Trial Outcomes & Findings for Study of ADCT-502 in Patients With Advanced Solid Tumors Withhuman Epidermal Growth Factor Receptor-2 (HER2) Expression (NCT NCT03125200)

NCT ID: NCT03125200

Last Updated: 2021-02-01

Results Overview

• Recruitment status: TERMINATED
• Study phase: PHASE1
• Target enrollment: 21 participants
• Primary outcome timeframe: Day 1 to 3 Weeks (one cycle)
• Results posted on: 2021-02-01

Participant Flow

Participant milestones

Measure	Part 1: Dose 30μg/kg Dose-escalation part of the study. Participants received ADCT-502 (30 μg/kg) via a 1-hour intravenous infusion once every 3 weeks.	Part 1: Dose 60μg/kg Dose-escalation part of the study. Participants received ADCT-502 (60 μg/kg) via a 1-hour intravenous infusion once every 3 weeks.	Part 1: Dose 120μg/kg Dose-escalation part of the study. Participants received ADCT-502 (120 μg/kg) via a 1-hour intravenous infusion once every 3 weeks.	Part 1: Dose 150μg/kg Dose-escalation part of the study. Participants received ADCT-502 (120 μg/kg) via a 1-hour intravenous infusion once every 3 weeks.	Part 1: Dose 180μg/kg Dose-escalation part of the study. Participants received ADCT-502 (120 μg/kg) via a 1-hour intravenous infusion once every 3 weeks.	Part 1: Dose 210μg/kg Dose-escalation part of the study. Participants received ADCT-502 (120 μg/kg) via a 1-hour intravenous infusion once every 3 weeks.	Part 1: Dose 240μg/kg Dose-escalation part of the study. Participants received ADCT-502 (120 μg/kg) via a 1-hour intravenous infusion once every 3 weeks.
Overall Study STARTED	2	2	2	5	4	3	3
Overall Study COMPLETED	0	0	0	0	0	0	0
Overall Study NOT COMPLETED	2	2	2	5	4	3	3

Reasons for withdrawal

Measure	Part 1: Dose 30μg/kg Dose-escalation part of the study. Participants received ADCT-502 (30 μg/kg) via a 1-hour intravenous infusion once every 3 weeks.	Part 1: Dose 60μg/kg Dose-escalation part of the study. Participants received ADCT-502 (60 μg/kg) via a 1-hour intravenous infusion once every 3 weeks.	Part 1: Dose 120μg/kg Dose-escalation part of the study. Participants received ADCT-502 (120 μg/kg) via a 1-hour intravenous infusion once every 3 weeks.	Part 1: Dose 150μg/kg Dose-escalation part of the study. Participants received ADCT-502 (120 μg/kg) via a 1-hour intravenous infusion once every 3 weeks.	Part 1: Dose 180μg/kg Dose-escalation part of the study. Participants received ADCT-502 (120 μg/kg) via a 1-hour intravenous infusion once every 3 weeks.	Part 1: Dose 210μg/kg Dose-escalation part of the study. Participants received ADCT-502 (120 μg/kg) via a 1-hour intravenous infusion once every 3 weeks.	Part 1: Dose 240μg/kg Dose-escalation part of the study. Participants received ADCT-502 (120 μg/kg) via a 1-hour intravenous infusion once every 3 weeks.
Overall Study Study Termination	0	0	0	1	1	2	1
Overall Study Clinical Progression	0	0	0	1	0	1	0
Overall Study Progressive Disease	2	1	2	1	2	0	1
Overall Study Lack of Efficacy	0	0	0	1	0	0	0
Overall Study Toxicity	0	0	0	1	0	0	0
Overall Study Consent Withdrawn by Subject	0	1	0	0	1	0	1

Baseline Characteristics

Study of ADCT-502 in Patients With Advanced Solid Tumors Withhuman Epidermal Growth Factor Receptor-2 (HER2) Expression

