Q2W) 0 Not reported Not reported Not reported Not reported Escalation Cohort (MEDI4736 3 mg/kg Q2W) 0 Not reported Not reported Not reported Not reported Escalation Cohort (MEDI4736 15 mg/kg Q3W) 0 Not reported Not reported Not reported Not reported Exploration Cohort (MEDI4736 20 mg/kg Q4W) 0 Not reported Not reported Not reported Not reported Escalation/Expansion Cohort (Total MEDI4736 10 mg/kg Q2W) 1 Not reported Not reported Not reported Not reported
Coagulation factor increased Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment Escalation Cohort (MEDI4736 0.1 mg/kg Q2W) 0 Not reported Not reported Not reported Not reported Escalation Cohort (MEDI4736 0.3 mg/kg Q2W) 0 Not reported Not reported Not reported Not reported Escalation Cohort (MEDI4736 1 mg/kg Q2W) 0 Not reported Not reported Not reported Not reported Escalation Cohort (MEDI4736 3 mg/kg Q2W) 0 Not reported Not reported Not reported Not reported Escalation Cohort (MEDI4736 15 mg/kg Q3W) 0 Not reported Not reported Not reported Not reported Exploration Cohort (MEDI4736 20 mg/kg Q4W) 0 Not reported Not reported Not reported Not reported Escalation/Expansion Cohort (Total MEDI4736 10 mg/kg Q2W) 1 Not reported Not reported Not reported Not reported
Coagulopathy Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment Escalation Cohort (MEDI4736 0.1 mg/kg Q2W) 0 Not reported Not reported Not reported Not reported Escalation Cohort (MEDI4736 0.3 mg/kg Q2W) 0 Not reported Not reported Not reported Not reported Escalation Cohort (MEDI4736 1 mg/kg Q2W) 0 Not reported Not reported Not reported Not reported Escalation Cohort (MEDI4736 3 mg/kg Q2W) 0 Not reported Not reported Not reported Not reported Escalation Cohort (MEDI4736 15 mg/kg Q3W) 0 Not reported Not reported Not reported Not reported Exploration Cohort (MEDI4736 20 mg/kg Q4W) 0 Not reported Not reported Not reported Not reported Escalation/Expansion Cohort (Total MEDI4736 10 mg/kg Q2W) 1 Not reported Not reported Not reported Not reported
Alanine aminotransferase increased Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment Escalation Cohort (MEDI4736 0.1 mg/kg Q2W) 0 Not reported Not reported Not reported Not reported Escalation Cohort (MEDI4736 0.3 mg/kg Q2W) 0 Not reported Not reported Not reported Not reported Escalation Cohort (MEDI4736 1 mg/kg Q2W) 1 Not reported Not reported Not reported Not reported Escalation Cohort (MEDI4736 3 mg/kg Q2W) 0 Not reported Not reported Not reported Not reported Escalation Cohort (MEDI4736 15 mg/kg Q3W) 1 Not reported Not reported Not reported Not reported Exploration Cohort (MEDI4736 20 mg/kg Q4W) 2 Not reported Not reported Not reported Not reported Escalation/Expansion Cohort (Total MEDI4736 10 mg/kg Q2W) 77 Not reported Not reported Not reported Not reported
Aspartate aminotransferase increased Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment Escalation Cohort (MEDI4736 0.1 mg/kg Q2W) 0 Not reported Not reported Not reported Not reported Escalation Cohort (MEDI4736 0.3 mg/kg Q2W) 0 Not reported Not reported Not reported Not reported Escalation Cohort (MEDI4736 1 mg/kg Q2W) 1 Not reported Not reported Not reported Not reported Escalation Cohort (MEDI4736 3 mg/kg Q2W) 0 Not reported Not reported Not reported Not reported Escalation Cohort (MEDI4736 15 mg/kg Q3W) 1 Not reported Not reported Not reported Not reported Exploration Cohort (MEDI4736 20 mg/kg Q4W) 2 Not reported Not reported Not reported Not reported Escalation/Expansion Cohort (Total MEDI4736 10 mg/kg Q2W) 99 Not reported Not reported Not reported Not reported
Blood alkaline phosphatase increased Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment Escalation Cohort (MEDI4736 0.1 mg/kg Q2W) 0 Not reported Not reported Not reported Not reported Escalation Cohort (MEDI4736 0.3 mg/kg Q2W) 0 Not reported Not reported Not reported Not reported Escalation Cohort (MEDI4736 1 mg/kg Q2W) 1 Not reported Not reported Not reported Not reported Escalation Cohort (MEDI4736 3 mg/kg Q2W) 0 Not reported Not reported Not reported Not reported Escalation Cohort (MEDI4736 15 mg/kg Q3W) 0 Not reported Not reported Not reported Not reported Exploration Cohort (MEDI4736 20 mg/kg Q4W) 1 Not reported Not reported Not reported Not reported Escalation/Expansion Cohort (Total MEDI4736 10 mg/kg Q2W) 70 Not reported Not reported Not reported Not reported
Blood bilirubin increased Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment Escalation Cohort (MEDI4736 0.1 mg/kg Q2W) 0 Not reported Not reported Not reported Not reported Escalation Cohort (MEDI4736 0.3 mg/kg Q2W) 0 Not reported Not reported Not reported Not reported Escalation Cohort (MEDI4736 1 mg/kg Q2W) 0 Not reported Not reported Not reported Not reported Escalation Cohort (MEDI4736 3 mg/kg Q2W) 0 Not reported Not reported Not reported Not reported Escalation Cohort (MEDI4736 15 mg/kg Q3W) 0 Not reported Not reported Not reported Not reported Exploration Cohort (MEDI4736 20 mg/kg Q4W) 1 Not reported Not reported Not reported Not reported Escalation/Expansion Cohort (Total MEDI4736 10 mg/kg Q2W) 42 Not reported Not reported Not reported Not reported
Gamma-glutamyltransferase increased Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment Escalation Cohort (MEDI4736 0.1 mg/kg Q2W) 0 Not reported Not reported Not reported Not reported Escalation Cohort (MEDI4736 0.3 mg/kg Q2W) 0 Not reported Not reported Not reported Not reported Escalation Cohort (MEDI4736 1 mg/kg Q2W) 0 Not reported Not reported Not reported Not reported Escalation Cohort (MEDI4736 3 mg/kg Q2W) 0 Not reported Not reported Not reported Not reported Escalation Cohort (MEDI4736 15 mg/kg Q3W) 0 Not reported Not reported Not reported Not reported Exploration Cohort (MEDI4736 20 mg/kg Q4W) 2 Not reported Not reported Not reported Not reported Escalation/Expansion Cohort (Total MEDI4736 10 mg/kg Q2W) 71 Not reported Not reported Not reported Not reported
Hyperbilirubinaemia Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment Escalation Cohort (MEDI4736 0.1 mg/kg Q2W) 0 Not reported Not reported Not reported Not reported Escalation Cohort (MEDI4736 0.3 mg/kg Q2W) 0 Not reported Not reported Not reported Not reported Escalation Cohort (MEDI4736 1 mg/kg Q2W) 0 Not reported Not reported Not reported Not reported Escalation Cohort (MEDI4736 3 mg/kg Q2W) 0 Not reported Not reported Not reported Not reported Escalation Cohort (MEDI4736 15 mg/kg Q3W) 0 Not reported Not reported Not reported Not reported Exploration Cohort (MEDI4736 20 mg/kg Q4W) 0 Not reported Not reported Not reported Not reported Escalation/Expansion Cohort (Total MEDI4736 10 mg/kg Q2W) 14 Not reported Not reported Not reported Not reported
