The composite response is measured by change from Baseline in skeletal lesions, extra-skeletal lesions, and prostate specific antigen (PSA) values. A participant is considered to have composite response, if 1 of the following responses occurs after the first dose of carlumab: (1) Complete response (CR) or partial response (PR) according to Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST), (2) PSA response at 12 weeks and absence of skeletal and extra-skeletal progression or (3) Stable disease at 24 weeks defined as the absence of PSA, skeletal, or extra-skeletal progression.

Analysis population included all the participants who received at least 1 administration of carlumab and had at least 1 post-baseline disease evaluation. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.

Objective response based on assessment of confirmed CR or PR according to RECIST. CR defined as disappearance of all target lesions. Any pathological lymph nodes must have reduction in short axis to less than 10 millimeter (mm). PR defined as at least 30 percent (%) decrease in sum of the diameters of the target lesions taking as reference the Baseline sum diameters. Confirmed responses are those that persist on repeat imaging study for at least 4 weeks after initial documentation of response.

Analysis population included all the participants who received at least 1 administration of carlumab and had a measurable, non-measurable or bone lesion at Baseline and had at least 1 post-treatment tumor evaluation. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.

The PFS is defined as the time from the date of initiation of study treatment to the date of initial documented skeletal or extra-skeletal progressive disease, or date of death, whichever occurs first. A participant is considered to have extra-skeletal disease progression if the disease has progressed as per the Response Evaluation Criteria in Solid Tumors (RECIST v1.1) criteria. A participant is considered to have skeletal disease progression if they have 1 post-baseline bone scan demonstrating 2 or more new skeletal lesions compared to Baseline and confirmed by a second bone scan 6 to 12 weeks later or with evidence of clinical progression.

Analysis population included all the participants who received at least 1 administration of carlumab.

The OS is defined as the time from the date of initiation of study treatment to death due to any cause. Participants were followed for 1 year after the last administration of carlumab for survival or until the end of study, whichever occurs first. For participants with unknown survival status as of the data cutoff date, OS was censored at the last date that the participant was known to be alive.

Analysis population included all the participants who received at least 1 administration of carlumab.

The PSA response for participants with elevated PSA levels at Baseline (more than or equal to 5 nanogram per milliliter (ng/mL) is defined as at least a 50% reduction in PSA from the Baseline value, confirmed by a second PSA value measurement 3 or more weeks later.

Analysis population included all the participants who received at least 1 administration of carlumab and had a Baseline PSA more than or equal to 5 ng/mL and at least 1 post-treatment PSA measurement. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.

Urinary NTx response for participants with elevated NTx level at Baseline (more than or equal to 50 nanomole per millimole (nmol/mmol)) is defined as a 30% reduction from Baseline NTx value, confirmed by a second NTx value 3 or more weeks later.

Analysis population included all the participants who received at least 1 administration of carlumab and had elevated urinary NTx level at Baseline (more than or equal to 50 nmol/mmol) and at least 1 post-treatment urinary NTx measurement. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.

Pain response is defined as 2-point decrease from Baseline in 'worst pain' intensity score (item 3) on the Brief Pain Inventory (BPI) questionnaire. The BPI is a nine-item questionnaire with 0 to 10 numeric rating scales in response to each item, where 0=No pain and 10=Pain as bad as you can imagine. Measure can be scored by item, with lower scores being indicative of less pain or pain interference.

Analysis population included all the participants who received at least 1 administration of carlumab, had Baseline BPI 'worst pain' intensity score (item 3) more than or equal to 2, and at least 1 post-treatment pain evaluation. Participants with disease progression were considered to be evaluable, regardless of the post-dose evaluation.

Radiologic response based on assessment of confirmed CR or PR according to RECIST. CR defined as disappearance of all target lesions. Any pathological lymph nodes must have reduction in short axis to less than 10 millimeter (mm). PR defined as at least 30% decrease in sum of the diameters of the target lesions taking as reference the Baseline sum diameters. Confirmed responses are those that persist on repeat imaging study for at least 4 weeks after initial documentation of response.

Analysis population included all the participants who received at least 1 administration of carlumab. No data was available for this endpoint as no participant achieved CR or PR.

Radiologic response based on assessment of confirmed CR or PR according to RECIST. CR defined as disappearance of all target lesions. Any pathological lymph nodes must have reduction in short axis to less than 10 millimeter (mm). PR defined as at least 30% decrease in sum of the diameters of the target lesions taking as reference the Baseline sum diameters. Confirmed responses are those that persist on repeat imaging study for at least 4 weeks after initial documentation of response.

Analysis population included all the participants who received at least 1 administration of carlumab. No data was available for this endpoint as no participant achieved CR or PR.

Analysis population included all the participants who received at least 1 administration of carlumab. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.

The maximum observed analyte concentration was measured.

Analysis population included all the participants who received at least 1 administration of carlumab.

Analysis population included all the participants who received at least 1 administration of carlumab except those whose serum samples were missing at the end of infusion.

The time measured for the serum concentration to decrease by one half.

Analysis population included all the participants who received at least 1 administration of carlumab except those whose serum samples were missing at the end of infusion.

A worsening in ECOG performance status score was defined as greater than or equal to 1-point increase from Baseline. Time to worsening is defined as the number of days from first dose to the first day of worsening in ECOG score, or death, whichever occurred first. ECOG is a 5-point scale 0=Fully active, 1=Ambulatory, carry out work of sedentary nature, 2=Ambulatory, capable of all selfcare, 3=Capable of limited selfcare, confined to bed or chair more than 50% of waking hours, 4=Completely disabled, no selfcare, totally confined to bed or chair, 5=Dead.

Analysis population included all the participants who received at least 1 administration of carlumab.