Trial Outcomes & Findings for A Safety and Efficacy Study of Intetumumab, Alone and in Combination With Dacarbazine, in Participants With Stage 4 Melanoma (NCT NCT00246012)

NCT ID: NCT00246012

Last Updated: 2013-08-19

Results Overview

The DLT is defined as any Grade 3 or higher adverse event identified by the safety data monitoring committee as attributable to intetumumab except for hypersensitivity reactions, which are not considered DLTs unless there are 2 or more occurrences of greater than or equal to Grade 3 hypersensitivity reaction within a group.

• Recruitment status: COMPLETED
• Study phase: PHASE1/PHASE2
• Target enrollment: 144 participants
• Primary outcome timeframe: Up to 21 days post-first infusion from the last treated participant in Phase 1
• Results posted on: 2013-08-19

Participant Flow

Participant milestones

Measure	Intetumumab 3 mg/kg [Phase 1 (Part 1)] Intetumumab was administered at the dose of 3 milligram per kilogram (mg/kg) as intravenous infusion (a fluid or a medicine delivered into a vein by way of a needle) over a period of 2 hours (hr) (± 15 minutes) once every 3 weeks until the occurrence of dose limiting toxicities (DLTs). If after an evaluation of the preliminary single-dose pharmacokinetics, receptor saturation was not observed at the 3 mg/kg or 5 mg/kg dose level, that dose of intetumumab was discontinued in Part 1 and participants were treated at the highest, documented safe dose level at which receptor saturation was observed.	Intetumumab 5 mg/kg [Phase 1 (Part 1)] Intetumumab was administered at the dose of 5 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks until the occurrence of DLTs. If after an evaluation of the preliminary single-dose pharmacokinetics, receptor saturation was not observed at the 3 mg/kg or 5 mg/kg dose level, that dose of intetumumab was discontinued in Part 1 and participants were treated at the highest, documented safe dose level at which receptor saturation was observed.	Intetumumab 10 mg/kg [Phase 1 (Part 1)] Intetumumab was administered at the dose of 10 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks until the occurrence of DLTs.	Dacarbazine + Intetumumab 5 mg/kg [Phase 1 (Part 2)] Intetumumab was administered at the dose of 5 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks for 8 cycles until no evidence of disease progression or unacceptable toxicity. If participants responded to therapy with stable disease (SD) or better, they were considered eligible to receive up to 8 cycles of extended administrations. Commercially available dacarbazine was administered at the dose of 1000 milligram per meter-square (mg/m\^2) intravenously over a period of 60 minutes (± 30 minutes) prior to intetumumab infusion.	Dacarbazine + Intetumumab 10 mg/kg [Phase 1 (Part 2)] Intetumumab was administered at the dose of 10 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks for 8 cycles until no evidence of disease progression or unacceptable toxicity. If participants responded to therapy with SD or better, they were considered eligible to receive up to 8 cycles of extended administrations. Commercially available dacarbazine was administered at the dose of 1000 mg/m\^2 intravenously over a period of 60 minutes (± 30 minutes) prior to intetumumab infusion.	Dacarbazine + Placebo [Phase 2] Placebo was administered intravenously over a period of 2 hr (±15 minutes). Commercially available dacarbazine was administered at the dose of 1000 mg/m\^2 intravenously over a period of 60 minutes (± 30 minutes) prior to placebo infusion. In case participants were unable to tolerate dacarbazine even after 2 dose reductions, they were given the option to continue with 10 mg/kg intetumumab alone.	Intetumumab 5 mg/kg [Phase 2] Intetumumab was administered at the dose of 5 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks for 8 cycles until no evidence of disease progression or unacceptable toxicity. If participants responded to therapy with SD or better, they were considered eligible to receive up to 8 cycles of extended administrations.	Intetumumab 10 mg/kg [Phase 2] Intetumumab was administered at the dose of 10 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks for 8 cycles until no evidence of disease progression or unacceptable toxicity. If participants responded to therapy with SD or better, they were considered eligible to receive up to 8 cycles of extended administrations.	Dacarbazine + Intetumumab 10 mg/kg [Phase 2] Intetumumab was administered at the dose of 10 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks for 8 cycles until no evidence of disease progression or unacceptable toxicity. If participants responded to therapy with SD or better, they were considered eligible to receive up to 8 cycles of extended administrations. Commercially available dacarbazine was administered at the dose of 1000 mg/m\^2 intravenously over a period of 60 minutes (± 30 minutes) prior to intetumumab infusion.
Overall Study STARTED	3	3	3	3	3	32	32	33	32
Overall Study Treated	3	3	3	3	3	31	31	33	32
Overall Study COMPLETED	0	2	1	0	0	4	1	5	4
Overall Study NOT COMPLETED	3	1	2	3	3	28	31	28	28

Reasons for withdrawal

Measure	Intetumumab 3 mg/kg [Phase 1 (Part 1)] Intetumumab was administered at the dose of 3 milligram per kilogram (mg/kg) as intravenous infusion (a fluid or a medicine delivered into a vein by way of a needle) over a period of 2 hours (hr) (± 15 minutes) once every 3 weeks until the occurrence of dose limiting toxicities (DLTs). If after an evaluation of the preliminary single-dose pharmacokinetics, receptor saturation was not observed at the 3 mg/kg or 5 mg/kg dose level, that dose of intetumumab was discontinued in Part 1 and participants were treated at the highest, documented safe dose level at which receptor saturation was observed.	Intetumumab 5 mg/kg [Phase 1 (Part 1)] Intetumumab was administered at the dose of 5 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks until the occurrence of DLTs. If after an evaluation of the preliminary single-dose pharmacokinetics, receptor saturation was not observed at the 3 mg/kg or 5 mg/kg dose level, that dose of intetumumab was discontinued in Part 1 and participants were treated at the highest, documented safe dose level at which receptor saturation was observed.	Intetumumab 10 mg/kg [Phase 1 (Part 1)] Intetumumab was administered at the dose of 10 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks until the occurrence of DLTs.	Dacarbazine + Intetumumab 5 mg/kg [Phase 1 (Part 2)] Intetumumab was administered at the dose of 5 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks for 8 cycles until no evidence of disease progression or unacceptable toxicity. If participants responded to therapy with stable disease (SD) or better, they were considered eligible to receive up to 8 cycles of extended administrations. Commercially available dacarbazine was administered at the dose of 1000 milligram per meter-square (mg/m\^2) intravenously over a period of 60 minutes (± 30 minutes) prior to intetumumab infusion.	Dacarbazine + Intetumumab 10 mg/kg [Phase 1 (Part 2)] Intetumumab was administered at the dose of 10 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks for 8 cycles until no evidence of disease progression or unacceptable toxicity. If participants responded to therapy with SD or better, they were considered eligible to receive up to 8 cycles of extended administrations. Commercially available dacarbazine was administered at the dose of 1000 mg/m\^2 intravenously over a period of 60 minutes (± 30 minutes) prior to intetumumab infusion.	Dacarbazine + Placebo [Phase 2] Placebo was administered intravenously over a period of 2 hr (±15 minutes). Commercially available dacarbazine was administered at the dose of 1000 mg/m\^2 intravenously over a period of 60 minutes (± 30 minutes) prior to placebo infusion. In case participants were unable to tolerate dacarbazine even after 2 dose reductions, they were given the option to continue with 10 mg/kg intetumumab alone.	Intetumumab 5 mg/kg [Phase 2] Intetumumab was administered at the dose of 5 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks for 8 cycles until no evidence of disease progression or unacceptable toxicity. If participants responded to therapy with SD or better, they were considered eligible to receive up to 8 cycles of extended administrations.	Intetumumab 10 mg/kg [Phase 2] Intetumumab was administered at the dose of 10 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks for 8 cycles until no evidence of disease progression or unacceptable toxicity. If participants responded to therapy with SD or better, they were considered eligible to receive up to 8 cycles of extended administrations.	Dacarbazine + Intetumumab 10 mg/kg [Phase 2] Intetumumab was administered at the dose of 10 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks for 8 cycles until no evidence of disease progression or unacceptable toxicity. If participants responded to therapy with SD or better, they were considered eligible to receive up to 8 cycles of extended administrations. Commercially available dacarbazine was administered at the dose of 1000 mg/m\^2 intravenously over a period of 60 minutes (± 30 minutes) prior to intetumumab infusion.
Overall Study Adverse Event	0	0	0	0	0	1	0	0	2
Overall Study Withdrawal by Subject	0	0	0	0	0	1	0	0	0
Overall Study Disease progression	3	1	2	3	3	25	30	27	26
Overall Study Other	0	0	0	0	0	0	0	1	0
Overall Study Randomly assigned but not treated	0	0	0	0	0	1	1	0	0

Baseline Characteristics

A Safety and Efficacy Study of Intetumumab, Alone and in Combination With Dacarbazine, in Participants With Stage 4 Melanoma

Baseline characteristics by cohort

Measure	Intetumumab 3 mg/kg [Phase 1 (Part 1)] n=3 Participants Intetumumab was administered at the dose of 3 milligram per kilogram (mg/kg) as intravenous infusion (a fluid or a medicine delivered into a vein by way of a needle) over a period of 2 hours (hr) (± 15 minutes) once every 3 weeks until the occurrence of dose limiting toxicities (DLTs). If after an evaluation of the preliminary single-dose pharmacokinetics, receptor saturation was not observed at the 3 mg/kg or 5 mg/kg dose level, that dose of intetumumab was discontinued in Part 1 and participants were treated at the highest, documented safe dose level at which receptor saturation was observed.	Intetumumab 5 mg/kg [Phase 1 (Part 1)] n=3 Participants Intetumumab was administered at the dose of 5 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks until the occurrence of DLTs. If after an evaluation of the preliminary single-dose pharmacokinetics, receptor saturation was not observed at the 3 mg/kg or 5 mg/kg dose level, that dose of intetumumab was discontinued in Part 1 and participants were treated at the highest, documented safe dose level at which receptor saturation was observed.	Intetumumab 10 mg/kg [Phase 1 (Part 1)] n=3 Participants Intetumumab was administered at the dose of 10 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks until the occurrence of DLTs.	Dacarbazine + Intetumumab 5 mg/kg [Phase 1 (Part 2)] n=3 Participants Intetumumab was administered at the dose of 5 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks for 8 cycles until no evidence of disease progression or unacceptable toxicity. If participants responded to therapy with stable disease (SD) or better, they were considered eligible to receive up to 8 cycles of extended administrations. Commercially available dacarbazine was administered at the dose of 1000 milligram per meter-square (mg/m\^2) intravenously over a period of 60 minutes (± 30 minutes) prior to intetumumab infusion.	Dacarbazine + Intetumumab 10 mg/kg [Phase 1 (Part 2)] n=3 Participants Intetumumab was administered at the dose of 10 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks for 8 cycles until no evidence of disease progression or unacceptable toxicity. If participants responded to therapy with SD or better, they were considered eligible to receive up to 8 cycles of extended administrations. Commercially available dacarbazine was administered at the dose of 1000 mg/m\^2 intravenously over a period of 60 minutes (± 30 minutes) prior to intetumumab infusion.	Dacarbazine + Placebo [Phase 2] n=31 Participants Placebo was administered intravenously over a period of 2 hr (±15 minutes). Commercially available dacarbazine was administered at the dose of 1000 mg/m\^2 intravenously over a period of 60 minutes (± 30 minutes) prior to placebo infusion. In case participants were unable to tolerate dacarbazine even after 2 dose reductions, they were given the option to continue with 10 mg/kg intetumumab alone.	Intetumumab 5 mg/kg [Phase 2] n=31 Participants Intetumumab was administered at the dose of 5 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks for 8 cycles until no evidence of disease progression or unacceptable toxicity. If participants responded to therapy with SD or better, they were considered eligible to receive up to 8 cycles of extended administrations.	Intetumumab 10 mg/kg [Phase 2] n=33 Participants Intetumumab was administered at the dose of 10 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks for 8 cycles until no evidence of disease progression or unacceptable toxicity. If participants responded to therapy with SD or better, they were considered eligible to receive up to 8 cycles of extended administrations.	Dacarbazine + Intetumumab 10 mg/kg [Phase 2] n=32 Participants Intetumumab was administered at the dose of 10 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks for 8 cycles until no evidence of disease progression or unacceptable toxicity. If participants responded to therapy with SD or better, they were considered eligible to receive up to 8 cycles of extended administrations. Commercially available dacarbazine was administered at the dose of 1000 mg/m\^2 intravenously over a period of 60 minutes (± 30 minutes) prior to intetumumab infusion.	Total n=142 Participants Total of all reporting groups
Age Continuous	62.0 Years STANDARD_DEVIATION 10.82 • n=5 Participants	46.7 Years STANDARD_DEVIATION 6.66 • n=7 Participants	61.7 Years STANDARD_DEVIATION 11.59 • n=5 Participants	52.7 Years STANDARD_DEVIATION 15.01 • n=4 Participants	66.0 Years STANDARD_DEVIATION 18.73 • n=21 Participants	63.5 Years STANDARD_DEVIATION 14.17 • n=8 Participants	67.3 Years STANDARD_DEVIATION 11.44 • n=8 Participants	61.5 Years STANDARD_DEVIATION 12.39 • n=24 Participants	57.2 Years STANDARD_DEVIATION 11.45 • n=42 Participants	61.8 Years STANDARD_DEVIATION 12.87 • n=42 Participants
Sex: Female, Male Female	1 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	1 Participants n=4 Participants	1 Participants n=21 Participants	13 Participants n=8 Participants	8 Participants n=8 Participants	7 Participants n=24 Participants	14 Participants n=42 Participants	47 Participants n=42 Participants
Sex: Female, Male Male	2 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants	2 Participants n=4 Participants	2 Participants n=21 Participants	18 Participants n=8 Participants	23 Participants n=8 Participants	26 Participants n=24 Participants	18 Participants n=42 Participants	95 Participants n=42 Participants
Region of Enrollment Germany	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	9 Participants n=8 Participants	12 Participants n=8 Participants	10 Participants n=24 Participants	13 Participants n=42 Participants	44 Participants n=42 Participants
Region of Enrollment United Kingdom	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	6 Participants n=8 Participants	9 Participants n=8 Participants	4 Participants n=24 Participants	5 Participants n=42 Participants	24 Participants n=42 Participants
Region of Enrollment United States	3 Participants n=5 Participants	3 Participants n=7 Participants	3 Participants n=5 Participants	3 Participants n=4 Participants	3 Participants n=21 Participants	16 Participants n=8 Participants	10 Participants n=8 Participants	19 Participants n=24 Participants	14 Participants n=42 Participants	74 Participants n=42 Participants

PRIMARY outcome

Timeframe: Up to 21 days post-first infusion from the last treated participant in Phase 1

Population: Safety population included all the participants who received at least 1 (partial or complete) dose of intetumumab/placebo or dacarbazine.

The DLT is defined as any Grade 3 or higher adverse event identified by the safety data monitoring committee as attributable to intetumumab except for hypersensitivity reactions, which are not considered DLTs unless there are 2 or more occurrences of greater than or equal to Grade 3 hypersensitivity reaction within a group.

