Trial Outcomes & Findings for Safety and Dose Determining Multi-dose Study of BT062 in Patients With Relapsed or Refractory Multiple Myeloma (NCT NCT01001442)

Last Updated: 2019-07-30

Results Overview

The primary safety variable was to determine the incidence of DLTs in subjects with relapsed or relapsed/refractory multiple myeloma treated with BT062.

Recruitment status

COMPLETED

Study phase

PHASE1/PHASE2

Target enrollment

35 participants

Primary outcome timeframe

Starting with first study drug administration until 30-day follow-up visit (average 4.99 months)

Results posted on

2019-07-30

Participant Flow

The Intention-to-treat (ITT) population included all subjects who were enrolled in the study and received at least 1 dose of BT062 and who had any post-Baseline evaluations or data. One subject did not have at least one post-injection assessment of the treatment response and was excluded from both the ITT and PP populations (n = 34).

Participant milestones

Participant milestones
Measure	BT062 40 mg/m² 40 mg/m² BT062 was administered by IV infusion on Days 1, 8, and 15 of every 28-day cycle.	BT062 50 mg/m² 50 mg/m² BT062 was administered by IV infusion on Days 1, 8, and 15 of every 28-day cycle.	BT062 65 mg/m² 65 mg/m² BT062 was administered by IV infusion on Days 1, 8, and 15 of every 28-day cycle.	BT062 80 mg/m² 80 mg/m² BT062 was administered by IV infusion on Days 1, 8, and 15 of every 28-day cycle.	BT062 100 mg/m² 100 mg/m² BT062 was administered by IV infusion on Days 1, 8, and 15 of every 28-day cycle.	BT062 120 mg/m² 120 mg/m² BT062 was administered by IV infusion on Days 1, 8, and 15 of every 28-day cycle.	BT062 140 mg/m² 140 mg/m² BT062 was administered by IV infusion on Days 1, 8, and 15 of every 28-day cycle.	BT062 160 mg/m² 160 mg/m² BT062 was administered by IV infusion on Days 1, 8, and 15 of every 28-day cycle.
Overall Study STARTED	4	3	4	3	4	3	10	4
Overall Study COMPLETED	4	3	4	3	2	3	6	2
Overall Study NOT COMPLETED	0	0	0	0	2	0	4	2

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Safety and Dose Determining Multi-dose Study of BT062 in Patients With Relapsed or Refractory Multiple Myeloma

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	BT062 40 mg/m² n=4 Participants 40 mg/m² BT062 was administered by IV infusion on Days 1, 8, and 15 of every 28-day cycle.	BT062 50 mg/m² n=3 Participants 50 mg/m² BT062 was administered by IV infusion on Days 1, 8, and 15 of every 28-day cycle.	BT062 65 mg/m² n=4 Participants 65 mg/m² BT062 was administered by IV infusion on Days 1, 8, and 15 of every 28-day cycle.	BT062 80 mg/m² n=3 Participants 80 mg/m² BT062 was administered by IV infusion on Days 1, 8, and 15 of every 28-day cycle.	BT062 100 mg/m² n=3 Participants 100 mg/m² BT062 was administered by IV infusion on Days 1, 8, and 15 of every 28-day cycle.	BT062 120 mg/m² n=3 Participants 120 mg/m² BT062 was administered by IV infusion on Days 1, 8, and 15 of every 28-day cycle.	BT062 140 mg/m² n=10 Participants 140 mg/m² BT062 was administered by IV infusion on Days 1, 8, and 15 of every 28-day cycle.	BT062 160 mg/m² n=4 Participants 160 mg/m² BT062 was administered by IV infusion on Days 1, 8, and 15 of every 28-day cycle.	Total n=34 Participants Total of all reporting groups
Age, Categorical <=18 years	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	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants
Age, Categorical Between 18 and 65 years	1 Participants n=5 Participants	3 Participants n=7 Participants	2 Participants n=5 Participants	2 Participants n=4 Participants	1 Participants n=21 Participants	3 Participants n=8 Participants	2 Participants n=8 Participants	3 Participants n=24 Participants	17 Participants n=42 Participants
Age, Categorical >=65 years	3 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants	1 Participants n=4 Participants	2 Participants n=21 Participants	0 Participants n=8 Participants	8 Participants n=8 Participants	1 Participants n=24 Participants	17 Participants n=42 Participants
Age, Continuous	70.3 years STANDARD_DEVIATION 15.56 • n=5 Participants	55.3 years STANDARD_DEVIATION 7.64 • n=7 Participants	64.3 years STANDARD_DEVIATION 9.39 • n=5 Participants	60.7 years STANDARD_DEVIATION 4.51 • n=4 Participants	64.3 years STANDARD_DEVIATION 8.02 • n=21 Participants	55.3 years STANDARD_DEVIATION 5.03 • n=8 Participants	66.8 years STANDARD_DEVIATION 8.80 • n=8 Participants	61.5 years STANDARD_DEVIATION 9.98 • n=24 Participants	63.5 years STANDARD_DEVIATION 9.63 • n=42 Participants
Sex: Female, Male Female	2 Participants n=5 Participants	3 Participants n=7 Participants	2 Participants n=5 Participants	1 Participants n=4 Participants	2 Participants n=21 Participants	1 Participants n=8 Participants	5 Participants n=8 Participants	2 Participants n=24 Participants	18 Participants n=42 Participants
Sex: Female, Male Male	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants	2 Participants n=4 Participants	1 Participants n=21 Participants	2 Participants n=8 Participants	5 Participants n=8 Participants	2 Participants n=24 Participants	16 Participants n=42 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	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	0 Participants n=8 Participants	1 Participants n=8 Participants	1 Participants n=24 Participants	2 Participants n=42 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	4 Participants n=5 Participants	3 Participants n=7 Participants	3 Participants n=5 Participants	3 Participants n=4 Participants	3 Participants n=21 Participants	3 Participants n=8 Participants	9 Participants n=8 Participants	3 Participants n=24 Participants	31 Participants n=42 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	1 Participants n=42 Participants
Race (NIH/OMB) American Indian or Alaska Native	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	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants
Race (NIH/OMB) Asian	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	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	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	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants	1 Participants n=8 Participants	4 Participants n=8 Participants	1 Participants n=24 Participants	7 Participants n=42 Participants
Race (NIH/OMB) White	4 Participants n=5 Participants	3 Participants n=7 Participants	3 Participants n=5 Participants	3 Participants n=4 Participants	2 Participants n=21 Participants	2 Participants n=8 Participants	6 Participants n=8 Participants	3 Participants n=24 Participants	26 Participants n=42 Participants
Race (NIH/OMB) More than one race	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	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	1 Participants n=42 Participants
Region of Enrollment United States	4 participants n=5 Participants	3 participants n=7 Participants	4 participants n=5 Participants	3 participants n=4 Participants	3 participants n=21 Participants	3 participants n=8 Participants	10 participants n=8 Participants	4 participants n=24 Participants	34 participants n=42 Participants

PRIMARY outcome

Timeframe: Starting with first study drug administration until 30-day follow-up visit (average 4.99 months)

Population: The Safety population included all subjects who were enrolled and received at least 1 dose of BT062 (n = 35).

The primary safety variable was to determine the incidence of DLTs in subjects with relapsed or relapsed/refractory multiple myeloma treated with BT062.