Baseline characteristics by cohort

Measure	Part 1: Dose 30μg/kg n=2 Participants Dose-escalation part of the study. Participants received ADCT-502 (30 μg/kg) via a 1-hour intravenous infusion once every 3 weeks.	Part 1: Dose 60μg/kg n=2 Participants Dose-escalation part of the study. Participants received ADCT-502 (60 μg/kg) via a 1-hour intravenous infusion once every 3 weeks.	Part 1: Dose 120μg/kg n=2 Participants Dose-escalation part of the study. Participants received ADCT-502 (120 μg/kg) via a 1-hour intravenous infusion once every 3 weeks.	Part 1: Dose 150μg/kg n=5 Participants Dose-escalation part of the study. Participants received ADCT-502 (150 μg/kg) via a 1-hour intravenous infusion once every 3 weeks.	Part 1: Dose 180μg/kg n=4 Participants Dose-escalation part of the study. Participants received ADCT-502 (180 μg/kg) via a 1-hour intravenous infusion once every 3 weeks.	Part 1: Dose 210μg/kg n=3 Participants Dose-escalation part of the study. Participants received ADCT-502 (210 μg/kg) via a 1-hour intravenous infusion once every 3 weeks.	Part 1: Dose 240μg/kg n=3 Participants Dose-escalation part of the study. Participants received ADCT-502 (240 μg/kg) via a 1-hour intravenous infusion once every 3 weeks.	Total n=21 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=10 Participants	0 Participants n=115 Participants	0 Participants n=6 Participants
Age, Categorical Between 18 and 65 years	1 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	3 Participants n=4 Participants	3 Participants n=21 Participants	2 Participants n=10 Participants	2 Participants n=115 Participants	13 Participants n=6 Participants
Age, Categorical >=65 years	1 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	2 Participants n=4 Participants	1 Participants n=21 Participants	1 Participants n=10 Participants	1 Participants n=115 Participants	8 Participants n=6 Participants
Sex: Female, Male Female	1 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants	4 Participants n=4 Participants	3 Participants n=21 Participants	1 Participants n=10 Participants	2 Participants n=115 Participants	15 Participants n=6 Participants
Sex: Female, Male Male	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	1 Participants n=21 Participants	2 Participants n=10 Participants	1 Participants n=115 Participants	6 Participants n=6 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 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=10 Participants	0 Participants n=115 Participants	1 Participants n=6 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	1 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants	5 Participants n=4 Participants	4 Participants n=21 Participants	3 Participants n=10 Participants	3 Participants n=115 Participants	20 Participants n=6 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	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=10 Participants	0 Participants n=115 Participants	0 Participants n=6 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=10 Participants	0 Participants n=115 Participants	0 Participants n=6 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	2 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	1 Participants n=115 Participants	4 Participants n=6 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=10 Participants	0 Participants n=115 Participants	0 Participants n=6 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	0 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants	0 Participants n=6 Participants
Race (NIH/OMB) White	2 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants	3 Participants n=4 Participants	4 Participants n=21 Participants	3 Participants n=10 Participants	2 Participants n=115 Participants	17 Participants n=6 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=10 Participants	0 Participants n=115 Participants	0 Participants n=6 Participants
Race (NIH/OMB) Unknown or Not Reported	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=10 Participants	0 Participants n=115 Participants	0 Participants n=6 Participants
Region of Enrollment Belgium	0 participants n=5 Participants	0 participants n=7 Participants	0 participants n=5 Participants	1 participants n=4 Participants	1 participants n=21 Participants	1 participants n=10 Participants	0 participants n=115 Participants	3 participants n=6 Participants
Region of Enrollment United States	2 participants n=5 Participants	2 participants n=7 Participants	2 participants n=5 Participants	4 participants n=4 Participants	3 participants n=21 Participants	2 participants n=10 Participants	3 participants n=115 Participants	18 participants n=6 Participants
Height	164.60 Centimetres STANDARD_DEVIATION 7.920 • n=5 Participants	161.00 Centimetres STANDARD_DEVIATION 7.071 • n=7 Participants	165.65 Centimetres STANDARD_DEVIATION 1.909 • n=5 Participants	161.02 Centimetres STANDARD_DEVIATION 7.814 • n=4 Participants	167.38 Centimetres STANDARD_DEVIATION 9.571 • n=21 Participants	169.33 Centimetres STANDARD_DEVIATION 9.504 • n=10 Participants	154.13 Centimetres STANDARD_DEVIATION 11.055 • n=115 Participants	163.21 Centimetres STANDARD_DEVIATION 8.772 • n=6 Participants
Weight	66.75 Kilograms STANDARD_DEVIATION 6.576 • n=5 Participants	76.85 Kilograms STANDARD_DEVIATION 49.427 • n=7 Participants	73.65 Kilograms STANDARD_DEVIATION 21.850 • n=5 Participants	61.70 Kilograms STANDARD_DEVIATION 9.113 • n=4 Participants	84.25 Kilograms STANDARD_DEVIATION 22.422 • n=21 Participants	67.93 Kilograms STANDARD_DEVIATION 2.173 • n=10 Participants	59.90 Kilograms STANDARD_DEVIATION 10.300 • n=115 Participants	69.69 Kilograms STANDARD_DEVIATION 18.222 • n=6 Participants
Body Mass Index	24.61 kg/m2 STANDARD_DEVIATION 0.059 • n=5 Participants	28.89 kg/m2 STANDARD_DEVIATION 16.514 • n=7 Participants	26.94 kg/m2 STANDARD_DEVIATION 8.583 • n=5 Participants	23.70 kg/m2 STANDARD_DEVIATION 2.218 • n=4 Participants	30.33 kg/m2 STANDARD_DEVIATION 8.873 • n=21 Participants	23.89 kg/m2 STANDARD_DEVIATION 3.330 • n=10 Participants	25.13 kg/m2 STANDARD_DEVIATION 2.762 • n=115 Participants	26.03 kg/m2 STANDARD_DEVIATION 6.241 • n=6 Participants

PRIMARY outcome

Timeframe: Day 1 to 3 Weeks (one cycle)

Outcome measures

Measure	Part 1: Dose 30μg/kg n=2 Participants Dose-escalation part of the study. Participants received ADCT-502 (30 μg/kg) via a 1-hour intravenous infusion once every 3 weeks.	Part 1: Dose 60μg/kg n=2 Participants Dose-escalation part of the study. Participants received ADCT-502 (60 μg/kg) via a 1-hour intravenous infusion once every 3 weeks.	Part 1: Dose 120μg/kg n=2 Participants Dose-escalation part of the study. Participants received ADCT-502 (120 μg/kg) via a 1-hour intravenous infusion once every 3 weeks.	Part 1: Dose 150μg/kg n=5 Participants Dose-escalation part of the study. Participants received ADCT-502 (150 μg/kg) via a 1-hour intravenous infusion once every 3 weeks.	Part 1: Dose 180μg/kg n=4 Participants Dose-escalation part of the study. Participants received ADCT-502 (180 μg/kg) via a 1-hour intravenous infusion once every 3 weeks.	Part 1: Dose 210μg/kg n=3 Participants Dose-escalation part of the study. Participants received ADCT-502 (210 μg/kg) via a 1-hour intravenous infusion once every 3 weeks.	Part 1: Dose 240μg/kg n=3 Participants Dose-escalation part of the study. Participants received ADCT-502 (240 μg/kg) via a 1-hour intravenous infusion once every 3 weeks.
Number of Participants Who Experienced Dose-Limiting Toxicities	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	1 Participants