Outcome measures

Measure	Intetumumab 3 mg/kg [Phase 1 (Part 1)] n=3 Participants Intetumumab was administered at the dose of 3 milligram per kilogram (mg/kg) as intravenous infusion (a fluid or a medicine delivered into a vein by way of a needle) over a period of 2 hours (hr) (± 15 minutes) once every 3 weeks until the occurrence of dose limiting toxicities (DLTs). If after an evaluation of the preliminary single-dose pharmacokinetics, receptor saturation was not observed at the 3 mg/kg or 5 mg/kg dose level, that dose of intetumumab was discontinued in Part 1 and participants were treated at the highest, documented safe dose level at which receptor saturation was observed.	Intetumumab 5 mg/kg [Phase 1 (Part 1)] n=3 Participants Intetumumab was administered at the dose of 5 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks until the occurrence of DLTs. If after an evaluation of the preliminary single-dose pharmacokinetics, receptor saturation was not observed at the 3 mg/kg or 5 mg/kg dose level, that dose of intetumumab was discontinued in Part 1 and participants were treated at the highest, documented safe dose level at which receptor saturation was observed.	Intetumumab 10 mg/kg [Phase 1 (Part 1)] n=3 Participants Intetumumab was administered at the dose of 10 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks until the occurrence of DLTs.	Dacarbazine + Intetumumab 5 mg/kg [Phase 1 (Part 2)] n=3 Participants Intetumumab was administered at the dose of 5 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks for 8 cycles until no evidence of disease progression or unacceptable toxicity. If participants responded to therapy with stable disease (SD) or better, they were considered eligible to receive up to 8 cycles of extended administrations. Commercially available dacarbazine was administered at the dose of 1000 milligram per meter-square (mg/m\^2) intravenously over a period of 60 minutes (± 30 minutes) prior to intetumumab infusion.	Dacarbazine + Intetumumab 10 mg/kg [Phase 1 (Part 2)] n=3 Participants Intetumumab was administered at the dose of 10 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks for 8 cycles until no evidence of disease progression or unacceptable toxicity. If participants responded to therapy with SD or better, they were considered eligible to receive up to 8 cycles of extended administrations. Commercially available dacarbazine was administered at the dose of 1000 mg/m\^2 intravenously over a period of 60 minutes (± 30 minutes) prior to intetumumab infusion.
Number of Participants With Dose Limiting Toxicities (DLTs) - Phase 1	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants

PRIMARY outcome

Timeframe: Pre-infusion, post-infusion at 2, 4, 8, 24 hour, Day 8, Day 15, post-last dose (3 weeks or 1 week) and 3 months post-last dose

Population: The Pharmacokinetics (PK)-evaluable population included all the participants who had at least 1 PK sample and who received at least 1 (partial or complete) dose of intetumumab.

The maximum observed analyte concentration in serum was reported.

Outcome measures

Measure	Intetumumab 3 mg/kg [Phase 1 (Part 1)] n=3 Participants Intetumumab was administered at the dose of 3 milligram per kilogram (mg/kg) as intravenous infusion (a fluid or a medicine delivered into a vein by way of a needle) over a period of 2 hours (hr) (± 15 minutes) once every 3 weeks until the occurrence of dose limiting toxicities (DLTs). If after an evaluation of the preliminary single-dose pharmacokinetics, receptor saturation was not observed at the 3 mg/kg or 5 mg/kg dose level, that dose of intetumumab was discontinued in Part 1 and participants were treated at the highest, documented safe dose level at which receptor saturation was observed.	Intetumumab 5 mg/kg [Phase 1 (Part 1)] n=3 Participants Intetumumab was administered at the dose of 5 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks until the occurrence of DLTs. If after an evaluation of the preliminary single-dose pharmacokinetics, receptor saturation was not observed at the 3 mg/kg or 5 mg/kg dose level, that dose of intetumumab was discontinued in Part 1 and participants were treated at the highest, documented safe dose level at which receptor saturation was observed.	Intetumumab 10 mg/kg [Phase 1 (Part 1)] n=3 Participants Intetumumab was administered at the dose of 10 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks until the occurrence of DLTs.	Dacarbazine + Intetumumab 5 mg/kg [Phase 1 (Part 2)] Intetumumab was administered at the dose of 5 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks for 8 cycles until no evidence of disease progression or unacceptable toxicity. If participants responded to therapy with stable disease (SD) or better, they were considered eligible to receive up to 8 cycles of extended administrations. Commercially available dacarbazine was administered at the dose of 1000 milligram per meter-square (mg/m\^2) intravenously over a period of 60 minutes (± 30 minutes) prior to intetumumab infusion.	Dacarbazine + Intetumumab 10 mg/kg [Phase 1 (Part 2)] Intetumumab was administered at the dose of 10 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks for 8 cycles until no evidence of disease progression or unacceptable toxicity. If participants responded to therapy with SD or better, they were considered eligible to receive up to 8 cycles of extended administrations. Commercially available dacarbazine was administered at the dose of 1000 mg/m\^2 intravenously over a period of 60 minutes (± 30 minutes) prior to intetumumab infusion.
Maximum Observed Serum Concentration (Cmax) of Intetumumab - Phase 1 (Part 1)	94.44 Microgram per milliliter (mcg/mL) Standard Deviation 9.037	199.45 Microgram per milliliter (mcg/mL) Standard Deviation 64.093	306.86 Microgram per milliliter (mcg/mL) Standard Deviation 54.979	—	—

PRIMARY outcome

Timeframe: Pre-infusion, post-infusion at 2, 4, 8, 24 hour, Day 8, Day 15, post-last dose (3 weeks or 1 week) and 3 months post-last dose

Population: The PK-evaluable population included all the participants who had at least 1 PK sample and who received at least 1 (partial or complete) dose of intetumumab. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.

The AUC is a measure of the serum concentration of the drug over time. It is used to characterize drug absorption.

Outcome measures

Measure	Intetumumab 3 mg/kg [Phase 1 (Part 1)] n=1 Participants Intetumumab was administered at the dose of 3 milligram per kilogram (mg/kg) as intravenous infusion (a fluid or a medicine delivered into a vein by way of a needle) over a period of 2 hours (hr) (± 15 minutes) once every 3 weeks until the occurrence of dose limiting toxicities (DLTs). If after an evaluation of the preliminary single-dose pharmacokinetics, receptor saturation was not observed at the 3 mg/kg or 5 mg/kg dose level, that dose of intetumumab was discontinued in Part 1 and participants were treated at the highest, documented safe dose level at which receptor saturation was observed.	Intetumumab 5 mg/kg [Phase 1 (Part 1)] n=1 Participants Intetumumab was administered at the dose of 5 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks until the occurrence of DLTs. If after an evaluation of the preliminary single-dose pharmacokinetics, receptor saturation was not observed at the 3 mg/kg or 5 mg/kg dose level, that dose of intetumumab was discontinued in Part 1 and participants were treated at the highest, documented safe dose level at which receptor saturation was observed.	Intetumumab 10 mg/kg [Phase 1 (Part 1)] n=3 Participants Intetumumab was administered at the dose of 10 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks until the occurrence of DLTs.	Dacarbazine + Intetumumab 5 mg/kg [Phase 1 (Part 2)] Intetumumab was administered at the dose of 5 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks for 8 cycles until no evidence of disease progression or unacceptable toxicity. If participants responded to therapy with stable disease (SD) or better, they were considered eligible to receive up to 8 cycles of extended administrations. Commercially available dacarbazine was administered at the dose of 1000 milligram per meter-square (mg/m\^2) intravenously over a period of 60 minutes (± 30 minutes) prior to intetumumab infusion.	Dacarbazine + Intetumumab 10 mg/kg [Phase 1 (Part 2)] Intetumumab was administered at the dose of 10 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks for 8 cycles until no evidence of disease progression or unacceptable toxicity. If participants responded to therapy with SD or better, they were considered eligible to receive up to 8 cycles of extended administrations. Commercially available dacarbazine was administered at the dose of 1000 mg/m\^2 intravenously over a period of 60 minutes (± 30 minutes) prior to intetumumab infusion.
Area Under the Serum Concentration Versus Time Curve (AUC) of Intetumumab - Phase 1 (Part 1)	257.55 mcg*day/mL Standard Deviation NA Standard deviation was not estimable based on one subject.	503.71 mcg*day/mL Standard Deviation NA Standard deviation was not estimable based on one subject.	1479.07 mcg*day/mL Standard Deviation 149.851	—	—

PRIMARY outcome

Timeframe: Pre-infusion, post-infusion at 2, 4, 8, 24 hour, Day 8, Day 15, post-last dose (3 weeks or 1 week) and 3 months post-last dose

Population: The PK-evaluable population included all the participants who had at least 1 PK sample and who received at least 1 (partial or complete) dose of intetumumab. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.

Plasma decay half-life is the time measured for the plasma concentration of the drug to decrease by one half.

Outcome measures

Measure	Intetumumab 3 mg/kg [Phase 1 (Part 1)] n=1 Participants Intetumumab was administered at the dose of 3 milligram per kilogram (mg/kg) as intravenous infusion (a fluid or a medicine delivered into a vein by way of a needle) over a period of 2 hours (hr) (± 15 minutes) once every 3 weeks until the occurrence of dose limiting toxicities (DLTs). If after an evaluation of the preliminary single-dose pharmacokinetics, receptor saturation was not observed at the 3 mg/kg or 5 mg/kg dose level, that dose of intetumumab was discontinued in Part 1 and participants were treated at the highest, documented safe dose level at which receptor saturation was observed.	Intetumumab 5 mg/kg [Phase 1 (Part 1)] n=1 Participants Intetumumab was administered at the dose of 5 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks until the occurrence of DLTs. If after an evaluation of the preliminary single-dose pharmacokinetics, receptor saturation was not observed at the 3 mg/kg or 5 mg/kg dose level, that dose of intetumumab was discontinued in Part 1 and participants were treated at the highest, documented safe dose level at which receptor saturation was observed.	Intetumumab 10 mg/kg [Phase 1 (Part 1)] n=3 Participants Intetumumab was administered at the dose of 10 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks until the occurrence of DLTs.	Dacarbazine + Intetumumab 5 mg/kg [Phase 1 (Part 2)] Intetumumab was administered at the dose of 5 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks for 8 cycles until no evidence of disease progression or unacceptable toxicity. If participants responded to therapy with stable disease (SD) or better, they were considered eligible to receive up to 8 cycles of extended administrations. Commercially available dacarbazine was administered at the dose of 1000 milligram per meter-square (mg/m\^2) intravenously over a period of 60 minutes (± 30 minutes) prior to intetumumab infusion.	Dacarbazine + Intetumumab 10 mg/kg [Phase 1 (Part 2)] Intetumumab was administered at the dose of 10 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks for 8 cycles until no evidence of disease progression or unacceptable toxicity. If participants responded to therapy with SD or better, they were considered eligible to receive up to 8 cycles of extended administrations. Commercially available dacarbazine was administered at the dose of 1000 mg/m\^2 intravenously over a period of 60 minutes (± 30 minutes) prior to intetumumab infusion.
Half-life of Intetumumab - Phase 1 (Part 1)	2.03 Days Standard Deviation NA Standard deviation was not estimable based on one subject.	2.13 Days Standard Deviation NA Standard deviation was not estimable based on one subject.	5.33 Days Standard Deviation 1.001	—	—

PRIMARY outcome

Timeframe: Pre-infusion, post-infusion at 2, 4, 8, 24 hour, Day 8, Day 15, post-last dose (3 weeks or 1 week) and 3 months post-last dose

Population: The PK-evaluable population included all the participants who had at least 1 PK sample and who received at least 1 (partial or complete) dose of intetumumab. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.

The CL is a quantitative measure of the rate at which a drug substance is removed from the body.

Outcome measures

Measure	Intetumumab 3 mg/kg [Phase 1 (Part 1)] n=1 Participants Intetumumab was administered at the dose of 3 milligram per kilogram (mg/kg) as intravenous infusion (a fluid or a medicine delivered into a vein by way of a needle) over a period of 2 hours (hr) (± 15 minutes) once every 3 weeks until the occurrence of dose limiting toxicities (DLTs). If after an evaluation of the preliminary single-dose pharmacokinetics, receptor saturation was not observed at the 3 mg/kg or 5 mg/kg dose level, that dose of intetumumab was discontinued in Part 1 and participants were treated at the highest, documented safe dose level at which receptor saturation was observed.	Intetumumab 5 mg/kg [Phase 1 (Part 1)] n=1 Participants Intetumumab was administered at the dose of 5 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks until the occurrence of DLTs. If after an evaluation of the preliminary single-dose pharmacokinetics, receptor saturation was not observed at the 3 mg/kg or 5 mg/kg dose level, that dose of intetumumab was discontinued in Part 1 and participants were treated at the highest, documented safe dose level at which receptor saturation was observed.	Intetumumab 10 mg/kg [Phase 1 (Part 1)] n=3 Participants Intetumumab was administered at the dose of 10 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks until the occurrence of DLTs.	Dacarbazine + Intetumumab 5 mg/kg [Phase 1 (Part 2)] Intetumumab was administered at the dose of 5 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks for 8 cycles until no evidence of disease progression or unacceptable toxicity. If participants responded to therapy with stable disease (SD) or better, they were considered eligible to receive up to 8 cycles of extended administrations. Commercially available dacarbazine was administered at the dose of 1000 milligram per meter-square (mg/m\^2) intravenously over a period of 60 minutes (± 30 minutes) prior to intetumumab infusion.	Dacarbazine + Intetumumab 10 mg/kg [Phase 1 (Part 2)] Intetumumab was administered at the dose of 10 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks for 8 cycles until no evidence of disease progression or unacceptable toxicity. If participants responded to therapy with SD or better, they were considered eligible to receive up to 8 cycles of extended administrations. Commercially available dacarbazine was administered at the dose of 1000 mg/m\^2 intravenously over a period of 60 minutes (± 30 minutes) prior to intetumumab infusion.
Total Clearance (CL) of Intetumumab After Intravenous Administration - Phase 1 (Part 1)	11.85 mL/day/kg Standard Deviation NA Standard deviation was not estimable based on one subject.	9.96 mL/day/kg Standard Deviation NA Standard deviation was not estimable based on one subject.	6.79 mL/day/kg Standard Deviation 1.634	—	—

PRIMARY outcome

Timeframe: Pre-infusion, post-infusion at 2, 4, 8, 24 hour, Day 8, Day 15, post-last dose (3 weeks or 1 week) and 3 months post-last dose

Population: The PK-evaluable population included all the participants who had at least 1 PK sample and who received at least 1 (partial or complete) dose of intetumumab. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.

Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug.

Outcome measures

Measure	Intetumumab 3 mg/kg [Phase 1 (Part 1)] n=1 Participants Intetumumab was administered at the dose of 3 milligram per kilogram (mg/kg) as intravenous infusion (a fluid or a medicine delivered into a vein by way of a needle) over a period of 2 hours (hr) (± 15 minutes) once every 3 weeks until the occurrence of dose limiting toxicities (DLTs). If after an evaluation of the preliminary single-dose pharmacokinetics, receptor saturation was not observed at the 3 mg/kg or 5 mg/kg dose level, that dose of intetumumab was discontinued in Part 1 and participants were treated at the highest, documented safe dose level at which receptor saturation was observed.	Intetumumab 5 mg/kg [Phase 1 (Part 1)] n=1 Participants Intetumumab was administered at the dose of 5 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks until the occurrence of DLTs. If after an evaluation of the preliminary single-dose pharmacokinetics, receptor saturation was not observed at the 3 mg/kg or 5 mg/kg dose level, that dose of intetumumab was discontinued in Part 1 and participants were treated at the highest, documented safe dose level at which receptor saturation was observed.	Intetumumab 10 mg/kg [Phase 1 (Part 1)] n=3 Participants Intetumumab was administered at the dose of 10 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks until the occurrence of DLTs.	Dacarbazine + Intetumumab 5 mg/kg [Phase 1 (Part 2)] Intetumumab was administered at the dose of 5 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks for 8 cycles until no evidence of disease progression or unacceptable toxicity. If participants responded to therapy with stable disease (SD) or better, they were considered eligible to receive up to 8 cycles of extended administrations. Commercially available dacarbazine was administered at the dose of 1000 milligram per meter-square (mg/m\^2) intravenously over a period of 60 minutes (± 30 minutes) prior to intetumumab infusion.	Dacarbazine + Intetumumab 10 mg/kg [Phase 1 (Part 2)] Intetumumab was administered at the dose of 10 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks for 8 cycles until no evidence of disease progression or unacceptable toxicity. If participants responded to therapy with SD or better, they were considered eligible to receive up to 8 cycles of extended administrations. Commercially available dacarbazine was administered at the dose of 1000 mg/m\^2 intravenously over a period of 60 minutes (± 30 minutes) prior to intetumumab infusion.
Volume of Distribution (Vz) of Intetumumab - Phase 1 (Part 1)	34.69 mL/kg Standard Deviation NA Standard deviation was not estimable based on one subject.	30.63 mL/kg Standard Deviation NA Standard deviation was not estimable based on one subject.	50.80 mL/kg Standard Deviation 4.981	—	—

PRIMARY outcome

Timeframe: Pre-infusion, post-infusion at 2, 4, 8, 24 hour, Day 8, Day 15, post-last dose (3 weeks or 1 week) and 3 months post-last dose

Population: The PK-evaluable population included all the participants who had at least 1 PK sample and who received at least 1 (partial or complete) dose of intetumumab. Serum concentration data was insufficient to robustly estimate the accumulation ratio.