Outcome measures

Outcome measures
Measure	BT062 40 mg/m² n=4 Participants 40 mg/m² BT062 was administered by IV infusion on Days 1, 8, and 15 of every 28-day cycle.	BT062 50 mg/m² n=3 Participants 50 mg/m² BT062 was administered by IV infusion on Days 1, 8, and 15 of every 28-day cycle.	BT062 65 mg/m² n=4 Participants 65 mg/m² BT062 was administered by IV infusion on Days 1, 8, and 15 of every 28-day cycle.	BT062 80 mg/m² n=3 Participants 80 mg/m² BT062 was administered by IV infusion on Days 1, 8, and 15 of every 28-day cycle.	BT062 100 mg/m² n=4 Participants 100 mg/m² BT062 was administered by IV infusion on Days 1, 8, and 15 of every 28-day cycle.	BT062 120 mg/m² n=3 Participants 120 mg/m² BT062 was administered by IV infusion on Days 1, 8, and 15 of every 28-day cycle.	BT062 140 mg/m² n=10 Participants 140 mg/m² BT062 was administered by IV infusion on Days 1, 8, and 15 of every 28-day cycle.	BT062 160 mg/m² n=4 Participants 160 mg/m² BT062 was administered by IV infusion on Days 1, 8, and 15 of every 28-day cycle.	Total n=35 Participants BT062 administration (all dose levels)
Dose Limiting Toxicities (DLT) - Number of Participants With at Least 1 DLT	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	2 Participants	2 Participants	5 Participants

PRIMARY outcome

Timeframe: First 28-day cycle

The Phase I part of the study was to include the dose escalation cohort; a conventional dose escalation design, following 3 + 3 rules was chosen to define the MTD. Only DLTs occurring in cycle 1 for each subject were counted in the dose escalation decisions. Three subjects were treated at the first or newest dose level as available. If none of the 3 subjects experienced a DLT during Cycle 1, three subjects could be treated at the next dose level as available. In case of a DLT the cohort was expanded to up to 6 subjects. If not more than 1 of these 6 subjects experienced a DLT during Cycle 1, a first subject could be treated at the next dose level. If 2 or more of the 6 subjects experienced a DLT during Cycle 1 the dose escalation was stopped. The highest dose level at which \< 2 of 6 subjects experienced a DLT is defined as the MTD.

Outcome measures

Outcome measures
Measure	BT062 40 mg/m² n=35 Participants 40 mg/m² BT062 was administered by IV infusion on Days 1, 8, and 15 of every 28-day cycle.	BT062 50 mg/m² 50 mg/m² BT062 was administered by IV infusion on Days 1, 8, and 15 of every 28-day cycle.	BT062 65 mg/m² 65 mg/m² BT062 was administered by IV infusion on Days 1, 8, and 15 of every 28-day cycle.	BT062 80 mg/m² 80 mg/m² BT062 was administered by IV infusion on Days 1, 8, and 15 of every 28-day cycle.	BT062 100 mg/m² 100 mg/m² BT062 was administered by IV infusion on Days 1, 8, and 15 of every 28-day cycle.	BT062 120 mg/m² 120 mg/m² BT062 was administered by IV infusion on Days 1, 8, and 15 of every 28-day cycle.	BT062 140 mg/m² 140 mg/m² BT062 was administered by IV infusion on Days 1, 8, and 15 of every 28-day cycle.	BT062 160 mg/m² 160 mg/m² BT062 was administered by IV infusion on Days 1, 8, and 15 of every 28-day cycle.	Total BT062 administration (all dose levels)
Maximum Tolerated Dose (MTD)	140 mg/m²	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Starting with first study drug administration until 30-day follow-up visit (average 4.99 months)

Population: Safety Population: The Safety population included all subjects who were enrolled and received at least 1 dose of BT062 (n = 35).

Qualitative and quantitative toxicities assessed by incidence of adverse events and by clinically significant changes in the patient's physical examination, vital signs, and clinical laboratory results. The incidence of treatment emergent adverse events (TEAEs), including serious adverse events (SAEs).

Outcome measures

Outcome measures
Measure	BT062 40 mg/m² n=4 Participants 40 mg/m² BT062 was administered by IV infusion on Days 1, 8, and 15 of every 28-day cycle.	BT062 50 mg/m² n=3 Participants 50 mg/m² BT062 was administered by IV infusion on Days 1, 8, and 15 of every 28-day cycle.	BT062 65 mg/m² n=4 Participants 65 mg/m² BT062 was administered by IV infusion on Days 1, 8, and 15 of every 28-day cycle.	BT062 80 mg/m² n=3 Participants 80 mg/m² BT062 was administered by IV infusion on Days 1, 8, and 15 of every 28-day cycle.	BT062 100 mg/m² n=4 Participants 100 mg/m² BT062 was administered by IV infusion on Days 1, 8, and 15 of every 28-day cycle.	BT062 120 mg/m² n=3 Participants 120 mg/m² BT062 was administered by IV infusion on Days 1, 8, and 15 of every 28-day cycle.	BT062 140 mg/m² n=10 Participants 140 mg/m² BT062 was administered by IV infusion on Days 1, 8, and 15 of every 28-day cycle.	BT062 160 mg/m² n=4 Participants 160 mg/m² BT062 was administered by IV infusion on Days 1, 8, and 15 of every 28-day cycle.	Total n=35 Participants BT062 administration (all dose levels)
Qualitative and Quantitative Toxicities of BT062 At least one SAE	2 Participants	0 Participants	0 Participants	2 Participants	2 Participants	1 Participants	5 Participants	2 Participants	14 Participants
Qualitative and Quantitative Toxicities of BT062 At least one treatment related SAE	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	2 Participants	1 Participants	3 Participants

SECONDARY outcome

Timeframe: Starting with first study drug administration until 30-day follow-up visit (average 4.99 months).

Population: Safety Population: The Safety population included all subjects who were enrolled and received at least 1 dose of BT062 (n = 35).

Multi-dose Pharmacokinetics properties of BT062 after intravenous (IV) Administration of escalating doses of BT062 as assessed by measuring intact BT062 conjugate. Please note that not all subjects reached Cycle 4 due to early termination . A lower number of samples could be analyzed for Cycle 4.

Outcome measures

Outcome measures
Measure	BT062 40 mg/m² n=4 Participants 40 mg/m² BT062 was administered by IV infusion on Days 1, 8, and 15 of every 28-day cycle.	BT062 50 mg/m² n=3 Participants 50 mg/m² BT062 was administered by IV infusion on Days 1, 8, and 15 of every 28-day cycle.	BT062 65 mg/m² n=4 Participants 65 mg/m² BT062 was administered by IV infusion on Days 1, 8, and 15 of every 28-day cycle.	BT062 80 mg/m² n=3 Participants 80 mg/m² BT062 was administered by IV infusion on Days 1, 8, and 15 of every 28-day cycle.	BT062 100 mg/m² n=4 Participants 100 mg/m² BT062 was administered by IV infusion on Days 1, 8, and 15 of every 28-day cycle.	BT062 120 mg/m² n=3 Participants 120 mg/m² BT062 was administered by IV infusion on Days 1, 8, and 15 of every 28-day cycle.	BT062 140 mg/m² n=10 Participants 140 mg/m² BT062 was administered by IV infusion on Days 1, 8, and 15 of every 28-day cycle.	BT062 160 mg/m² n=4 Participants 160 mg/m² BT062 was administered by IV infusion on Days 1, 8, and 15 of every 28-day cycle.	Total BT062 administration (all dose levels)
Multi-dose Pharmacokinetics Properties of BT062 - Cmax BT062 plasma concentration Cycle 1 - Cmax	13409.0 ng/ml Interval 3725.0 to 15888.0	10156.0 ng/ml Interval 7108.0 to 14028.0	26229.0 ng/ml Interval 17114.0 to 58194.0	21498.0 ng/ml Interval 18827.0 to 31112.0	51593.0 ng/ml Interval 36526.0 to 93993.0	61190.0 ng/ml Interval 29640.0 to 66623.0	48463.0 ng/ml Interval 32175.0 to 70734.0	62876.5 ng/ml Interval 47149.0 to 78604.0	—
Multi-dose Pharmacokinetics Properties of BT062 - Cmax BT062 plasma concentration Cycle 4 - Cmax	9427.0 ng/ml Interval 9427.0 to 9427.0	14193.0 ng/ml Interval 14193.0 to 14193.0	27770.5 ng/ml Interval 23740.0 to 31801.0	38144.0 ng/ml Interval 38144.0 to 38144.0	92046.0 ng/ml Interval 92046.0 to 92046.0	96178.0 ng/ml Interval 42123.0 to 150233.0	50073.0 ng/ml Interval 50073.0 to 50073.0	79248.0 ng/ml Interval 79248.0 to 79248.0	—