Transaminases increased Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment Escalation Cohort (MEDI4736 0.1 mg/kg Q2W) 0 Not reported Not reported Not reported Not reported Escalation Cohort (MEDI4736 0.3 mg/kg Q2W) 0 Not reported Not reported Not reported Not reported Escalation Cohort (MEDI4736 1 mg/kg Q2W) 0 Not reported Not reported Not reported Not reported Escalation Cohort (MEDI4736 3 mg/kg Q2W) 0 Not reported Not reported Not reported Not reported Escalation Cohort (MEDI4736 15 mg/kg Q3W) 0 Not reported Not reported Not reported Not reported Exploration Cohort (MEDI4736 20 mg/kg Q4W) 0 Not reported Not reported Not reported Not reported Escalation/Expansion Cohort (Total MEDI4736 10 mg/kg Q2W) 8 Not reported Not reported Not reported Not reported
Blood lactate dehydrogenase increased Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment Escalation Cohort (MEDI4736 0.1 mg/kg Q2W) 0 Not reported Not reported Not reported Not reported Escalation Cohort (MEDI4736 0.3 mg/kg Q2W) 0 Not reported Not reported Not reported Not reported Escalation Cohort (MEDI4736 1 mg/kg Q2W) 0 Not reported Not reported Not reported Not reported Escalation Cohort (MEDI4736 3 mg/kg Q2W) 0 Not reported Not reported Not reported Not reported Escalation Cohort (MEDI4736 15 mg/kg Q3W) 0 Not reported Not reported Not reported Not reported Exploration Cohort (MEDI4736 20 mg/kg Q4W) 0 Not reported Not reported Not reported Not reported Escalation/Expansion Cohort (Total MEDI4736 10 mg/kg Q2W) 7 Not reported Not reported Not reported Not reported
Hepatic function abnormal Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment Escalation Cohort (MEDI4736 0.1 mg/kg Q2W) 0 Not reported Not reported Not reported Not reported Escalation Cohort (MEDI4736 0.3 mg/kg Q2W) 0 Not reported Not reported Not reported Not reported Escalation Cohort (MEDI4736 1 mg/kg Q2W) 0 Not reported Not reported Not reported Not reported Escalation Cohort (MEDI4736 3 mg/kg Q2W) 0 Not reported Not reported Not reported Not reported Escalation Cohort (MEDI4736 15 mg/kg Q3W) 0 Not reported Not reported Not reported Not reported Exploration Cohort (MEDI4736 20 mg/kg Q4W) 0 Not reported Not reported Not reported Not reported Escalation/Expansion Cohort (Total MEDI4736 10 mg/kg Q2W) 6 Not reported Not reported Not reported Not reported
Alanine aminotransferase decreased Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment Escalation Cohort (MEDI4736 0.1 mg/kg Q2W) 0 Not reported Not reported Not reported Not reported Escalation Cohort (MEDI4736 0.3 mg/kg Q2W) 0 Not reported Not reported Not reported Not reported Escalation Cohort (MEDI4736 1 mg/kg Q2W) 0 Not reported Not reported Not reported Not reported Escalation Cohort (MEDI4736 3 mg/kg Q2W) 0 Not reported Not reported Not reported Not reported Escalation Cohort (MEDI4736 15 mg/kg Q3W) 0 Not reported Not reported Not reported Not reported Exploration Cohort (MEDI4736 20 mg/kg Q4W) 0 Not reported Not reported Not reported Not reported Escalation/Expansion Cohort (Total MEDI4736 10 mg/kg Q2W) 1 Not reported Not reported Not reported Not reported
Aspartate aminotransferase decreased Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment Escalation Cohort (MEDI4736 0.1 mg/kg Q2W) 0 Not reported Not reported Not reported Not reported Escalation Cohort (MEDI4736 0.3 mg/kg Q2W) 0 Not reported Not reported Not reported Not reported Escalation Cohort (MEDI4736 1 mg/kg Q2W) 0 Not reported Not reported Not reported Not reported Escalation Cohort (MEDI4736 3 mg/kg Q2W) 0 Not reported Not reported Not reported Not reported Escalation Cohort (MEDI4736 15 mg/kg Q3W) 0 Not reported Not reported Not reported Not reported Exploration Cohort (MEDI4736 20 mg/kg Q4W) 0 Not reported Not reported Not reported Not reported Escalation/Expansion Cohort (Total MEDI4736 10 mg/kg Q2W) 1 Not reported Not reported Not reported Not reported
Blood albumin decreased Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment Escalation Cohort (MEDI4736 0.1 mg/kg Q2W) 0 Not reported Not reported Not reported Not reported Escalation Cohort (MEDI4736 0.3 mg/kg Q2W) 0 Not reported Not reported Not reported Not reported Escalation Cohort (MEDI4736 1 mg/kg Q2W) 0 Not reported Not reported Not reported Not reported Escalation Cohort (MEDI4736 3 mg/kg Q2W) 0 Not reported Not reported Not reported Not reported Escalation Cohort (MEDI4736 15 mg/kg Q3W) 0 Not reported Not reported Not reported Not reported Exploration Cohort (MEDI4736 20 mg/kg Q4W) 0 Not reported Not reported Not reported Not reported Escalation/Expansion Cohort (Total MEDI4736 10 mg/kg Q2W) 1 Not reported Not reported Not reported Not reported
Hepatic enzyme increased Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment Escalation Cohort (MEDI4736 0.1 mg/kg Q2W) 0 Not reported Not reported Not reported Not reported Escalation Cohort (MEDI4736 0.3 mg/kg Q2W) 0 Not reported Not reported Not reported Not reported Escalation Cohort (MEDI4736 1 mg/kg Q2W) 0 Not reported Not reported Not reported Not reported Escalation Cohort (MEDI4736 3 mg/kg Q2W) 0 Not reported Not reported Not reported Not reported Escalation Cohort (MEDI4736 15 mg/kg Q3W) 0 Not reported Not reported Not reported Not reported Exploration Cohort (MEDI4736 20 mg/kg Q4W) 0 Not reported Not reported Not reported Not reported Escalation/Expansion Cohort (Total MEDI4736 10 mg/kg Q2W) 1 Not reported Not reported Not reported Not reported
Liver function test increased Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment Escalation Cohort (MEDI4736 0.1 mg/kg Q2W) 0 Not reported Not reported Not reported Not reported Escalation Cohort (MEDI4736 0.3 mg/kg Q2W) 0 Not reported Not reported Not reported Not reported Escalation Cohort (MEDI4736 1 mg/kg Q2W) 0 Not reported Not reported Not reported Not reported Escalation Cohort (MEDI4736 3 mg/kg Q2W) 0 Not reported Not reported Not reported Not reported Escalation Cohort (MEDI4736 15 mg/kg Q3W) 0 Not reported Not reported Not reported Not reported Exploration Cohort (MEDI4736 20 mg/kg Q4W) 0 Not reported Not reported Not reported Not reported Escalation/Expansion Cohort (Total MEDI4736 10 mg/kg Q2W) 1 Not reported Not reported Not reported Not reported
White blood cell count decreased Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment Escalation Cohort (MEDI4736 0.1 mg/kg Q2W) 0 Not reported Not reported Not reported Not reported Escalation Cohort (MEDI4736 0.3 mg/kg Q2W) 0 Not reported Not reported Not reported Not reported Escalation Cohort (MEDI4736 1 mg/kg Q2W) 0 Not reported Not reported Not reported Not reported Escalation Cohort (MEDI4736 3 mg/kg Q2W) 0 Not reported Not reported Not reported Not reported Escalation Cohort (MEDI4736 15 mg/kg Q3W) 0 Not reported Not reported Not reported Not reported Exploration Cohort (MEDI4736 20 mg/kg Q4W) 0 Not reported Not reported Not reported Not reported Escalation/Expansion Cohort (Total MEDI4736 10 mg/kg Q2W) 8 Not reported Not reported Not reported Not reported