The R is obtained by dividing AUC at two different time points.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: From the date of randomization to date of initial documented progressive disease or death, whichever occured first, as assessed upto 6 months after last dose of study medication

Population: The Intent-to-treat (ITT) population included all the participants who were randomly assigned to treatment.

The PFS was defined as the time from the date of randomization to the date of initial documented progressive disease (PD), or the date of initial documented symptomatic deterioration, or the date of death, whichever occurred first. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as at least a 20% increase in the sum of the longest diameter of target lesions, taking as a reference the smallest sum longest diameter recorded since the treatment started or the appearance of 1 or more new lesions.

Outcome measures

Measure	Intetumumab 3 mg/kg [Phase 1 (Part 1)] n=32 Participants Intetumumab was administered at the dose of 3 milligram per kilogram (mg/kg) as intravenous infusion (a fluid or a medicine delivered into a vein by way of a needle) over a period of 2 hours (hr) (± 15 minutes) once every 3 weeks until the occurrence of dose limiting toxicities (DLTs). If after an evaluation of the preliminary single-dose pharmacokinetics, receptor saturation was not observed at the 3 mg/kg or 5 mg/kg dose level, that dose of intetumumab was discontinued in Part 1 and participants were treated at the highest, documented safe dose level at which receptor saturation was observed.	Intetumumab 5 mg/kg [Phase 1 (Part 1)] n=32 Participants Intetumumab was administered at the dose of 5 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks until the occurrence of DLTs. If after an evaluation of the preliminary single-dose pharmacokinetics, receptor saturation was not observed at the 3 mg/kg or 5 mg/kg dose level, that dose of intetumumab was discontinued in Part 1 and participants were treated at the highest, documented safe dose level at which receptor saturation was observed.	Intetumumab 10 mg/kg [Phase 1 (Part 1)] n=33 Participants Intetumumab was administered at the dose of 10 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks until the occurrence of DLTs.	Dacarbazine + Intetumumab 5 mg/kg [Phase 1 (Part 2)] n=32 Participants Intetumumab was administered at the dose of 5 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks for 8 cycles until no evidence of disease progression or unacceptable toxicity. If participants responded to therapy with stable disease (SD) or better, they were considered eligible to receive up to 8 cycles of extended administrations. Commercially available dacarbazine was administered at the dose of 1000 milligram per meter-square (mg/m\^2) intravenously over a period of 60 minutes (± 30 minutes) prior to intetumumab infusion.	Dacarbazine + Intetumumab 10 mg/kg [Phase 1 (Part 2)] Intetumumab was administered at the dose of 10 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks for 8 cycles until no evidence of disease progression or unacceptable toxicity. If participants responded to therapy with SD or better, they were considered eligible to receive up to 8 cycles of extended administrations. Commercially available dacarbazine was administered at the dose of 1000 mg/m\^2 intravenously over a period of 60 minutes (± 30 minutes) prior to intetumumab infusion.
Progression-Free Survival (PFS) - Phase 2	54.0 Days Interval 41.0 to 85.0	42.0 Days Interval 39.0 to 43.0	42.0 Days Interval 40.0 to 48.0	75.0 Days Interval 43.0 to 121.0	—

SECONDARY outcome

Timeframe: Screening, within 1 week of the end of Cycles 2, 4, 6, 8 (but prior to the next cycle dose), and follow-up (3 and 6 months post-last dose where applicable)

Population: The response-evaluable population included all the participants who were evaluable for response.

The CR: complete disappearance of all measurable and non-measurable target lesions and PR: 50 percent (%) or more decrease in sum of the longest diameters of target lesion(s), with at least stable disease (SD) in all other evaluable disease in the absence of treatment failure. The best response achieved among all the evaluated time points was reported.

Outcome measures

Measure	Intetumumab 3 mg/kg [Phase 1 (Part 1)] n=31 Participants Intetumumab was administered at the dose of 3 milligram per kilogram (mg/kg) as intravenous infusion (a fluid or a medicine delivered into a vein by way of a needle) over a period of 2 hours (hr) (± 15 minutes) once every 3 weeks until the occurrence of dose limiting toxicities (DLTs). If after an evaluation of the preliminary single-dose pharmacokinetics, receptor saturation was not observed at the 3 mg/kg or 5 mg/kg dose level, that dose of intetumumab was discontinued in Part 1 and participants were treated at the highest, documented safe dose level at which receptor saturation was observed.	Intetumumab 5 mg/kg [Phase 1 (Part 1)] n=31 Participants Intetumumab was administered at the dose of 5 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks until the occurrence of DLTs. If after an evaluation of the preliminary single-dose pharmacokinetics, receptor saturation was not observed at the 3 mg/kg or 5 mg/kg dose level, that dose of intetumumab was discontinued in Part 1 and participants were treated at the highest, documented safe dose level at which receptor saturation was observed.	Intetumumab 10 mg/kg [Phase 1 (Part 1)] n=33 Participants Intetumumab was administered at the dose of 10 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks until the occurrence of DLTs.	Dacarbazine + Intetumumab 5 mg/kg [Phase 1 (Part 2)] n=30 Participants Intetumumab was administered at the dose of 5 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks for 8 cycles until no evidence of disease progression or unacceptable toxicity. If participants responded to therapy with stable disease (SD) or better, they were considered eligible to receive up to 8 cycles of extended administrations. Commercially available dacarbazine was administered at the dose of 1000 milligram per meter-square (mg/m\^2) intravenously over a period of 60 minutes (± 30 minutes) prior to intetumumab infusion.	Dacarbazine + Intetumumab 10 mg/kg [Phase 1 (Part 2)] Intetumumab was administered at the dose of 10 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks for 8 cycles until no evidence of disease progression or unacceptable toxicity. If participants responded to therapy with SD or better, they were considered eligible to receive up to 8 cycles of extended administrations. Commercially available dacarbazine was administered at the dose of 1000 mg/m\^2 intravenously over a period of 60 minutes (± 30 minutes) prior to intetumumab infusion.
Percentage of Participants Who Achieved a Best Overall Tumor Response as Complete Response (CR) or Partial Response (PR) - Phase 2	9.7 Percentage of Participants	0 Percentage of Participants	6.1 Percentage of Participants	3.3 Percentage of Participants	—

SECONDARY outcome

Timeframe: Screening, within 1 week of the end of Cycles 2, 4, 6, 8 (but prior to the next cycle dose), and follow-up (3 and 6 months post-last dose where applicable)

Population: The response-evaluable population included all the participants who were evaluable for response.

The CR: complete disappearance of all measurable and non-measurable target lesions. The participants who achieved CR as the best response were reported.

Outcome measures

Measure	Intetumumab 3 mg/kg [Phase 1 (Part 1)] n=31 Participants Intetumumab was administered at the dose of 3 milligram per kilogram (mg/kg) as intravenous infusion (a fluid or a medicine delivered into a vein by way of a needle) over a period of 2 hours (hr) (± 15 minutes) once every 3 weeks until the occurrence of dose limiting toxicities (DLTs). If after an evaluation of the preliminary single-dose pharmacokinetics, receptor saturation was not observed at the 3 mg/kg or 5 mg/kg dose level, that dose of intetumumab was discontinued in Part 1 and participants were treated at the highest, documented safe dose level at which receptor saturation was observed.	Intetumumab 5 mg/kg [Phase 1 (Part 1)] n=31 Participants Intetumumab was administered at the dose of 5 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks until the occurrence of DLTs. If after an evaluation of the preliminary single-dose pharmacokinetics, receptor saturation was not observed at the 3 mg/kg or 5 mg/kg dose level, that dose of intetumumab was discontinued in Part 1 and participants were treated at the highest, documented safe dose level at which receptor saturation was observed.	Intetumumab 10 mg/kg [Phase 1 (Part 1)] n=33 Participants Intetumumab was administered at the dose of 10 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks until the occurrence of DLTs.	Dacarbazine + Intetumumab 5 mg/kg [Phase 1 (Part 2)] n=30 Participants Intetumumab was administered at the dose of 5 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks for 8 cycles until no evidence of disease progression or unacceptable toxicity. If participants responded to therapy with stable disease (SD) or better, they were considered eligible to receive up to 8 cycles of extended administrations. Commercially available dacarbazine was administered at the dose of 1000 milligram per meter-square (mg/m\^2) intravenously over a period of 60 minutes (± 30 minutes) prior to intetumumab infusion.	Dacarbazine + Intetumumab 10 mg/kg [Phase 1 (Part 2)] Intetumumab was administered at the dose of 10 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks for 8 cycles until no evidence of disease progression or unacceptable toxicity. If participants responded to therapy with SD or better, they were considered eligible to receive up to 8 cycles of extended administrations. Commercially available dacarbazine was administered at the dose of 1000 mg/m\^2 intravenously over a period of 60 minutes (± 30 minutes) prior to intetumumab infusion.
Percentage of Participants Who Achieved CR - Phase 2	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants	—

SECONDARY outcome

Timeframe: Screening, within 1 week of the end of Cycles 2, 4, 6, 8 (but prior to the next cycle dose), and follow-up (3 and 6 months post-last dose where applicable)

Population: The response-evaluable population included all the participants who were evaluable for response.

The SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for Progressive disease (PD), taking as a reference the smallest sum longest diameter since the treatment started. The participants who achieved SD as the best response were reported.

Outcome measures

Measure	Intetumumab 3 mg/kg [Phase 1 (Part 1)] n=31 Participants Intetumumab was administered at the dose of 3 milligram per kilogram (mg/kg) as intravenous infusion (a fluid or a medicine delivered into a vein by way of a needle) over a period of 2 hours (hr) (± 15 minutes) once every 3 weeks until the occurrence of dose limiting toxicities (DLTs). If after an evaluation of the preliminary single-dose pharmacokinetics, receptor saturation was not observed at the 3 mg/kg or 5 mg/kg dose level, that dose of intetumumab was discontinued in Part 1 and participants were treated at the highest, documented safe dose level at which receptor saturation was observed.	Intetumumab 5 mg/kg [Phase 1 (Part 1)] n=31 Participants Intetumumab was administered at the dose of 5 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks until the occurrence of DLTs. If after an evaluation of the preliminary single-dose pharmacokinetics, receptor saturation was not observed at the 3 mg/kg or 5 mg/kg dose level, that dose of intetumumab was discontinued in Part 1 and participants were treated at the highest, documented safe dose level at which receptor saturation was observed.	Intetumumab 10 mg/kg [Phase 1 (Part 1)] n=33 Participants Intetumumab was administered at the dose of 10 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks until the occurrence of DLTs.	Dacarbazine + Intetumumab 5 mg/kg [Phase 1 (Part 2)] n=30 Participants Intetumumab was administered at the dose of 5 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks for 8 cycles until no evidence of disease progression or unacceptable toxicity. If participants responded to therapy with stable disease (SD) or better, they were considered eligible to receive up to 8 cycles of extended administrations. Commercially available dacarbazine was administered at the dose of 1000 milligram per meter-square (mg/m\^2) intravenously over a period of 60 minutes (± 30 minutes) prior to intetumumab infusion.	Dacarbazine + Intetumumab 10 mg/kg [Phase 1 (Part 2)] Intetumumab was administered at the dose of 10 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks for 8 cycles until no evidence of disease progression or unacceptable toxicity. If participants responded to therapy with SD or better, they were considered eligible to receive up to 8 cycles of extended administrations. Commercially available dacarbazine was administered at the dose of 1000 mg/m\^2 intravenously over a period of 60 minutes (± 30 minutes) prior to intetumumab infusion.
Percentage of Participants Who Achieved Stable Disease (SD) - Phase 2	32.3 Percentage of Participants	25.8 Percentage of Participants	24.2 Percentage of Participants	53.3 Percentage of Participants	—

SECONDARY outcome

Timeframe: Every 3 months until death, until lost to follow-up, until withdrawal of consent, or until the Sponsor ends the study, as assessed up to 6 months post-last dose of study medication

Population: The ITT population included all the participants who were randomly assigned to treatment.

The OS is defined as the time from the date of randomization to the date of death due to any cause and was to be censored at the date that the subject is last known to be alive.

Outcome measures

Measure	Intetumumab 3 mg/kg [Phase 1 (Part 1)] n=32 Participants Intetumumab was administered at the dose of 3 milligram per kilogram (mg/kg) as intravenous infusion (a fluid or a medicine delivered into a vein by way of a needle) over a period of 2 hours (hr) (± 15 minutes) once every 3 weeks until the occurrence of dose limiting toxicities (DLTs). If after an evaluation of the preliminary single-dose pharmacokinetics, receptor saturation was not observed at the 3 mg/kg or 5 mg/kg dose level, that dose of intetumumab was discontinued in Part 1 and participants were treated at the highest, documented safe dose level at which receptor saturation was observed.	Intetumumab 5 mg/kg [Phase 1 (Part 1)] n=32 Participants Intetumumab was administered at the dose of 5 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks until the occurrence of DLTs. If after an evaluation of the preliminary single-dose pharmacokinetics, receptor saturation was not observed at the 3 mg/kg or 5 mg/kg dose level, that dose of intetumumab was discontinued in Part 1 and participants were treated at the highest, documented safe dose level at which receptor saturation was observed.	Intetumumab 10 mg/kg [Phase 1 (Part 1)] n=33 Participants Intetumumab was administered at the dose of 10 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks until the occurrence of DLTs.	Dacarbazine + Intetumumab 5 mg/kg [Phase 1 (Part 2)] n=32 Participants Intetumumab was administered at the dose of 5 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks for 8 cycles until no evidence of disease progression or unacceptable toxicity. If participants responded to therapy with stable disease (SD) or better, they were considered eligible to receive up to 8 cycles of extended administrations. Commercially available dacarbazine was administered at the dose of 1000 milligram per meter-square (mg/m\^2) intravenously over a period of 60 minutes (± 30 minutes) prior to intetumumab infusion.	Dacarbazine + Intetumumab 10 mg/kg [Phase 1 (Part 2)] Intetumumab was administered at the dose of 10 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks for 8 cycles until no evidence of disease progression or unacceptable toxicity. If participants responded to therapy with SD or better, they were considered eligible to receive up to 8 cycles of extended administrations. Commercially available dacarbazine was administered at the dose of 1000 mg/m\^2 intravenously over a period of 60 minutes (± 30 minutes) prior to intetumumab infusion.
Overall Survival (OS) - Phase 2	233.0 Days Interval 175.0 to 356.0	298.0 Days Interval 213.0 to 343.0	426.0 Days Interval 257.0 to 614.0	333.5 Days Interval 253.0 to 536.0	—

SECONDARY outcome

Timeframe: From the time of initial documented response (CR or PR) to the first documented sign of progression, assessed up to 6 months post-last dose of study medication

Population: The response-evaluable population included all the participants who were evaluable for response. The results were reported as individual participant's listings, but not statistically summarized.

Time duration required to achieve a CR or PR.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline (within 7 days of first infusion of study medication), Day 1 of all 8 cycles, 3 weeks or 1 week post-last dose, 3 months and 6 months post-last dose of study medication

Population: The ITT population included all the participants who were randomly assigned to treatment.

Eastern Cooperative Oncology (ECOG) performance status: Participants will be graded from 0 (Fully active, able to carry on all pre-disease activities without restriction) to 4 (Completely disabled, cannot carry on any self-care, totally confined to bed or chair). Worsening in ECOG score was defined as ≥ 1 point increase in ECOG score from baseline.