SECONDARY outcome

Timeframe: On day 1 of each treatment cycle (on a monthly basis) starting with first study drug administration until Close Out visit (average 3.84 months).

Population: ITT: The Intention-to-treat (ITT) population included all subjects who were enrolled in the study and received at least 1 dose of BT062 and who had any post-Baseline evaluations or data. One subject did not have at least one post-injection assessment of the treatment response and was excluded from both the ITT and PP populations (n = 34).

sCR:CR+normal FLC+absence of clonal cells in BM; CR:Negative immunofixation,disappearance of soft tissue plasmacytomas +≤5% plasma cells in BM+normal FLC; VGPR:M-protein detectable by immunofixation,not on electrophoresis or 90% or greater reduction in serum M-protein+urine M-protein level \<100mg per 24h,\>90% decrease in the difference between involved/uninvolved FLC; PR:≥50% reduction of serum M-protein and reduction in 24-h urinary M-protein by ≥90% or to \<200 mg per 24 h or ≥50% decrease in the difference between involved/uninvolved FLC or ≥50% reduction in plasma cells, provided baseline bone marrow plasma cell percentage was ≥30%, ≥50% size reduction of soft tissue plasmacytomas; MR:25%-49% reduction of serum M-protein+reduction in 24h urinary M-protein by 50-89%(still \>200 mg/24h),25-49% soft tissue plasmacytomas size reduction,no increase in size or number of lytic bone lesions; SD:no response or PD ORR: %of subjects with MR+PR+VGPR+CR+sCR CBR:ORR + %of subjects with SD.

Outcome measures

Outcome measures
Measure	BT062 40 mg/m² n=4 Participants 40 mg/m² BT062 was administered by IV infusion on Days 1, 8, and 15 of every 28-day cycle.	BT062 50 mg/m² n=3 Participants 50 mg/m² BT062 was administered by IV infusion on Days 1, 8, and 15 of every 28-day cycle.	BT062 65 mg/m² n=4 Participants 65 mg/m² BT062 was administered by IV infusion on Days 1, 8, and 15 of every 28-day cycle.	BT062 80 mg/m² n=3 Participants 80 mg/m² BT062 was administered by IV infusion on Days 1, 8, and 15 of every 28-day cycle.	BT062 100 mg/m² n=3 Participants 100 mg/m² BT062 was administered by IV infusion on Days 1, 8, and 15 of every 28-day cycle.	BT062 120 mg/m² n=3 Participants 120 mg/m² BT062 was administered by IV infusion on Days 1, 8, and 15 of every 28-day cycle.	BT062 140 mg/m² n=10 Participants 140 mg/m² BT062 was administered by IV infusion on Days 1, 8, and 15 of every 28-day cycle.	BT062 160 mg/m² n=4 Participants 160 mg/m² BT062 was administered by IV infusion on Days 1, 8, and 15 of every 28-day cycle.	Total n=34 Participants BT062 administration (all dose levels)
Anti-tumor Activity of BT062 in Subjects With Relapsed or Relapsed/Refractory Multiple Myeloma by Number of Participants With Objective Response(ORR) and/or Clinial Benefit(CBR) Based on the International Myeloma Working Group Uniform Response Criteria Objective Response rate · yes	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	1 Participants	0 Participants	2 Participants
Anti-tumor Activity of BT062 in Subjects With Relapsed or Relapsed/Refractory Multiple Myeloma by Number of Participants With Objective Response(ORR) and/or Clinial Benefit(CBR) Based on the International Myeloma Working Group Uniform Response Criteria Objective Response rate · no	4 Participants	3 Participants	4 Participants	2 Participants	3 Participants	3 Participants	9 Participants	4 Participants	32 Participants
Anti-tumor Activity of BT062 in Subjects With Relapsed or Relapsed/Refractory Multiple Myeloma by Number of Participants With Objective Response(ORR) and/or Clinial Benefit(CBR) Based on the International Myeloma Working Group Uniform Response Criteria Clinical Benefit rate · yes	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	1 Participants	1 Participants	2 Participants	5 Participants
Anti-tumor Activity of BT062 in Subjects With Relapsed or Relapsed/Refractory Multiple Myeloma by Number of Participants With Objective Response(ORR) and/or Clinial Benefit(CBR) Based on the International Myeloma Working Group Uniform Response Criteria Clinical Benefit rate · no	4 Participants	3 Participants	4 Participants	2 Participants	3 Participants	2 Participants	9 Participants	2 Participants	29 Participants

SECONDARY outcome

Timeframe: Starting with first study drug administration until death or 3 years from first study treatment.

Population: The Intention-to-treat (ITT) population included all subjects who were enrolled in the study and received at least 1 dose of BT062 and who had any post-Baseline evaluations or data (n = 34).

Progressive disease Requires any one or more of the following: Increase of ≥ 25% from baseline in * Serum M-component and/or (the absolute increase must be ≥ 0.5 g/dL) (increases of ≥ 1 g/dL are sufficient to define relapse if starting M-component is ≥ 5 g/dL). * Urine M-component and/or (the absolute increase must be ≥ 200mg/24h). Only in patients without measurable serum and urine M-protein levels: the difference between involved and uninvolved FLC levels. The absolute increase must be \> 10 mg/dL. Bone marrow plasma cell percentage: the absolute % must be ≥ 10% (relapse form CR as a 5% cutoff instead of 10%). Definite development of new bone lesions or soft tissue plasmacytomas or definite increase in the size of existing bone lesions or soft tissue plasmacytomas. Development of hypercalcemia (corrected serum calcium \> 11.5 mg/dL or 2.65 mmol/l) that can be attributed solely to the plasma cell proliferative disorder.