Neutrophil count decreased Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment Escalation Cohort (MEDI4736 0.1 mg/kg Q2W) 0 Not reported Not reported Not reported Not reported Escalation Cohort (MEDI4736 0.3 mg/kg Q2W) 0 Not reported Not reported Not reported Not reported Escalation Cohort (MEDI4736 1 mg/kg Q2W) 0 Not reported Not reported Not reported Not reported Escalation Cohort (MEDI4736 3 mg/kg Q2W) 0 Not reported Not reported Not reported Not reported Escalation Cohort (MEDI4736 15 mg/kg Q3W) 0 Not reported Not reported Not reported Not reported Exploration Cohort (MEDI4736 20 mg/kg Q4W) 0 Not reported Not reported Not reported Not reported Escalation/Expansion Cohort (Total MEDI4736 10 mg/kg Q2W) 5 Not reported Not reported Not reported Not reported
Lymphopenia Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment Escalation Cohort (MEDI4736 0.1 mg/kg Q2W) 0 Not reported Not reported Not reported Not reported Escalation Cohort (MEDI4736 0.3 mg/kg Q2W) 0 Not reported Not reported Not reported Not reported Escalation Cohort (MEDI4736 1 mg/kg Q2W) 0 Not reported Not reported Not reported Not reported Escalation Cohort (MEDI4736 3 mg/kg Q2W) 0 Not reported Not reported Not reported Not reported Escalation Cohort (MEDI4736 15 mg/kg Q3W) 0 Not reported Not reported Not reported Not reported Exploration Cohort (MEDI4736 20 mg/kg Q4W) 0 Not reported Not reported Not reported Not reported Escalation/Expansion Cohort (Total MEDI4736 10 mg/kg Q2W) 5 Not reported Not reported Not reported Not reported
Blood creatinine increased Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment Escalation Cohort (MEDI4736 0.1 mg/kg Q2W) 0 Not reported Not reported Not reported Not reported Escalation Cohort (MEDI4736 0.3 mg/kg Q2W) 1 Not reported Not reported Not reported Not reported Escalation Cohort (MEDI4736 1 mg/kg Q2W) 1 Not reported Not reported Not reported Not reported Escalation Cohort (MEDI4736 3 mg/kg Q2W) 0 Not reported Not reported Not reported Not reported Escalation Cohort (MEDI4736 15 mg/kg Q3W) 0 Not reported Not reported Not reported Not reported Exploration Cohort (MEDI4736 20 mg/kg Q4W) 0 Not reported Not reported Not reported Not reported Escalation/Expansion Cohort (Total MEDI4736 10 mg/kg Q2W) 46 Not reported Not reported Not reported Not reported
Hyperuricaemia Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment Escalation Cohort (MEDI4736 0.1 mg/kg Q2W) 0 Not reported Not reported Not reported Not reported Escalation Cohort (MEDI4736 0.3 mg/kg Q2W) 0 Not reported Not reported Not reported Not reported Escalation Cohort (MEDI4736 1 mg/kg Q2W) 0 Not reported Not reported Not reported Not reported Escalation Cohort (MEDI4736 3 mg/kg Q2W) 0 Not reported Not reported Not reported Not reported Escalation Cohort (MEDI4736 15 mg/kg Q3W) 0 Not reported Not reported Not reported Not reported Exploration Cohort (MEDI4736 20 mg/kg Q4W) 0 Not reported Not reported Not reported Not reported Escalation/Expansion Cohort (Total MEDI4736 10 mg/kg Q2W) 22 Not reported Not reported Not reported Not reported
Blood urea increased Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment Escalation Cohort (MEDI4736 0.1 mg/kg Q2W) 0 Not reported Not reported Not reported Not reported Escalation Cohort (MEDI4736 0.3 mg/kg Q2W) 0 Not reported Not reported Not reported Not reported Escalation Cohort (MEDI4736 1 mg/kg Q2W) 0 Not reported Not reported Not reported Not reported Escalation Cohort (MEDI4736 3 mg/kg Q2W) 0 Not reported Not reported Not reported Not reported Escalation Cohort (MEDI4736 15 mg/kg Q3W) 0 Not reported Not reported Not reported Not reported Exploration Cohort (MEDI4736 20 mg/kg Q4W) 0 Not reported Not reported Not reported Not reported Escalation/Expansion Cohort (Total MEDI4736 10 mg/kg Q2W) 10 Not reported Not reported Not reported Not reported
Glomerular filtration rate decreased Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment Escalation Cohort (MEDI4736 0.1 mg/kg Q2W) 0 Not reported Not reported Not reported Not reported Escalation Cohort (MEDI4736 0.3 mg/kg Q2W) 0 Not reported Not reported Not reported Not reported Escalation Cohort (MEDI4736 1 mg/kg Q2W) 0 Not reported Not reported Not reported Not reported Escalation Cohort (MEDI4736 3 mg/kg Q2W) 0 Not reported Not reported Not reported Not reported Escalation Cohort (MEDI4736 15 mg/kg Q3W) 0 Not reported Not reported Not reported Not reported Exploration Cohort (MEDI4736 20 mg/kg Q4W) 0 Not reported Not reported Not reported Not reported Escalation/Expansion Cohort (Total MEDI4736 10 mg/kg Q2W) 2 Not reported Not reported Not reported Not reported
Hypothyroidism Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment Escalation Cohort (MEDI4736 0.1 mg/kg Q2W) 0 Not reported Not reported Not reported Not reported Escalation Cohort (MEDI4736 0.3 mg/kg Q2W) 1 Not reported Not reported Not reported Not reported Escalation Cohort (MEDI4736 1 mg/kg Q2W) 1 Not reported Not reported Not reported Not reported Escalation Cohort (MEDI4736 3 mg/kg Q2W) 0 Not reported Not reported Not reported Not reported Escalation Cohort (MEDI4736 15 mg/kg Q3W) 1 Not reported Not reported Not reported Not reported Exploration Cohort (MEDI4736 20 mg/kg Q4W) 3 Not reported Not reported Not reported Not reported Escalation/Expansion Cohort (Total MEDI4736 10 mg/kg Q2W) 89 Not reported Not reported Not reported Not reported
Hyperthyroidism Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment Escalation Cohort (MEDI4736 0.1 mg/kg Q2W) 0 Not reported Not reported Not reported Not reported Escalation Cohort (MEDI4736 0.3 mg/kg Q2W) 0 Not reported Not reported Not reported Not reported Escalation Cohort (MEDI4736 1 mg/kg Q2W) 0 Not reported Not reported Not reported Not reported Escalation Cohort (MEDI4736 3 mg/kg Q2W) 0 Not reported Not reported Not reported Not reported Escalation Cohort (MEDI4736 15 mg/kg Q3W) 0 Not reported Not reported Not reported Not reported Exploration Cohort (MEDI4736 20 mg/kg Q4W) 1 Not reported Not reported Not reported Not reported Escalation/Expansion Cohort (Total MEDI4736 10 mg/kg Q2W) 30 Not reported Not reported Not reported Not reported
Blood thyroid stimulating hormone increased Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment Escalation Cohort (MEDI4736 0.1 mg/kg Q2W) 0 Not reported Not reported Not reported Not reported Escalation Cohort (MEDI4736 0.3 mg/kg Q2W) 0 Not reported Not reported Not reported Not reported Escalation Cohort (MEDI4736 1 mg/kg Q2W) 0 Not reported Not reported Not reported Not reported Escalation Cohort (MEDI4736 3 mg/kg Q2W) 0 Not reported Not reported Not reported Not reported Escalation Cohort (MEDI4736 15 mg/kg Q3W) 0 Not reported Not reported Not reported Not reported Exploration Cohort (MEDI4736 20 mg/kg Q4W) 0 Not reported Not reported Not reported Not reported Escalation/Expansion Cohort (Total MEDI4736 10 mg/kg Q2W) 16 Not reported Not reported Not reported Not reported