Outcome measures

Measure	Intetumumab 3 mg/kg [Phase 1 (Part 1)] n=32 Participants Intetumumab was administered at the dose of 3 milligram per kilogram (mg/kg) as intravenous infusion (a fluid or a medicine delivered into a vein by way of a needle) over a period of 2 hours (hr) (± 15 minutes) once every 3 weeks until the occurrence of dose limiting toxicities (DLTs). If after an evaluation of the preliminary single-dose pharmacokinetics, receptor saturation was not observed at the 3 mg/kg or 5 mg/kg dose level, that dose of intetumumab was discontinued in Part 1 and participants were treated at the highest, documented safe dose level at which receptor saturation was observed.	Intetumumab 5 mg/kg [Phase 1 (Part 1)] n=32 Participants Intetumumab was administered at the dose of 5 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks until the occurrence of DLTs. If after an evaluation of the preliminary single-dose pharmacokinetics, receptor saturation was not observed at the 3 mg/kg or 5 mg/kg dose level, that dose of intetumumab was discontinued in Part 1 and participants were treated at the highest, documented safe dose level at which receptor saturation was observed.	Intetumumab 10 mg/kg [Phase 1 (Part 1)] n=33 Participants Intetumumab was administered at the dose of 10 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks until the occurrence of DLTs.	Dacarbazine + Intetumumab 5 mg/kg [Phase 1 (Part 2)] n=32 Participants Intetumumab was administered at the dose of 5 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks for 8 cycles until no evidence of disease progression or unacceptable toxicity. If participants responded to therapy with stable disease (SD) or better, they were considered eligible to receive up to 8 cycles of extended administrations. Commercially available dacarbazine was administered at the dose of 1000 milligram per meter-square (mg/m\^2) intravenously over a period of 60 minutes (± 30 minutes) prior to intetumumab infusion.	Dacarbazine + Intetumumab 10 mg/kg [Phase 1 (Part 2)] Intetumumab was administered at the dose of 10 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks for 8 cycles until no evidence of disease progression or unacceptable toxicity. If participants responded to therapy with SD or better, they were considered eligible to receive up to 8 cycles of extended administrations. Commercially available dacarbazine was administered at the dose of 1000 mg/m\^2 intravenously over a period of 60 minutes (± 30 minutes) prior to intetumumab infusion.
Time to Worsening in Eastern Cooperative Oncology Group (ECOG) Performance Status - Phase 2	135.0 Days Interval 86.0 to The upper limit of 95% confidence interval was not estimable due to inadequate events.	226.0 Days Interval 52.0 to 226.0	194.0 Days Interval 113.0 to The upper limit of 95% confidence interval was not estimable due to inadequate events.	170.0 Days Interval 110.0 to 395.0	—

SECONDARY outcome

Timeframe: Pre-infusion, post-infusion at 2, 4, 8, 24 hour, Day 8, Day 15, post-last dose (3 weeks or 1 week) and 3 months post-last dose

Population: The PK-evaluable population included all the participants who had at least 1 PK sample and who received at least 1 (partial or complete) dose of intetumumab.

The maximum observed analyte concentration in serum was reported.

Outcome measures

Measure	Intetumumab 3 mg/kg [Phase 1 (Part 1)] n=31 Participants Intetumumab was administered at the dose of 3 milligram per kilogram (mg/kg) as intravenous infusion (a fluid or a medicine delivered into a vein by way of a needle) over a period of 2 hours (hr) (± 15 minutes) once every 3 weeks until the occurrence of dose limiting toxicities (DLTs). If after an evaluation of the preliminary single-dose pharmacokinetics, receptor saturation was not observed at the 3 mg/kg or 5 mg/kg dose level, that dose of intetumumab was discontinued in Part 1 and participants were treated at the highest, documented safe dose level at which receptor saturation was observed.	Intetumumab 5 mg/kg [Phase 1 (Part 1)] n=31 Participants Intetumumab was administered at the dose of 5 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks until the occurrence of DLTs. If after an evaluation of the preliminary single-dose pharmacokinetics, receptor saturation was not observed at the 3 mg/kg or 5 mg/kg dose level, that dose of intetumumab was discontinued in Part 1 and participants were treated at the highest, documented safe dose level at which receptor saturation was observed.	Intetumumab 10 mg/kg [Phase 1 (Part 1)] n=33 Participants Intetumumab was administered at the dose of 10 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks until the occurrence of DLTs.	Dacarbazine + Intetumumab 5 mg/kg [Phase 1 (Part 2)] n=32 Participants Intetumumab was administered at the dose of 5 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks for 8 cycles until no evidence of disease progression or unacceptable toxicity. If participants responded to therapy with stable disease (SD) or better, they were considered eligible to receive up to 8 cycles of extended administrations. Commercially available dacarbazine was administered at the dose of 1000 milligram per meter-square (mg/m\^2) intravenously over a period of 60 minutes (± 30 minutes) prior to intetumumab infusion.	Dacarbazine + Intetumumab 10 mg/kg [Phase 1 (Part 2)] Intetumumab was administered at the dose of 10 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks for 8 cycles until no evidence of disease progression or unacceptable toxicity. If participants responded to therapy with SD or better, they were considered eligible to receive up to 8 cycles of extended administrations. Commercially available dacarbazine was administered at the dose of 1000 mg/m\^2 intravenously over a period of 60 minutes (± 30 minutes) prior to intetumumab infusion.
Maximum Observed Serum Concentration (Cmax) of Intetumumab - Phase 2	NA mcg/mL Standard Deviation NA Participants in this group did not receive CNTO 95. Therefore, the data was not available for this group.	131.18 mcg/mL Standard Deviation 61.122	240.81 mcg/mL Standard Deviation 87.332	219.47 mcg/mL Standard Deviation 118.267	—

SECONDARY outcome

Timeframe: Day 1 (pre-dose) of Cycles 1, 2, 3; and final visit (3 weeks post-last dose of study medication)

Population: The ITT population included all the participants who were randomly assigned to treatment. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure and 'n' signifies those participants who were evaluable for this measure at given time points.

The FACT-MS subscale is used to evaluate health related quality of life. It consists of 16 items: 12 items related to physical well-being, 3 to emotional well-being and 1 to social well-being. Scores for all items will range from 0 to 4. Total score ranges from 0-64; higher score indicates a more positive quality of life.

Outcome measures

Measure	Intetumumab 3 mg/kg [Phase 1 (Part 1)] n=32 Participants Intetumumab was administered at the dose of 3 milligram per kilogram (mg/kg) as intravenous infusion (a fluid or a medicine delivered into a vein by way of a needle) over a period of 2 hours (hr) (± 15 minutes) once every 3 weeks until the occurrence of dose limiting toxicities (DLTs). If after an evaluation of the preliminary single-dose pharmacokinetics, receptor saturation was not observed at the 3 mg/kg or 5 mg/kg dose level, that dose of intetumumab was discontinued in Part 1 and participants were treated at the highest, documented safe dose level at which receptor saturation was observed.	Intetumumab 5 mg/kg [Phase 1 (Part 1)] n=32 Participants Intetumumab was administered at the dose of 5 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks until the occurrence of DLTs. If after an evaluation of the preliminary single-dose pharmacokinetics, receptor saturation was not observed at the 3 mg/kg or 5 mg/kg dose level, that dose of intetumumab was discontinued in Part 1 and participants were treated at the highest, documented safe dose level at which receptor saturation was observed.	Intetumumab 10 mg/kg [Phase 1 (Part 1)] n=33 Participants Intetumumab was administered at the dose of 10 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks until the occurrence of DLTs.	Dacarbazine + Intetumumab 5 mg/kg [Phase 1 (Part 2)] n=32 Participants Intetumumab was administered at the dose of 5 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks for 8 cycles until no evidence of disease progression or unacceptable toxicity. If participants responded to therapy with stable disease (SD) or better, they were considered eligible to receive up to 8 cycles of extended administrations. Commercially available dacarbazine was administered at the dose of 1000 milligram per meter-square (mg/m\^2) intravenously over a period of 60 minutes (± 30 minutes) prior to intetumumab infusion.	Dacarbazine + Intetumumab 10 mg/kg [Phase 1 (Part 2)] Intetumumab was administered at the dose of 10 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks for 8 cycles until no evidence of disease progression or unacceptable toxicity. If participants responded to therapy with SD or better, they were considered eligible to receive up to 8 cycles of extended administrations. Commercially available dacarbazine was administered at the dose of 1000 mg/m\^2 intravenously over a period of 60 minutes (± 30 minutes) prior to intetumumab infusion.
Change From Baseline in Functional Assessment of Cancer Therapy-Melanoma Subscale (FACT-MS) Score - Phase 2 Baseline (Cycle 1) (n=23, 24, 26, 26)	53.8 Units on a scale Standard Deviation 8.26	55.6 Units on a scale Standard Deviation 5.29	55.3 Units on a scale Standard Deviation 6.91	53.3 Units on a scale Standard Deviation 8.22	—
Change From Baseline in Functional Assessment of Cancer Therapy-Melanoma Subscale (FACT-MS) Score - Phase 2 Change at final visit (n = 15, 20, 20, 17)	-5.7 Units on a scale Standard Deviation 8.79	-5.5 Units on a scale Standard Deviation 7.08	-2.2 Units on a scale Standard Deviation 4.61	-3.2 Units on a scale Standard Deviation 8.39	—
Change From Baseline in Functional Assessment of Cancer Therapy-Melanoma Subscale (FACT-MS) Score - Phase 2 Change at Cycle 3 (pre-dose) (n = 19, 11, 5, 14)	-2.6 Units on a scale Standard Deviation 7.18	-1.3 Units on a scale Standard Deviation 5.90	0.2 Units on a scale Standard Deviation 0.84	-0.1 Units on a scale Standard Deviation 5.96	—
Change From Baseline in Functional Assessment of Cancer Therapy-Melanoma Subscale (FACT-MS) Score - Phase 2 Change at Cycle 2 (pre-dose) (n=20, 24, 22, 23)	-2.2 Units on a scale Standard Deviation 8.13	-1.9 Units on a scale Standard Deviation 5.21	-2.9 Units on a scale Standard Deviation 5.24	-2.0 Units on a scale Standard Deviation 4.96	—

SECONDARY outcome

Timeframe: Day 1 (pre-dose) of Cycles 1, 2, 3; and final visit (3 weeks post-last dose of study medication)

Population: The ITT population included all the participants who were randomly assigned to treatment. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure and 'n' signifies those participants who were evaluable for this measure at given time points.

The BPI questionnaire is used to evaluate heath related quality of life. BPI allows participants to rate the severity of their pain on a scale of 0 (no pain) to 10 (pain as bad as you can imagine).

Outcome measures

Measure	Intetumumab 3 mg/kg [Phase 1 (Part 1)] n=32 Participants Intetumumab was administered at the dose of 3 milligram per kilogram (mg/kg) as intravenous infusion (a fluid or a medicine delivered into a vein by way of a needle) over a period of 2 hours (hr) (± 15 minutes) once every 3 weeks until the occurrence of dose limiting toxicities (DLTs). If after an evaluation of the preliminary single-dose pharmacokinetics, receptor saturation was not observed at the 3 mg/kg or 5 mg/kg dose level, that dose of intetumumab was discontinued in Part 1 and participants were treated at the highest, documented safe dose level at which receptor saturation was observed.	Intetumumab 5 mg/kg [Phase 1 (Part 1)] n=32 Participants Intetumumab was administered at the dose of 5 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks until the occurrence of DLTs. If after an evaluation of the preliminary single-dose pharmacokinetics, receptor saturation was not observed at the 3 mg/kg or 5 mg/kg dose level, that dose of intetumumab was discontinued in Part 1 and participants were treated at the highest, documented safe dose level at which receptor saturation was observed.	Intetumumab 10 mg/kg [Phase 1 (Part 1)] n=33 Participants Intetumumab was administered at the dose of 10 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks until the occurrence of DLTs.	Dacarbazine + Intetumumab 5 mg/kg [Phase 1 (Part 2)] n=32 Participants Intetumumab was administered at the dose of 5 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks for 8 cycles until no evidence of disease progression or unacceptable toxicity. If participants responded to therapy with stable disease (SD) or better, they were considered eligible to receive up to 8 cycles of extended administrations. Commercially available dacarbazine was administered at the dose of 1000 milligram per meter-square (mg/m\^2) intravenously over a period of 60 minutes (± 30 minutes) prior to intetumumab infusion.	Dacarbazine + Intetumumab 10 mg/kg [Phase 1 (Part 2)] Intetumumab was administered at the dose of 10 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks for 8 cycles until no evidence of disease progression or unacceptable toxicity. If participants responded to therapy with SD or better, they were considered eligible to receive up to 8 cycles of extended administrations. Commercially available dacarbazine was administered at the dose of 1000 mg/m\^2 intravenously over a period of 60 minutes (± 30 minutes) prior to intetumumab infusion.
Change From Baseline in Brief Pain Inventory (BPI) Score - Phase 2 Baseline (Cycle 1) (n=23, 23, 27, 25)	1.3 Units on a scale Standard Deviation 1.77	2.0 Units on a scale Standard Deviation 2.50	0.9 Units on a scale Standard Deviation 1.79	2.2 Units on a scale Standard Deviation 2.37	—
Change From Baseline in Brief Pain Inventory (BPI) Score - Phase 2 Change at Cycle 2 (pre-dose) (n=20, 22, 22, 22)	0.9 Units on a scale Standard Deviation 1.92	0.0 Units on a scale Standard Deviation 1.96	0.5 Units on a scale Standard Deviation 2.09	-0.3 Units on a scale Standard Deviation 1.94	—
Change From Baseline in Brief Pain Inventory (BPI) Score - Phase 2 Change at Cycle 3 (pre-dose) (n = 19, 10, 6, 14)	0.5 Units on a scale Standard Deviation 2.41	0.5 Units on a scale Standard Deviation 1.27	0.0 Units on a scale Standard Deviation 0.63	-0.8 Units on a scale Standard Deviation 2.19	—
Change From Baseline in Brief Pain Inventory (BPI) Score - Phase 2 Change at final visit (n = 15, 20, 20, 16)	1.4 Units on a scale Standard Deviation 2.85	0.8 Units on a scale Standard Deviation 1.80	1.0 Units on a scale Standard Deviation 1.96	0.3 Units on a scale Standard Deviation 3.48	—

SECONDARY outcome

Timeframe: Pre-infusion, post-infusion at 2, 4, 8, 24 hour, Day 8, Day 15, post-last dose (3 weeks or 1 week) and 3 months post-last dose

Population: The PK-evaluable population included all the participants who had at least 1 PK sample and who received at least 1 (partial or complete) dose of intetumumab. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.

The maximum observed analyte concentration in serum was reported.

Outcome measures

Measure	Intetumumab 3 mg/kg [Phase 1 (Part 1)] n=3 Participants Intetumumab was administered at the dose of 3 milligram per kilogram (mg/kg) as intravenous infusion (a fluid or a medicine delivered into a vein by way of a needle) over a period of 2 hours (hr) (± 15 minutes) once every 3 weeks until the occurrence of dose limiting toxicities (DLTs). If after an evaluation of the preliminary single-dose pharmacokinetics, receptor saturation was not observed at the 3 mg/kg or 5 mg/kg dose level, that dose of intetumumab was discontinued in Part 1 and participants were treated at the highest, documented safe dose level at which receptor saturation was observed.	Intetumumab 5 mg/kg [Phase 1 (Part 1)] n=2 Participants Intetumumab was administered at the dose of 5 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks until the occurrence of DLTs. If after an evaluation of the preliminary single-dose pharmacokinetics, receptor saturation was not observed at the 3 mg/kg or 5 mg/kg dose level, that dose of intetumumab was discontinued in Part 1 and participants were treated at the highest, documented safe dose level at which receptor saturation was observed.	Intetumumab 10 mg/kg [Phase 1 (Part 1)] Intetumumab was administered at the dose of 10 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks until the occurrence of DLTs.	Dacarbazine + Intetumumab 5 mg/kg [Phase 1 (Part 2)] Intetumumab was administered at the dose of 5 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks for 8 cycles until no evidence of disease progression or unacceptable toxicity. If participants responded to therapy with stable disease (SD) or better, they were considered eligible to receive up to 8 cycles of extended administrations. Commercially available dacarbazine was administered at the dose of 1000 milligram per meter-square (mg/m\^2) intravenously over a period of 60 minutes (± 30 minutes) prior to intetumumab infusion.	Dacarbazine + Intetumumab 10 mg/kg [Phase 1 (Part 2)] Intetumumab was administered at the dose of 10 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks for 8 cycles until no evidence of disease progression or unacceptable toxicity. If participants responded to therapy with SD or better, they were considered eligible to receive up to 8 cycles of extended administrations. Commercially available dacarbazine was administered at the dose of 1000 mg/m\^2 intravenously over a period of 60 minutes (± 30 minutes) prior to intetumumab infusion.
Maximum Observed Serum Concentration (Cmax) of Intetumumab - Phase 1 (Part 2)	118.47 Microgram per milliliter (mcg/mL) Standard Deviation 33.462	220.87 Microgram per milliliter (mcg/mL) Standard Deviation 122.662	—	—	—

SECONDARY outcome

Timeframe: Pre-infusion, post-infusion at 2, 4, 8, 24 hour, Day 8, Day 15, post-last dose (3 weeks or 1 week) and 3 months post-last dose

Population: The PK-evaluable population included all the participants who had at least 1 PK sample and who received at least 1 (partial or complete) dose of intetumumab. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.