PRIMARY outcome

Timeframe: Day 1 to 3 Weeks (one cycle)

The Common Terminology Criteria For Adverse Events (CTCAE) Version 4 will be used.

Outcome measures

Measure	Part 1: Dose 30μg/kg n=2 Participants Dose-escalation part of the study. Participants received ADCT-502 (30 μg/kg) via a 1-hour intravenous infusion once every 3 weeks.	Part 1: Dose 60μg/kg n=2 Participants Dose-escalation part of the study. Participants received ADCT-502 (60 μg/kg) via a 1-hour intravenous infusion once every 3 weeks.	Part 1: Dose 120μg/kg n=2 Participants Dose-escalation part of the study. Participants received ADCT-502 (120 μg/kg) via a 1-hour intravenous infusion once every 3 weeks.	Part 1: Dose 150μg/kg n=5 Participants Dose-escalation part of the study. Participants received ADCT-502 (150 μg/kg) via a 1-hour intravenous infusion once every 3 weeks.	Part 1: Dose 180μg/kg n=4 Participants Dose-escalation part of the study. Participants received ADCT-502 (180 μg/kg) via a 1-hour intravenous infusion once every 3 weeks.	Part 1: Dose 210μg/kg n=3 Participants Dose-escalation part of the study. Participants received ADCT-502 (210 μg/kg) via a 1-hour intravenous infusion once every 3 weeks.	Part 1: Dose 240μg/kg n=3 Participants Dose-escalation part of the study. Participants received ADCT-502 (240 μg/kg) via a 1-hour intravenous infusion once every 3 weeks.
Number of Participants Who Experienced a Dose-Limiting Toxicity With a CTCAE Grade of 3 or Above	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	1 Participants

PRIMARY outcome

Timeframe: Day 1 to end of trial, a maximum of 168 days (+ 30 days)

An adverse event is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. A TEAE is defined as an adverse event with an onset that occurs after receiving study drug.

Outcome measures

Measure	Part 1: Dose 30μg/kg n=2 Participants Dose-escalation part of the study. Participants received ADCT-502 (30 μg/kg) via a 1-hour intravenous infusion once every 3 weeks.	Part 1: Dose 60μg/kg n=2 Participants Dose-escalation part of the study. Participants received ADCT-502 (60 μg/kg) via a 1-hour intravenous infusion once every 3 weeks.	Part 1: Dose 120μg/kg n=2 Participants Dose-escalation part of the study. Participants received ADCT-502 (120 μg/kg) via a 1-hour intravenous infusion once every 3 weeks.	Part 1: Dose 150μg/kg n=5 Participants Dose-escalation part of the study. Participants received ADCT-502 (150 μg/kg) via a 1-hour intravenous infusion once every 3 weeks.	Part 1: Dose 180μg/kg n=4 Participants Dose-escalation part of the study. Participants received ADCT-502 (180 μg/kg) via a 1-hour intravenous infusion once every 3 weeks.	Part 1: Dose 210μg/kg n=3 Participants Dose-escalation part of the study. Participants received ADCT-502 (210 μg/kg) via a 1-hour intravenous infusion once every 3 weeks.	Part 1: Dose 240μg/kg n=3 Participants Dose-escalation part of the study. Participants received ADCT-502 (240 μg/kg) via a 1-hour intravenous infusion once every 3 weeks.
Number of Participants Who Experience At Least One Treatment Emergent Adverse Event (TEAE)	2 Participants	2 Participants	2 Participants	5 Participants	4 Participants	3 Participants	3 Participants

PRIMARY outcome

Timeframe: Day 1 to end of trial, a maximum of 168 days (+ 30 days)

Outcome measures

Measure	Part 1: Dose 30μg/kg n=2 Participants Dose-escalation part of the study. Participants received ADCT-502 (30 μg/kg) via a 1-hour intravenous infusion once every 3 weeks.	Part 1: Dose 60μg/kg n=2 Participants Dose-escalation part of the study. Participants received ADCT-502 (60 μg/kg) via a 1-hour intravenous infusion once every 3 weeks.	Part 1: Dose 120μg/kg n=2 Participants Dose-escalation part of the study. Participants received ADCT-502 (120 μg/kg) via a 1-hour intravenous infusion once every 3 weeks.	Part 1: Dose 150μg/kg n=5 Participants Dose-escalation part of the study. Participants received ADCT-502 (150 μg/kg) via a 1-hour intravenous infusion once every 3 weeks.	Part 1: Dose 180μg/kg n=4 Participants Dose-escalation part of the study. Participants received ADCT-502 (180 μg/kg) via a 1-hour intravenous infusion once every 3 weeks.	Part 1: Dose 210μg/kg n=3 Participants Dose-escalation part of the study. Participants received ADCT-502 (210 μg/kg) via a 1-hour intravenous infusion once every 3 weeks.	Part 1: Dose 240μg/kg n=3 Participants Dose-escalation part of the study. Participants received ADCT-502 (240 μg/kg) via a 1-hour intravenous infusion once every 3 weeks.
Number of Participants Who Experience At Least One Treatment Emergent Serious Adverse Event (SAE)	0 Participants	1 Participants	0 Participants	2 Participants	1 Participants	2 Participants	1 Participants

PRIMARY outcome

Timeframe: Day 1 to end of trial, a maximum of 168 days (+ 30 days)

Population: This analysis was planned but data was not collected as the study was terminated due to safety reasons.