Blood thyroid stimulating hormone decreased Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment Escalation Cohort (MEDI4736 0.1 mg/kg Q2W) 0 Not reported Not reported Not reported Not reported Escalation Cohort (MEDI4736 0.3 mg/kg Q2W) 0 Not reported Not reported Not reported Not reported Escalation Cohort (MEDI4736 1 mg/kg Q2W) 0 Not reported Not reported Not reported Not reported Escalation Cohort (MEDI4736 3 mg/kg Q2W) 0 Not reported Not reported Not reported Not reported Escalation Cohort (MEDI4736 15 mg/kg Q3W) 0 Not reported Not reported Not reported Not reported Exploration Cohort (MEDI4736 20 mg/kg Q4W) 0 Not reported Not reported Not reported Not reported Escalation/Expansion Cohort (Total MEDI4736 10 mg/kg Q2W) 5 Not reported Not reported Not reported Not reported
Thyroxine decreased Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment Escalation Cohort (MEDI4736 0.1 mg/kg Q2W) 0 Not reported Not reported Not reported Not reported Escalation Cohort (MEDI4736 0.3 mg/kg Q2W) 0 Not reported Not reported Not reported Not reported Escalation Cohort (MEDI4736 1 mg/kg Q2W) 0 Not reported Not reported Not reported Not reported Escalation Cohort (MEDI4736 3 mg/kg Q2W) 0 Not reported Not reported Not reported Not reported Escalation Cohort (MEDI4736 15 mg/kg Q3W) 0 Not reported Not reported Not reported Not reported Exploration Cohort (MEDI4736 20 mg/kg Q4W) 0 Not reported Not reported Not reported Not reported Escalation/Expansion Cohort (Total MEDI4736 10 mg/kg Q2W) 2 Not reported Not reported Not reported Not reported
Thyroxine free decreased Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment Escalation Cohort (MEDI4736 0.1 mg/kg Q2W) 0 Not reported Not reported Not reported Not reported Escalation Cohort (MEDI4736 0.3 mg/kg Q2W) 0 Not reported Not reported Not reported Not reported Escalation Cohort (MEDI4736 1 mg/kg Q2W) 0 Not reported Not reported Not reported Not reported Escalation Cohort (MEDI4736 3 mg/kg Q2W) 0 Not reported Not reported Not reported Not reported Escalation Cohort (MEDI4736 15 mg/kg Q3W) 0 Not reported Not reported Not reported Not reported Exploration Cohort (MEDI4736 20 mg/kg Q4W) 0 Not reported Not reported Not reported Not reported Escalation/Expansion Cohort (Total MEDI4736 10 mg/kg Q2W) 2 Not reported Not reported Not reported Not reported
Thyroxine free increased Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment Escalation Cohort (MEDI4736 0.1 mg/kg Q2W) 0 Not reported Not reported Not reported Not reported Escalation Cohort (MEDI4736 0.3 mg/kg Q2W) 0 Not reported Not reported Not reported Not reported Escalation Cohort (MEDI4736 1 mg/kg Q2W) 0 Not reported Not reported Not reported Not reported Escalation Cohort (MEDI4736 3 mg/kg Q2W) 0 Not reported Not reported Not reported Not reported Escalation Cohort (MEDI4736 15 mg/kg Q3W) 0 Not reported Not reported Not reported Not reported Exploration Cohort (MEDI4736 20 mg/kg Q4W) 0 Not reported Not reported Not reported Not reported Escalation/Expansion Cohort (Total MEDI4736 10 mg/kg Q2W) 2 Not reported Not reported Not reported Not reported
Tri-iodothyronine free decreased Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment Escalation Cohort (MEDI4736 0.1 mg/kg Q2W) 0 Not reported Not reported Not reported Not reported Escalation Cohort (MEDI4736 0.3 mg/kg Q2W) 0 Not reported Not reported Not reported Not reported Escalation Cohort (MEDI4736 1 mg/kg Q2W) 0 Not reported Not reported Not reported Not reported Escalation Cohort (MEDI4736 3 mg/kg Q2W) 0 Not reported Not reported Not reported Not reported Escalation Cohort (MEDI4736 15 mg/kg Q3W) 0 Not reported Not reported Not reported Not reported Exploration Cohort (MEDI4736 20 mg/kg Q4W) 0 Not reported Not reported Not reported Not reported Escalation/Expansion Cohort (Total MEDI4736 10 mg/kg Q2W) 2 Not reported Not reported Not reported Not reported
Thyroxine increased Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment Escalation Cohort (MEDI4736 0.1 mg/kg Q2W) 0 Not reported Not reported Not reported Not reported Escalation Cohort (MEDI4736 0.3 mg/kg Q2W) 0 Not reported Not reported Not reported Not reported Escalation Cohort (MEDI4736 1 mg/kg Q2W) 0 Not reported Not reported Not reported Not reported Escalation Cohort (MEDI4736 3 mg/kg Q2W) 0 Not reported Not reported Not reported Not reported Escalation Cohort (MEDI4736 15 mg/kg Q3W) 0 Not reported Not reported Not reported Not reported Exploration Cohort (MEDI4736 20 mg/kg Q4W) 0 Not reported Not reported Not reported Not reported Escalation/Expansion Cohort (Total MEDI4736 10 mg/kg Q2W) 1 Not reported Not reported Not reported Not reported
Tri-iodothyronine decreased Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment Escalation Cohort (MEDI4736 0.1 mg/kg Q2W) 0 Not reported Not reported Not reported Not reported Escalation Cohort (MEDI4736 0.3 mg/kg Q2W) 0 Not reported Not reported Not reported Not reported Escalation Cohort (MEDI4736 1 mg/kg Q2W) 0 Not reported Not reported Not reported Not reported Escalation Cohort (MEDI4736 3 mg/kg Q2W) 0 Not reported Not reported Not reported Not reported Escalation Cohort (MEDI4736 15 mg/kg Q3W) 0 Not reported Not reported Not reported Not reported Exploration Cohort (MEDI4736 20 mg/kg Q4W) 0 Not reported Not reported Not reported Not reported Escalation/Expansion Cohort (Total MEDI4736 10 mg/kg Q2W) 1 Not reported Not reported Not reported Not reported
Tri-iodothyronine increased Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment Escalation Cohort (MEDI4736 0.1 mg/kg Q2W) 0 Not reported Not reported Not reported Not reported Escalation Cohort (MEDI4736 0.3 mg/kg Q2W) 0 Not reported Not reported Not reported Not reported Escalation Cohort (MEDI4736 1 mg/kg Q2W) 0 Not reported Not reported Not reported Not reported Escalation Cohort (MEDI4736 3 mg/kg Q2W) 0 Not reported Not reported Not reported Not reported Escalation Cohort (MEDI4736 15 mg/kg Q3W) 0 Not reported Not reported Not reported Not reported Exploration Cohort (MEDI4736 20 mg/kg Q4W) 0 Not reported Not reported Not reported Not reported Escalation/Expansion Cohort (Total MEDI4736 10 mg/kg Q2W) 1 Not reported Not reported Not reported Not reported
Hyponatraemia Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment Escalation Cohort (MEDI4736 0.1 mg/kg Q2W) 0 Not reported Not reported Not reported Not reported Escalation Cohort (MEDI4736 0.3 mg/kg Q2W) 0 Not reported Not reported Not reported Not reported Escalation Cohort (MEDI4736 1 mg/kg Q2W) 1 Not reported Not reported Not reported Not reported Escalation Cohort (MEDI4736 3 mg/kg Q2W) 0 Not reported Not reported Not reported Not reported Escalation Cohort (MEDI4736 15 mg/kg Q3W) 1 Not reported Not reported Not reported Not reported Exploration Cohort (MEDI4736 20 mg/kg Q4W) 1 Not reported Not reported Not reported Not reported Escalation/Expansion Cohort (Total MEDI4736 10 mg/kg Q2W) 91 Not reported Not reported Not reported Not reported