The AUC is a measure of the serum concentration of the drug over time. It is used to characterize drug absorption.

Outcome measures

Measure	Intetumumab 3 mg/kg [Phase 1 (Part 1)] n=2 Participants Intetumumab was administered at the dose of 3 milligram per kilogram (mg/kg) as intravenous infusion (a fluid or a medicine delivered into a vein by way of a needle) over a period of 2 hours (hr) (± 15 minutes) once every 3 weeks until the occurrence of dose limiting toxicities (DLTs). If after an evaluation of the preliminary single-dose pharmacokinetics, receptor saturation was not observed at the 3 mg/kg or 5 mg/kg dose level, that dose of intetumumab was discontinued in Part 1 and participants were treated at the highest, documented safe dose level at which receptor saturation was observed.	Intetumumab 5 mg/kg [Phase 1 (Part 1)] n=1 Participants Intetumumab was administered at the dose of 5 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks until the occurrence of DLTs. If after an evaluation of the preliminary single-dose pharmacokinetics, receptor saturation was not observed at the 3 mg/kg or 5 mg/kg dose level, that dose of intetumumab was discontinued in Part 1 and participants were treated at the highest, documented safe dose level at which receptor saturation was observed.	Intetumumab 10 mg/kg [Phase 1 (Part 1)] Intetumumab was administered at the dose of 10 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks until the occurrence of DLTs.	Dacarbazine + Intetumumab 5 mg/kg [Phase 1 (Part 2)] Intetumumab was administered at the dose of 5 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks for 8 cycles until no evidence of disease progression or unacceptable toxicity. If participants responded to therapy with stable disease (SD) or better, they were considered eligible to receive up to 8 cycles of extended administrations. Commercially available dacarbazine was administered at the dose of 1000 milligram per meter-square (mg/m\^2) intravenously over a period of 60 minutes (± 30 minutes) prior to intetumumab infusion.	Dacarbazine + Intetumumab 10 mg/kg [Phase 1 (Part 2)] Intetumumab was administered at the dose of 10 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks for 8 cycles until no evidence of disease progression or unacceptable toxicity. If participants responded to therapy with SD or better, they were considered eligible to receive up to 8 cycles of extended administrations. Commercially available dacarbazine was administered at the dose of 1000 mg/m\^2 intravenously over a period of 60 minutes (± 30 minutes) prior to intetumumab infusion.
Area Under the Serum Concentration Versus Time Curve (AUC) of Intetumumab - Phase 1 (Part 2)	368.74 mcg*day/mL Standard Deviation 36.056	963.17 mcg*day/mL Standard Deviation NA Standard deviation was not estimable based on one subject.	—	—	—

SECONDARY outcome

Timeframe: Pre-infusion, post-infusion at 2, 4, 8, 24 hour, Day 8, Day 15, post-last dose (3 weeks or 1 week) and 3 months post-last dose

Population: The PK-evaluable population included all the participants who had at least 1 PK sample and who received at least 1 (partial or complete) dose of intetumumab. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.

Plasma decay half-life is the time measured for the plasma concentration of the drug to decrease by one half.

Outcome measures

Measure	Intetumumab 3 mg/kg [Phase 1 (Part 1)] n=2 Participants Intetumumab was administered at the dose of 3 milligram per kilogram (mg/kg) as intravenous infusion (a fluid or a medicine delivered into a vein by way of a needle) over a period of 2 hours (hr) (± 15 minutes) once every 3 weeks until the occurrence of dose limiting toxicities (DLTs). If after an evaluation of the preliminary single-dose pharmacokinetics, receptor saturation was not observed at the 3 mg/kg or 5 mg/kg dose level, that dose of intetumumab was discontinued in Part 1 and participants were treated at the highest, documented safe dose level at which receptor saturation was observed.	Intetumumab 5 mg/kg [Phase 1 (Part 1)] n=1 Participants Intetumumab was administered at the dose of 5 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks until the occurrence of DLTs. If after an evaluation of the preliminary single-dose pharmacokinetics, receptor saturation was not observed at the 3 mg/kg or 5 mg/kg dose level, that dose of intetumumab was discontinued in Part 1 and participants were treated at the highest, documented safe dose level at which receptor saturation was observed.	Intetumumab 10 mg/kg [Phase 1 (Part 1)] Intetumumab was administered at the dose of 10 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks until the occurrence of DLTs.	Dacarbazine + Intetumumab 5 mg/kg [Phase 1 (Part 2)] Intetumumab was administered at the dose of 5 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks for 8 cycles until no evidence of disease progression or unacceptable toxicity. If participants responded to therapy with stable disease (SD) or better, they were considered eligible to receive up to 8 cycles of extended administrations. Commercially available dacarbazine was administered at the dose of 1000 milligram per meter-square (mg/m\^2) intravenously over a period of 60 minutes (± 30 minutes) prior to intetumumab infusion.	Dacarbazine + Intetumumab 10 mg/kg [Phase 1 (Part 2)] Intetumumab was administered at the dose of 10 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks for 8 cycles until no evidence of disease progression or unacceptable toxicity. If participants responded to therapy with SD or better, they were considered eligible to receive up to 8 cycles of extended administrations. Commercially available dacarbazine was administered at the dose of 1000 mg/m\^2 intravenously over a period of 60 minutes (± 30 minutes) prior to intetumumab infusion.
Half-life of Intetumumab - Phase 1 (Part 2)	2.41 Days Standard Deviation 0.559	2.36 Days Standard Deviation NA Standard deviation was not estimable based on one subject.	—	—	—

SECONDARY outcome

Timeframe: Pre-infusion, post-infusion at 2, 4, 8, 24 hour, Day 8, Day 15, post-last dose (3 weeks or 1 week) and 3 months post-last dose

Population: The PK-evaluable population included all the participants who had at least 1 PK sample and who received at least 1 (partial or complete) dose of intetumumab. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.

The CL is a quantitative measure of the rate at which a drug substance is removed from the body.

Outcome measures

Measure	Intetumumab 3 mg/kg [Phase 1 (Part 1)] n=2 Participants Intetumumab was administered at the dose of 3 milligram per kilogram (mg/kg) as intravenous infusion (a fluid or a medicine delivered into a vein by way of a needle) over a period of 2 hours (hr) (± 15 minutes) once every 3 weeks until the occurrence of dose limiting toxicities (DLTs). If after an evaluation of the preliminary single-dose pharmacokinetics, receptor saturation was not observed at the 3 mg/kg or 5 mg/kg dose level, that dose of intetumumab was discontinued in Part 1 and participants were treated at the highest, documented safe dose level at which receptor saturation was observed.	Intetumumab 5 mg/kg [Phase 1 (Part 1)] n=1 Participants Intetumumab was administered at the dose of 5 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks until the occurrence of DLTs. If after an evaluation of the preliminary single-dose pharmacokinetics, receptor saturation was not observed at the 3 mg/kg or 5 mg/kg dose level, that dose of intetumumab was discontinued in Part 1 and participants were treated at the highest, documented safe dose level at which receptor saturation was observed.	Intetumumab 10 mg/kg [Phase 1 (Part 1)] Intetumumab was administered at the dose of 10 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks until the occurrence of DLTs.	Dacarbazine + Intetumumab 5 mg/kg [Phase 1 (Part 2)] Intetumumab was administered at the dose of 5 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks for 8 cycles until no evidence of disease progression or unacceptable toxicity. If participants responded to therapy with stable disease (SD) or better, they were considered eligible to receive up to 8 cycles of extended administrations. Commercially available dacarbazine was administered at the dose of 1000 milligram per meter-square (mg/m\^2) intravenously over a period of 60 minutes (± 30 minutes) prior to intetumumab infusion.	Dacarbazine + Intetumumab 10 mg/kg [Phase 1 (Part 2)] Intetumumab was administered at the dose of 10 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks for 8 cycles until no evidence of disease progression or unacceptable toxicity. If participants responded to therapy with SD or better, they were considered eligible to receive up to 8 cycles of extended administrations. Commercially available dacarbazine was administered at the dose of 1000 mg/m\^2 intravenously over a period of 60 minutes (± 30 minutes) prior to intetumumab infusion.
Total Clearance (CL) of Intetumumab After Intravenous Administration - Phase 1 (Part 2)	13.44 mL/day/kg Standard Deviation 1.537	10.34 mL/day/kg Standard Deviation NA Standard deviation was not estimable based on one subject.	—	—	—

SECONDARY outcome

Timeframe: Pre-infusion, post-infusion at 2, 4, 8, 24 hour, Day 8, Day 15, post-last dose (3 weeks or 1 week) and 3 months post-last dose

Population: The PK-evaluable population included all the participants who had at least 1 PK sample and who received at least 1 (partial or complete) dose of intetumumab. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.

Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug.

Outcome measures

Measure	Intetumumab 3 mg/kg [Phase 1 (Part 1)] n=2 Participants Intetumumab was administered at the dose of 3 milligram per kilogram (mg/kg) as intravenous infusion (a fluid or a medicine delivered into a vein by way of a needle) over a period of 2 hours (hr) (± 15 minutes) once every 3 weeks until the occurrence of dose limiting toxicities (DLTs). If after an evaluation of the preliminary single-dose pharmacokinetics, receptor saturation was not observed at the 3 mg/kg or 5 mg/kg dose level, that dose of intetumumab was discontinued in Part 1 and participants were treated at the highest, documented safe dose level at which receptor saturation was observed.	Intetumumab 5 mg/kg [Phase 1 (Part 1)] n=1 Participants Intetumumab was administered at the dose of 5 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks until the occurrence of DLTs. If after an evaluation of the preliminary single-dose pharmacokinetics, receptor saturation was not observed at the 3 mg/kg or 5 mg/kg dose level, that dose of intetumumab was discontinued in Part 1 and participants were treated at the highest, documented safe dose level at which receptor saturation was observed.	Intetumumab 10 mg/kg [Phase 1 (Part 1)] Intetumumab was administered at the dose of 10 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks until the occurrence of DLTs.	Dacarbazine + Intetumumab 5 mg/kg [Phase 1 (Part 2)] Intetumumab was administered at the dose of 5 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks for 8 cycles until no evidence of disease progression or unacceptable toxicity. If participants responded to therapy with stable disease (SD) or better, they were considered eligible to receive up to 8 cycles of extended administrations. Commercially available dacarbazine was administered at the dose of 1000 milligram per meter-square (mg/m\^2) intravenously over a period of 60 minutes (± 30 minutes) prior to intetumumab infusion.	Dacarbazine + Intetumumab 10 mg/kg [Phase 1 (Part 2)] Intetumumab was administered at the dose of 10 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks for 8 cycles until no evidence of disease progression or unacceptable toxicity. If participants responded to therapy with SD or better, they were considered eligible to receive up to 8 cycles of extended administrations. Commercially available dacarbazine was administered at the dose of 1000 mg/m\^2 intravenously over a period of 60 minutes (± 30 minutes) prior to intetumumab infusion.
Volume of Distribution (Vz) of Intetumumab - Phase 1 (Part 2)	47.38 mL/kg Standard Deviation 16.187	35.18 mL/kg Standard Deviation NA Standard deviation was not estimable based on one subject.	—	—	—

SECONDARY outcome

Timeframe: Pre-infusion, post-infusion at 2, 4, 8, 24 hour, Day 8, Day 15, post-last dose (3 weeks or 1 week) and 3 months post-last dose

Population: The PK-evaluable population included all the participants who had at least 1 PK sample and who received at least 1 (partial or complete) dose of intetumumab. Serum concentration data was insufficient to robustly estimate the accumulation ratio.

The R is obtained by dividing AUC at two different time points.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Pre-infusion, post-infusion at 2, 4, 8, 24 hour, Day 8, Day 15, post-last dose (3 weeks or 1 week) and 3 months post-last dose

Population: The PK-evaluable population included all the participants who had at least 1 PK sample and who received at least 1 (partial or complete) dose of intetumumab. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.

The AUCinf = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - ∞). It is obtained from AUC (0 - t) plus AUC (t - ∞).

Outcome measures

Measure	Intetumumab 3 mg/kg [Phase 1 (Part 1)] n=1 Participants Intetumumab was administered at the dose of 3 milligram per kilogram (mg/kg) as intravenous infusion (a fluid or a medicine delivered into a vein by way of a needle) over a period of 2 hours (hr) (± 15 minutes) once every 3 weeks until the occurrence of dose limiting toxicities (DLTs). If after an evaluation of the preliminary single-dose pharmacokinetics, receptor saturation was not observed at the 3 mg/kg or 5 mg/kg dose level, that dose of intetumumab was discontinued in Part 1 and participants were treated at the highest, documented safe dose level at which receptor saturation was observed.	Intetumumab 5 mg/kg [Phase 1 (Part 1)] n=1 Participants Intetumumab was administered at the dose of 5 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks until the occurrence of DLTs. If after an evaluation of the preliminary single-dose pharmacokinetics, receptor saturation was not observed at the 3 mg/kg or 5 mg/kg dose level, that dose of intetumumab was discontinued in Part 1 and participants were treated at the highest, documented safe dose level at which receptor saturation was observed.	Intetumumab 10 mg/kg [Phase 1 (Part 1)] n=3 Participants Intetumumab was administered at the dose of 10 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks until the occurrence of DLTs.	Dacarbazine + Intetumumab 5 mg/kg [Phase 1 (Part 2)] Intetumumab was administered at the dose of 5 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks for 8 cycles until no evidence of disease progression or unacceptable toxicity. If participants responded to therapy with stable disease (SD) or better, they were considered eligible to receive up to 8 cycles of extended administrations. Commercially available dacarbazine was administered at the dose of 1000 milligram per meter-square (mg/m\^2) intravenously over a period of 60 minutes (± 30 minutes) prior to intetumumab infusion.	Dacarbazine + Intetumumab 10 mg/kg [Phase 1 (Part 2)] Intetumumab was administered at the dose of 10 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks for 8 cycles until no evidence of disease progression or unacceptable toxicity. If participants responded to therapy with SD or better, they were considered eligible to receive up to 8 cycles of extended administrations. Commercially available dacarbazine was administered at the dose of 1000 mg/m\^2 intravenously over a period of 60 minutes (± 30 minutes) prior to intetumumab infusion.
Area Under the Concentration Versus Time Curve Between Zero to Infinite Time (AUCinf) of Intetumumab - Phase 1 (Part 1)	257.80 mcg*day/mL Standard Deviation NA Standard deviation was not estimable based on one subject.	503.88 mcg*day/mL Standard Deviation NA Standard deviation was not estimable based on one subject.	1591.54 mcg*day/mL Standard Deviation 213.858	—	—

OTHER_PRE_SPECIFIED outcome

Timeframe: Within 28 days of first infusion of study medication, within 1 week of the end of Cycles 2, 4, 6, 8; 3 months and 6 months post-last dose of study medication

Population: The response-evaluable population included all the participants who were evaluable for response.