Clinical significance was determined by the investigator.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: Day 1 to end of trial, a maximum of 168 days (+ 30 days)

Population: This analysis was planned but data was not collected as the study was terminated due to safety reasons.

Clinical significance was determined by the investigator.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: Day 1 to end of trial, a maximum of 168 days (+ 30 days)

Population: This analysis was planned but data was not collected as the study was terminated due to safety reasons.

Performance status was assessed using the ECOG performance status grades. These range between Grade 0 (fully active) and Grade 5 (dead). Clinical significance was determined by the investigator.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: Day 1 to end of trial, a maximum of 168 days (+ 30 days)

Vital sign measurements include arterial blood pressure, heart rate, respiratory rate, and body temperature. Clinical significance was determined by the investigator.

Outcome measures

Measure	Part 1: Dose 30μg/kg n=2 Participants Dose-escalation part of the study. Participants received ADCT-502 (30 μg/kg) via a 1-hour intravenous infusion once every 3 weeks.	Part 1: Dose 60μg/kg n=2 Participants Dose-escalation part of the study. Participants received ADCT-502 (60 μg/kg) via a 1-hour intravenous infusion once every 3 weeks.	Part 1: Dose 120μg/kg n=2 Participants Dose-escalation part of the study. Participants received ADCT-502 (120 μg/kg) via a 1-hour intravenous infusion once every 3 weeks.	Part 1: Dose 150μg/kg n=5 Participants Dose-escalation part of the study. Participants received ADCT-502 (150 μg/kg) via a 1-hour intravenous infusion once every 3 weeks.	Part 1: Dose 180μg/kg n=4 Participants Dose-escalation part of the study. Participants received ADCT-502 (180 μg/kg) via a 1-hour intravenous infusion once every 3 weeks.	Part 1: Dose 210μg/kg n=3 Participants Dose-escalation part of the study. Participants received ADCT-502 (210 μg/kg) via a 1-hour intravenous infusion once every 3 weeks.	Part 1: Dose 240μg/kg n=3 Participants Dose-escalation part of the study. Participants received ADCT-502 (240 μg/kg) via a 1-hour intravenous infusion once every 3 weeks.
Number of Participants With Clinically Significant Vital Signs	0 Participants	0 Participants	1 Participants	1 Participants	0 Participants	2 Participants	0 Participants

PRIMARY outcome

Timeframe: Day 1 to end of trial, a maximum of 168 days (+ 30 days)

Standard 12-lead ECG's will be used. Clinical significance was determined by the investigator.

Outcome measures

Measure	Part 1: Dose 30μg/kg n=2 Participants Dose-escalation part of the study. Participants received ADCT-502 (30 μg/kg) via a 1-hour intravenous infusion once every 3 weeks.	Part 1: Dose 60μg/kg n=2 Participants Dose-escalation part of the study. Participants received ADCT-502 (60 μg/kg) via a 1-hour intravenous infusion once every 3 weeks.	Part 1: Dose 120μg/kg n=2 Participants Dose-escalation part of the study. Participants received ADCT-502 (120 μg/kg) via a 1-hour intravenous infusion once every 3 weeks.	Part 1: Dose 150μg/kg n=5 Participants Dose-escalation part of the study. Participants received ADCT-502 (150 μg/kg) via a 1-hour intravenous infusion once every 3 weeks.	Part 1: Dose 180μg/kg n=4 Participants Dose-escalation part of the study. Participants received ADCT-502 (180 μg/kg) via a 1-hour intravenous infusion once every 3 weeks.	Part 1: Dose 210μg/kg n=3 Participants Dose-escalation part of the study. Participants received ADCT-502 (210 μg/kg) via a 1-hour intravenous infusion once every 3 weeks.	Part 1: Dose 240μg/kg n=3 Participants Dose-escalation part of the study. Participants received ADCT-502 (240 μg/kg) via a 1-hour intravenous infusion once every 3 weeks.
Number of Participants Who Experience Clinically Significant Electrocardiogram (ECG) Results	0 Participants	0 Participants	1 Participants	0 Participants	1 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Screening, day 1 of cycle 3 and cycle 5, then every 4 cycles, approximately every 12 weeks

ORR was defined as the number of participants with a best overall response of Complete Response (CR) or Partial Response (PR) at the time each participant discontinues ADCT-502. Analysis will be determined by the investigator per Response Evaluation In Solid Criteria (RECIST) version 1.1 criteria: partial response is when there is a decrease in sum of target disease ≥ 30%, and complete response is when all lesions have disappeared or all lesions have disappeared and all nodal disease is < 10 mm each.

