Trial Outcomes & Findings for Study of Dalantercept and Axitinib in Patients With Advanced Renal Cell Carcinoma (NCT NCT01727336)

NCT ID: NCT01727336

Last Updated: 2022-10-06

Results Overview

Outcome measure is intended for Part 1 of the study in order to determine recommended dose level for Part 2.

• Recruitment status: TERMINATED
• Study phase: PHASE2
• Target enrollment: 160 participants
• Primary outcome timeframe: Assessed from time of first dose to approximately 30 days after last dose. Participants were allowed to remain on treatment until documented disease progression. The time frame for Part 1 of the study was up to 21.6 months
• Results posted on: 2022-10-06

Participant Flow

In the Part 1 dose escalation portion of the study, 4 dose levels of dalantercept plus an expansion cohort were planned. However, dose escalation was suspended following the 1.2 mg/kg dose level and additional subjects were added to the 1.2 mg/kg dose cohort, which represented the expansion; no subjects were enrolled in the 1.5 mg/kg dose level.

Participant milestones

Measure	Part 1 Dalantercept 0.6 mg/kg Dose escalation cohort 1: dalantercept 0.6 mg/kg plus axitinib 5 mg PO BID	Part 1 Dalantercept 0.9 mg/kg Dose escalation cohort 2: dalantercept 0.9 mg/kg plus axitinib 5 mg PO BID	Part 1: Dalantercept 1.2 mg/kg Part 1 cohort 3: dalantercept 1.2 mg/kg plus axitinib 5 mg PO BID	Part 1: Dalantercept 1.5 mg/kg Dose escalation cohort 4: dalantercept 1.5 mg/kg	Part 2: Dalantercept 0.9 mg/kg Plus Axitinib Subcutaneous (SC) injection of Dalantercept once every 3 weeks and oral axitinib 5 mg PO BID for continuous dosing.	Part 2: Placebo Plus Axitinib Subcutaneous injection of normal saline once every 3 weeks and oral axitinib 5 mg PO BID for continuous dosing
Part 1 Dalantercept Dose Escalation STARTED	6	9	14	0	0	0
Part 1 Dalantercept Dose Escalation COMPLETED	3	7	6	0	0	0
Part 1 Dalantercept Dose Escalation NOT COMPLETED	3	2	8	0	0	0
Part 2 Blinded STARTED	0	0	0	0	63	68
Part 2 Blinded COMPLETED	0	0	0	0	0	0
Part 2 Blinded NOT COMPLETED	0	0	0	0	63	68

Reasons for withdrawal

Measure	Part 1 Dalantercept 0.6 mg/kg Dose escalation cohort 1: dalantercept 0.6 mg/kg plus axitinib 5 mg PO BID	Part 1 Dalantercept 0.9 mg/kg Dose escalation cohort 2: dalantercept 0.9 mg/kg plus axitinib 5 mg PO BID	Part 1: Dalantercept 1.2 mg/kg Part 1 cohort 3: dalantercept 1.2 mg/kg plus axitinib 5 mg PO BID	Part 1: Dalantercept 1.5 mg/kg Dose escalation cohort 4: dalantercept 1.5 mg/kg	Part 2: Dalantercept 0.9 mg/kg Plus Axitinib Subcutaneous (SC) injection of Dalantercept once every 3 weeks and oral axitinib 5 mg PO BID for continuous dosing.	Part 2: Placebo Plus Axitinib Subcutaneous injection of normal saline once every 3 weeks and oral axitinib 5 mg PO BID for continuous dosing
Part 1 Dalantercept Dose Escalation Adverse Event	0	1	5	0	0	0
Part 1 Dalantercept Dose Escalation Lack of Efficacy	3	1	3	0	0	0
Part 2 Blinded Death	0	0	0	0	20	16
Part 2 Blinded Lack of Efficacy	0	0	0	0	42	44
Part 2 Blinded Lost to Follow-up	0	0	0	0	0	1
Part 2 Blinded Withdrawal by Subject	0	0	0	0	0	4
Part 2 Blinded use of prohibited medications	0	0	0	0	1	3

Baseline Characteristics

Study of Dalantercept and Axitinib in Patients With Advanced Renal Cell Carcinoma

Baseline characteristics by cohort

Measure	Part 1 Dalantercept 0.6 mg/kg n=6 Participants Dose escalation cohort 1: dalantercept 0.6 mg/kg	Part 1 Dalantercept 0.9 mg/kg n=9 Participants Dose escalation cohort 2: dalantercept 0.9 mg/kg	Part 1 Dalantercept 1.2 mg/kg n=14 Participants Dose escalation cohort 3: dalantercept 1.2 mg/kg	Part 1 Dalantercept 1.5 mg/kg Dose escalation cohort 4: dalantercept 1.5 mg/kg	Part 2 Dalantercept 0.9 mg/kg Plus Axitinib n=63 Participants Subcutaneous (SC) injection of Dalantercept once every 3 weeks and oral axitinib 5 mg BID for continuous dosing.	Placebo Plus Axitinib n=68 Participants Subcutaneous injection of normal saline once every 3 weeks and oral axitinib 5 mg BID for continuous dosing	Total n=160 Participants Total of all reporting groups
Age, Continuous	64.3 years STANDARD_DEVIATION 7.2 • n=5 Participants	56.2 years STANDARD_DEVIATION 9.2 • n=7 Participants	61.5 years STANDARD_DEVIATION 10.9 • n=5 Participants	—	62.8 years STANDARD_DEVIATION 8.1 • n=21 Participants	58.9 years STANDARD_DEVIATION 10.1 • n=8 Participants	60.7 years STANDARD_DEVIATION 9.4 • n=8 Participants
Sex: Female, Male Female	1 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants	—	22 Participants n=21 Participants	28 Participants n=8 Participants	56 Participants n=8 Participants
Sex: Female, Male Male	5 Participants n=5 Participants	7 Participants n=7 Participants	11 Participants n=5 Participants	—	41 Participants n=21 Participants	40 Participants n=8 Participants	104 Participants n=8 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	—	1 Participants n=21 Participants	6 Participants n=8 Participants	9 Participants n=8 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	6 Participants n=5 Participants	8 Participants n=7 Participants	13 Participants n=5 Participants	—	58 Participants n=21 Participants	58 Participants n=8 Participants	143 Participants n=8 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	—	4 Participants n=21 Participants	4 Participants n=8 Participants	8 Participants n=8 Participants
Region of Enrollment United States	6 participants n=5 Participants	9 participants n=7 Participants	14 participants n=5 Participants	—	63 participants n=21 Participants	68 participants n=8 Participants	160 participants n=8 Participants

PRIMARY outcome

Timeframe: Assessed from time of first dose to approximately 30 days after last dose. Participants were allowed to remain on treatment until documented disease progression. The time frame for Part 1 of the study was up to 21.6 months

Population: Safety Analysis Set (SAF) consisted of all patients who received at least 1 dose of study drug

Outcome measure is intended for Part 1 of the study in order to determine recommended dose level for Part 2.