Hypomagnesaemia Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment Escalation Cohort (MEDI4736 0.1 mg/kg Q2W) 0 Not reported Not reported Not reported Not reported Escalation Cohort (MEDI4736 0.3 mg/kg Q2W) 0 Not reported Not reported Not reported Not reported Escalation Cohort (MEDI4736 1 mg/kg Q2W) 0 Not reported Not reported Not reported Not reported Escalation Cohort (MEDI4736 3 mg/kg Q2W) 0 Not reported Not reported Not reported Not reported Escalation Cohort (MEDI4736 15 mg/kg Q3W) 0 Not reported Not reported Not reported Not reported Exploration Cohort (MEDI4736 20 mg/kg Q4W) 1 Not reported Not reported Not reported Not reported Escalation/Expansion Cohort (Total MEDI4736 10 mg/kg Q2W) 55 Not reported Not reported Not reported Not reported
Hypercalcaemia Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment Escalation Cohort (MEDI4736 0.1 mg/kg Q2W) 0 Not reported Not reported Not reported Not reported Escalation Cohort (MEDI4736 0.3 mg/kg Q2W) 0 Not reported Not reported Not reported Not reported Escalation Cohort (MEDI4736 1 mg/kg Q2W) 0 Not reported Not reported Not reported Not reported Escalation Cohort (MEDI4736 3 mg/kg Q2W) 0 Not reported Not reported Not reported Not reported Escalation Cohort (MEDI4736 15 mg/kg Q3W) 0 Not reported Not reported Not reported Not reported Exploration Cohort (MEDI4736 20 mg/kg Q4W) 0 Not reported Not reported Not reported Not reported Escalation/Expansion Cohort (Total MEDI4736 10 mg/kg Q2W) 47 Not reported Not reported Not reported Not reported
Hyperglycaemia Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment Escalation Cohort (MEDI4736 0.1 mg/kg Q2W) 0 Not reported Not reported Not reported Not reported Escalation Cohort (MEDI4736 0.3 mg/kg Q2W) 0 Not reported Not reported Not reported Not reported Escalation Cohort (MEDI4736 1 mg/kg Q2W) 1 Not reported Not reported Not reported Not reported Escalation Cohort (MEDI4736 3 mg/kg Q2W) 0 Not reported Not reported Not reported Not reported Escalation Cohort (MEDI4736 15 mg/kg Q3W) 0 Not reported Not reported Not reported Not reported Exploration Cohort (MEDI4736 20 mg/kg Q4W) 0 Not reported Not reported Not reported Not reported Escalation/Expansion Cohort (Total MEDI4736 10 mg/kg Q2W) 32 Not reported Not reported Not reported Not reported
Hypokalaemia Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment Escalation Cohort (MEDI4736 0.1 mg/kg Q2W) 0 Not reported Not reported Not reported Not reported Escalation Cohort (MEDI4736 0.3 mg/kg Q2W) 0 Not reported Not reported Not reported Not reported Escalation Cohort (MEDI4736 1 mg/kg Q2W) 0 Not reported Not reported Not reported Not reported Escalation Cohort (MEDI4736 3 mg/kg Q2W) 0 Not reported Not reported Not reported Not reported Escalation Cohort (MEDI4736 15 mg/kg Q3W) 0 Not reported Not reported Not reported Not reported Exploration Cohort (MEDI4736 20 mg/kg Q4W) 0 Not reported Not reported Not reported Not reported Escalation/Expansion Cohort (Total MEDI4736 10 mg/kg Q2W) 60 Not reported Not reported Not reported Not reported
Hypocalcaemia Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment Escalation Cohort (MEDI4736 0.1 mg/kg Q2W) 0 Not reported Not reported Not reported Not reported Escalation Cohort (MEDI4736 0.3 mg/kg Q2W) 0 Not reported Not reported Not reported Not reported Escalation Cohort (MEDI4736 1 mg/kg Q2W) 0 Not reported Not reported Not reported Not reported Escalation Cohort (MEDI4736 3 mg/kg Q2W) 0 Not reported Not reported Not reported Not reported Escalation Cohort (MEDI4736 15 mg/kg Q3W) 0 Not reported Not reported Not reported Not reported Exploration Cohort (MEDI4736 20 mg/kg Q4W) 0 Not reported Not reported Not reported Not reported Escalation/Expansion Cohort (Total MEDI4736 10 mg/kg Q2W) 17 Not reported Not reported Not reported Not reported
Hypophosphataemia Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment Escalation Cohort (MEDI4736 0.1 mg/kg Q2W) 0 Not reported Not reported Not reported Not reported Escalation Cohort (MEDI4736 0.3 mg/kg Q2W) 0 Not reported Not reported Not reported Not reported Escalation Cohort (MEDI4736 1 mg/kg Q2W) 0 Not reported Not reported Not reported Not reported Escalation Cohort (MEDI4736 3 mg/kg Q2W) 0 Not reported Not reported Not reported Not reported Escalation Cohort (MEDI4736 15 mg/kg Q3W) 0 Not reported Not reported Not reported Not reported Exploration Cohort (MEDI4736 20 mg/kg Q4W) 0 Not reported Not reported Not reported Not reported Escalation/Expansion Cohort (Total MEDI4736 10 mg/kg Q2W) 16 Not reported Not reported Not reported Not reported
Hypertriglyceridaemia Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment Escalation Cohort (MEDI4736 0.1 mg/kg Q2W) 0 Not reported Not reported Not reported Not reported Escalation Cohort (MEDI4736 0.3 mg/kg Q2W) 0 Not reported Not reported Not reported Not reported Escalation Cohort (MEDI4736 1 mg/kg Q2W) 0 Not reported Not reported Not reported Not reported Escalation Cohort (MEDI4736 3 mg/kg Q2W) 0 Not reported Not reported Not reported Not reported Escalation Cohort (MEDI4736 15 mg/kg Q3W) 0 Not reported Not reported Not reported Not reported Exploration Cohort (MEDI4736 20 mg/kg Q4W) 0 Not reported Not reported Not reported Not reported Escalation/Expansion Cohort (Total MEDI4736 10 mg/kg Q2W) 13 Not reported Not reported Not reported Not reported
Hypoglycaemia Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment Escalation Cohort (MEDI4736 0.1 mg/kg Q2W) 0 Not reported Not reported Not reported Not reported Escalation Cohort (MEDI4736 0.3 mg/kg Q2W) 0 Not reported Not reported Not reported Not reported Escalation Cohort (MEDI4736 1 mg/kg Q2W) 0 Not reported Not reported Not reported Not reported Escalation Cohort (MEDI4736 3 mg/kg Q2W) 0 Not reported Not reported Not reported Not reported Escalation Cohort (MEDI4736 15 mg/kg Q3W) 0 Not reported Not reported Not reported Not reported Exploration Cohort (MEDI4736 20 mg/kg Q4W) 0 Not reported Not reported Not reported Not reported Escalation/Expansion Cohort (Total MEDI4736 10 mg/kg Q2W) 10 Not reported Not reported Not reported Not reported
Blood cholesterol increased Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment Escalation Cohort (MEDI4736 0.1 mg/kg Q2W) 0 Not reported Not reported Not reported Not reported Escalation Cohort (MEDI4736 0.3 mg/kg Q2W) 0 Not reported Not reported Not reported Not reported Escalation Cohort (MEDI4736 1 mg/kg Q2W) 0 Not reported Not reported Not reported Not reported Escalation Cohort (MEDI4736 3 mg/kg Q2W) 0 Not reported Not reported Not reported Not reported Escalation Cohort (MEDI4736 15 mg/kg Q3W) 0 Not reported Not reported Not reported Not reported Exploration Cohort (MEDI4736 20 mg/kg Q4W) 0 Not reported Not reported Not reported Not reported Escalation/Expansion Cohort (Total MEDI4736 10 mg/kg Q2W) 6 Not reported Not reported Not reported Not reported