Outcome measures

Outcome measures
Measure	BT062 40 mg/m² n=34 Participants 40 mg/m² BT062 was administered by IV infusion on Days 1, 8, and 15 of every 28-day cycle.	BT062 50 mg/m² 50 mg/m² BT062 was administered by IV infusion on Days 1, 8, and 15 of every 28-day cycle.	BT062 65 mg/m² 65 mg/m² BT062 was administered by IV infusion on Days 1, 8, and 15 of every 28-day cycle.	BT062 80 mg/m² 80 mg/m² BT062 was administered by IV infusion on Days 1, 8, and 15 of every 28-day cycle.	BT062 100 mg/m² 100 mg/m² BT062 was administered by IV infusion on Days 1, 8, and 15 of every 28-day cycle.	BT062 120 mg/m² 120 mg/m² BT062 was administered by IV infusion on Days 1, 8, and 15 of every 28-day cycle.	BT062 140 mg/m² 140 mg/m² BT062 was administered by IV infusion on Days 1, 8, and 15 of every 28-day cycle.	BT062 160 mg/m² 160 mg/m² BT062 was administered by IV infusion on Days 1, 8, and 15 of every 28-day cycle.	Total BT062 administration (all dose levels)
Time to Progression (TTP), Progression Free Survival (PFS) and Overall Survival (OS) TTP	3 months Interval 1.1 to 4.4	—	—	—	—	—	—	—	—
Time to Progression (TTP), Progression Free Survival (PFS) and Overall Survival (OS) PFS	3 months Interval 1.1 to 3.9	—	—	—	—	—	—	—	—
Time to Progression (TTP), Progression Free Survival (PFS) and Overall Survival (OS) OS	26.7 months Interval 13.2 to 42.4	—	—	—	—	—	—	—	—

Adverse Events

BT062 40 mg/m²

Serious events: 2 serious events

Other events: 3 other events

Deaths: 0 deaths

BT062 50 mg/m²

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

BT062 65 mg/m²

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

BT062 80 mg/m²

Serious events: 2 serious events

Other events: 2 other events

Deaths: 0 deaths

BT062 100 mg/m²

Serious events: 2 serious events

Other events: 3 other events

Deaths: 1 deaths

BT062 120 mg/m²

Serious events: 1 serious events

Other events: 3 other events

Deaths: 1 deaths

BT062 140 mg/m²

Serious events: 5 serious events

Other events: 8 other events

Deaths: 1 deaths

BT062 160 mg/m²

Serious events: 2 serious events

Other events: 3 other events

Deaths: 1 deaths

Total

Serious events: 14 serious events

Other events: 28 other events

Deaths: 4 deaths

Serious adverse events

Serious adverse events
Measure	BT062 40 mg/m² n=4 participants at risk 40 mg/m² BT062 was administered by IV infusion on Days 1, 8, and 15 of every 28-day cycle.	BT062 50 mg/m² n=3 participants at risk 50 mg/m² BT062 was administered by IV infusion on Days 1, 8, and 15 of every 28-day cycle.	BT062 65 mg/m² n=4 participants at risk 65 mg/m² BT062 was administered by IV infusion on Days 1, 8, and 15 of every 28-day cycle.	BT062 80 mg/m² n=3 participants at risk 80 mg/m² BT062 was administered by IV infusion on Days 1, 8, and 15 of every 28-day cycle.	BT062 100 mg/m² n=4 participants at risk 100 mg/m² BT062 was administered by IV infusion on Days 1, 8, and 15 of every 28-day cycle.	BT062 120 mg/m² n=3 participants at risk 120 mg/m² BT062 was administered by IV infusion on Days 1, 8, and 15 of every 28-day cycle.	BT062 140 mg/m² n=10 participants at risk 140 mg/m² BT062 was administered by IV infusion on Days 1, 8, and 15 of every 28-day cycle.	BT062 160 mg/m² n=4 participants at risk 160 mg/m² BT062 was administered by IV infusion on Days 1, 8, and 15 of every 28-day cycle.	Total n=35 participants at risk BT062 administration (all dose levels)
Blood and lymphatic system disorders NEUTROPENIA	0.00% 0/4 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	0.00% 0/3 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	0.00% 0/4 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	0.00% 0/3 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	0.00% 0/4 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	0.00% 0/3 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	0.00% 0/10 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	25.0% 1/4 • Number of events 1 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	2.9% 1/35 • Number of events 1 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).
Cardiac disorders ATRIAL FIBRILLATION	25.0% 1/4 • Number of events 1 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	0.00% 0/3 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	0.00% 0/4 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	0.00% 0/3 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	0.00% 0/4 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	0.00% 0/3 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	0.00% 0/10 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	0.00% 0/4 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	2.9% 1/35 • Number of events 1 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).
Eye disorders EXTRAOCULAR MUSCLE PARESIS	0.00% 0/4 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	0.00% 0/3 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	0.00% 0/4 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	0.00% 0/3 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	25.0% 1/4 • Number of events 1 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	0.00% 0/3 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	0.00% 0/10 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	0.00% 0/4 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	2.9% 1/35 • Number of events 1 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).
General disorders PYREXIA	0.00% 0/4 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	0.00% 0/3 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	0.00% 0/4 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	0.00% 0/3 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	0.00% 0/4 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	0.00% 0/3 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	20.0% 2/10 • Number of events 2 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	0.00% 0/4 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	5.7% 2/35 • Number of events 2 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).
Infections and infestations PNEUMONIA	0.00% 0/4 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	0.00% 0/3 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	0.00% 0/4 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	0.00% 0/3 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	0.00% 0/4 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	0.00% 0/3 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	20.0% 2/10 • Number of events 2 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	25.0% 1/4 • Number of events 1 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	8.6% 3/35 • Number of events 3 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).
Injury, poisoning and procedural complications HEAD INJURY	0.00% 0/4 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	0.00% 0/3 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	0.00% 0/4 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	0.00% 0/3 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	25.0% 1/4 • Number of events 1 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	0.00% 0/3 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	0.00% 0/10 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	0.00% 0/4 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	2.9% 1/35 • Number of events 1 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).
Injury, poisoning and procedural complications HIP FRACTURE	0.00% 0/4 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	0.00% 0/3 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	0.00% 0/4 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	0.00% 0/3 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	0.00% 0/4 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	0.00% 0/3 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	0.00% 0/10 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	25.0% 1/4 • Number of events 1 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	2.9% 1/35 • Number of events 1 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).
Injury, poisoning and procedural complications PELVIC FRACTURE	0.00% 0/4 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	0.00% 0/3 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	0.00% 0/4 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	0.00% 0/3 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	0.00% 0/4 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	0.00% 0/3 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	10.0% 1/10 • Number of events 1 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	0.00% 0/4 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	2.9% 1/35 • Number of events 1 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).
Investigations TRANSAMINASES INCREASED	0.00% 0/4 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	0.00% 0/3 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	0.00% 0/4 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	33.3% 1/3 • Number of events 1 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	0.00% 0/4 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	0.00% 0/3 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	0.00% 0/10 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	0.00% 0/4 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	2.9% 1/35 • Number of events 1 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).
Musculoskeletal and connective tissue disorders BONE PAIN	25.0% 1/4 • Number of events 1 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	0.00% 0/3 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	0.00% 0/4 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	0.00% 0/3 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	0.00% 0/4 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	0.00% 0/3 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	0.00% 0/10 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	0.00% 0/4 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	2.9% 1/35 • Number of events 1 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).
Nervous system disorders BRAIN MASS	0.00% 0/4 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	0.00% 0/3 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	0.00% 0/4 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	33.3% 1/3 • Number of events 1 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	0.00% 0/4 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	0.00% 0/3 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	0.00% 0/10 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	0.00% 0/4 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	2.9% 1/35 • Number of events 1 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).
Nervous system disorders HAEMORRHAGE INTRACRANIAL	0.00% 0/4 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	0.00% 0/3 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	0.00% 0/4 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	0.00% 0/3 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	0.00% 0/4 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	0.00% 0/3 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	0.00% 0/10 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	25.0% 1/4 • Number of events 1 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	2.9% 1/35 • Number of events 1 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).
Renal and urinary disorders RENAL FAILURE ACUTE	0.00% 0/4 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	0.00% 0/3 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	0.00% 0/4 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	0.00% 0/3 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	0.00% 0/4 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	33.3% 1/3 • Number of events 1 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	10.0% 1/10 • Number of events 1 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	0.00% 0/4 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	5.7% 2/35 • Number of events 2 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).
Respiratory, thoracic and mediastinal disorders ALVEOLITIS ALLERGIC	0.00% 0/4 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	0.00% 0/3 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	0.00% 0/4 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	33.3% 1/3 • Number of events 1 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	0.00% 0/4 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	0.00% 0/3 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	0.00% 0/10 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	0.00% 0/4 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	2.9% 1/35 • Number of events 1 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).
Respiratory, thoracic and mediastinal disorders PULMONARY EMBOLISM	25.0% 1/4 • Number of events 1 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	0.00% 0/3 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	0.00% 0/4 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	0.00% 0/3 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	0.00% 0/4 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	0.00% 0/3 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	0.00% 0/10 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	0.00% 0/4 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	2.9% 1/35 • Number of events 1 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).
Skin and subcutaneous tissue disorders PALMAR-PLANTAR / ERYTHRODYSAESTHESIA SYNDROME	0.00% 0/4 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	0.00% 0/3 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	0.00% 0/4 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	0.00% 0/3 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	0.00% 0/4 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	0.00% 0/3 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	10.0% 1/10 • Number of events 1 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	0.00% 0/4 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	2.9% 1/35 • Number of events 1 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).
Skin and subcutaneous tissue disorders STEVENS-JOHNSON SYNDROME	0.00% 0/4 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	0.00% 0/3 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	0.00% 0/4 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	0.00% 0/3 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	25.0% 1/4 • Number of events 1 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	0.00% 0/3 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	0.00% 0/10 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	0.00% 0/4 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	2.9% 1/35 • Number of events 1 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).
Vascular disorders DEEP VEIN THROMBOSIS	25.0% 1/4 • Number of events 1 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	0.00% 0/3 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	0.00% 0/4 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	0.00% 0/3 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	0.00% 0/4 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	0.00% 0/3 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	0.00% 0/10 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	0.00% 0/4 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	2.9% 1/35 • Number of events 1 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).

