{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"},{"groupId":"OG003","value":"0"},{"groupId":"OG004","value":"0"},{"groupId":"OG005","value":"0"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"4"},{"groupId":"OG001","value":"4"},{"groupId":"OG002","value":"3"},{"groupId":"OG003","value":"3"},{"groupId":"OG004","value":"6"},{"groupId":"OG005","value":"7"}],"units":"Participants"}],"description":"A DLT was defined as any Grade 3 or higher treatment-related toxicity that occurred during the DLT-evaluation period including any \\>= Grade 3 colitis or \\>= Grade 3 immune-related adverse event (irAE; AEs of immune nature in the absence of a clear alternative etiology) including rash, pruritus, or diarrhea that did not downgrade to =\\< Grade 2 within 3 days after onset of the event despite maximal supportive care including systemic corticosteroids. The DLT-evaluation period for 0.1 to 10 mg/kg arms was from Day 1 to Day 28 of first dose and for 15 mg/kg arm was from Day 1 to Day 42 of first dose.","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 10 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":"OG004","title":"Escalation Cohort (MEDI4736 10 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":"OG005","title":"Escalation Cohort (MEDI4736 15 mg/kg Q3W)"}],"paramType":"COUNT_OF_PARTICIPANTS","populationDescription":"DLT-evaluable population included all participants in the dose-escalation phase who received at least 2 doses of study drug and completed safety follow-up through DLT-evaluable period or experienced any DLT during the DLT-evaluation period.","reportingStatus":"POSTED","timeFrame":"For MEDI4736 0.1 to MEDI4736 10 mg/kg arms: from Day 1 to Day 28 of first dose; for MEDI4736 15 mg/kg arm: from Day 1 to Day 42 of first dose","title":"Number of Participants With Dose-limiting Toxicities in the Dose-escalation Phase","type":"PRIMARY","unitOfMeasure":"Participants"}