Outcome measures

Measure	Part 1: Dose 30μg/kg n=2 Participants Dose-escalation part of the study. Participants received ADCT-502 (30 μg/kg) via a 1-hour intravenous infusion once every 3 weeks.	Part 1: Dose 60μg/kg n=2 Participants Dose-escalation part of the study. Participants received ADCT-502 (60 μg/kg) via a 1-hour intravenous infusion once every 3 weeks.	Part 1: Dose 120μg/kg n=2 Participants Dose-escalation part of the study. Participants received ADCT-502 (120 μg/kg) via a 1-hour intravenous infusion once every 3 weeks.	Part 1: Dose 150μg/kg n=5 Participants Dose-escalation part of the study. Participants received ADCT-502 (150 μg/kg) via a 1-hour intravenous infusion once every 3 weeks.	Part 1: Dose 180μg/kg n=4 Participants Dose-escalation part of the study. Participants received ADCT-502 (180 μg/kg) via a 1-hour intravenous infusion once every 3 weeks.	Part 1: Dose 210μg/kg n=3 Participants Dose-escalation part of the study. Participants received ADCT-502 (210 μg/kg) via a 1-hour intravenous infusion once every 3 weeks.	Part 1: Dose 240μg/kg n=3 Participants Dose-escalation part of the study. Participants received ADCT-502 (240 μg/kg) via a 1-hour intravenous infusion once every 3 weeks.
Overall Response Rate (ORR) Complete Response	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Overall Response Rate (ORR) Partial Response	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Screening, day 1 of cycle 3 and cycle 5, then every 4 cycles, approximately every 12 weeks

DCR was defined as the number of participants with a best overall response of Complete Response (CR) or Partial Response (PR), or Stable Disease (SD). Analysis will be determined by the investigator per Response Evaluation In Solid Criteria (RECIST) version 1.1 criteria: stable disease is when the change is > -30% and ≤ 20%, partial response is when there is a decrease in sum of target disease ≥ 30%, and complete response is when all lesions have disappeared or all lesions have disappeared and all nodal disease is < 10 mm each.

Outcome measures

Measure	Part 1: Dose 30μg/kg n=2 Participants Dose-escalation part of the study. Participants received ADCT-502 (30 μg/kg) via a 1-hour intravenous infusion once every 3 weeks.	Part 1: Dose 60μg/kg n=2 Participants Dose-escalation part of the study. Participants received ADCT-502 (60 μg/kg) via a 1-hour intravenous infusion once every 3 weeks.	Part 1: Dose 120μg/kg n=2 Participants Dose-escalation part of the study. Participants received ADCT-502 (120 μg/kg) via a 1-hour intravenous infusion once every 3 weeks.	Part 1: Dose 150μg/kg n=5 Participants Dose-escalation part of the study. Participants received ADCT-502 (150 μg/kg) via a 1-hour intravenous infusion once every 3 weeks.	Part 1: Dose 180μg/kg n=4 Participants Dose-escalation part of the study. Participants received ADCT-502 (180 μg/kg) via a 1-hour intravenous infusion once every 3 weeks.	Part 1: Dose 210μg/kg n=3 Participants Dose-escalation part of the study. Participants received ADCT-502 (210 μg/kg) via a 1-hour intravenous infusion once every 3 weeks.	Part 1: Dose 240μg/kg n=3 Participants Dose-escalation part of the study. Participants received ADCT-502 (240 μg/kg) via a 1-hour intravenous infusion once every 3 weeks.
Disease Control Rate (DCR) Complete Response	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Disease Control Rate (DCR) Partial Response	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants
Disease Control Rate (DCR) Stable Disease	2 Participants	1 Participants	0 Participants	4 Participants	2 Participants	2 Participants	0 Participants

SECONDARY outcome

Timeframe: Screening, day 1 of cycle 3 and cycle 5, then every 4 cycles, approximately every 12 weeks

Population: This analysis was planned but data was not collected as the study was terminated due to safety reasons.

DOR was defined among responders (CR or PR) as the time from the earliest date of first response until the first date of either disease progression or death due to any cause.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Screening, day 1 of cycle 3 and cycle 5, then every 4 cycles, approximately every 12 weeks

Population: This analysis was planned but data was not collected as the study was terminated due to safety reasons.

PFS was defined among the efficacy population as the time from first dose of study drug until the first date of either disease progression or death due to any cause.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Screening, day 1 of cycle 3 and cycle 5, then every 4 cycles, approximately every 12 weeks

Population: This analysis was planned but data was not collected as the study was terminated due to safety reasons.

Median OS was defined as the time from the beginning of study drug treatment until death due to any cause.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Before infusion, End of Infusion, and 1, 3, 6, 24, 48, 96, 168 and 336 hours post infusion for Cycle 1 & 2. Before infusion and end of infusion of Cycle 3 to disease progression, and 30 days and 12 weeks after last dose

Population: This analysis was planned but data was not collected as the study was terminated due to safety reasons.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Before infusion, End of Infusion, and 1, 3, 6, 24, 48, 96, 168 and 336 hours post infusion for Cycle 1 & 2. Before infusion and end of infusion of Cycle 3 to disease progression, and 30 days and 12 weeks after last dose

Population: This analysis was planned but data was not collected as the study was terminated due to safety reasons.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Before infusion, End of Infusion, and 1, 3, 6, 24, 48, 96, 168 and 336 hours post infusion for Cycle 1 & 2. Before infusion and end of infusion of Cycle 3 to disease progression, and 30 days and 12 weeks after last dose