Outcome measures

Measure	Part 1 Dalantercept 0.6 mg/kg n=6 Participants Part 1 cohort 1; dalantercept 0.6 mg/kg plus axitinib 5 mg PO BID	Part 1 Dalantercept 0.9 mg/kg n=9 Participants Part 1 cohort 2; dalantercept 0.9 mg/kg plus axitinib 5 mg PO BID	Part 1 Dalantercept 1.2 mg/kg n=14 Participants Part 1 cohort 3; dalantercept 1.2 mg/kg plus axitinib 5 mg PO BID	Part 1 Dalantercept 1.5 mg/kg Part 1 cohort 1; dalantercept 1.5 mg/kg plus axitinib 5 mg PO BID
Part 1: Number of Participants With Adverse Events as a Measure of Safety and Tolerability.	6 Participants	9 Participants	14 Participants	—

PRIMARY outcome

Timeframe: Progression free survival is defined as the time from the date of the randomization to the first documented disease progression (according to RECIST v1.1) or death due to any cause. The Time frame for Part 2 was up to 29.0 months

Population: The All Treated Set (ATS) included all randomized patients who received any study drug

PFS was defined as the time from randomization to the date of first documentation of disease progression based on RECIST (version 1.1) or to death due to any cause, whichever occurred first. Disease progression is defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study.

RECIST 1.1 defines disease progression as an increase of at least a 20% in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered progression)

Outcome measures

Measure	Part 1 Dalantercept 0.6 mg/kg n=58 Participants Part 1 cohort 1; dalantercept 0.6 mg/kg plus axitinib 5 mg PO BID	Part 1 Dalantercept 0.9 mg/kg n=61 Participants Part 1 cohort 2; dalantercept 0.9 mg/kg plus axitinib 5 mg PO BID	Part 1 Dalantercept 1.2 mg/kg Part 1 cohort 3; dalantercept 1.2 mg/kg plus axitinib 5 mg PO BID	Part 1 Dalantercept 1.5 mg/kg Part 1 cohort 1; dalantercept 1.5 mg/kg plus axitinib 5 mg PO BID
Part 2: Progression Free Survival (PFS).	6.8 Months Interval 4.5 to 9.4	5.6 Months Interval 3.3 to 8.3	—	—

SECONDARY outcome

Timeframe: The time frame for Part 1 of the study was up to 21.6 months

Population: Full Analysis Set; all subjects randomized in Part 1 of the study

PFS was defined as the time from randomization to the date of first documentation of disease progression based on RECIST (version 1.1) or to death due to any cause, whichever occurred first. Disease progression is defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study.

Outcome measures

Measure	Part 1 Dalantercept 0.6 mg/kg n=6 Participants Part 1 cohort 1; dalantercept 0.6 mg/kg plus axitinib 5 mg PO BID	Part 1 Dalantercept 0.9 mg/kg n=9 Participants Part 1 cohort 2; dalantercept 0.9 mg/kg plus axitinib 5 mg PO BID	Part 1 Dalantercept 1.2 mg/kg n=14 Participants Part 1 cohort 3; dalantercept 1.2 mg/kg plus axitinib 5 mg PO BID	Part 1 Dalantercept 1.5 mg/kg Part 1 cohort 1; dalantercept 1.5 mg/kg plus axitinib 5 mg PO BID
Part 1: Progression Free Survival (PFS).	5.5 Months Interval 1.3 to 20.6	21.6 Months Interval 2.8 to 21.6	6.9 Months Interval 2.7 to 20.7	—

SECONDARY outcome

Timeframe: Up to 21.6 months

Population: Full Analysis Set; all subjects randomized in Part 1 of the study

Percentage of Part 1 subjects alive at the end of Part 1 of the study. [The time frame for Part 1 of the study was up to 21.6 months]

Outcome measures

Measure	Part 1 Dalantercept 0.6 mg/kg n=6 Participants Part 1 cohort 1; dalantercept 0.6 mg/kg plus axitinib 5 mg PO BID	Part 1 Dalantercept 0.9 mg/kg n=9 Participants Part 1 cohort 2; dalantercept 0.9 mg/kg plus axitinib 5 mg PO BID	Part 1 Dalantercept 1.2 mg/kg n=14 Participants Part 1 cohort 3; dalantercept 1.2 mg/kg plus axitinib 5 mg PO BID	Part 1 Dalantercept 1.5 mg/kg Part 1 cohort 1; dalantercept 1.5 mg/kg plus axitinib 5 mg PO BID
Part 1: Overall Survival (OS). [The Time Frame for Part 1 of the Study Was up to 21.6 Months]	4 Participants	7 Participants	9 Participants	—

SECONDARY outcome

Timeframe: Up to 21.6 months from randomization in Part 1 of the study

Population: Full Analysis Set; all subjects randomized in Part 1 of the study

Objective response rate (ORR) is defined as the number and percentage of patients who have a partial response (PR) or complete response (CR) to therapy. A CR is defined as the disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. A PR is defined as a decrease of at least a 30% in the sum of diameters of target lesions, taking as reference the baseline sum diameters. As no subjects in Part 1 experienced a CR, the ORR in Part 1 is defined by the PR

Outcome measures

Measure	Part 1 Dalantercept 0.6 mg/kg n=6 Participants Part 1 cohort 1; dalantercept 0.6 mg/kg plus axitinib 5 mg PO BID	Part 1 Dalantercept 0.9 mg/kg n=9 Participants Part 1 cohort 2; dalantercept 0.9 mg/kg plus axitinib 5 mg PO BID	Part 1 Dalantercept 1.2 mg/kg n=14 Participants Part 1 cohort 3; dalantercept 1.2 mg/kg plus axitinib 5 mg PO BID	Part 1 Dalantercept 1.5 mg/kg Part 1 cohort 1; dalantercept 1.5 mg/kg plus axitinib 5 mg PO BID
Part 1: Objective Response Rate (ORR)	2 Participants	3 Participants	2 Participants	—

SECONDARY outcome

Timeframe: From randomization up to 21.6 months in Part 1 of the study

The number and percentage of patients whose disease shrinks or remains stable. DCR is the sum of the complete, partial and stable disease rates.

Outcome measures

Measure	Part 1 Dalantercept 0.6 mg/kg n=6 Participants Part 1 cohort 1; dalantercept 0.6 mg/kg plus axitinib 5 mg PO BID	Part 1 Dalantercept 0.9 mg/kg n=9 Participants Part 1 cohort 2; dalantercept 0.9 mg/kg plus axitinib 5 mg PO BID	Part 1 Dalantercept 1.2 mg/kg n=14 Participants Part 1 cohort 3; dalantercept 1.2 mg/kg plus axitinib 5 mg PO BID	Part 1 Dalantercept 1.5 mg/kg Part 1 cohort 1; dalantercept 1.5 mg/kg plus axitinib 5 mg PO BID
Part 1: Disease Control Rate (DCR)	3 Participants	5 Participants	6 Participants	—

SECONDARY outcome

Timeframe: From randomization up to 21.6 months in Part 1 of the study.