The CR: complete disappearance of all measurable and non-measurable target lesions and PR: 50% or more decrease in sum of the longest diameters of target lesion(s), with at least stable disease (SD) in all other evaluable disease in the absence of treatment failure.

Outcome measures

Measure	Intetumumab 3 mg/kg [Phase 1 (Part 1)] n=31 Participants Intetumumab was administered at the dose of 3 milligram per kilogram (mg/kg) as intravenous infusion (a fluid or a medicine delivered into a vein by way of a needle) over a period of 2 hours (hr) (± 15 minutes) once every 3 weeks until the occurrence of dose limiting toxicities (DLTs). If after an evaluation of the preliminary single-dose pharmacokinetics, receptor saturation was not observed at the 3 mg/kg or 5 mg/kg dose level, that dose of intetumumab was discontinued in Part 1 and participants were treated at the highest, documented safe dose level at which receptor saturation was observed.	Intetumumab 5 mg/kg [Phase 1 (Part 1)] n=31 Participants Intetumumab was administered at the dose of 5 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks until the occurrence of DLTs. If after an evaluation of the preliminary single-dose pharmacokinetics, receptor saturation was not observed at the 3 mg/kg or 5 mg/kg dose level, that dose of intetumumab was discontinued in Part 1 and participants were treated at the highest, documented safe dose level at which receptor saturation was observed.	Intetumumab 10 mg/kg [Phase 1 (Part 1)] n=33 Participants Intetumumab was administered at the dose of 10 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks until the occurrence of DLTs.	Dacarbazine + Intetumumab 5 mg/kg [Phase 1 (Part 2)] n=30 Participants Intetumumab was administered at the dose of 5 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks for 8 cycles until no evidence of disease progression or unacceptable toxicity. If participants responded to therapy with stable disease (SD) or better, they were considered eligible to receive up to 8 cycles of extended administrations. Commercially available dacarbazine was administered at the dose of 1000 milligram per meter-square (mg/m\^2) intravenously over a period of 60 minutes (± 30 minutes) prior to intetumumab infusion.	Dacarbazine + Intetumumab 10 mg/kg [Phase 1 (Part 2)] Intetumumab was administered at the dose of 10 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks for 8 cycles until no evidence of disease progression or unacceptable toxicity. If participants responded to therapy with SD or better, they were considered eligible to receive up to 8 cycles of extended administrations. Commercially available dacarbazine was administered at the dose of 1000 mg/m\^2 intravenously over a period of 60 minutes (± 30 minutes) prior to intetumumab infusion.
Percentage of Participants Who Achieved a Best Overall Response as CR, PR, or SD - Phase 2	41.9 Percentage of Participants	25.8 Percentage of Participants	30.3 Percentage of Participants	56.7 Percentage of Participants	—

Adverse Events

Intetumumab 3 mg/kg [Phase 1 (Part 1)]

Serious events: 2 serious events

Other events: 3 other events

Deaths: 0 deaths

Intetumumab 5 mg/kg [Phase 1 (Part 1)]

Serious events: 1 serious events

Other events: 3 other events

Deaths: 0 deaths

Intetumumab 10 mg/kg [Phase 1 (Part 1)]

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Dacarbazine + Intetumumab 5 mg/kg [Phase 1 (Part 2)]

Serious events: 1 serious events

Other events: 3 other events

Deaths: 0 deaths

Dacarbazine + Intetumumab 10 mg/kg [Phase 1 (Part 2)]

Serious events: 2 serious events

Other events: 3 other events

Deaths: 0 deaths

Dacarbazine + Placebo [Phase 2]

Serious events: 9 serious events

Other events: 30 other events

Deaths: 0 deaths

Intetumumab 5 mg/kg [Phase 2]

Serious events: 4 serious events

Other events: 30 other events

Deaths: 0 deaths

Intetumumab 10 mg/kg [Phase 2]

Serious events: 6 serious events

Other events: 32 other events

Deaths: 0 deaths

Dacarbazine + Intetumumab 10 mg/kg [Phase 2]

Serious events: 7 serious events

Other events: 30 other events

Deaths: 0 deaths

Serious adverse events

Measure	Intetumumab 3 mg/kg [Phase 1 (Part 1)] n=3 participants at risk Intetumumab was administered at the dose of 3 milligram per kilogram (mg/kg) as intravenous infusion (a fluid or a medicine delivered into a vein by way of a needle) over a period of 2 hours (hr) (± 15 minutes) once every 3 weeks until the occurrence of dose limiting toxicities (DLTs). If after an evaluation of the preliminary single-dose pharmacokinetics, receptor saturation was not observed at the 3 mg/kg or 5 mg/kg dose level, that dose of intetumumab was discontinued in Part 1 and participants were treated at the highest, documented safe dose level at which receptor saturation was observed.	Intetumumab 5 mg/kg [Phase 1 (Part 1)] n=3 participants at risk Intetumumab was administered at the dose of 5 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks until the occurrence of DLTs. If after an evaluation of the preliminary single-dose pharmacokinetics, receptor saturation was not observed at the 3 mg/kg or 5 mg/kg dose level, that dose of intetumumab was discontinued in Part 1 and participants were treated at the highest, documented safe dose level at which receptor saturation was observed.	Intetumumab 10 mg/kg [Phase 1 (Part 1)] n=3 participants at risk Intetumumab was administered at the dose of 10 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks until the occurrence of DLTs.	Dacarbazine + Intetumumab 5 mg/kg [Phase 1 (Part 2)] n=3 participants at risk Intetumumab was administered at the dose of 5 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks for 8 cycles until no evidence of disease progression or unacceptable toxicity. If participants responded to therapy with stable disease (SD) or better, they were considered eligible to receive up to 8 cycles of extended administrations. Commercially available dacarbazine was administered at the dose of 1000 milligram per meter-square (mg/m\^2) intravenously over a period of 60 minutes (± 30 minutes) prior to intetumumab infusion.	Dacarbazine + Intetumumab 10 mg/kg [Phase 1 (Part 2)] n=3 participants at risk Intetumumab was administered at the dose of 10 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks for 8 cycles until no evidence of disease progression or unacceptable toxicity. If participants responded to therapy with SD or better, they were considered eligible to receive up to 8 cycles of extended administrations. Commercially available dacarbazine was administered at the dose of 1000 mg/m\^2 intravenously over a period of 60 minutes (± 30 minutes) prior to intetumumab infusion.	Dacarbazine + Placebo [Phase 2] n=31 participants at risk Placebo was administered intravenously over a period of 2 hr (±15 minutes). Commercially available dacarbazine was administered at the dose of 1000 mg/m\^2 intravenously over a period of 60 minutes (± 30 minutes) prior to placebo infusion. In case participants were unable to tolerate dacarbazine even after 2 dose reductions, they were given the option to continue with 10 mg/kg intetumumab alone.	Intetumumab 5 mg/kg [Phase 2] n=31 participants at risk Intetumumab was administered at the dose of 5 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks for 8 cycles until no evidence of disease progression or unacceptable toxicity. If participants responded to therapy with SD or better, they were considered eligible to receive up to 8 cycles of extended administrations.	Intetumumab 10 mg/kg [Phase 2] n=33 participants at risk Intetumumab was administered at the dose of 10 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks for 8 cycles until no evidence of disease progression or unacceptable toxicity. If participants responded to therapy with SD or better, they were considered eligible to receive up to 8 cycles of extended administrations.	Dacarbazine + Intetumumab 10 mg/kg [Phase 2] n=32 participants at risk Intetumumab was administered at the dose of 10 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks for 8 cycles until no evidence of disease progression or unacceptable toxicity. If participants responded to therapy with SD or better, they were considered eligible to receive up to 8 cycles of extended administrations. Commercially available dacarbazine was administered at the dose of 1000 mg/m\^2 intravenously over a period of 60 minutes (± 30 minutes) prior to intetumumab infusion.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasm Progression	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	3.2% 1/31 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/31 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/33 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/32 • Day 1 up to Follow-up period (30 days post-last dose).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Skin Neoplasm Bleeding	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/31 • Day 1 up to Follow-up period (30 days post-last dose).	3.2% 1/31 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/33 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/32 • Day 1 up to Follow-up period (30 days post-last dose).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumour Haemorrhage	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	3.2% 1/31 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/31 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/33 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/32 • Day 1 up to Follow-up period (30 days post-last dose).
Nervous system disorders Cerebrovascular Accident	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	3.2% 1/31 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/31 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/33 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/32 • Day 1 up to Follow-up period (30 days post-last dose).
Nervous system disorders Headache	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/31 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/31 • Day 1 up to Follow-up period (30 days post-last dose).	3.0% 1/33 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/32 • Day 1 up to Follow-up period (30 days post-last dose).
Nervous system disorders Hypotonia	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/31 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/31 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/33 • Day 1 up to Follow-up period (30 days post-last dose).	3.1% 1/32 • Day 1 up to Follow-up period (30 days post-last dose).
Nervous system disorders Reversible Posterior Leukoencephalopathy Syndrome	33.3% 1/3 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/31 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/31 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/33 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/32 • Day 1 up to Follow-up period (30 days post-last dose).
Nervous system disorders Spinal Cord Compression	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/31 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/31 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/33 • Day 1 up to Follow-up period (30 days post-last dose).	3.1% 1/32 • Day 1 up to Follow-up period (30 days post-last dose).
Blood and lymphatic system disorders Febrile Neutropenia	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	6.5% 2/31 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/31 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/33 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/32 • Day 1 up to Follow-up period (30 days post-last dose).
Blood and lymphatic system disorders Neutropenia	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	3.2% 1/31 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/31 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/33 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/32 • Day 1 up to Follow-up period (30 days post-last dose).
Blood and lymphatic system disorders Thrombocytopenia	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	33.3% 1/3 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	6.5% 2/31 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/31 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/33 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/32 • Day 1 up to Follow-up period (30 days post-last dose).
Cardiac disorders Cyanosis	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/31 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/31 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/33 • Day 1 up to Follow-up period (30 days post-last dose).	3.1% 1/32 • Day 1 up to Follow-up period (30 days post-last dose).
Eye disorders Eye Haemorrhage	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	33.3% 1/3 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/31 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/31 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/33 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/32 • Day 1 up to Follow-up period (30 days post-last dose).
Gastrointestinal disorders Abdominal Pain	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/31 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/31 • Day 1 up to Follow-up period (30 days post-last dose).	3.0% 1/33 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/32 • Day 1 up to Follow-up period (30 days post-last dose).
Gastrointestinal disorders Nausea	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/31 • Day 1 up to Follow-up period (30 days post-last dose).	3.2% 1/31 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/33 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/32 • Day 1 up to Follow-up period (30 days post-last dose).
Gastrointestinal disorders Vomiting	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/31 • Day 1 up to Follow-up period (30 days post-last dose).	3.2% 1/31 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/33 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/32 • Day 1 up to Follow-up period (30 days post-last dose).
General disorders Disease Progression	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	3.2% 1/31 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/31 • Day 1 up to Follow-up period (30 days post-last dose).	3.0% 1/33 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/32 • Day 1 up to Follow-up period (30 days post-last dose).
General disorders General Physical Health Deterioration	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/31 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/31 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/33 • Day 1 up to Follow-up period (30 days post-last dose).	3.1% 1/32 • Day 1 up to Follow-up period (30 days post-last dose).
General disorders Pyrexia	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	33.3% 1/3 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	3.2% 1/31 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/31 • Day 1 up to Follow-up period (30 days post-last dose).	3.0% 1/33 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/32 • Day 1 up to Follow-up period (30 days post-last dose).
Immune system disorders Anaphylactic Reaction	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	3.2% 1/31 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/31 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/33 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/32 • Day 1 up to Follow-up period (30 days post-last dose).
Immune system disorders Hypersensitivity	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/31 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/31 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/33 • Day 1 up to Follow-up period (30 days post-last dose).	3.1% 1/32 • Day 1 up to Follow-up period (30 days post-last dose).
Infections and infestations Appendicitis	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	3.2% 1/31 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/31 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/33 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/32 • Day 1 up to Follow-up period (30 days post-last dose).
Infections and infestations Cellulitis	33.3% 1/3 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/31 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/31 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/33 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/32 • Day 1 up to Follow-up period (30 days post-last dose).
Infections and infestations Gastroenteritis Norovirus	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/31 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/31 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/33 • Day 1 up to Follow-up period (30 days post-last dose).	3.1% 1/32 • Day 1 up to Follow-up period (30 days post-last dose).
Infections and infestations Infection	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/31 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/31 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/33 • Day 1 up to Follow-up period (30 days post-last dose).	3.1% 1/32 • Day 1 up to Follow-up period (30 days post-last dose).
Infections and infestations Wound Infection	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/31 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/31 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/33 • Day 1 up to Follow-up period (30 days post-last dose).	3.1% 1/32 • Day 1 up to Follow-up period (30 days post-last dose).
Metabolism and nutrition disorders Dehydration	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/31 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/31 • Day 1 up to Follow-up period (30 days post-last dose).	3.0% 1/33 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/32 • Day 1 up to Follow-up period (30 days post-last dose).
Musculoskeletal and connective tissue disorders Back Pain	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/31 • Day 1 up to Follow-up period (30 days post-last dose).	3.2% 1/31 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/33 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/32 • Day 1 up to Follow-up period (30 days post-last dose).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Basal Cell Carcinoma	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/31 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/31 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/33 • Day 1 up to Follow-up period (30 days post-last dose).	3.1% 1/32 • Day 1 up to Follow-up period (30 days post-last dose).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant Pleural Effusion	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/31 • Day 1 up to Follow-up period (30 days post-last dose).	3.2% 1/31 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/33 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/32 • Day 1 up to Follow-up period (30 days post-last dose).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to Central Nervous System	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/31 • Day 1 up to Follow-up period (30 days post-last dose).	3.2% 1/31 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/33 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/32 • Day 1 up to Follow-up period (30 days post-last dose).
Psychiatric disorders Disorientation	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/31 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/31 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/33 • Day 1 up to Follow-up period (30 days post-last dose).	3.1% 1/32 • Day 1 up to Follow-up period (30 days post-last dose).
Respiratory, thoracic and mediastinal disorders Asthma	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	3.2% 1/31 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/31 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/33 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/32 • Day 1 up to Follow-up period (30 days post-last dose).
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	33.3% 1/3 • Day 1 up to Follow-up period (30 days post-last dose).	3.2% 1/31 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/31 • Day 1 up to Follow-up period (30 days post-last dose).	3.0% 1/33 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/32 • Day 1 up to Follow-up period (30 days post-last dose).
Respiratory, thoracic and mediastinal disorders Pleural Effusion	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	3.2% 1/31 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/31 • Day 1 up to Follow-up period (30 days post-last dose).	3.0% 1/33 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/32 • Day 1 up to Follow-up period (30 days post-last dose).
Respiratory, thoracic and mediastinal disorders Pneumonia Aspiration	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	3.2% 1/31 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/31 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/33 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/32 • Day 1 up to Follow-up period (30 days post-last dose).
Vascular disorders Deep Vein Thrombosis	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/31 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/31 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/33 • Day 1 up to Follow-up period (30 days post-last dose).	3.1% 1/32 • Day 1 up to Follow-up period (30 days post-last dose).
Vascular disorders Pallor	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/31 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/31 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/33 • Day 1 up to Follow-up period (30 days post-last dose).	3.1% 1/32 • Day 1 up to Follow-up period (30 days post-last dose).