Blood magnesium decreased Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment Escalation Cohort (MEDI4736 0.1 mg/kg Q2W) 0 Not reported Not reported Not reported Not reported Escalation Cohort (MEDI4736 0.3 mg/kg Q2W) 0 Not reported Not reported Not reported Not reported Escalation Cohort (MEDI4736 1 mg/kg Q2W) 0 Not reported Not reported Not reported Not reported Escalation Cohort (MEDI4736 3 mg/kg Q2W) 0 Not reported Not reported Not reported Not reported Escalation Cohort (MEDI4736 15 mg/kg Q3W) 0 Not reported Not reported Not reported Not reported Exploration Cohort (MEDI4736 20 mg/kg Q4W) 0 Not reported Not reported Not reported Not reported Escalation/Expansion Cohort (Total MEDI4736 10 mg/kg Q2W) 5 Not reported Not reported Not reported Not reported
Blood triglycerides increased Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment Escalation Cohort (MEDI4736 0.1 mg/kg Q2W) 0 Not reported Not reported Not reported Not reported Escalation Cohort (MEDI4736 0.3 mg/kg Q2W) 0 Not reported Not reported Not reported Not reported Escalation Cohort (MEDI4736 1 mg/kg Q2W) 0 Not reported Not reported Not reported Not reported Escalation Cohort (MEDI4736 3 mg/kg Q2W) 0 Not reported Not reported Not reported Not reported Escalation Cohort (MEDI4736 15 mg/kg Q3W) 0 Not reported Not reported Not reported Not reported Exploration Cohort (MEDI4736 20 mg/kg Q4W) 0 Not reported Not reported Not reported Not reported Escalation/Expansion Cohort (Total MEDI4736 10 mg/kg Q2W) 5 Not reported Not reported Not reported Not reported
Blood glucose increased Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment Escalation Cohort (MEDI4736 0.1 mg/kg Q2W) 0 Not reported Not reported Not reported Not reported Escalation Cohort (MEDI4736 0.3 mg/kg Q2W) 0 Not reported Not reported Not reported Not reported Escalation Cohort (MEDI4736 1 mg/kg Q2W) 0 Not reported Not reported Not reported Not reported Escalation Cohort (MEDI4736 3 mg/kg Q2W) 0 Not reported Not reported Not reported Not reported Escalation Cohort (MEDI4736 15 mg/kg Q3W) 0 Not reported Not reported Not reported Not reported Exploration Cohort (MEDI4736 20 mg/kg Q4W) 0 Not reported Not reported Not reported Not reported Escalation/Expansion Cohort (Total MEDI4736 10 mg/kg Q2W) 4 Not reported Not reported Not reported Not reported
Hypercholesterolaemia Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment Escalation Cohort (MEDI4736 0.1 mg/kg Q2W) 0 Not reported Not reported Not reported Not reported Escalation Cohort (MEDI4736 0.3 mg/kg Q2W) 0 Not reported Not reported Not reported Not reported Escalation Cohort (MEDI4736 1 mg/kg Q2W) 0 Not reported Not reported Not reported Not reported Escalation Cohort (MEDI4736 3 mg/kg Q2W) 0 Not reported Not reported Not reported Not reported Escalation Cohort (MEDI4736 15 mg/kg Q3W) 0 Not reported Not reported Not reported Not reported Exploration Cohort (MEDI4736 20 mg/kg Q4W) 0 Not reported Not reported Not reported Not reported Escalation/Expansion Cohort (Total MEDI4736 10 mg/kg Q2W) 4 Not reported Not reported Not reported Not reported
Blood potassium increased Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment Escalation Cohort (MEDI4736 0.1 mg/kg Q2W) 0 Not reported Not reported Not reported Not reported Escalation Cohort (MEDI4736 0.3 mg/kg Q2W) 0 Not reported Not reported Not reported Not reported Escalation Cohort (MEDI4736 1 mg/kg Q2W) 0 Not reported Not reported Not reported Not reported Escalation Cohort (MEDI4736 3 mg/kg Q2W) 0 Not reported Not reported Not reported Not reported Escalation Cohort (MEDI4736 15 mg/kg Q3W) 0 Not reported Not reported Not reported Not reported Exploration Cohort (MEDI4736 20 mg/kg Q4W) 0 Not reported Not reported Not reported Not reported Escalation/Expansion Cohort (Total MEDI4736 10 mg/kg Q2W) 3 Not reported Not reported Not reported Not reported
Blood chloride increased Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment Escalation Cohort (MEDI4736 0.1 mg/kg Q2W) 0 Not reported Not reported Not reported Not reported Escalation Cohort (MEDI4736 0.3 mg/kg Q2W) 0 Not reported Not reported Not reported Not reported Escalation Cohort (MEDI4736 1 mg/kg Q2W) 0 Not reported Not reported Not reported Not reported Escalation Cohort (MEDI4736 3 mg/kg Q2W) 0 Not reported Not reported Not reported Not reported Escalation Cohort (MEDI4736 15 mg/kg Q3W) 0 Not reported Not reported Not reported Not reported Exploration Cohort (MEDI4736 20 mg/kg Q4W) 0 Not reported Not reported Not reported Not reported Escalation/Expansion Cohort (Total MEDI4736 10 mg/kg Q2W) 2 Not reported Not reported Not reported Not reported
Blood electrolytes decreased Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment Escalation Cohort (MEDI4736 0.1 mg/kg Q2W) 0 Not reported Not reported Not reported Not reported Escalation Cohort (MEDI4736 0.3 mg/kg Q2W) 0 Not reported Not reported Not reported Not reported Escalation Cohort (MEDI4736 1 mg/kg Q2W) 0 Not reported Not reported Not reported Not reported Escalation Cohort (MEDI4736 3 mg/kg Q2W) 0 Not reported Not reported Not reported Not reported Escalation Cohort (MEDI4736 15 mg/kg Q3W) 0 Not reported Not reported Not reported Not reported Exploration Cohort (MEDI4736 20 mg/kg Q4W) 0 Not reported Not reported Not reported Not reported Escalation/Expansion Cohort (Total MEDI4736 10 mg/kg Q2W) 2 Not reported Not reported Not reported Not reported
Blood potassium decreased Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment Escalation Cohort (MEDI4736 0.1 mg/kg Q2W) 0 Not reported Not reported Not reported Not reported Escalation Cohort (MEDI4736 0.3 mg/kg Q2W) 0 Not reported Not reported Not reported Not reported Escalation Cohort (MEDI4736 1 mg/kg Q2W) 0 Not reported Not reported Not reported Not reported Escalation Cohort (MEDI4736 3 mg/kg Q2W) 0 Not reported Not reported Not reported Not reported Escalation Cohort (MEDI4736 15 mg/kg Q3W) 0 Not reported Not reported Not reported Not reported Exploration Cohort (MEDI4736 20 mg/kg Q4W) 0 Not reported Not reported Not reported Not reported Escalation/Expansion Cohort (Total MEDI4736 10 mg/kg Q2W) 2 Not reported Not reported Not reported Not reported
