{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"2"},{"groupId":"OG001","value":"10"},{"groupId":"OG002","value":"10"},{"groupId":"OG003","value":"4"},{"groupId":"OG004","value":"3"},{"groupId":"OG005","value":"264"},{"groupId":"OG006","value":"6"},{"groupId":"OG007","value":"10"}]}],"title":"Any adverse event"},{"categories":[{"measurements":[{"groupId":"OG000","value":"1"},{"groupId":"OG001","value":"1"},{"groupId":"OG002","value":"6"},{"groupId":"OG003","value":"2"},{"groupId":"OG004","value":"1"},{"groupId":"OG005","value":"138"},{"groupId":"OG006","value":"3"},{"groupId":"OG007","value":"5"}]}],"title":"Serious adverse events"}],"denoms":[{"counts":[{"groupId":"OG000","value":"3"},{"groupId":"OG001","value":"10"},{"groupId":"OG002","value":"11"},{"groupId":"OG003","value":"4"},{"groupId":"OG004","value":"3"},{"groupId":"OG005","value":"265"},{"groupId":"OG006","value":"6"},{"groupId":"OG007","value":"10"}],"units":"Participants"}],"description":"An AE is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation, patient-administered study drug and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (such as an abnormal laboratory finding), symptom, or disease temporally associated with the use of study drug, whether or not considered related to the study drug.\n\nA Serious Adverse Event (SAE) is any untoward medical occurrence that at any dose:\n\n* Resulted in death;\n* Was life-threatening;\n* Required inpatient hospitalization or causes prolongation of existing hospitalization;\n* Resulted in persistent or significant disability/incapacity;\n* Was a congenital anomaly/birth defect;\n* Was an important medical event that may jeopardize the patient or may require intervention (e.g., medical, surgical) to prevent one of the other serious outcomes listed in the definition above.","groups":[{"description":"Participants received 2 mg/kg cabiralizumab IV Q2W until disease progression, unacceptable toxicity, or other reason for treatment discontinuation.","id":"OG000","title":"Cabiralizumab 2 mg/kg Q2W"},{"description":"Participants received 4 mg/kg cabiralizumab IV Q2W until disease progression, unacceptable toxicity, or other reason for treatment discontinuation.","id":"OG001","title":"Cabiralizumab 4 mg/kg Q2W"},{"description":"Participants received 6 mg/kg cabiralizumab IV Q2W until disease progression, unacceptable toxicity, or other reason for treatment discontinuation.","id":"OG002","title":"Cabiralizumab 6 mg/kg Q2W"},{"description":"Participants received 1 mg/kg cabiralizumab IV and 3 mg/kg nivolumab IV Q2W until disease progression, unacceptable toxicity, or other reason for treatment discontinuation.","id":"OG003","title":"Cabiralizumab 1 mg/kg + Nivolumab 3 mg/kg Q2W"},{"description":"Participants received 2 mg/kg cabiralizumab IV and 3 mg/kg nivolumab IV Q2W until disease progression, unacceptable toxicity, or other reason for treatment discontinuation.","id":"OG004","title":"Cabiralizumab 2 mg/kg + Nivolumab 3 mg/kg Q2W"},{"description":"Participants received 4 mg/kg cabiralizumab IV and 3 mg/kg nivolumab IV Q2W until disease progression, unacceptable toxicity, or other reason for treatment discontinuation.","id":"OG005","title":"Cabiralizumab 4 mg/kg + Nivolumab 3 mg/kg Q2W"},{"description":"Participants received 6 mg/kg cabiralizumab IV and 3 mg/kg nivolumab IV Q2W until disease progression, unacceptable toxicity, or other reason for treatment discontinuation.","id":"OG006","title":"Cabiralizumab 6 mg/kg + Nivolumab 3 mg/kg Q2W"},{"description":"Participants received 4 mg/kg cabiralizumab IV and 3 mg/kg nivolumab IV every 3 weeks (Q3W) until disease progression, unacceptable toxicity, or other reason for treatment discontinuation.","id":"OG007","title":"Cabiralizumab 4 mg/kg + Nivolumab 3 mg/kg Q3W"}],"paramType":"COUNT_OF_PARTICIPANTS","populationDescription":"All participants who received at least 1 dose of cabiralizumab and/or nivolumab. Safety results are grouped by participants who received the same treatment regimen.","reportingStatus":"POSTED","timeFrame":"From first dose of study drug up to 100 days after last dose. Median (range) duration of exposure was 6 (2-32) weeks in the monotherapy cohorts and 8 (2-108) weeks for cabiralizumab and 8 (2-156) weeks for nivolumab in the combination groups.","title":"Safety: Number of Participants With Adverse Events and Serious Adverse Events (Phase 1a and 1b)","type":"PRIMARY","unitOfMeasure":"Participants"}