Other adverse events

Measure	Intetumumab 3 mg/kg [Phase 1 (Part 1)] n=3 participants at risk Intetumumab was administered at the dose of 3 milligram per kilogram (mg/kg) as intravenous infusion (a fluid or a medicine delivered into a vein by way of a needle) over a period of 2 hours (hr) (± 15 minutes) once every 3 weeks until the occurrence of dose limiting toxicities (DLTs). If after an evaluation of the preliminary single-dose pharmacokinetics, receptor saturation was not observed at the 3 mg/kg or 5 mg/kg dose level, that dose of intetumumab was discontinued in Part 1 and participants were treated at the highest, documented safe dose level at which receptor saturation was observed.	Intetumumab 5 mg/kg [Phase 1 (Part 1)] n=3 participants at risk Intetumumab was administered at the dose of 5 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks until the occurrence of DLTs. If after an evaluation of the preliminary single-dose pharmacokinetics, receptor saturation was not observed at the 3 mg/kg or 5 mg/kg dose level, that dose of intetumumab was discontinued in Part 1 and participants were treated at the highest, documented safe dose level at which receptor saturation was observed.	Intetumumab 10 mg/kg [Phase 1 (Part 1)] n=3 participants at risk Intetumumab was administered at the dose of 10 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks until the occurrence of DLTs.	Dacarbazine + Intetumumab 5 mg/kg [Phase 1 (Part 2)] n=3 participants at risk Intetumumab was administered at the dose of 5 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks for 8 cycles until no evidence of disease progression or unacceptable toxicity. If participants responded to therapy with stable disease (SD) or better, they were considered eligible to receive up to 8 cycles of extended administrations. Commercially available dacarbazine was administered at the dose of 1000 milligram per meter-square (mg/m\^2) intravenously over a period of 60 minutes (± 30 minutes) prior to intetumumab infusion.	Dacarbazine + Intetumumab 10 mg/kg [Phase 1 (Part 2)] n=3 participants at risk Intetumumab was administered at the dose of 10 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks for 8 cycles until no evidence of disease progression or unacceptable toxicity. If participants responded to therapy with SD or better, they were considered eligible to receive up to 8 cycles of extended administrations. Commercially available dacarbazine was administered at the dose of 1000 mg/m\^2 intravenously over a period of 60 minutes (± 30 minutes) prior to intetumumab infusion.	Dacarbazine + Placebo [Phase 2] n=31 participants at risk Placebo was administered intravenously over a period of 2 hr (±15 minutes). Commercially available dacarbazine was administered at the dose of 1000 mg/m\^2 intravenously over a period of 60 minutes (± 30 minutes) prior to placebo infusion. In case participants were unable to tolerate dacarbazine even after 2 dose reductions, they were given the option to continue with 10 mg/kg intetumumab alone.	Intetumumab 5 mg/kg [Phase 2] n=31 participants at risk Intetumumab was administered at the dose of 5 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks for 8 cycles until no evidence of disease progression or unacceptable toxicity. If participants responded to therapy with SD or better, they were considered eligible to receive up to 8 cycles of extended administrations.	Intetumumab 10 mg/kg [Phase 2] n=33 participants at risk Intetumumab was administered at the dose of 10 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks for 8 cycles until no evidence of disease progression or unacceptable toxicity. If participants responded to therapy with SD or better, they were considered eligible to receive up to 8 cycles of extended administrations.	Dacarbazine + Intetumumab 10 mg/kg [Phase 2] n=32 participants at risk Intetumumab was administered at the dose of 10 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks for 8 cycles until no evidence of disease progression or unacceptable toxicity. If participants responded to therapy with SD or better, they were considered eligible to receive up to 8 cycles of extended administrations. Commercially available dacarbazine was administered at the dose of 1000 mg/m\^2 intravenously over a period of 60 minutes (± 30 minutes) prior to intetumumab infusion.
Blood and lymphatic system disorders Anaemia	66.7% 2/3 • Day 1 up to Follow-up period (30 days post-last dose).	33.3% 1/3 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	33.3% 1/3 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	19.4% 6/31 • Day 1 up to Follow-up period (30 days post-last dose).	3.2% 1/31 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/33 • Day 1 up to Follow-up period (30 days post-last dose).	21.9% 7/32 • Day 1 up to Follow-up period (30 days post-last dose).
Blood and lymphatic system disorders Leukopenia	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	33.3% 1/3 • Day 1 up to Follow-up period (30 days post-last dose).	12.9% 4/31 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/31 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/33 • Day 1 up to Follow-up period (30 days post-last dose).	18.8% 6/32 • Day 1 up to Follow-up period (30 days post-last dose).
Blood and lymphatic system disorders Neutropenia	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	100.0% 3/3 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	22.6% 7/31 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/31 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/33 • Day 1 up to Follow-up period (30 days post-last dose).	18.8% 6/32 • Day 1 up to Follow-up period (30 days post-last dose).
Blood and lymphatic system disorders Thrombocytopenia	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	33.3% 1/3 • Day 1 up to Follow-up period (30 days post-last dose).	33.3% 1/3 • Day 1 up to Follow-up period (30 days post-last dose).	25.8% 8/31 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/31 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/33 • Day 1 up to Follow-up period (30 days post-last dose).	18.8% 6/32 • Day 1 up to Follow-up period (30 days post-last dose).
Cardiac disorders Palpitations	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	6.5% 2/31 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/31 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/33 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/32 • Day 1 up to Follow-up period (30 days post-last dose).
Cardiac disorders Tachycardia	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	9.7% 3/31 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/31 • Day 1 up to Follow-up period (30 days post-last dose).	3.0% 1/33 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/32 • Day 1 up to Follow-up period (30 days post-last dose).
Endocrine disorders Hyperparathyroidism	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	33.3% 1/3 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/31 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/31 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/33 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/32 • Day 1 up to Follow-up period (30 days post-last dose).
Eye disorders Eye Irritation	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	33.3% 1/3 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/31 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/31 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/33 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/32 • Day 1 up to Follow-up period (30 days post-last dose).
Eye disorders Eye Pain	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	33.3% 1/3 • Day 1 up to Follow-up period (30 days post-last dose).	33.3% 1/3 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/31 • Day 1 up to Follow-up period (30 days post-last dose).	3.2% 1/31 • Day 1 up to Follow-up period (30 days post-last dose).	3.0% 1/33 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/32 • Day 1 up to Follow-up period (30 days post-last dose).
Eye disorders Lacrimation Increased	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	33.3% 1/3 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/31 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/31 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/33 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/32 • Day 1 up to Follow-up period (30 days post-last dose).
Eye disorders Ocular Discomfort	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	33.3% 1/3 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/31 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/31 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/33 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/32 • Day 1 up to Follow-up period (30 days post-last dose).
Eye disorders Ocular Hyperaemia	33.3% 1/3 • Day 1 up to Follow-up period (30 days post-last dose).	33.3% 1/3 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/31 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/31 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/33 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/32 • Day 1 up to Follow-up period (30 days post-last dose).
Eye disorders Uveitis	33.3% 1/3 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	3.2% 1/31 • Day 1 up to Follow-up period (30 days post-last dose).	22.6% 7/31 • Day 1 up to Follow-up period (30 days post-last dose).	30.3% 10/33 • Day 1 up to Follow-up period (30 days post-last dose).	21.9% 7/32 • Day 1 up to Follow-up period (30 days post-last dose).
Eye disorders Visual Acuity Reduced	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	33.3% 1/3 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/31 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/31 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/33 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/32 • Day 1 up to Follow-up period (30 days post-last dose).
Eye disorders Vitreous Floaters	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	33.3% 1/3 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/31 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/31 • Day 1 up to Follow-up period (30 days post-last dose).	3.0% 1/33 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/32 • Day 1 up to Follow-up period (30 days post-last dose).
Gastrointestinal disorders Abdominal Pain	33.3% 1/3 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	12.9% 4/31 • Day 1 up to Follow-up period (30 days post-last dose).	3.2% 1/31 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/33 • Day 1 up to Follow-up period (30 days post-last dose).	6.2% 2/32 • Day 1 up to Follow-up period (30 days post-last dose).
Gastrointestinal disorders Abdominal Pain Lower	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	33.3% 1/3 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/31 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/31 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/33 • Day 1 up to Follow-up period (30 days post-last dose).	3.1% 1/32 • Day 1 up to Follow-up period (30 days post-last dose).
Gastrointestinal disorders Abdominal Pain Upper	33.3% 1/3 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	9.7% 3/31 • Day 1 up to Follow-up period (30 days post-last dose).	3.2% 1/31 • Day 1 up to Follow-up period (30 days post-last dose).	6.1% 2/33 • Day 1 up to Follow-up period (30 days post-last dose).	3.1% 1/32 • Day 1 up to Follow-up period (30 days post-last dose).
Gastrointestinal disorders Abdominal Tenderness	33.3% 1/3 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/31 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/31 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/33 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/32 • Day 1 up to Follow-up period (30 days post-last dose).
Gastrointestinal disorders Constipation	33.3% 1/3 • Day 1 up to Follow-up period (30 days post-last dose).	33.3% 1/3 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	66.7% 2/3 • Day 1 up to Follow-up period (30 days post-last dose).	19.4% 6/31 • Day 1 up to Follow-up period (30 days post-last dose).	9.7% 3/31 • Day 1 up to Follow-up period (30 days post-last dose).	9.1% 3/33 • Day 1 up to Follow-up period (30 days post-last dose).	21.9% 7/32 • Day 1 up to Follow-up period (30 days post-last dose).
Gastrointestinal disorders Diarrhoea	33.3% 1/3 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	9.7% 3/31 • Day 1 up to Follow-up period (30 days post-last dose).	9.7% 3/31 • Day 1 up to Follow-up period (30 days post-last dose).	18.2% 6/33 • Day 1 up to Follow-up period (30 days post-last dose).	21.9% 7/32 • Day 1 up to Follow-up period (30 days post-last dose).
Gastrointestinal disorders Dyspepsia	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/31 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/31 • Day 1 up to Follow-up period (30 days post-last dose).	6.1% 2/33 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/32 • Day 1 up to Follow-up period (30 days post-last dose).
Gastrointestinal disorders Nausea	66.7% 2/3 • Day 1 up to Follow-up period (30 days post-last dose).	66.7% 2/3 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	33.3% 1/3 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	51.6% 16/31 • Day 1 up to Follow-up period (30 days post-last dose).	22.6% 7/31 • Day 1 up to Follow-up period (30 days post-last dose).	36.4% 12/33 • Day 1 up to Follow-up period (30 days post-last dose).	46.9% 15/32 • Day 1 up to Follow-up period (30 days post-last dose).
Gastrointestinal disorders Rectal Haemorrhage	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/31 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/31 • Day 1 up to Follow-up period (30 days post-last dose).	6.1% 2/33 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/32 • Day 1 up to Follow-up period (30 days post-last dose).
Gastrointestinal disorders Vomiting	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	66.7% 2/3 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	12.9% 4/31 • Day 1 up to Follow-up period (30 days post-last dose).	19.4% 6/31 • Day 1 up to Follow-up period (30 days post-last dose).	39.4% 13/33 • Day 1 up to Follow-up period (30 days post-last dose).	25.0% 8/32 • Day 1 up to Follow-up period (30 days post-last dose).
General disorders Chest Pain	66.7% 2/3 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/31 • Day 1 up to Follow-up period (30 days post-last dose).	3.2% 1/31 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/33 • Day 1 up to Follow-up period (30 days post-last dose).	3.1% 1/32 • Day 1 up to Follow-up period (30 days post-last dose).
General disorders Chills	33.3% 1/3 • Day 1 up to Follow-up period (30 days post-last dose).	100.0% 3/3 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	33.3% 1/3 • Day 1 up to Follow-up period (30 days post-last dose).	33.3% 1/3 • Day 1 up to Follow-up period (30 days post-last dose).	16.1% 5/31 • Day 1 up to Follow-up period (30 days post-last dose).	16.1% 5/31 • Day 1 up to Follow-up period (30 days post-last dose).	27.3% 9/33 • Day 1 up to Follow-up period (30 days post-last dose).	15.6% 5/32 • Day 1 up to Follow-up period (30 days post-last dose).
General disorders Fatigue	66.7% 2/3 • Day 1 up to Follow-up period (30 days post-last dose).	66.7% 2/3 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	100.0% 3/3 • Day 1 up to Follow-up period (30 days post-last dose).	33.3% 1/3 • Day 1 up to Follow-up period (30 days post-last dose).	41.9% 13/31 • Day 1 up to Follow-up period (30 days post-last dose).	22.6% 7/31 • Day 1 up to Follow-up period (30 days post-last dose).	42.4% 14/33 • Day 1 up to Follow-up period (30 days post-last dose).	31.2% 10/32 • Day 1 up to Follow-up period (30 days post-last dose).
General disorders Influenza Like Illness	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	33.3% 1/3 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	33.3% 1/3 • Day 1 up to Follow-up period (30 days post-last dose).	6.5% 2/31 • Day 1 up to Follow-up period (30 days post-last dose).	16.1% 5/31 • Day 1 up to Follow-up period (30 days post-last dose).	9.1% 3/33 • Day 1 up to Follow-up period (30 days post-last dose).	6.2% 2/32 • Day 1 up to Follow-up period (30 days post-last dose).
General disorders Infusion Site Extravasation	33.3% 1/3 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/31 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/31 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/33 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/32 • Day 1 up to Follow-up period (30 days post-last dose).
General disorders Infusion Site Pain	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	33.3% 1/3 • Day 1 up to Follow-up period (30 days post-last dose).	33.3% 1/3 • Day 1 up to Follow-up period (30 days post-last dose).	6.5% 2/31 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/31 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/33 • Day 1 up to Follow-up period (30 days post-last dose).	18.8% 6/32 • Day 1 up to Follow-up period (30 days post-last dose).
General disorders Oedema Peripheral	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	33.3% 1/3 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	6.5% 2/31 • Day 1 up to Follow-up period (30 days post-last dose).	9.7% 3/31 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/33 • Day 1 up to Follow-up period (30 days post-last dose).	3.1% 1/32 • Day 1 up to Follow-up period (30 days post-last dose).
General disorders Pain	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	66.7% 2/3 • Day 1 up to Follow-up period (30 days post-last dose).	3.2% 1/31 • Day 1 up to Follow-up period (30 days post-last dose).	16.1% 5/31 • Day 1 up to Follow-up period (30 days post-last dose).	3.0% 1/33 • Day 1 up to Follow-up period (30 days post-last dose).	3.1% 1/32 • Day 1 up to Follow-up period (30 days post-last dose).
General disorders Pyrexia	66.7% 2/3 • Day 1 up to Follow-up period (30 days post-last dose).	100.0% 3/3 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	33.3% 1/3 • Day 1 up to Follow-up period (30 days post-last dose).	12.9% 4/31 • Day 1 up to Follow-up period (30 days post-last dose).	29.0% 9/31 • Day 1 up to Follow-up period (30 days post-last dose).	36.4% 12/33 • Day 1 up to Follow-up period (30 days post-last dose).	18.8% 6/32 • Day 1 up to Follow-up period (30 days post-last dose).
Infections and infestations Abscess	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	33.3% 1/3 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/31 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/31 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/33 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/32 • Day 1 up to Follow-up period (30 days post-last dose).
Infections and infestations Influenza	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/31 • Day 1 up to Follow-up period (30 days post-last dose).	6.5% 2/31 • Day 1 up to Follow-up period (30 days post-last dose).	3.0% 1/33 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/32 • Day 1 up to Follow-up period (30 days post-last dose).
Infections and infestations Nasopharyngitis	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	3.2% 1/31 • Day 1 up to Follow-up period (30 days post-last dose).	3.2% 1/31 • Day 1 up to Follow-up period (30 days post-last dose).	6.1% 2/33 • Day 1 up to Follow-up period (30 days post-last dose).	3.1% 1/32 • Day 1 up to Follow-up period (30 days post-last dose).
Infections and infestations Oral Herpes	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	33.3% 1/3 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/31 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/31 • Day 1 up to Follow-up period (30 days post-last dose).	3.0% 1/33 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/32 • Day 1 up to Follow-up period (30 days post-last dose).
Infections and infestations Rhinitis	33.3% 1/3 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/31 • Day 1 up to Follow-up period (30 days post-last dose).	3.2% 1/31 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/33 • Day 1 up to Follow-up period (30 days post-last dose).	6.2% 2/32 • Day 1 up to Follow-up period (30 days post-last dose).
Infections and infestations Sinusitis	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	33.3% 1/3 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/31 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/31 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/33 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/32 • Day 1 up to Follow-up period (30 days post-last dose).
Infections and infestations Upper Respiratory Tract Infection	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	3.2% 1/31 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/31 • Day 1 up to Follow-up period (30 days post-last dose).	6.1% 2/33 • Day 1 up to Follow-up period (30 days post-last dose).	3.1% 1/32 • Day 1 up to Follow-up period (30 days post-last dose).