Other adverse events

Other adverse events
Measure	BT062 40 mg/m² n=4 participants at risk 40 mg/m² BT062 was administered by IV infusion on Days 1, 8, and 15 of every 28-day cycle.	BT062 50 mg/m² n=3 participants at risk 50 mg/m² BT062 was administered by IV infusion on Days 1, 8, and 15 of every 28-day cycle.	BT062 65 mg/m² n=4 participants at risk 65 mg/m² BT062 was administered by IV infusion on Days 1, 8, and 15 of every 28-day cycle.	BT062 80 mg/m² n=3 participants at risk 80 mg/m² BT062 was administered by IV infusion on Days 1, 8, and 15 of every 28-day cycle.	BT062 100 mg/m² n=4 participants at risk 100 mg/m² BT062 was administered by IV infusion on Days 1, 8, and 15 of every 28-day cycle.	BT062 120 mg/m² n=3 participants at risk 120 mg/m² BT062 was administered by IV infusion on Days 1, 8, and 15 of every 28-day cycle.	BT062 140 mg/m² n=10 participants at risk 140 mg/m² BT062 was administered by IV infusion on Days 1, 8, and 15 of every 28-day cycle.	BT062 160 mg/m² n=4 participants at risk 160 mg/m² BT062 was administered by IV infusion on Days 1, 8, and 15 of every 28-day cycle.	Total n=35 participants at risk BT062 administration (all dose levels)
Respiratory, thoracic and mediastinal disorders DYSPNOEA	25.0% 1/4 • Number of events 1 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	33.3% 1/3 • Number of events 1 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	0.00% 0/4 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	0.00% 0/3 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	0.00% 0/4 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	0.00% 0/3 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	0.00% 0/10 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	0.00% 0/4 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	5.7% 2/35 • Number of events 2 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).
Respiratory, thoracic and mediastinal disorders DYSPNOEA EXERTIONAL	0.00% 0/4 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	0.00% 0/3 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	0.00% 0/4 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	33.3% 1/3 • Number of events 1 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	25.0% 1/4 • Number of events 1 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	0.00% 0/3 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	0.00% 0/10 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	25.0% 1/4 • Number of events 1 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	8.6% 3/35 • Number of events 3 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).
Respiratory, thoracic and mediastinal disorders PRODUCTIVE COUGH	50.0% 2/4 • Number of events 2 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	0.00% 0/3 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	0.00% 0/4 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	33.3% 1/3 • Number of events 1 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	0.00% 0/4 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	0.00% 0/3 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	0.00% 0/10 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	0.00% 0/4 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	8.6% 3/35 • Number of events 3 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).
Respiratory, thoracic and mediastinal disorders UPPER-AIRWAY COUGH SYNDROME	0.00% 0/4 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	33.3% 1/3 • Number of events 1 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	25.0% 1/4 • Number of events 1 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	0.00% 0/3 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	0.00% 0/4 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	0.00% 0/3 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	0.00% 0/10 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	0.00% 0/4 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	5.7% 2/35 • Number of events 2 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).
Skin and subcutaneous tissue disorders RASH	0.00% 0/4 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	0.00% 0/3 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	0.00% 0/4 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	33.3% 1/3 • Number of events 3 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	0.00% 0/4 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	33.3% 1/3 • Number of events 1 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	20.0% 2/10 • Number of events 2 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	25.0% 1/4 • Number of events 1 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	14.3% 5/35 • Number of events 7 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).
Skin and subcutaneous tissue disorders BLISTER	0.00% 0/4 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	0.00% 0/3 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	0.00% 0/4 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	0.00% 0/3 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	25.0% 1/4 • Number of events 1 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	0.00% 0/3 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	10.0% 1/10 • Number of events 1 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	0.00% 0/4 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	5.7% 2/35 • Number of events 2 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).
Skin and subcutaneous tissue disorders DRY SKIN	50.0% 2/4 • Number of events 2 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	0.00% 0/3 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	0.00% 0/4 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	0.00% 0/3 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	50.0% 2/4 • Number of events 3 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	0.00% 0/3 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	0.00% 0/10 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	25.0% 1/4 • Number of events 2 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	14.3% 5/35 • Number of events 7 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).
Skin and subcutaneous tissue disorders RASH ERYTHEMATOUS	0.00% 0/4 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	0.00% 0/3 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	0.00% 0/4 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	0.00% 0/3 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	0.00% 0/4 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	0.00% 0/3 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	10.0% 1/10 • Number of events 1 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	25.0% 1/4 • Number of events 1 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	5.7% 2/35 • Number of events 2 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).
Vascular disorders HOT FLUSH	0.00% 0/4 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	0.00% 0/3 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	25.0% 1/4 • Number of events 1 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	0.00% 0/3 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	0.00% 0/4 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	0.00% 0/3 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	0.00% 0/10 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	25.0% 1/4 • Number of events 1 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	5.7% 2/35 • Number of events 2 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).
Skin and subcutaneous tissue disorders ERYTHEMA	0.00% 0/4 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	0.00% 0/3 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	0.00% 0/4 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	0.00% 0/3 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	0.00% 0/4 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	66.7% 2/3 • Number of events 5 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	0.00% 0/10 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	25.0% 1/4 • Number of events 1 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	8.6% 3/35 • Number of events 6 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).
Skin and subcutaneous tissue disorders PRURITUS	0.00% 0/4 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	0.00% 0/3 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	0.00% 0/4 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	0.00% 0/3 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	25.0% 1/4 • Number of events 1 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	0.00% 0/3 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	10.0% 1/10 • Number of events 1 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	0.00% 0/4 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	5.7% 2/35 • Number of events 2 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).
Blood and lymphatic system disorders ANAEMIA	25.0% 1/4 • Number of events 1 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	66.7% 2/3 • Number of events 2 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	0.00% 0/4 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	33.3% 1/3 • Number of events 2 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	50.0% 2/4 • Number of events 2 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	33.3% 1/3 • Number of events 2 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	30.0% 3/10 • Number of events 4 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	25.0% 1/4 • Number of events 1 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	31.4% 11/35 • Number of events 14 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).
Blood and lymphatic system disorders LEUKOPENIA	0.00% 0/4 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	0.00% 0/3 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	0.00% 0/4 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	0.00% 0/3 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	25.0% 1/4 • Number of events 1 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	0.00% 0/3 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	10.0% 1/10 • Number of events 1 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	25.0% 1/4 • Number of events 2 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	8.6% 3/35 • Number of events 4 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).
Blood and lymphatic system disorders LYMPHOPENIA	0.00% 0/4 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	66.7% 2/3 • Number of events 2 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	25.0% 1/4 • Number of events 1 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	33.3% 1/3 • Number of events 1 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	0.00% 0/4 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	0.00% 0/3 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	10.0% 1/10 • Number of events 1 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	0.00% 0/4 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	14.3% 5/35 • Number of events 5 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).
Blood and lymphatic system disorders NEUTROPENIA	0.00% 0/4 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	0.00% 0/3 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	25.0% 1/4 • Number of events 1 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	0.00% 0/3 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	25.0% 1/4 • Number of events 1 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	0.00% 0/3 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	10.0% 1/10 • Number of events 1 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	25.0% 1/4 • Number of events 2 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	11.4% 4/35 • Number of events 5 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).
Blood and lymphatic system disorders THROMBOCYTOPENIA	0.00% 0/4 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	0.00% 0/3 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	0.00% 0/4 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	0.00% 0/3 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	25.0% 1/4 • Number of events 1 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	66.7% 2/3 • Number of events 3 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	10.0% 1/10 • Number of events 1 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	0.00% 0/4 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	11.4% 4/35 • Number of events 5 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).