Population: Full Analysis Set; all subjects randomized in Part 1 of the study

Response duration is measured from the time measurement criteria are first met for objective response until the first date that recurrent or progressive disease is objectively documented (taking as reference for progressive disease the smallest measurements recorded on study.

Outcome measures

Measure	Part 1 Dalantercept 0.6 mg/kg n=6 Participants Part 1 cohort 1; dalantercept 0.6 mg/kg plus axitinib 5 mg PO BID	Part 1 Dalantercept 0.9 mg/kg n=9 Participants Part 1 cohort 2; dalantercept 0.9 mg/kg plus axitinib 5 mg PO BID	Part 1 Dalantercept 1.2 mg/kg n=14 Participants Part 1 cohort 3; dalantercept 1.2 mg/kg plus axitinib 5 mg PO BID	Part 1 Dalantercept 1.5 mg/kg Part 1 cohort 1; dalantercept 1.5 mg/kg plus axitinib 5 mg PO BID
Part 1: Duration of Response (DoR)	3 months Interval 2.8 to 21.6	6.9 months Interval 6.9 to 21.6	10 months Interval 8.8 to 11.1	—

SECONDARY outcome

Timeframe: Progression free survival is defined as the time from the date of the randomization to the first documented disease progression (according to RECIST v1.1) or death due to any cause. The Time frame for Part 2 was up to 29.0 months

Population: Subgroup of Part 2 participants: 24 of 63 participants in the dalantercept arm and 22 of 68 participants in the placebo arm had at least 2 lines of prior systemic chemotherapy

Progression Free Survival (PFS) for the subset of participants with 2 or more lines of prior systemic chemotherapy. PFS was based upon RECIST 1.1 assessment, as described in outcome measure 2.

Outcome measures

Measure	Part 1 Dalantercept 0.6 mg/kg n=24 Participants Part 1 cohort 1; dalantercept 0.6 mg/kg plus axitinib 5 mg PO BID	Part 1 Dalantercept 0.9 mg/kg n=22 Participants Part 1 cohort 2; dalantercept 0.9 mg/kg plus axitinib 5 mg PO BID	Part 1 Dalantercept 1.2 mg/kg Part 1 cohort 3; dalantercept 1.2 mg/kg plus axitinib 5 mg PO BID	Part 1 Dalantercept 1.5 mg/kg Part 1 cohort 1; dalantercept 1.5 mg/kg plus axitinib 5 mg PO BID
Part 2: Progression Free Survival (PFS) for the Subset of Participants With 2 or More Lines of Prior Systemic Chemotherapy	8.1 Months Interval 3.6 to 10.5	7.0 Months Interval 2.8 to 9.5	—	—

SECONDARY outcome

Timeframe: Patients to be contacted every 3 months for up to 12 months (anticipated) for survival follow-up, as well as tumor assessment scans if progression of disease has not previously been documented. The time frame for Part 2 was up to 29.0 months

Population: The All Treated Set (ATS) included all randomized patients who received any study drug

The number of months from the date of randomization to the date of death.

Outcome measures

Measure	Part 1 Dalantercept 0.6 mg/kg n=58 Participants Part 1 cohort 1; dalantercept 0.6 mg/kg plus axitinib 5 mg PO BID	Part 1 Dalantercept 0.9 mg/kg n=61 Participants Part 1 cohort 2; dalantercept 0.9 mg/kg plus axitinib 5 mg PO BID	Part 1 Dalantercept 1.2 mg/kg Part 1 cohort 3; dalantercept 1.2 mg/kg plus axitinib 5 mg PO BID	Part 1 Dalantercept 1.5 mg/kg Part 1 cohort 1; dalantercept 1.5 mg/kg plus axitinib 5 mg PO BID
Part 2: Overall Survival.	13.0 Months Interval 9.3 to 14.5	14.7 Months Interval 7.3 to 20.0	—	—

SECONDARY outcome

Timeframe: Assessed at 30 days after last dose of study drug; up to 29.0 months for Part 2 of the study

Population: The All Treated Set (ATS) included all randomized patients who received any study drug

Objective response rate (ORR) is defined as the number and percentage of patients who have a partial response (PR) or complete response (CR) to therapy. A CR is defined as the disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. A PR is defined as a decrease of at least a 30% in the sum of diameters of target lesions, taking as reference the baseline sum diameters.

Outcome measures

Measure	Part 1 Dalantercept 0.6 mg/kg n=58 Participants Part 1 cohort 1; dalantercept 0.6 mg/kg plus axitinib 5 mg PO BID	Part 1 Dalantercept 0.9 mg/kg n=61 Participants Part 1 cohort 2; dalantercept 0.9 mg/kg plus axitinib 5 mg PO BID	Part 1 Dalantercept 1.2 mg/kg Part 1 cohort 3; dalantercept 1.2 mg/kg plus axitinib 5 mg PO BID	Part 1 Dalantercept 1.5 mg/kg Part 1 cohort 1; dalantercept 1.5 mg/kg plus axitinib 5 mg PO BID
Part 2: Objective Response Rate.	11 Participants	15 Participants	—	—

SECONDARY outcome

Timeframe: Assessed at 30 days after the last dose of study drug; up to 29.0 months for Part 2 of the study.

Population: The All Treatment Set (ATS) included all randomized patients who received any study drug. Please see Outcome Measure 5 for Objective Response Rate data. Since there were too few participants with events, an estimation of response duration was not able to be calculated due to the early termination of the study.

Response duration is measured from the time measurement criteria are first met for objective response until the first date that recurrent or progressive disease is objectively documented (taking as reference for progressive disease the smallest measurements recorded on study.

Outcome measures

Measure	Part 1 Dalantercept 0.6 mg/kg n=58 Participants Part 1 cohort 1; dalantercept 0.6 mg/kg plus axitinib 5 mg PO BID	Part 1 Dalantercept 0.9 mg/kg n=61 Participants Part 1 cohort 2; dalantercept 0.9 mg/kg plus axitinib 5 mg PO BID	Part 1 Dalantercept 1.2 mg/kg Part 1 cohort 3; dalantercept 1.2 mg/kg plus axitinib 5 mg PO BID	Part 1 Dalantercept 1.5 mg/kg Part 1 cohort 1; dalantercept 1.5 mg/kg plus axitinib 5 mg PO BID
Part 2: Duration of Response	NA Months too few participants with events were available for an estimation of response duration due to the early termination of the study	NA Months too few participants with events were available for an estimation of response duration due to the early termination of the study	—	—

SECONDARY outcome

Timeframe: Assessed at 30 days after last dose of study drug. The time frame for Part 2 was up to 29.0 months

Population: The All Treated Set (ATS) included all randomized patients who received any study drug

The number and percentage of patients whose disease shrinks or remains stable. DCR is the sum of the complete, partial and stable disease rates.