Injury, poisoning and procedural complications Procedural Pain	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/31 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/31 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/33 • Day 1 up to Follow-up period (30 days post-last dose).	6.2% 2/32 • Day 1 up to Follow-up period (30 days post-last dose).
Injury, poisoning and procedural complications Wound Secretion	33.3% 1/3 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/31 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/31 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/33 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/32 • Day 1 up to Follow-up period (30 days post-last dose).
Investigations Blood Alkaline Phosphatase Increased	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/31 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/31 • Day 1 up to Follow-up period (30 days post-last dose).	6.1% 2/33 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/32 • Day 1 up to Follow-up period (30 days post-last dose).
Investigations Blood Creatinine Increased	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/31 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/31 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/33 • Day 1 up to Follow-up period (30 days post-last dose).	6.2% 2/32 • Day 1 up to Follow-up period (30 days post-last dose).
Investigations Blood Lactate Dehydrogenase Increased	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	33.3% 1/3 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/31 • Day 1 up to Follow-up period (30 days post-last dose).	9.7% 3/31 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/33 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/32 • Day 1 up to Follow-up period (30 days post-last dose).
Investigations Heart Rate Increased	33.3% 1/3 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	6.5% 2/31 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/31 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/33 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/32 • Day 1 up to Follow-up period (30 days post-last dose).
Investigations Weight Decreased	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	6.5% 2/31 • Day 1 up to Follow-up period (30 days post-last dose).	9.7% 3/31 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/33 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/32 • Day 1 up to Follow-up period (30 days post-last dose).
Metabolism and nutrition disorders Anorexia	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	33.3% 1/3 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/31 • Day 1 up to Follow-up period (30 days post-last dose).	3.2% 1/31 • Day 1 up to Follow-up period (30 days post-last dose).	9.1% 3/33 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/32 • Day 1 up to Follow-up period (30 days post-last dose).
Metabolism and nutrition disorders Decreased Appetite	33.3% 1/3 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	3.2% 1/31 • Day 1 up to Follow-up period (30 days post-last dose).	6.5% 2/31 • Day 1 up to Follow-up period (30 days post-last dose).	3.0% 1/33 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/32 • Day 1 up to Follow-up period (30 days post-last dose).
Metabolism and nutrition disorders Hyperglycaemia	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	6.5% 2/31 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/31 • Day 1 up to Follow-up period (30 days post-last dose).	3.0% 1/33 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/32 • Day 1 up to Follow-up period (30 days post-last dose).
Metabolism and nutrition disorders Hypokalaemia	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/31 • Day 1 up to Follow-up period (30 days post-last dose).	3.2% 1/31 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/33 • Day 1 up to Follow-up period (30 days post-last dose).	6.2% 2/32 • Day 1 up to Follow-up period (30 days post-last dose).
Metabolism and nutrition disorders Hypomagnesaemia	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	6.5% 2/31 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/31 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/33 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/32 • Day 1 up to Follow-up period (30 days post-last dose).
Musculoskeletal and connective tissue disorders Arthralgia	33.3% 1/3 • Day 1 up to Follow-up period (30 days post-last dose).	33.3% 1/3 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	6.5% 2/31 • Day 1 up to Follow-up period (30 days post-last dose).	3.2% 1/31 • Day 1 up to Follow-up period (30 days post-last dose).	3.0% 1/33 • Day 1 up to Follow-up period (30 days post-last dose).	3.1% 1/32 • Day 1 up to Follow-up period (30 days post-last dose).
Musculoskeletal and connective tissue disorders Back Pain	33.3% 1/3 • Day 1 up to Follow-up period (30 days post-last dose).	33.3% 1/3 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	33.3% 1/3 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	3.2% 1/31 • Day 1 up to Follow-up period (30 days post-last dose).	12.9% 4/31 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/33 • Day 1 up to Follow-up period (30 days post-last dose).	12.5% 4/32 • Day 1 up to Follow-up period (30 days post-last dose).
Musculoskeletal and connective tissue disorders Bone Pain	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	33.3% 1/3 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	33.3% 1/3 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	3.2% 1/31 • Day 1 up to Follow-up period (30 days post-last dose).	3.2% 1/31 • Day 1 up to Follow-up period (30 days post-last dose).	3.0% 1/33 • Day 1 up to Follow-up period (30 days post-last dose).	3.1% 1/32 • Day 1 up to Follow-up period (30 days post-last dose).
Musculoskeletal and connective tissue disorders Musculoskeletal Chest Pain	33.3% 1/3 • Day 1 up to Follow-up period (30 days post-last dose).	66.7% 2/3 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	33.3% 1/3 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	6.5% 2/31 • Day 1 up to Follow-up period (30 days post-last dose).	3.2% 1/31 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/33 • Day 1 up to Follow-up period (30 days post-last dose).	3.1% 1/32 • Day 1 up to Follow-up period (30 days post-last dose).
Musculoskeletal and connective tissue disorders Musculoskeletal Pain	33.3% 1/3 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	3.2% 1/31 • Day 1 up to Follow-up period (30 days post-last dose).	9.7% 3/31 • Day 1 up to Follow-up period (30 days post-last dose).	9.1% 3/33 • Day 1 up to Follow-up period (30 days post-last dose).	3.1% 1/32 • Day 1 up to Follow-up period (30 days post-last dose).
Musculoskeletal and connective tissue disorders Musculoskeletal Stiffness	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	33.3% 1/3 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/31 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/31 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/33 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/32 • Day 1 up to Follow-up period (30 days post-last dose).
Musculoskeletal and connective tissue disorders Neck Pain	33.3% 1/3 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/31 • Day 1 up to Follow-up period (30 days post-last dose).	3.2% 1/31 • Day 1 up to Follow-up period (30 days post-last dose).	9.1% 3/33 • Day 1 up to Follow-up period (30 days post-last dose).	3.1% 1/32 • Day 1 up to Follow-up period (30 days post-last dose).
Musculoskeletal and connective tissue disorders Pain in Extremity	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	33.3% 1/3 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	33.3% 1/3 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	3.2% 1/31 • Day 1 up to Follow-up period (30 days post-last dose).	3.2% 1/31 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/33 • Day 1 up to Follow-up period (30 days post-last dose).	15.6% 5/32 • Day 1 up to Follow-up period (30 days post-last dose).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumour Pain	33.3% 1/3 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	3.2% 1/31 • Day 1 up to Follow-up period (30 days post-last dose).	6.5% 2/31 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/33 • Day 1 up to Follow-up period (30 days post-last dose).	3.1% 1/32 • Day 1 up to Follow-up period (30 days post-last dose).
Nervous system disorders Disturbance in Attention	33.3% 1/3 • Day 1 up to Follow-up period (30 days post-last dose).	33.3% 1/3 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/31 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/31 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/33 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/32 • Day 1 up to Follow-up period (30 days post-last dose).
Nervous system disorders Dizziness	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	33.3% 1/3 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	6.5% 2/31 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/31 • Day 1 up to Follow-up period (30 days post-last dose).	3.0% 1/33 • Day 1 up to Follow-up period (30 days post-last dose).	6.2% 2/32 • Day 1 up to Follow-up period (30 days post-last dose).
Nervous system disorders Headache	100.0% 3/3 • Day 1 up to Follow-up period (30 days post-last dose).	100.0% 3/3 • Day 1 up to Follow-up period (30 days post-last dose).	66.7% 2/3 • Day 1 up to Follow-up period (30 days post-last dose).	66.7% 2/3 • Day 1 up to Follow-up period (30 days post-last dose).	66.7% 2/3 • Day 1 up to Follow-up period (30 days post-last dose).	38.7% 12/31 • Day 1 up to Follow-up period (30 days post-last dose).	51.6% 16/31 • Day 1 up to Follow-up period (30 days post-last dose).	69.7% 23/33 • Day 1 up to Follow-up period (30 days post-last dose).	37.5% 12/32 • Day 1 up to Follow-up period (30 days post-last dose).
Nervous system disorders Neuropathy Peripheral	33.3% 1/3 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/31 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/31 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/33 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/32 • Day 1 up to Follow-up period (30 days post-last dose).
Nervous system disorders Paraesthesia	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	3.2% 1/31 • Day 1 up to Follow-up period (30 days post-last dose).	6.5% 2/31 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/33 • Day 1 up to Follow-up period (30 days post-last dose).	9.4% 3/32 • Day 1 up to Follow-up period (30 days post-last dose).
Psychiatric disorders Anxiety	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	3.2% 1/31 • Day 1 up to Follow-up period (30 days post-last dose).	3.2% 1/31 • Day 1 up to Follow-up period (30 days post-last dose).	3.0% 1/33 • Day 1 up to Follow-up period (30 days post-last dose).	6.2% 2/32 • Day 1 up to Follow-up period (30 days post-last dose).
Psychiatric disorders Depression	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/31 • Day 1 up to Follow-up period (30 days post-last dose).	3.2% 1/31 • Day 1 up to Follow-up period (30 days post-last dose).	6.1% 2/33 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/32 • Day 1 up to Follow-up period (30 days post-last dose).
Psychiatric disorders Insomnia	33.3% 1/3 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/31 • Day 1 up to Follow-up period (30 days post-last dose).	3.2% 1/31 • Day 1 up to Follow-up period (30 days post-last dose).	6.1% 2/33 • Day 1 up to Follow-up period (30 days post-last dose).	3.1% 1/32 • Day 1 up to Follow-up period (30 days post-last dose).
Psychiatric disorders Libido Decreased	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	3.2% 1/31 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/31 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/33 • Day 1 up to Follow-up period (30 days post-last dose).	6.2% 2/32 • Day 1 up to Follow-up period (30 days post-last dose).
Renal and urinary disorders Dysuria	33.3% 1/3 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/31 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/31 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/33 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/32 • Day 1 up to Follow-up period (30 days post-last dose).
Reproductive system and breast disorders Dysmenorrhoea	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	33.3% 1/3 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/31 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/31 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/33 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/32 • Day 1 up to Follow-up period (30 days post-last dose).
Reproductive system and breast disorders Menstruation Irregular	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	33.3% 1/3 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/31 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/31 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/33 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/32 • Day 1 up to Follow-up period (30 days post-last dose).
Reproductive system and breast disorders Sexual Dysfunction	33.3% 1/3 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/31 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/31 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/33 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/32 • Day 1 up to Follow-up period (30 days post-last dose).
Respiratory, thoracic and mediastinal disorders Cough	66.7% 2/3 • Day 1 up to Follow-up period (30 days post-last dose).	33.3% 1/3 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	33.3% 1/3 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	9.7% 3/31 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/31 • Day 1 up to Follow-up period (30 days post-last dose).	15.2% 5/33 • Day 1 up to Follow-up period (30 days post-last dose).	6.2% 2/32 • Day 1 up to Follow-up period (30 days post-last dose).
Respiratory, thoracic and mediastinal disorders Dyspnoea	66.7% 2/3 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	33.3% 1/3 • Day 1 up to Follow-up period (30 days post-last dose).	19.4% 6/31 • Day 1 up to Follow-up period (30 days post-last dose).	9.7% 3/31 • Day 1 up to Follow-up period (30 days post-last dose).	3.0% 1/33 • Day 1 up to Follow-up period (30 days post-last dose).	15.6% 5/32 • Day 1 up to Follow-up period (30 days post-last dose).
Respiratory, thoracic and mediastinal disorders Nasal Congestion	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	6.5% 2/31 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/31 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/33 • Day 1 up to Follow-up period (30 days post-last dose).	3.1% 1/32 • Day 1 up to Follow-up period (30 days post-last dose).
Respiratory, thoracic and mediastinal disorders Pharyngolaryngeal Pain	33.3% 1/3 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	3.2% 1/31 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/31 • Day 1 up to Follow-up period (30 days post-last dose).	6.1% 2/33 • Day 1 up to Follow-up period (30 days post-last dose).	3.1% 1/32 • Day 1 up to Follow-up period (30 days post-last dose).
Respiratory, thoracic and mediastinal disorders Pulmonary Congestion	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	33.3% 1/3 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/31 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/31 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/33 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/32 • Day 1 up to Follow-up period (30 days post-last dose).
Skin and subcutaneous tissue disorders Alopecia	33.3% 1/3 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/31 • Day 1 up to Follow-up period (30 days post-last dose).	3.2% 1/31 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/33 • Day 1 up to Follow-up period (30 days post-last dose).	3.1% 1/32 • Day 1 up to Follow-up period (30 days post-last dose).
Skin and subcutaneous tissue disorders Erythema	33.3% 1/3 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/31 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/31 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/33 • Day 1 up to Follow-up period (30 days post-last dose).	3.1% 1/32 • Day 1 up to Follow-up period (30 days post-last dose).
Skin and subcutaneous tissue disorders Hyperhidrosis	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/31 • Day 1 up to Follow-up period (30 days post-last dose).	6.5% 2/31 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/33 • Day 1 up to Follow-up period (30 days post-last dose).	6.2% 2/32 • Day 1 up to Follow-up period (30 days post-last dose).
Skin and subcutaneous tissue disorders Night Sweats	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	33.3% 1/3 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/31 • Day 1 up to Follow-up period (30 days post-last dose).	6.5% 2/31 • Day 1 up to Follow-up period (30 days post-last dose).	3.0% 1/33 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/32 • Day 1 up to Follow-up period (30 days post-last dose).
Skin and subcutaneous tissue disorders Petechiae	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	33.3% 1/3 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/31 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/31 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/33 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/32 • Day 1 up to Follow-up period (30 days post-last dose).
Skin and subcutaneous tissue disorders Pruritus	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	33.3% 1/3 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	33.3% 1/3 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	6.5% 2/31 • Day 1 up to Follow-up period (30 days post-last dose).	3.2% 1/31 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/33 • Day 1 up to Follow-up period (30 days post-last dose).	3.1% 1/32 • Day 1 up to Follow-up period (30 days post-last dose).
Skin and subcutaneous tissue disorders Rash	66.7% 2/3 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	3.2% 1/31 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/31 • Day 1 up to Follow-up period (30 days post-last dose).	3.0% 1/33 • Day 1 up to Follow-up period (30 days post-last dose).	9.4% 3/32 • Day 1 up to Follow-up period (30 days post-last dose).
Skin and subcutaneous tissue disorders Urticaria	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	33.3% 1/3 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/31 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/31 • Day 1 up to Follow-up period (30 days post-last dose).	3.0% 1/33 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/32 • Day 1 up to Follow-up period (30 days post-last dose).
Skin and subcutaneous tissue disorders Vitiligo	33.3% 1/3 • Day 1 up to Follow-up period (30 days post-last dose).	33.3% 1/3 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/31 • Day 1 up to Follow-up period (30 days post-last dose).	3.2% 1/31 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/33 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/32 • Day 1 up to Follow-up period (30 days post-last dose).
Vascular disorders Hot Flush	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	33.3% 1/3 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/31 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/31 • Day 1 up to Follow-up period (30 days post-last dose).	3.0% 1/33 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/32 • Day 1 up to Follow-up period (30 days post-last dose).
Vascular disorders Hypertension	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	9.7% 3/31 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/31 • Day 1 up to Follow-up period (30 days post-last dose).	6.1% 2/33 • Day 1 up to Follow-up period (30 days post-last dose).	3.1% 1/32 • Day 1 up to Follow-up period (30 days post-last dose).
Vascular disorders Hypotension	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	19.4% 6/31 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/31 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/33 • Day 1 up to Follow-up period (30 days post-last dose).	3.1% 1/32 • Day 1 up to Follow-up period (30 days post-last dose).
Vascular disorders Lymphoedema	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	33.3% 1/3 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/3 • Day 1 up to Follow-up period (30 days post-last dose).	33.3% 1/3 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/31 • Day 1 up to Follow-up period (30 days post-last dose).	6.5% 2/31 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/33 • Day 1 up to Follow-up period (30 days post-last dose).	0.00% 0/32 • Day 1 up to Follow-up period (30 days post-last dose).

Additional Information

Senior Director

Centocor, Inc.

Phone: 908-927-2116

Results disclosure agreements

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

Restriction type: LTE60