Gastrointestinal disorders ABDOMINAL DISTENSION	0.00% 0/4 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	0.00% 0/3 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	25.0% 1/4 • Number of events 1 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	0.00% 0/3 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	0.00% 0/4 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	0.00% 0/3 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	10.0% 1/10 • Number of events 1 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	0.00% 0/4 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	5.7% 2/35 • Number of events 2 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).
Gastrointestinal disorders ABDOMINAL PAIN	0.00% 0/4 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	33.3% 1/3 • Number of events 1 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	0.00% 0/4 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	0.00% 0/3 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	0.00% 0/4 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	0.00% 0/3 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	10.0% 1/10 • Number of events 1 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	25.0% 1/4 • Number of events 1 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	8.6% 3/35 • Number of events 3 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).
Gastrointestinal disorders CONSTIPATION	0.00% 0/4 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	33.3% 1/3 • Number of events 1 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	25.0% 1/4 • Number of events 1 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	0.00% 0/3 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	0.00% 0/4 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	33.3% 1/3 • Number of events 1 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	10.0% 1/10 • Number of events 1 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	25.0% 1/4 • Number of events 1 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	14.3% 5/35 • Number of events 5 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).
Gastrointestinal disorders DIARRHOEA	25.0% 1/4 • Number of events 1 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	66.7% 2/3 • Number of events 3 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	25.0% 1/4 • Number of events 2 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	33.3% 1/3 • Number of events 1 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	0.00% 0/4 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	66.7% 2/3 • Number of events 7 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	30.0% 3/10 • Number of events 3 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	75.0% 3/4 • Number of events 4 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	37.1% 13/35 • Number of events 21 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).
Gastrointestinal disorders DYSPEPSIA	0.00% 0/4 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	33.3% 1/3 • Number of events 1 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	0.00% 0/4 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	0.00% 0/3 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	0.00% 0/4 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	0.00% 0/3 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	10.0% 1/10 • Number of events 1 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	0.00% 0/4 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	5.7% 2/35 • Number of events 2 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).
Gastrointestinal disorders HAEMATOCHEZIA	0.00% 0/4 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	0.00% 0/3 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	0.00% 0/4 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	0.00% 0/3 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	25.0% 1/4 • Number of events 1 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	0.00% 0/3 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	10.0% 1/10 • Number of events 1 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	0.00% 0/4 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	5.7% 2/35 • Number of events 2 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).
Gastrointestinal disorders NAUSEA	25.0% 1/4 • Number of events 1 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	66.7% 2/3 • Number of events 2 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	0.00% 0/4 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	0.00% 0/3 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	25.0% 1/4 • Number of events 1 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	33.3% 1/3 • Number of events 1 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	30.0% 3/10 • Number of events 4 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	0.00% 0/4 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	22.9% 8/35 • Number of events 9 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).
General disorders FATIGUE	75.0% 3/4 • Number of events 5 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	0.00% 0/3 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	0.00% 0/4 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	33.3% 1/3 • Number of events 1 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	50.0% 2/4 • Number of events 2 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	100.0% 3/3 • Number of events 5 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	20.0% 2/10 • Number of events 2 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	25.0% 1/4 • Number of events 2 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	34.3% 12/35 • Number of events 17 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).
General disorders INFLUENZA LIKE ILLNESS	0.00% 0/4 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	0.00% 0/3 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	0.00% 0/4 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	0.00% 0/3 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	0.00% 0/4 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	33.3% 1/3 • Number of events 2 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	0.00% 0/10 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	25.0% 1/4 • Number of events 1 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	5.7% 2/35 • Number of events 3 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).
General disorders INFUSION SITE ERYTHEMA	0.00% 0/4 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	0.00% 0/3 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	0.00% 0/4 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	0.00% 0/3 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	0.00% 0/4 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	0.00% 0/3 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	0.00% 0/10 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	50.0% 2/4 • Number of events 2 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	5.7% 2/35 • Number of events 2 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).
General disorders NON-CARDIAC CHEST PAIN	0.00% 0/4 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	0.00% 0/3 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	0.00% 0/4 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	0.00% 0/3 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	25.0% 1/4 • Number of events 1 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	33.3% 1/3 • Number of events 1 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	0.00% 0/10 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	0.00% 0/4 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	5.7% 2/35 • Number of events 2 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).
General disorders OEDEMA PERIPHERAL	25.0% 1/4 • Number of events 1 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	33.3% 1/3 • Number of events 1 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	25.0% 1/4 • Number of events 1 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	0.00% 0/3 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	50.0% 2/4 • Number of events 2 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	33.3% 1/3 • Number of events 1 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	10.0% 1/10 • Number of events 1 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	0.00% 0/4 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	20.0% 7/35 • Number of events 7 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).
General disorders PYREXIA	0.00% 0/4 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	0.00% 0/3 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	0.00% 0/4 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	0.00% 0/3 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	0.00% 0/4 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	33.3% 1/3 • Number of events 1 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	10.0% 1/10 • Number of events 1 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	0.00% 0/4 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	5.7% 2/35 • Number of events 2 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).
Infections and infestations PNEUMONIA	0.00% 0/4 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	0.00% 0/3 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	0.00% 0/4 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	0.00% 0/3 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	0.00% 0/4 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	0.00% 0/3 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	10.0% 1/10 • Number of events 1 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	25.0% 1/4 • Number of events 1 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	5.7% 2/35 • Number of events 2 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).
Infections and infestations UPPER RESPIRATORY TRACT INFECTION	0.00% 0/4 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	0.00% 0/3 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	50.0% 2/4 • Number of events 2 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	0.00% 0/3 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	25.0% 1/4 • Number of events 1 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	33.3% 1/3 • Number of events 1 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	0.00% 0/10 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	0.00% 0/4 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	11.4% 4/35 • Number of events 4 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).
Injury, poisoning and procedural complications FALL	0.00% 0/4 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	0.00% 0/3 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	50.0% 2/4 • Number of events 2 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	0.00% 0/3 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	0.00% 0/4 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	0.00% 0/3 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	0.00% 0/10 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	0.00% 0/4 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	5.7% 2/35 • Number of events 2 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).
Injury, poisoning and procedural complications INFUSION RELATED	0.00% 0/4 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	0.00% 0/3 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	0.00% 0/4 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	0.00% 0/3 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	0.00% 0/4 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	0.00% 0/3 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	10.0% 1/10 • Number of events 1 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	25.0% 1/4 • Number of events 1 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	5.7% 2/35 • Number of events 2 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).