Outcome measures

Measure	Part 1 Dalantercept 0.6 mg/kg n=58 Participants Part 1 cohort 1; dalantercept 0.6 mg/kg plus axitinib 5 mg PO BID	Part 1 Dalantercept 0.9 mg/kg n=61 Participants Part 1 cohort 2; dalantercept 0.9 mg/kg plus axitinib 5 mg PO BID	Part 1 Dalantercept 1.2 mg/kg Part 1 cohort 3; dalantercept 1.2 mg/kg plus axitinib 5 mg PO BID	Part 1 Dalantercept 1.5 mg/kg Part 1 cohort 1; dalantercept 1.5 mg/kg plus axitinib 5 mg PO BID
Part 2: Disease Control Rate.	48 Participants	50 Participants	—	—

OTHER_PRE_SPECIFIED outcome

Timeframe: From randomization up to 21.6 months in Part 1 of the study

Population: All subjects randomized to Part 1 of the study and treated with at least 1 dose of dalantercept. Given the high degree of variability in serum BMP9 levels in study subjects \[Baseline value 23.55 ng/mL (SD 20.54 ng/mL)\] and the relative small numbers of subjects in each treatment arm, it was decided that the best way to understand a treatment effect was to conduct a pooled analysis of all 29 Part 1 subjects for the comparison of change from Baseline.

Exploratory analysis. Absolute change from baseline in serum Bone Morphogenetic Protein 9 (BMP9)

Outcome measures

Measure	Part 1 Dalantercept 0.6 mg/kg n=29 Participants Part 1 cohort 1; dalantercept 0.6 mg/kg plus axitinib 5 mg PO BID	Part 1 Dalantercept 0.9 mg/kg Part 1 cohort 2; dalantercept 0.9 mg/kg plus axitinib 5 mg PO BID	Part 1 Dalantercept 1.2 mg/kg Part 1 cohort 3; dalantercept 1.2 mg/kg plus axitinib 5 mg PO BID	Part 1 Dalantercept 1.5 mg/kg Part 1 cohort 1; dalantercept 1.5 mg/kg plus axitinib 5 mg PO BID
Part 1: Exploratory PD - Serum BMP9	-11.5 ng/mL Standard Deviation 2.58	—	—	—

OTHER_PRE_SPECIFIED outcome

Timeframe: Assessed at 30 days after the last dose of dalantercept ± 10 days. The time frame for Part 2 was up to 29.0 months.

Population: The All Treated Set (ATS) included all randomized patients who received any study drug, and for whom sufficient blood sample was available to assess the exploratory biomarker.

Exploratory analysis. Absolute change from baseline in serum Bone Morphogenetic Protein 9 (BMP9)

Outcome measures

Measure	Part 1 Dalantercept 0.6 mg/kg n=45 Participants Part 1 cohort 1; dalantercept 0.6 mg/kg plus axitinib 5 mg PO BID	Part 1 Dalantercept 0.9 mg/kg n=46 Participants Part 1 cohort 2; dalantercept 0.9 mg/kg plus axitinib 5 mg PO BID	Part 1 Dalantercept 1.2 mg/kg Part 1 cohort 3; dalantercept 1.2 mg/kg plus axitinib 5 mg PO BID	Part 1 Dalantercept 1.5 mg/kg Part 1 cohort 1; dalantercept 1.5 mg/kg plus axitinib 5 mg PO BID
Part 2: PD Biomarker Activities.	-53.34 pg/mL Standard Deviation 37.87	8.55 pg/mL Standard Deviation 86.32	—	—

Adverse Events

Part 1: Dalantercept 0.6 mg/kg

Serious events: 2 serious events

Other events: 6 other events

Deaths: 2 deaths

Part 1: Dalantercept 0.9 mg/kg

Serious events: 1 serious events

Other events: 9 other events

Deaths: 2 deaths

Part 1: Dalantercept 1.2 mg/kg

Serious events: 6 serious events

Other events: 14 other events

Deaths: 5 deaths

Part 1: Dalantercept 1.5 mg/kg

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Part 2: Dalantercept 0.9 mg/kg Plus Axitinib