Population: This analysis was planned but data was not collected as the study was terminated due to safety reasons.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Before infusion, End of Infusion, and 1, 3, 6, 24, 48, 96, 168 and 336 hours post infusion for Cycle 1 & 2. Before infusion and end of infusion of Cycle 3 to disease progression, and 30 days and 12 weeks after last dose

Population: This analysis was planned but data was not collected as the study was terminated due to safety reasons.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Before infusion, End of Infusion, and 1, 3, 6, 24, 48, 96, 168 and 336 hours post infusion for Cycle 1 & 2. Before infusion and end of infusion of Cycle 3 to disease progression, and 30 days and 12 weeks after last dose

Population: This analysis was planned but data was not collected as the study was terminated due to safety reasons.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Before infusion, End of Infusion, and 1, 3, 6, 24, 48, 96, 168 and 336 hours post infusion for Cycle 1 & 2. Before infusion and end of infusion of Cycle 3 to disease progression, and 30 days and 12 weeks after last dose

Population: This analysis was planned but data was not collected as the study was terminated due to safety reasons.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Before infusion, End of Infusion, and 1, 3, 6, 24, 48, 96, 168 and 336 hours post infusion for Cycle 1 & 2. Before infusion and end of infusion of Cycle 3 to disease progression, and 30 days and 12 weeks after last dose

Population: This analysis was planned but data was not collected as the study was terminated due to safety reasons.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Before infusion, End of Infusion, and 1, 3, 6, 24, 48, 96, 168 and 336 hours post infusion for Cycle 1 & 2. Before infusion and end of infusion of Cycle 3 to disease progression, and 30 days and 12 weeks after last dose

Population: This analysis was planned but data was not collected as the study was terminated due to safety reasons.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Before infusion, End of Infusion, and 1, 3, 6, 24, 48, 96, 168 and 336 hours post infusion for Cycle 1 & 2. Before infusion and end of infusion of Cycle 3 to disease progression, and 30 days and 12 weeks after last dose

Population: This analysis was planned but data was not collected as the study was terminated due to safety reasons.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Before infusion, End of Infusion, and 1, 3, 6, 24, 48, 96, 168 and 336 hours post infusion for Cycle 1 & 2. Before infusion and end of infusion of Cycle 3 to disease progression, and 30 days and 12 weeks after last dose

Population: This analysis was planned but data was not collected as the study was terminated due to safety reasons.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Before infusion, End of Infusion, and 1, 3, 6, 24, 48, 96, 168 and 336 hours post infusion for Cycle 1 & 2. Before infusion and end of infusion of Cycle 3 to disease progression, and 30 days and 12 weeks after last dose

Population: This analysis was planned but data was not collected as the study was terminated due to safety reasons.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Before infusion, End of Infusion, and 1, 3, 6, 24, 48, 96, 168 and 336 hours post infusion for Cycle 1 & 2. Before infusion and end of infusion of Cycle 3 to disease progression, and 30 days and 12 weeks after last dose

Population: This analysis was planned but data was not collected as the study was terminated due to safety reasons.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Blood sample collection before start of infusion in Cycles 1 and 2, and on Day 1 starting with Cycle 3 until disease progression, 30 days and 12 weeks after last dose

Population: This analysis was planned but data was not collected as the study was terminated due to safety reasons.