Injury, poisoning and procedural complications SKIN ABRASION	0.00% 0/4 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	0.00% 0/3 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	0.00% 0/4 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	0.00% 0/3 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	25.0% 1/4 • Number of events 1 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	33.3% 1/3 • Number of events 1 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	0.00% 0/10 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	0.00% 0/4 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	5.7% 2/35 • Number of events 2 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).
Investigations ALANINE AMINOTRANSFERASE INCREASED	0.00% 0/4 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	0.00% 0/3 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	0.00% 0/4 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	0.00% 0/3 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	0.00% 0/4 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	66.7% 2/3 • Number of events 4 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	30.0% 3/10 • Number of events 4 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	25.0% 1/4 • Number of events 2 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	17.1% 6/35 • Number of events 10 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).
Investigations AMYLASE INCREASED	0.00% 0/4 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	33.3% 1/3 • Number of events 2 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	0.00% 0/4 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	0.00% 0/3 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	0.00% 0/4 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	0.00% 0/3 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	20.0% 2/10 • Number of events 3 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	0.00% 0/4 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	8.6% 3/35 • Number of events 5 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).
Investigations ASPARTATE AMINOTRANSFERASE INCREASED	25.0% 1/4 • Number of events 1 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	0.00% 0/3 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	50.0% 2/4 • Number of events 3 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	0.00% 0/3 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	0.00% 0/4 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	66.7% 2/3 • Number of events 2 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	30.0% 3/10 • Number of events 4 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	25.0% 1/4 • Number of events 1 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	25.7% 9/35 • Number of events 11 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).
Investigations BLOOD CREATINE PHOSPHOKINASE INCREASED	0.00% 0/4 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	0.00% 0/3 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	0.00% 0/4 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	0.00% 0/3 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	0.00% 0/4 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	0.00% 0/3 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	20.0% 2/10 • Number of events 2 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	0.00% 0/4 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	5.7% 2/35 • Number of events 2 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).
Investigations BLOOD CREATININE INCREASED	0.00% 0/4 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	33.3% 1/3 • Number of events 1 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	25.0% 1/4 • Number of events 1 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	0.00% 0/3 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	0.00% 0/4 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	0.00% 0/3 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	0.00% 0/10 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	0.00% 0/4 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	5.7% 2/35 • Number of events 2 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).
Investigations BLOOD LACTATE DEHYDROGENASE INCREASED	0.00% 0/4 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	0.00% 0/3 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	0.00% 0/4 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	0.00% 0/3 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	0.00% 0/4 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	33.3% 1/3 • Number of events 1 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	20.0% 2/10 • Number of events 2 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	25.0% 1/4 • Number of events 1 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	11.4% 4/35 • Number of events 4 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).
Investigations BLOOD URIC ACID INCREASED	0.00% 0/4 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	33.3% 1/3 • Number of events 1 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	25.0% 1/4 • Number of events 1 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	0.00% 0/3 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	0.00% 0/4 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	0.00% 0/3 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	0.00% 0/10 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	0.00% 0/4 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	5.7% 2/35 • Number of events 2 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).
Investigations GAMMA-GLUTAMYLTRANSFERASE INCREASED	0.00% 0/4 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	0.00% 0/3 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	0.00% 0/4 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	33.3% 1/3 • Number of events 1 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	0.00% 0/4 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	33.3% 1/3 • Number of events 1 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	20.0% 2/10 • Number of events 2 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	0.00% 0/4 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	11.4% 4/35 • Number of events 4 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).
Investigations LIPASE INCREASED	0.00% 0/4 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	0.00% 0/3 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	0.00% 0/4 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	0.00% 0/3 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	0.00% 0/4 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	0.00% 0/3 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	20.0% 2/10 • Number of events 2 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	0.00% 0/4 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	5.7% 2/35 • Number of events 2 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).
Investigations LYMPHOCYTE COUNT DECREASED	0.00% 0/4 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	66.7% 2/3 • Number of events 6 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	25.0% 1/4 • Number of events 1 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	0.00% 0/3 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	0.00% 0/4 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	0.00% 0/3 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	0.00% 0/10 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	0.00% 0/4 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	8.6% 3/35 • Number of events 7 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).
Investigations NEUTROPHIL COUNT DECREASED	0.00% 0/4 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	66.7% 2/3 • Number of events 5 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	0.00% 0/4 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	0.00% 0/3 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	0.00% 0/4 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	0.00% 0/3 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	0.00% 0/10 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	0.00% 0/4 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	5.7% 2/35 • Number of events 5 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).
Investigations OCCULT BLOOD POSITIVE	0.00% 0/4 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	0.00% 0/3 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	25.0% 1/4 • Number of events 1 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	33.3% 1/3 • Number of events 1 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	0.00% 0/4 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	33.3% 1/3 • Number of events 1 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	10.0% 1/10 • Number of events 1 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	0.00% 0/4 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	11.4% 4/35 • Number of events 4 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).
Metabolism and nutrition disorders DECREASED APPETITE	25.0% 1/4 • Number of events 1 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	0.00% 0/3 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	0.00% 0/4 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	0.00% 0/3 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	50.0% 2/4 • Number of events 2 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	0.00% 0/3 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	0.00% 0/10 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	0.00% 0/4 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	8.6% 3/35 • Number of events 3 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).
Metabolism and nutrition disorders HYPERCALCAEMIA	0.00% 0/4 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	33.3% 1/3 • Number of events 1 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	25.0% 1/4 • Number of events 1 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	33.3% 1/3 • Number of events 1 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	0.00% 0/4 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	0.00% 0/3 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	0.00% 0/10 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	0.00% 0/4 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	8.6% 3/35 • Number of events 3 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).
Metabolism and nutrition disorders HYPERGLYCAEMIA	0.00% 0/4 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	66.7% 2/3 • Number of events 6 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	25.0% 1/4 • Number of events 1 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	0.00% 0/3 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	0.00% 0/4 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	0.00% 0/3 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	30.0% 3/10 • Number of events 4 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	0.00% 0/4 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	17.1% 6/35 • Number of events 11 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).
Metabolism and nutrition disorders HYPERKALAEMIA	0.00% 0/4 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	33.3% 1/3 • Number of events 1 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	0.00% 0/4 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	0.00% 0/3 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	0.00% 0/4 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	0.00% 0/3 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	10.0% 1/10 • Number of events 1 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	0.00% 0/4 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	5.7% 2/35 • Number of events 2 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).
Metabolism and nutrition disorders HYPOKALAEMIA	0.00% 0/4 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	0.00% 0/3 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	50.0% 2/4 • Number of events 3 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	33.3% 1/3 • Number of events 1 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	0.00% 0/4 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	33.3% 1/3 • Number of events 4 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	10.0% 1/10 • Number of events 1 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	50.0% 2/4 • Number of events 2 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	20.0% 7/35 • Number of events 11 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).