Serious events: 19 serious events

Other events: 61 other events

Deaths: 20 deaths

Part 2: Placebo Plus Axitinib

Serious events: 16 serious events

Other events: 64 other events

Deaths: 16 deaths

Serious adverse events

Measure	Part 1: Dalantercept 0.6 mg/kg n=6 participants at risk Part 1 cohort 1: dalantercept 0.6 mg/kg plus axitinib 5 mg PO BID	Part 1: Dalantercept 0.9 mg/kg n=9 participants at risk Part 1 cohort 1: dalantercept 0.9 mg/kg plus axitinib 5 mg PO BID	Part 1: Dalantercept 1.2 mg/kg n=14 participants at risk Part 1 cohort 1: dalantercept 1.2 mg/kg plus axitinib 5 mg PO BID	Part 1: Dalantercept 1.5 mg/kg Part 1 cohort 1: dalantercept 1.5 mg/kg plus axitinib 5 mg PO BID	Part 2: Dalantercept 0.9 mg/kg Plus Axitinib n=62 participants at risk Subcutaneous (SC) injection of Dalantercept 0.9 mg/kg once every 3 weeks and oral axitinib 5 mg BID for continuous dosing.	Part 2: Placebo Plus Axitinib n=64 participants at risk Subcutaneous injection of normal saline once every 3 weeks and oral axitinib 5 mg BID for continuous dosing
Infections and infestations pneumonia	0.00% 0/6 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	0.00% 0/9 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	0.00% 0/14 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	— 0/0 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	3.2% 2/62 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	0.00% 0/64 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events
Infections and infestations Anorectal infection	0.00% 0/6 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	0.00% 0/9 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	0.00% 0/14 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	— 0/0 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	1.6% 1/62 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	0.00% 0/64 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events
Infections and infestations Diverticulitis	0.00% 0/6 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	0.00% 0/9 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	0.00% 0/14 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	— 0/0 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	1.6% 1/62 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	0.00% 0/64 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events
Infections and infestations Gastroenteritis	0.00% 0/6 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	0.00% 0/9 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	0.00% 0/14 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	— 0/0 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	1.6% 1/62 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	0.00% 0/64 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events
Infections and infestations Skin infection	0.00% 0/6 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	0.00% 0/9 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	0.00% 0/14 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	— 0/0 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	0.00% 0/62 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	1.6% 1/64 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events
Infections and infestations Upper respiratory tract infection	0.00% 0/6 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	0.00% 0/9 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	0.00% 0/14 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	— 0/0 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	0.00% 0/62 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	1.6% 1/64 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events
General disorders Disease progression	0.00% 0/6 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	0.00% 0/9 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	0.00% 0/14 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	— 0/0 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	1.6% 1/62 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	1.6% 1/64 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events
General disorders Non-cardiac chest pain	0.00% 0/6 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	0.00% 0/9 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	0.00% 0/14 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	— 0/0 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	3.2% 2/62 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	0.00% 0/64 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events
General disorders Oedema peripheral	0.00% 0/6 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	0.00% 0/9 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	7.1% 1/14 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	— 0/0 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	0.00% 0/62 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	1.6% 1/64 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events
General disorders Pain	0.00% 0/6 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	0.00% 0/9 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	0.00% 0/14 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	— 0/0 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	0.00% 0/62 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	1.6% 1/64 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events
Respiratory, thoracic and mediastinal disorders PLeural effusion	0.00% 0/6 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	0.00% 0/9 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	0.00% 0/14 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	— 0/0 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	4.8% 3/62 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	0.00% 0/64 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	16.7% 1/6 • Number of events 1 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	0.00% 0/9 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	0.00% 0/14 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	— 0/0 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	1.6% 1/62 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	1.6% 1/64 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events
Respiratory, thoracic and mediastinal disorders Epistaxis	0.00% 0/6 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	0.00% 0/9 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	0.00% 0/14 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	— 0/0 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	1.6% 1/62 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	0.00% 0/64 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events
Respiratory, thoracic and mediastinal disorders Hypoxia	0.00% 0/6 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	0.00% 0/9 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	0.00% 0/14 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	— 0/0 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	1.6% 1/62 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	0.00% 0/64 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events
Respiratory, thoracic and mediastinal disorders Pneumothorax	0.00% 0/6 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	0.00% 0/9 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	0.00% 0/14 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	— 0/0 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	1.6% 1/62 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	0.00% 0/64 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events
Gastrointestinal disorders Abdominal pain	0.00% 0/6 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	0.00% 0/9 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	0.00% 0/14 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	— 0/0 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	0.00% 0/62 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	1.6% 1/64 • Number of events 1 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events
Gastrointestinal disorders Anal ulcer	0.00% 0/6 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	0.00% 0/9 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	0.00% 0/14 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	— 0/0 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	0.00% 0/62 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	1.6% 1/64 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events
Gastrointestinal disorders Obstruction gastric	0.00% 0/6 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	0.00% 0/9 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	0.00% 0/14 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	— 0/0 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	0.00% 0/62 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	1.6% 1/64 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events
Gastrointestinal disorders Mouth haemorrhage	0.00% 0/6 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	0.00% 0/9 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	0.00% 0/14 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	— 0/0 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	1.6% 1/62 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	0.00% 0/64 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events
Gastrointestinal disorders Pancreatitus	0.00% 0/6 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	0.00% 0/9 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	0.00% 0/14 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	— 0/0 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	0.00% 0/62 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	1.6% 1/64 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events
Metabolism and nutrition disorders Dehydration	0.00% 0/6 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	0.00% 0/9 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	0.00% 0/14 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	— 0/0 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	0.00% 0/62 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	1.6% 1/64 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events
Metabolism and nutrition disorders Diabetes mellitus	0.00% 0/6 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	0.00% 0/9 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	0.00% 0/14 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	— 0/0 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	1.6% 1/62 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	0.00% 0/64 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events
Metabolism and nutrition disorders Hypoglycaemia	0.00% 0/6 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	0.00% 0/9 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	0.00% 0/14 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	— 0/0 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	1.6% 1/62 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	0.00% 0/64 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events
Metabolism and nutrition disorders Hyponatraemia	0.00% 0/6 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	0.00% 0/9 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	0.00% 0/14 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	— 0/0 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	0.00% 0/62 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	1.6% 1/64 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events
Nervous system disorders Peripheral motor neuropathy	0.00% 0/6 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	0.00% 0/9 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	0.00% 0/14 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	— 0/0 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	1.6% 1/62 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	0.00% 0/64 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events
Nervous system disorders Spinal cord compression	0.00% 0/6 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	0.00% 0/9 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	0.00% 0/14 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	— 0/0 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	0.00% 0/62 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	1.6% 1/64 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events
Nervous system disorders Transient ischaemic attack	0.00% 0/6 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	0.00% 0/9 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	0.00% 0/14 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	— 0/0 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	0.00% 0/62 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	1.6% 1/64 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events
Renal and urinary disorders Renal failure acute	0.00% 0/6 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	0.00% 0/9 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	14.3% 2/14 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	— 0/0 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	3.2% 2/62 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	1.6% 1/64 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events
Cardiac disorders Acute myocardial infarction	0.00% 0/6 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	0.00% 0/9 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	0.00% 0/14 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	— 0/0 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	0.00% 0/62 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	1.6% 1/64 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events
Cardiac disorders Sinus bradycardia	0.00% 0/6 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	0.00% 0/9 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	0.00% 0/14 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	— 0/0 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	0.00% 0/62 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	1.6% 1/64 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/6 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	0.00% 0/9 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	0.00% 0/14 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	— 0/0 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	0.00% 0/62 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	3.1% 2/64 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Hodgkin's disease	0.00% 0/6 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	0.00% 0/9 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	0.00% 0/14 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	— 0/0 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	1.6% 1/62 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	0.00% 0/64 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumour thrombosis	0.00% 0/6 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	0.00% 0/9 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	0.00% 0/14 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	— 0/0 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	0.00% 0/62 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	1.6% 1/64 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events
Hepatobiliary disorders Periportal oedema	0.00% 0/6 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	0.00% 0/9 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	0.00% 0/14 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	— 0/0 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	0.00% 0/62 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	1.6% 1/64 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events
Vascular disorders Hypertension	0.00% 0/6 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	0.00% 0/9 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	0.00% 0/14 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	— 0/0 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	1.6% 1/62 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	0.00% 0/64 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events
Respiratory, thoracic and mediastinal disorders Dyspnea	16.7% 1/6 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	0.00% 0/9 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	7.1% 1/14 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	— 0/0 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	0.00% 0/58 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	0.00% 0/61 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events
Nervous system disorders Convulsion	0.00% 0/6 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	11.1% 1/9 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	0.00% 0/14 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	— 0/0 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	0.00% 0/62 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	0.00% 0/64 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events
Gastrointestinal disorders Bile duct stenosis	0.00% 0/6 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	0.00% 0/9 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	7.1% 1/14 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	— 0/0 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	0.00% 0/62 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	0.00% 0/64 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events
General disorders Gate disturbance	0.00% 0/6 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	0.00% 0/9 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	0.00% 0/14 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	— 0/0 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	0.00% 0/62 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	0.00% 0/64 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events
Injury, poisoning and procedural complications Soft tissue injury	0.00% 0/6 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	0.00% 0/9 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	7.1% 1/14 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	— 0/0 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	0.00% 0/62 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	0.00% 0/64 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events
Gastrointestinal disorders Transaminase increase	0.00% 0/6 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	0.00% 0/9 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	7.1% 1/14 • Number of events 1 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	— 0/0 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	0.00% 0/62 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	0.00% 0/64 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events