Outcome measures

Outcome data not reported

Adverse Events

Part 1: Dose 30μg/kg

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Part 1: Dose 60μg/kg

Serious events: 1 serious events

Other events: 2 other events

Deaths: 0 deaths

Part 1: Dose 120μg/kg

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Part 1: Dose 150μg/kg

Serious events: 2 serious events

Other events: 5 other events

Deaths: 0 deaths

Part 1: Dose 180μg/kg

Serious events: 1 serious events

Other events: 4 other events

Deaths: 0 deaths

Part 1: Dose 210μg/kg

Serious events: 2 serious events

Other events: 3 other events

Deaths: 0 deaths

Part 1: Dose 240μg/kg

Serious events: 1 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Measure	Part 1: Dose 30μg/kg n=2 participants at risk Dose-escalation part of the study. Participants received ADCT-502 (30 μg/kg) via a 1-hour intravenous infusion once every 3 weeks.	Part 1: Dose 60μg/kg n=2 participants at risk Dose-escalation part of the study. Participants received ADCT-502 (60 μg/kg) via a 1-hour intravenous infusion once every 3 weeks.	Part 1: Dose 120μg/kg n=2 participants at risk Dose-escalation part of the study. Participants received ADCT-502 (120 μg/kg) via a 1-hour intravenous infusion once every 3 weeks.	Part 1: Dose 150μg/kg n=5 participants at risk Dose-escalation part of the study. Participants received ADCT-502 (150 μg/kg) via a 1-hour intravenous infusion once every 3 weeks.	Part 1: Dose 180μg/kg n=4 participants at risk Dose-escalation part of the study. Participants received ADCT-502 (180 μg/kg) via a 1-hour intravenous infusion once every 3 weeks.	Part 1: Dose 210μg/kg n=3 participants at risk Dose-escalation part of the study. Participants received ADCT-502 (210 μg/kg) via a 1-hour intravenous infusion once every 3 weeks.	Part 1: Dose 240μg/kg n=3 participants at risk Dose-escalation part of the study. Participants received ADCT-502 (240 μg/kg) via a 1-hour intravenous infusion once every 3 weeks.
Gastrointestinal disorders Small intestinal obstruction	0.00% 0/2 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	50.0% 1/2 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/2 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	40.0% 2/5 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/4 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/3 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/3 • Baseline to end of trial, a maximum of 168 days (+ 30 days)
Respiratory, thoracic and mediastinal disorders Cough	0.00% 0/2 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/2 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/2 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	20.0% 1/5 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/4 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/3 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/3 • Baseline to end of trial, a maximum of 168 days (+ 30 days)
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.00% 0/2 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/2 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/2 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	20.0% 1/5 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/4 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/3 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/3 • Baseline to end of trial, a maximum of 168 days (+ 30 days)
Vascular disorders Hypotension	0.00% 0/2 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/2 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/2 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	20.0% 1/5 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/4 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/3 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/3 • Baseline to end of trial, a maximum of 168 days (+ 30 days)
Gastrointestinal disorders Abdominal pain	0.00% 0/2 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/2 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/2 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/5 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	25.0% 1/4 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/3 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/3 • Baseline to end of trial, a maximum of 168 days (+ 30 days)
Infections and infestations Escherichia bacteraemia	0.00% 0/2 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/2 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/2 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/5 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/4 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	33.3% 1/3 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/3 • Baseline to end of trial, a maximum of 168 days (+ 30 days)
Infections and infestations Sepsis	0.00% 0/2 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/2 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/2 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/5 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/4 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	33.3% 1/3 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/3 • Baseline to end of trial, a maximum of 168 days (+ 30 days)
Infections and infestations Pneumonia	0.00% 0/2 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/2 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/2 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/5 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/4 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	33.3% 1/3 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/3 • Baseline to end of trial, a maximum of 168 days (+ 30 days)
Gastrointestinal disorders Ascites	0.00% 0/2 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/2 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/2 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/5 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/4 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	33.3% 1/3 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/3 • Baseline to end of trial, a maximum of 168 days (+ 30 days)
General disorders Pyrexia	0.00% 0/2 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/2 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/2 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/5 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/4 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	33.3% 1/3 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/3 • Baseline to end of trial, a maximum of 168 days (+ 30 days)
Infections and infestations Klebsiella infection	0.00% 0/2 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/2 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/2 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/5 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/4 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	33.3% 1/3 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/3 • Baseline to end of trial, a maximum of 168 days (+ 30 days)
Respiratory, thoracic and mediastinal disorders Pleuritic pain	0.00% 0/2 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/2 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/2 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/5 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/4 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/3 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	33.3% 1/3 • Baseline to end of trial, a maximum of 168 days (+ 30 days)
Respiratory, thoracic and mediastinal disorders Hypoxia	0.00% 0/2 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/2 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/2 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	20.0% 1/5 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/4 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/3 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/3 • Baseline to end of trial, a maximum of 168 days (+ 30 days)
General disorders Fatigue	0.00% 0/2 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/2 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/2 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/5 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/4 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	33.3% 1/3 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/3 • Baseline to end of trial, a maximum of 168 days (+ 30 days)
General disorders Oedema peripheral	0.00% 0/2 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/2 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/2 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/5 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/4 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	33.3% 1/3 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/3 • Baseline to end of trial, a maximum of 168 days (+ 30 days)