Hyperphosphataemia Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment Escalation Cohort (MEDI4736 0.1 mg/kg Q2W) 0 Not reported Not reported Not reported Not reported Escalation Cohort (MEDI4736 0.3 mg/kg Q2W) 0 Not reported Not reported Not reported Not reported Escalation Cohort (MEDI4736 1 mg/kg Q2W) 0 Not reported Not reported Not reported Not reported Escalation Cohort (MEDI4736 3 mg/kg Q2W) 0 Not reported Not reported Not reported Not reported Escalation Cohort (MEDI4736 15 mg/kg Q3W) 0 Not reported Not reported Not reported Not reported Exploration Cohort (MEDI4736 20 mg/kg Q4W) 0 Not reported Not reported Not reported Not reported Escalation/Expansion Cohort (Total MEDI4736 10 mg/kg Q2W) 2 Not reported Not reported Not reported Not reported
Protein total decreased Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment Escalation Cohort (MEDI4736 0.1 mg/kg Q2W) 0 Not reported Not reported Not reported Not reported Escalation Cohort (MEDI4736 0.3 mg/kg Q2W) 0 Not reported Not reported Not reported Not reported Escalation Cohort (MEDI4736 1 mg/kg Q2W) 0 Not reported Not reported Not reported Not reported Escalation Cohort (MEDI4736 3 mg/kg Q2W) 0 Not reported Not reported Not reported Not reported Escalation Cohort (MEDI4736 15 mg/kg Q3W) 0 Not reported Not reported Not reported Not reported Exploration Cohort (MEDI4736 20 mg/kg Q4W) 0 Not reported Not reported Not reported Not reported Escalation/Expansion Cohort (Total MEDI4736 10 mg/kg Q2W) 2 Not reported Not reported Not reported Not reported
Protein urine present Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment Escalation Cohort (MEDI4736 0.1 mg/kg Q2W) 0 Not reported Not reported Not reported Not reported Escalation Cohort (MEDI4736 0.3 mg/kg Q2W) 0 Not reported Not reported Not reported Not reported Escalation Cohort (MEDI4736 1 mg/kg Q2W) 0 Not reported Not reported Not reported Not reported Escalation Cohort (MEDI4736 3 mg/kg Q2W) 0 Not reported Not reported Not reported Not reported Escalation Cohort (MEDI4736 15 mg/kg Q3W) 0 Not reported Not reported Not reported Not reported Exploration Cohort (MEDI4736 20 mg/kg Q4W) 0 Not reported Not reported Not reported Not reported Escalation/Expansion Cohort (Total MEDI4736 10 mg/kg Q2W) 2 Not reported Not reported Not reported Not reported
Blood bicarbonate decreased Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment Escalation Cohort (MEDI4736 0.1 mg/kg Q2W) 0 Not reported Not reported Not reported Not reported Escalation Cohort (MEDI4736 0.3 mg/kg Q2W) 0 Not reported Not reported Not reported Not reported Escalation Cohort (MEDI4736 1 mg/kg Q2W) 0 Not reported Not reported Not reported Not reported Escalation Cohort (MEDI4736 3 mg/kg Q2W) 0 Not reported Not reported Not reported Not reported Escalation Cohort (MEDI4736 15 mg/kg Q3W) 0 Not reported Not reported Not reported Not reported Exploration Cohort (MEDI4736 20 mg/kg Q4W) 0 Not reported Not reported Not reported Not reported Escalation/Expansion Cohort (Total MEDI4736 10 mg/kg Q2W) 1 Not reported Not reported Not reported Not reported
Blood chloride decreased Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment Escalation Cohort (MEDI4736 0.1 mg/kg Q2W) 0 Not reported Not reported Not reported Not reported Escalation Cohort (MEDI4736 0.3 mg/kg Q2W) 0 Not reported Not reported Not reported Not reported Escalation Cohort (MEDI4736 1 mg/kg Q2W) 0 Not reported Not reported Not reported Not reported Escalation Cohort (MEDI4736 3 mg/kg Q2W) 0 Not reported Not reported Not reported Not reported Escalation Cohort (MEDI4736 15 mg/kg Q3W) 0 Not reported Not reported Not reported Not reported Exploration Cohort (MEDI4736 20 mg/kg Q4W) 0 Not reported Not reported Not reported Not reported Escalation/Expansion Cohort (Total MEDI4736 10 mg/kg Q2W) 1 Not reported Not reported Not reported Not reported
Blood sodium decreased Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment Escalation Cohort (MEDI4736 0.1 mg/kg Q2W) 0 Not reported Not reported Not reported Not reported Escalation Cohort (MEDI4736 0.3 mg/kg Q2W) 0 Not reported Not reported Not reported Not reported Escalation Cohort (MEDI4736 1 mg/kg Q2W) 0 Not reported Not reported Not reported Not reported Escalation Cohort (MEDI4736 3 mg/kg Q2W) 0 Not reported Not reported Not reported Not reported Escalation Cohort (MEDI4736 15 mg/kg Q3W) 0 Not reported Not reported Not reported Not reported Exploration Cohort (MEDI4736 20 mg/kg Q4W) 0 Not reported Not reported Not reported Not reported Escalation/Expansion Cohort (Total MEDI4736 10 mg/kg Q2W) 1 Not reported Not reported Not reported Not reported
Hypermagnesaemia Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment Escalation Cohort (MEDI4736 0.1 mg/kg Q2W) 0 Not reported Not reported Not reported Not reported Escalation Cohort (MEDI4736 0.3 mg/kg Q2W) 0 Not reported Not reported Not reported Not reported Escalation Cohort (MEDI4736 1 mg/kg Q2W) 0 Not reported Not reported Not reported Not reported Escalation Cohort (MEDI4736 3 mg/kg Q2W) 0 Not reported Not reported Not reported Not reported Escalation Cohort (MEDI4736 15 mg/kg Q3W) 0 Not reported Not reported Not reported Not reported Exploration Cohort (MEDI4736 20 mg/kg Q4W) 0 Not reported Not reported Not reported Not reported Escalation/Expansion Cohort (Total MEDI4736 10 mg/kg Q2W) 1 Not reported Not reported Not reported Not reported
Hypernatraemia Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment Escalation Cohort (MEDI4736 0.1 mg/kg Q2W) 0 Not reported Not reported Not reported Not reported Escalation Cohort (MEDI4736 0.3 mg/kg Q2W) 0 Not reported Not reported Not reported Not reported Escalation Cohort (MEDI4736 1 mg/kg Q2W) 0 Not reported Not reported Not reported Not reported Escalation Cohort (MEDI4736 3 mg/kg Q2W) 0 Not reported Not reported Not reported Not reported Escalation Cohort (MEDI4736 15 mg/kg Q3W) 0 Not reported Not reported Not reported Not reported Exploration Cohort (MEDI4736 20 mg/kg Q4W) 0 Not reported Not reported Not reported Not reported Escalation/Expansion Cohort (Total MEDI4736 10 mg/kg Q2W) 1 Not reported Not reported Not reported Not reported
Hypochloraemia Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment Escalation Cohort (MEDI4736 0.1 mg/kg Q2W) 0 Not reported Not reported Not reported Not reported Escalation Cohort (MEDI4736 0.3 mg/kg Q2W) 0 Not reported Not reported Not reported Not reported Escalation Cohort (MEDI4736 1 mg/kg Q2W) 0 Not reported Not reported Not reported Not reported Escalation Cohort (MEDI4736 3 mg/kg Q2W) 0 Not reported Not reported Not reported Not reported Escalation Cohort (MEDI4736 15 mg/kg Q3W) 0 Not reported Not reported Not reported Not reported Exploration Cohort (MEDI4736 20 mg/kg Q4W) 0 Not reported Not reported Not reported Not reported Escalation/Expansion Cohort (Total MEDI4736 10 mg/kg Q2W) 1 Not reported Not reported Not reported Not reported