Other adverse events

Measure	Part 1: Dalantercept 0.6 mg/kg n=6 participants at risk Part 1 cohort 1: dalantercept 0.6 mg/kg plus axitinib 5 mg PO BID	Part 1: Dalantercept 0.9 mg/kg n=9 participants at risk Part 1 cohort 1: dalantercept 0.9 mg/kg plus axitinib 5 mg PO BID	Part 1: Dalantercept 1.2 mg/kg n=14 participants at risk Part 1 cohort 1: dalantercept 1.2 mg/kg plus axitinib 5 mg PO BID	Part 1: Dalantercept 1.5 mg/kg Part 1 cohort 1: dalantercept 1.5 mg/kg plus axitinib 5 mg PO BID	Part 2: Dalantercept 0.9 mg/kg Plus Axitinib n=62 participants at risk Subcutaneous (SC) injection of Dalantercept 0.9 mg/kg once every 3 weeks and oral axitinib 5 mg BID for continuous dosing.	Part 2: Placebo Plus Axitinib n=64 participants at risk Subcutaneous injection of normal saline once every 3 weeks and oral axitinib 5 mg BID for continuous dosing
Gastrointestinal disorders Diarrhoea	33.3% 2/6 • Number of events 2 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	44.4% 4/9 • Number of events 4 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	42.9% 6/14 • Number of events 6 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	— 0/0 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	87.1% 54/62 • Number of events 54 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	85.9% 55/64 • Number of events 55 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events
Gastrointestinal disorders Nausea	33.3% 2/6 • Number of events 2 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	33.3% 3/9 • Number of events 3 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	21.4% 3/14 • Number of events 3 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	— 0/0 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	61.3% 38/62 • Number of events 38 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	62.5% 40/64 • Number of events 40 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events
Gastrointestinal disorders Constipation	16.7% 1/6 • Number of events 1 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	33.3% 3/9 • Number of events 3 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	0.00% 0/14 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	— 0/0 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	38.7% 24/62 • Number of events 24 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	43.8% 28/64 • Number of events 28 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events
Gastrointestinal disorders Vomiting	0.00% 0/6 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	0.00% 0/9 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	0.00% 0/14 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	— 0/0 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	29.0% 18/62 • Number of events 18 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	28.1% 18/64 • Number of events 18 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events
Gastrointestinal disorders Abdominal pain	0.00% 0/6 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	11.1% 1/9 • Number of events 1 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	21.4% 3/14 • Number of events 3 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	— 0/0 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	21.0% 13/62 • Number of events 13 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	25.0% 16/64 • Number of events 16 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events
Gastrointestinal disorders Stomatitis	0.00% 0/6 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	0.00% 0/9 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	0.00% 0/14 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	— 0/0 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	12.9% 8/62 • Number of events 8 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	23.4% 15/64 • Number of events 15 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events
Gastrointestinal disorders Dyspepsia	0.00% 0/6 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	0.00% 0/9 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	0.00% 0/14 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	— 0/0 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	9.7% 6/62 • Number of events 6 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	12.5% 8/64 • Number of events 8 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events
Gastrointestinal disorders Abdominal pain upper	0.00% 0/6 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	11.1% 1/9 • Number of events 1 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	21.4% 3/14 • Number of events 3 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	— 0/0 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	6.5% 4/62 • Number of events 4 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	7.8% 5/64 • Number of events 5 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events
Gastrointestinal disorders Oral pain	0.00% 0/6 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	0.00% 0/9 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	0.00% 0/14 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	— 0/0 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	9.7% 6/62 • Number of events 6 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	4.7% 3/64 • Number of events 3 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events
Gastrointestinal disorders Dry mouth	0.00% 0/6 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	0.00% 0/9 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	0.00% 0/14 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	— 0/0 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	11.3% 7/62 • Number of events 7 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	1.6% 1/64 • Number of events 1 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events
Gastrointestinal disorders Dysphagia	0.00% 0/6 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	0.00% 0/9 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	0.00% 0/14 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	— 0/0 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	3.2% 2/62 • Number of events 2 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	7.8% 5/64 • Number of events 5 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events
Gastrointestinal disorders Flatulence	0.00% 0/6 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	0.00% 0/9 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	0.00% 0/14 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	— 0/0 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	4.8% 3/62 • Number of events 3 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	6.2% 4/64 • Number of events 4 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events
General disorders Fatigue	66.7% 4/6 • Number of events 4 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	55.6% 5/9 • Number of events 5 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	71.4% 10/14 • Number of events 10 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	— 0/0 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	56.5% 35/62 • Number of events 35 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	73.4% 47/64 • Number of events 47 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events
General disorders Chills	0.00% 0/6 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	0.00% 0/9 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	0.00% 0/14 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	— 0/0 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	12.9% 8/62 • Number of events 8 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	7.8% 5/64 • Number of events 5 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events
General disorders Oedema peripheral	0.00% 0/6 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	33.3% 3/9 • Number of events 3 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	42.9% 6/14 • Number of events 6 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	— 0/0 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	38.7% 24/62 • Number of events 24 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	21.9% 14/64 • Number of events 14 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events
General disorders Non-cardiac chest pain	0.00% 0/6 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	0.00% 0/9 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	0.00% 0/14 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	— 0/0 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	9.7% 6/62 • Number of events 6 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	9.4% 6/64 • Number of events 6 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events
General disorders Pyrexia	0.00% 0/6 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	0.00% 0/9 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	0.00% 0/14 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	— 0/0 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	11.3% 7/62 • Number of events 7 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	7.8% 5/64 • Number of events 5 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events
General disorders Mucosal inflammation	0.00% 0/6 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	0.00% 0/9 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	0.00% 0/14 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	— 0/0 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	11.3% 7/62 • Number of events 7 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	4.7% 3/64 • Number of events 3 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events
Respiratory, thoracic and mediastinal disorders Dysphonia	16.7% 1/6 • Number of events 1 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	11.1% 1/9 • Number of events 1 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	21.4% 3/14 • Number of events 3 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	— 0/0 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	17.7% 11/62 • Number of events 11 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	39.1% 25/64 • Number of events 25 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events
Respiratory, thoracic and mediastinal disorders Epistaxis	16.7% 1/6 • Number of events 1 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	11.1% 1/9 • Number of events 1 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	28.6% 4/14 • Number of events 4 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	— 0/0 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	38.7% 24/62 • Number of events 24 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	12.5% 8/64 • Number of events 8 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events
Respiratory, thoracic and mediastinal disorders Cough	0.00% 0/6 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	0.00% 0/9 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	0.00% 0/14 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	— 0/0 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	25.8% 16/62 • Number of events 16 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	20.3% 13/64 • Number of events 13 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	0.00% 0/6 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	0.00% 0/9 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	0.00% 0/14 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	— 0/0 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	11.3% 7/62 • Number of events 7 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	12.5% 8/64 • Number of events 8 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events
Respiratory, thoracic and mediastinal disorders Nasal congestion	0.00% 0/6 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	0.00% 0/9 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	0.00% 0/14 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	— 0/0 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	9.7% 6/62 • Number of events 6 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	10.9% 7/64 • Number of events 7 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.00% 0/6 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	11.1% 1/9 • Number of events 1 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	21.4% 3/14 • Number of events 3 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	— 0/0 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	9.7% 6/62 • Number of events 6 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	4.7% 3/64 • Number of events 3 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events