Metabolism and nutrition disorders HYPONATRAEMIA	25.0% 1/4 • Number of events 2 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	0.00% 0/3 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	0.00% 0/4 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	0.00% 0/3 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	0.00% 0/4 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	0.00% 0/3 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	10.0% 1/10 • Number of events 1 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	0.00% 0/4 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	5.7% 2/35 • Number of events 3 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).
Musculoskeletal and connective tissue disorders ARTHRALGIA	25.0% 1/4 • Number of events 2 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	33.3% 1/3 • Number of events 1 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	0.00% 0/4 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	0.00% 0/3 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	0.00% 0/4 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	33.3% 1/3 • Number of events 1 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	0.00% 0/10 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	0.00% 0/4 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	8.6% 3/35 • Number of events 4 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).
Musculoskeletal and connective tissue disorders BACK PAIN	25.0% 1/4 • Number of events 1 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	0.00% 0/3 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	0.00% 0/4 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	0.00% 0/3 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	50.0% 2/4 • Number of events 2 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	0.00% 0/3 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	0.00% 0/10 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	25.0% 1/4 • Number of events 1 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	11.4% 4/35 • Number of events 4 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).
Musculoskeletal and connective tissue disorders BONE PAIN	25.0% 1/4 • Number of events 1 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	0.00% 0/3 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	0.00% 0/4 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	33.3% 1/3 • Number of events 1 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	25.0% 1/4 • Number of events 1 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	33.3% 1/3 • Number of events 1 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	10.0% 1/10 • Number of events 1 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	0.00% 0/4 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	14.3% 5/35 • Number of events 5 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).
Musculoskeletal and connective tissue disorders FLANK PAIN	0.00% 0/4 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	33.3% 1/3 • Number of events 1 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	25.0% 1/4 • Number of events 1 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	0.00% 0/3 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	0.00% 0/4 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	0.00% 0/3 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	0.00% 0/10 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	0.00% 0/4 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	5.7% 2/35 • Number of events 2 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).
Musculoskeletal and connective tissue disorders MUSCULOSKELETAL CHEST PAIN	0.00% 0/4 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	0.00% 0/3 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	0.00% 0/4 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	33.3% 1/3 • Number of events 1 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	25.0% 1/4 • Number of events 1 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	0.00% 0/3 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	0.00% 0/10 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	0.00% 0/4 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	5.7% 2/35 • Number of events 2 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).
Musculoskeletal and connective tissue disorders MUSCULOSKELETAL PAIN	25.0% 1/4 • Number of events 1 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	0.00% 0/3 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	25.0% 1/4 • Number of events 1 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	33.3% 1/3 • Number of events 1 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	0.00% 0/4 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	0.00% 0/3 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	0.00% 0/10 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	0.00% 0/4 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	8.6% 3/35 • Number of events 3 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).
Musculoskeletal and connective tissue disorders MYALGIA	0.00% 0/4 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	0.00% 0/3 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	25.0% 1/4 • Number of events 1 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	0.00% 0/3 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	0.00% 0/4 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	0.00% 0/3 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	0.00% 0/10 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	25.0% 1/4 • Number of events 1 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	5.7% 2/35 • Number of events 2 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).
Musculoskeletal and connective tissue disorders PAIN IN EXTREMITY	25.0% 1/4 • Number of events 1 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	0.00% 0/3 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	0.00% 0/4 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	0.00% 0/3 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	0.00% 0/4 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	33.3% 1/3 • Number of events 1 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	10.0% 1/10 • Number of events 1 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	0.00% 0/4 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	8.6% 3/35 • Number of events 3 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).
Nervous system disorders HYPOAESTHESIA	0.00% 0/4 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	0.00% 0/3 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	0.00% 0/4 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	0.00% 0/3 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	0.00% 0/4 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	0.00% 0/3 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	10.0% 1/10 • Number of events 1 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	25.0% 1/4 • Number of events 1 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	5.7% 2/35 • Number of events 2 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).
Nervous system disorders NEURALGIA	0.00% 0/4 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	0.00% 0/3 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	0.00% 0/4 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	0.00% 0/3 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	75.0% 3/4 • Number of events 3 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	0.00% 0/3 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	0.00% 0/10 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	0.00% 0/4 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	8.6% 3/35 • Number of events 3 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).
Nervous system disorders NEUROPATHY PERIPHERAL	25.0% 1/4 • Number of events 1 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	0.00% 0/3 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	0.00% 0/4 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	0.00% 0/3 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	0.00% 0/4 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	66.7% 2/3 • Number of events 2 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	0.00% 0/10 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	25.0% 1/4 • Number of events 1 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	11.4% 4/35 • Number of events 4 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).
Psychiatric disorders ANXIETY	0.00% 0/4 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	0.00% 0/3 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	25.0% 1/4 • Number of events 1 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	0.00% 0/3 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	25.0% 1/4 • Number of events 1 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	0.00% 0/3 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	0.00% 0/10 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	0.00% 0/4 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	5.7% 2/35 • Number of events 2 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).
Psychiatric disorders INSOMNIA	0.00% 0/4 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	0.00% 0/3 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	25.0% 1/4 • Number of events 1 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	0.00% 0/3 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	0.00% 0/4 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	0.00% 0/3 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	10.0% 1/10 • Number of events 1 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	0.00% 0/4 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	5.7% 2/35 • Number of events 2 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).
Renal and urinary disorders DYSURIA	25.0% 1/4 • Number of events 1 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	33.3% 1/3 • Number of events 1 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	0.00% 0/4 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	0.00% 0/3 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	0.00% 0/4 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	0.00% 0/3 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	0.00% 0/10 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	0.00% 0/4 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	5.7% 2/35 • Number of events 2 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).
Respiratory, thoracic and mediastinal disorders COUGH	25.0% 1/4 • Number of events 1 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	0.00% 0/3 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	0.00% 0/4 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	0.00% 0/3 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	0.00% 0/4 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	0.00% 0/3 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	10.0% 1/10 • Number of events 1 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	25.0% 1/4 • Number of events 1 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).	8.6% 3/35 • Number of events 3 • Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).

Additional Information

Iris Bobenhausen

Biotest AG

Phone: +49 6103 801

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Part of CTA:The Investigator or any Site employee, consultant or admitting physician to the Site or Study Team member is not allowed to make any publication of any Study Data, information, results, or similar information without the review and comment of SPONSOR. As the Study is part of a multi-center trial, and the Investigator/site agree that no publication by Site/Investigator of the results of the Study conducted at the Site shall be made before the first multi-centre publication.
Publication restrictions are in place

Restriction type: OTHER