Hypoproteinaemia Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment Escalation Cohort (MEDI4736 0.1 mg/kg Q2W) 0 Not reported Not reported Not reported Not reported Escalation Cohort (MEDI4736 0.3 mg/kg Q2W) 0 Not reported Not reported Not reported Not reported Escalation Cohort (MEDI4736 1 mg/kg Q2W) 0 Not reported Not reported Not reported Not reported Escalation Cohort (MEDI4736 3 mg/kg Q2W) 0 Not reported Not reported Not reported Not reported Escalation Cohort (MEDI4736 15 mg/kg Q3W) 0 Not reported Not reported Not reported Not reported Exploration Cohort (MEDI4736 20 mg/kg Q4W) 0 Not reported Not reported Not reported Not reported Escalation/Expansion Cohort (Total MEDI4736 10 mg/kg Q2W) 1 Not reported Not reported Not reported Not reported
Hyperkalaemia Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment Escalation Cohort (MEDI4736 0.1 mg/kg Q2W) 0 Not reported Not reported Not reported Not reported Escalation Cohort (MEDI4736 0.3 mg/kg Q2W) 0 Not reported Not reported Not reported Not reported Escalation Cohort (MEDI4736 1 mg/kg Q2W) 0 Not reported Not reported Not reported Not reported Escalation Cohort (MEDI4736 3 mg/kg Q2W) 0 Not reported Not reported Not reported Not reported Escalation Cohort (MEDI4736 15 mg/kg Q3W) 0 Not reported Not reported Not reported Not reported Exploration Cohort (MEDI4736 20 mg/kg Q4W) 0 Not reported Not reported Not reported Not reported Escalation/Expansion Cohort (Total MEDI4736 10 mg/kg Q2W) 30 Not reported Not reported Not reported Not reported
Complete source fields classes categories measurements
group Id OG000
value 1
group Id OG001
value 0
group Id OG002
value 0
group Id OG003
value 0
group Id OG004
value 0
group Id OG005
value 0
group Id OG006
value 166
title Anaemia categories measurements
group Id OG000
value 0
group Id OG001
value 0
group Id OG002
value 0
group Id OG003
value 0
group Id OG004
value 0
group Id OG005
value 1
group Id OG006
value 24
title Thrombocytopenia categories measurements
group Id OG000
value 0
group Id OG001
value 0
group Id OG002
value 0
group Id OG003
value 0
group Id OG004
value 0
group Id OG005
value 1
group Id OG006
value 3
title White blood cell count increased categories measurements
group Id OG000
value 0
group Id OG001
value 0
group Id OG002
value 0
group Id OG003
value 0
group Id OG004
value 0
group Id OG005
value 0
group Id OG006
value 20
title Leukocytosis categories measurements
group Id OG000
value 0
group Id OG001
value 0
group Id OG002
value 0
group Id OG003
value 0
group Id OG004
value 0
group Id OG005
value 0
group Id OG006
value 12
title Lymphocyte count decreased categories measurements
group Id OG000
value 0
group Id OG001
value 0
group Id OG002
value 0
group Id OG003
value 0
group Id OG004
value 0
group Id OG005
value 0
group Id OG006
value 8
title Neutropenia categories measurements
group Id OG000
value 0
group Id OG001
value 0
group Id OG002
value 0
group Id OG003
value 0
group Id OG004
value 0
group Id OG005
value 0
group Id OG006
value 7
title Leukopenia categories measurements
group Id OG000
value 0
group Id OG001
value 0
group Id OG002
value 0
group Id OG003
value 0
group Id OG004
value 0
group Id OG005
value 0
group Id OG006
value 5
title Thrombocytosis categories measurements
group Id OG000
value 0
group Id OG001
value 0
group Id OG002
value 0
group Id OG003
value 0
group Id OG004
value 0
group Id OG005
value 0
group Id OG006
value 3
title Iron deficiency anaemia categories measurements
group Id OG000
value 0
group Id OG001
value 0
group Id OG002
value 0
group Id OG003
value 0
group Id OG004
value 0
group Id OG005
value 0
group Id OG006
value 2
title Haemoglobin decreased categories measurements
group Id OG000
value 0
group Id OG001
value 0
group Id OG002
value 0
group Id OG003
value 0
group Id OG004
value 0
group Id OG005
value 0
group Id OG006
value 2
title Neutrophil count increased categories measurements
group Id OG000
value 0
group Id OG001
value 0
group Id OG002
value 0
group Id OG003
value 0
group Id OG004
value 0
group Id OG005
value 0
group Id OG006
value 1
title Red blood cell count decreased Show more (12 of 87) denoms counts
group Id OG000
value 4
group Id OG001
value 4
group Id OG002
value 3
group Id OG003
value 3
group Id OG004
value 7
group Id OG005
value 21
group Id OG006
value 980
units Participants
description Number of participants with abnormal clinical laboratory parameters reported as TEAEs are reported. Abnormal clinical laboratory parameters defined as any abnormal finding during analysis of coagulation, urine, hematology, and serum chemistry. groups
description Participants received intravenous (IV) infusion of MEDI4736 (durvalumab) 0.1 mg/kg every 2 weeks (Q2W) in the dose-escalation phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.
id OG000
title Escalation Cohort (MEDI4736 0.1 mg/kg Q2W)
description Participants received IV infusion of MEDI4736 0.3 mg/kg Q2W in the dose-escalation phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation , whichever occurred first
id OG001
title Escalation Cohort (MEDI4736 0.3 mg/kg Q2W)
description Participants received IV infusion of MEDI4736 1 mg/kg Q2W in the dose-escalation phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.
id OG002
title Escalation Cohort (MEDI4736 1 mg/kg Q2W)
description Participants received IV infusion of MEDI4736 3 mg/kg Q2W in the dose-escalation phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation , whichever occurred first.
id OG003
title Escalation Cohort (MEDI4736 3 mg/kg Q2W)
description Participants received IV infusion of MEDI4736 15 mg/kg every 3 weeks (Q3W) in the dose-escalation phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.
id OG004
title Escalation Cohort (MEDI4736 15 mg/kg Q3W)
description Participants received IV infusion of MEDI4736 20 mg/kg every 4 weeks (Q4W) in the dose-exploration phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.
id OG005
title Exploration Cohort (MEDI4736 20 mg/kg Q4W)
description Participants received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-escalation or dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation , whichever occurred first.
id OG006
title Escalation/Expansion Cohort (Total MEDI4736 10 mg/kg Q2W)
param Type COUNT_OF_PARTICIPANTS
population Description As-treated population included all participants who received any dose of study drug. Participants enrolled in the 10 mg/kg Q2W Expansion and Escalation Cohort have been summarized as a total only. This is because the safety profile of durvalumab monotherapy 10 mg/kg Q2W was manageable and generally consistent with the known safety profile of the anti-PD-L1/PD-1 drug class.
reporting Status POSTED
time Frame From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)
title Number of Participants With Abnormal Clinical Laboratory Parameters Reported as TEAEs in the Dose-escalation, Dose-exploration, and Dose-expansion Phase
type PRIMARY
unit Of Measure Participants Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice
Triangle