Respiratory, thoracic and mediastinal disorders Dyspnoea exertional	16.7% 1/6 • Number of events 1 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	11.1% 1/9 • Number of events 1 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	21.4% 3/14 • Number of events 3 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	— 0/0 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	6.5% 4/62 • Number of events 4 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	4.7% 3/64 • Number of events 3 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/6 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	22.2% 2/9 • Number of events 2 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	21.4% 3/14 • Number of events 3 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	— 0/0 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	27.4% 17/62 • Number of events 17 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	29.7% 19/64 • Number of events 19 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/6 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	0.00% 0/9 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	0.00% 0/14 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	— 0/0 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	16.1% 10/62 • Number of events 10 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	21.9% 14/64 • Number of events 14 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events
Musculoskeletal and connective tissue disorders Myalgia	0.00% 0/6 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	0.00% 0/9 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	0.00% 0/14 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	— 0/0 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	22.6% 14/62 • Number of events 14 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	14.1% 9/64 • Number of events 9 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events
Musculoskeletal and connective tissue disorders Muscle spasms	33.3% 2/6 • Number of events 2 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	0.00% 0/9 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	14.3% 2/14 • Number of events 2 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	— 0/0 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	11.3% 7/62 • Number of events 7 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	15.6% 10/64 • Number of events 10 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events
Musculoskeletal and connective tissue disorders Pain in extremity	0.00% 0/6 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	0.00% 0/9 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	0.00% 0/14 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	— 0/0 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	14.5% 9/62 • Number of events 9 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	6.2% 4/64 • Number of events 4 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events
Musculoskeletal and connective tissue disorders Muscular weakness	0.00% 0/6 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	0.00% 0/9 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	0.00% 0/14 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	— 0/0 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	6.5% 4/62 • Number of events 4 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	9.4% 6/64 • Number of events 6 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events
Musculoskeletal and connective tissue disorders Musculoskeletal chest pain	0.00% 0/6 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	0.00% 0/9 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	0.00% 0/14 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	— 0/0 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	4.8% 3/62 • Number of events 3 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	10.9% 7/64 • Number of events 7 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events
Investigations Lipase increased	0.00% 0/6 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	0.00% 0/9 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	0.00% 0/14 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	— 0/0 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	11.3% 7/62 • Number of events 7 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	7.8% 5/64 • Number of events 5 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events
Musculoskeletal and connective tissue disorders Musculoskeletal pain	0.00% 0/6 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	0.00% 0/9 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	0.00% 0/14 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	— 0/0 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	4.8% 3/62 • Number of events 3 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	10.9% 7/64 • Number of events 7 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events
Musculoskeletal and connective tissue disorders Flank pain	0.00% 0/6 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	0.00% 0/9 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	0.00% 0/14 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	— 0/0 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	3.2% 2/62 • Number of events 2 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	7.8% 5/64 • Number of events 5 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events
Musculoskeletal and connective tissue disorders Neck pain	0.00% 0/6 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	0.00% 0/9 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	0.00% 0/14 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	— 0/0 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	6.5% 4/62 • Number of events 4 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	4.7% 3/64 • Number of events 3 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events
Skin and subcutaneous tissue disorders Palmar-plantar erythrodysaesthesia syndrome	0.00% 0/6 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	11.1% 1/9 • Number of events 1 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	21.4% 3/14 • Number of events 3 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	— 0/0 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	24.2% 15/62 • Number of events 15 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	23.4% 15/64 • Number of events 15 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events
Skin and subcutaneous tissue disorders Pruritus	0.00% 0/6 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	0.00% 0/9 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	0.00% 0/14 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	— 0/0 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	6.5% 4/62 • Number of events 4 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	18.8% 12/64 • Number of events 12 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events
Skin and subcutaneous tissue disorders Rash	0.00% 0/6 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	22.2% 2/9 • Number of events 2 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	7.1% 1/14 • Number of events 1 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	— 0/0 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	9.7% 6/62 • Number of events 6 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	12.5% 8/64 • Number of events 8 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events
Skin and subcutaneous tissue disorders Rash maculo-papular	0.00% 0/6 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	0.00% 0/9 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	0.00% 0/14 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	— 0/0 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	9.7% 6/62 • Number of events 6 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	9.4% 6/64 • Number of events 6 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events
Skin and subcutaneous tissue disorders Night sweats	0.00% 0/6 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	0.00% 0/9 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	0.00% 0/14 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	— 0/0 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	8.1% 5/62 • Number of events 5 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	9.4% 6/64 • Number of events 6 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events
Skin and subcutaneous tissue disorders Telangiectasia	0.00% 0/6 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	55.6% 5/9 • Number of events 5 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	7.1% 1/14 • Number of events 1 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	— 0/0 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	9.7% 6/62 • Number of events 6 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	7.8% 5/64 • Number of events 5 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events
Skin and subcutaneous tissue disorders Dry skin	0.00% 0/6 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	0.00% 0/9 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	0.00% 0/14 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	— 0/0 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	3.2% 2/62 • Number of events 2 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	10.9% 7/64 • Number of events 7 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events
Skin and subcutaneous tissue disorders Alopecia	0.00% 0/6 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	0.00% 0/9 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	0.00% 0/14 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	— 0/0 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	1.6% 1/62 • Number of events 1 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	9.4% 6/64 • Number of events 6 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events
Investigations Weight decreased	16.7% 1/6 • Number of events 1 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	11.1% 1/9 • Number of events 1 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	21.4% 3/14 • Number of events 3 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	— 0/0 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	21.0% 13/62 • Number of events 13 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	31.2% 20/64 • Number of events 20 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events
Investigations Blood creatinine increased	0.00% 0/6 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	0.00% 0/9 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	42.9% 6/14 • Number of events 6 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	— 0/0 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	33.9% 21/62 • Number of events 21 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	17.2% 11/64 • Number of events 11 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events
Investigations Aspartate aminotransferase increased	0.00% 0/6 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	0.00% 0/9 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	0.00% 0/14 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	— 0/0 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	8.1% 5/62 • Number of events 5 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	10.9% 7/64 • Number of events 7 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events
Investigations Ejection fraction decreased	0.00% 0/6 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	0.00% 0/9 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	0.00% 0/14 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	— 0/0 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	3.2% 2/62 • Number of events 2 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	14.1% 9/64 • Number of events 9 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events
Investigations Amylase increased	0.00% 0/6 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	0.00% 0/9 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	0.00% 0/14 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	— 0/0 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	8.1% 5/62 • Number of events 5 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	7.8% 5/64 • Number of events 5 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events
Investigations Alanine aminotransferase increased	0.00% 0/6 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	0.00% 0/9 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	0.00% 0/14 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	— 0/0 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	3.2% 2/62 • Number of events 2 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	7.8% 5/64 • Number of events 5 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events
Investigations Weight increased	0.00% 0/6 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	0.00% 0/9 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	0.00% 0/14 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	— 0/0 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	9.7% 6/62 • Number of events 6 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	1.6% 1/64 • Number of events 1 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events
Metabolism and nutrition disorders Decreased appetite	0.00% 0/6 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	0.00% 0/9 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	35.7% 5/14 • Number of events 5 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	— 0/0 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	37.1% 23/62 • Number of events 23 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	31.2% 20/64 • Number of events 20 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events
Metabolism and nutrition disorders Hyponatraemia	0.00% 0/6 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	0.00% 0/9 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	0.00% 0/14 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	— 0/0 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	8.1% 5/62 • Number of events 5 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	20.3% 13/64 • Number of events 13 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events
Metabolism and nutrition disorders Hyperkalaemia	0.00% 0/6 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	0.00% 0/9 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	0.00% 0/14 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	— 0/0 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	11.3% 7/62 • Number of events 7 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	12.5% 8/64 • Number of events 8 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events
Metabolism and nutrition disorders Dehydration	0.00% 0/6 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	0.00% 0/9 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	0.00% 0/14 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	— 0/0 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	9.7% 6/62 • Number of events 6 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	12.5% 8/64 • Number of events 8 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events
Metabolism and nutrition disorders Hypophosphataemia	16.7% 1/6 • Number of events 1 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	0.00% 0/9 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	14.3% 2/14 • Number of events 2 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	— 0/0 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	11.3% 7/62 • Number of events 7 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	9.4% 6/64 • Number of events 6 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events
Nervous system disorders Headache	0.00% 0/6 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	11.1% 1/9 • Number of events 1 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	14.3% 2/14 • Number of events 2 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	— 0/0 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	22.6% 14/62 • Number of events 14 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	32.8% 21/64 • Number of events 21 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events
Nervous system disorders Dizziness	0.00% 0/6 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	0.00% 0/9 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	0.00% 0/14 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	— 0/0 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	11.3% 7/62 • Number of events 7 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	9.4% 6/64 • Number of events 6 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events
Nervous system disorders Dysgeusia	0.00% 0/6 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	0.00% 0/9 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	0.00% 0/14 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	— 0/0 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	6.5% 4/62 • Number of events 4 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	9.4% 6/64 • Number of events 6 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events
Vascular disorders Hypertension	0.00% 0/6 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	22.2% 2/9 • Number of events 2 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	7.1% 1/14 • Number of events 1 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	— 0/0 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	21.0% 13/62 • Number of events 13 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	46.9% 30/64 • Number of events 30 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events
Infections and infestations Upper respiratory tract infection	0.00% 0/6 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	0.00% 0/9 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	0.00% 0/14 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	— 0/0 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	3.2% 2/62 • Number of events 2 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	9.4% 6/64 • Number of events 6 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events
Infections and infestations Sinusitis	0.00% 0/6 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	0.00% 0/9 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	0.00% 0/14 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	— 0/0 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	6.5% 4/62 • Number of events 4 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	4.7% 3/64 • Number of events 3 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events
Infections and infestations Urinary tract infection	0.00% 0/6 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	0.00% 0/9 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	0.00% 0/14 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	— 0/0 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	4.8% 3/62 • Number of events 3 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	6.2% 4/64 • Number of events 4 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events
Renal and urinary disorders Proteinuria	0.00% 0/6 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	0.00% 0/9 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	0.00% 0/14 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	— 0/0 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	6.5% 4/62 • Number of events 4 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	17.2% 11/64 • Number of events 11 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events
Renal and urinary disorders Pollakiuria	0.00% 0/6 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	0.00% 0/9 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	0.00% 0/14 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	— 0/0 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	14.5% 9/62 • Number of events 9 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	3.1% 2/64 • Number of events 2 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events
Psychiatric disorders Insomnia	0.00% 0/6 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	0.00% 0/9 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	0.00% 0/14 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	— 0/0 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	6.5% 4/62 • Number of events 4 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	14.1% 9/64 • Number of events 9 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events
Psychiatric disorders Depression	0.00% 0/6 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	0.00% 0/9 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	0.00% 0/14 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	— 0/0 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	9.7% 6/62 • Number of events 6 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	7.8% 5/64 • Number of events 5 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events
Psychiatric disorders Anxiety	0.00% 0/6 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	0.00% 0/9 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	0.00% 0/14 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	— 0/0 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	3.2% 2/62 • Number of events 2 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	7.8% 5/64 • Number of events 5 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events
Blood and lymphatic system disorders Anaemia	0.00% 0/6 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	11.1% 1/9 • Number of events 1 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	21.4% 3/14 • Number of events 3 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	— 0/0 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	21.0% 13/62 • Number of events 13 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	6.2% 4/64 • Number of events 4 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events
Blood and lymphatic system disorders Thrombocytopenia	0.00% 0/6 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	11.1% 1/9 • Number of events 1 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	21.4% 3/14 • Number of events 3 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	— 0/0 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	6.5% 4/62 • Number of events 4 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	6.2% 4/64 • Number of events 4 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events
Endocrine disorders Hypothyroidism	0.00% 0/6 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	22.2% 2/9 • Number of events 2 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	21.4% 3/14 • Number of events 3 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	— 0/0 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	12.9% 8/62 • Number of events 8 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	18.8% 12/64 • Number of events 12 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events
Eye disorders Vision blurred	0.00% 0/6 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	0.00% 0/9 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	0.00% 0/14 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	— 0/0 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	3.2% 2/62 • Number of events 2 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events	10.9% 7/64 • Number of events 7 • Adverse events were collected from the initial study drug administration on Cycle 1, Day 1 (C1D1) until 30 days after the last study drug administration for each subject on study, up to a total of 29.0 months of study drug exposure Analyses of adverse events were carried out on the Safety Analysis Set, defined as all participants who received at least one dose of study drug. There were no subjects enrolled in Part 1 cohort 4 (1.5 mg/kg dalantercept), thus no subjects were at risk for adverse events

Additional Information

Senior Vice President, Global Clinical Development

Merck Sharp & Dohme LLC

Phone: 1-800-672-6372

Email: ClinicalTrialsDisclosure@merck.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place