Other adverse events

Measure	Part 1: Dose 30μg/kg n=2 participants at risk Dose-escalation part of the study. Participants received ADCT-502 (30 μg/kg) via a 1-hour intravenous infusion once every 3 weeks.	Part 1: Dose 60μg/kg n=2 participants at risk Dose-escalation part of the study. Participants received ADCT-502 (60 μg/kg) via a 1-hour intravenous infusion once every 3 weeks.	Part 1: Dose 120μg/kg n=2 participants at risk Dose-escalation part of the study. Participants received ADCT-502 (120 μg/kg) via a 1-hour intravenous infusion once every 3 weeks.	Part 1: Dose 150μg/kg n=5 participants at risk Dose-escalation part of the study. Participants received ADCT-502 (150 μg/kg) via a 1-hour intravenous infusion once every 3 weeks.	Part 1: Dose 180μg/kg n=4 participants at risk Dose-escalation part of the study. Participants received ADCT-502 (180 μg/kg) via a 1-hour intravenous infusion once every 3 weeks.	Part 1: Dose 210μg/kg n=3 participants at risk Dose-escalation part of the study. Participants received ADCT-502 (210 μg/kg) via a 1-hour intravenous infusion once every 3 weeks.	Part 1: Dose 240μg/kg n=3 participants at risk Dose-escalation part of the study. Participants received ADCT-502 (240 μg/kg) via a 1-hour intravenous infusion once every 3 weeks.
Blood and lymphatic system disorders Anaemia	0.00% 0/2 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/2 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/2 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	20.0% 1/5 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	25.0% 1/4 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/3 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	33.3% 1/3 • Baseline to end of trial, a maximum of 168 days (+ 30 days)
Blood and lymphatic system disorders Thrombocytopenia	0.00% 0/2 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/2 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/2 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/5 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/4 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/3 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	33.3% 1/3 • Baseline to end of trial, a maximum of 168 days (+ 30 days)
Cardiac disorders Pericardial effusion	0.00% 0/2 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/2 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/2 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	20.0% 1/5 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	25.0% 1/4 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/3 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/3 • Baseline to end of trial, a maximum of 168 days (+ 30 days)
Cardiac disorders Sinus tachycardia	0.00% 0/2 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/2 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	50.0% 1/2 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/5 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/4 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/3 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/3 • Baseline to end of trial, a maximum of 168 days (+ 30 days)
Eye disorders Blepharitis	0.00% 0/2 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/2 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/2 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	20.0% 1/5 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/4 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/3 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	33.3% 1/3 • Baseline to end of trial, a maximum of 168 days (+ 30 days)
Eye disorders Dry eye	0.00% 0/2 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/2 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/2 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	40.0% 2/5 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/4 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/3 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/3 • Baseline to end of trial, a maximum of 168 days (+ 30 days)
Eye disorders Eye pain	0.00% 0/2 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/2 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/2 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	20.0% 1/5 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/4 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/3 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	33.3% 1/3 • Baseline to end of trial, a maximum of 168 days (+ 30 days)
Eye disorders Periorbital oedema	0.00% 0/2 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/2 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/2 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	20.0% 1/5 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/4 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/3 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	33.3% 1/3 • Baseline to end of trial, a maximum of 168 days (+ 30 days)
Eye disorders Eye pruritus	0.00% 0/2 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/2 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/2 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/5 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/4 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/3 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	33.3% 1/3 • Baseline to end of trial, a maximum of 168 days (+ 30 days)
Eye disorders Lacrimation increased	0.00% 0/2 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/2 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/2 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	20.0% 1/5 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/4 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/3 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/3 • Baseline to end of trial, a maximum of 168 days (+ 30 days)
Eye disorders Photophobia	0.00% 0/2 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/2 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/2 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	20.0% 1/5 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/4 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/3 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/3 • Baseline to end of trial, a maximum of 168 days (+ 30 days)
Gastrointestinal disorders Nausea	0.00% 0/2 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	100.0% 2/2 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	100.0% 2/2 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/5 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	50.0% 2/4 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/3 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	33.3% 1/3 • Baseline to end of trial, a maximum of 168 days (+ 30 days)
Gastrointestinal disorders Abdominal pain	0.00% 0/2 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/2 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/2 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/5 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	75.0% 3/4 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	33.3% 1/3 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/3 • Baseline to end of trial, a maximum of 168 days (+ 30 days)
Gastrointestinal disorders Diarrhoea	50.0% 1/2 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/2 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	50.0% 1/2 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/5 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	25.0% 1/4 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/3 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	33.3% 1/3 • Baseline to end of trial, a maximum of 168 days (+ 30 days)
Gastrointestinal disorders Constipation	0.00% 0/2 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	50.0% 1/2 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/2 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/5 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	25.0% 1/4 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/3 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/3 • Baseline to end of trial, a maximum of 168 days (+ 30 days)
Gastrointestinal disorders Ascites	0.00% 0/2 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/2 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/2 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/5 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/4 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	33.3% 1/3 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/3 • Baseline to end of trial, a maximum of 168 days (+ 30 days)
Gastrointestinal disorders Cheilitis	0.00% 0/2 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/2 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/2 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	20.0% 1/5 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/4 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/3 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/3 • Baseline to end of trial, a maximum of 168 days (+ 30 days)
Gastrointestinal disorders Colitis	0.00% 0/2 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/2 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/2 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	20.0% 1/5 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/4 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/3 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/3 • Baseline to end of trial, a maximum of 168 days (+ 30 days)
Gastrointestinal disorders Dyspepsia	0.00% 0/2 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/2 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/2 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/5 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	25.0% 1/4 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/3 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/3 • Baseline to end of trial, a maximum of 168 days (+ 30 days)
Gastrointestinal disorders Gastrooesophageal reflux disease	0.00% 0/2 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/2 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/2 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	20.0% 1/5 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/4 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/3 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/3 • Baseline to end of trial, a maximum of 168 days (+ 30 days)
Gastrointestinal disorders Lip ulceration	0.00% 0/2 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/2 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/2 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/5 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	25.0% 1/4 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/3 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/3 • Baseline to end of trial, a maximum of 168 days (+ 30 days)
Gastrointestinal disorders Mouth ulceration	0.00% 0/2 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/2 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/2 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/5 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	25.0% 1/4 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/3 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/3 • Baseline to end of trial, a maximum of 168 days (+ 30 days)
Gastrointestinal disorders Small intestinal obstruction	0.00% 0/2 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	50.0% 1/2 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/2 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/5 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/4 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/3 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/3 • Baseline to end of trial, a maximum of 168 days (+ 30 days)
Gastrointestinal disorders Stomatitis	0.00% 0/2 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/2 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	50.0% 1/2 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/5 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/4 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/3 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/3 • Baseline to end of trial, a maximum of 168 days (+ 30 days)
Gastrointestinal disorders Vomiting	0.00% 0/2 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/2 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/2 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/5 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	25.0% 1/4 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/3 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/3 • Baseline to end of trial, a maximum of 168 days (+ 30 days)
General disorders Fatigue	50.0% 1/2 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/2 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	50.0% 1/2 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	100.0% 5/5 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	50.0% 2/4 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	66.7% 2/3 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/3 • Baseline to end of trial, a maximum of 168 days (+ 30 days)
General disorders Oedema peripheral	0.00% 0/2 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/2 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/2 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	60.0% 3/5 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	25.0% 1/4 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	33.3% 1/3 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	66.7% 2/3 • Baseline to end of trial, a maximum of 168 days (+ 30 days)
General disorders Pyrexia	0.00% 0/2 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/2 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	50.0% 1/2 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/5 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/4 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	66.7% 2/3 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/3 • Baseline to end of trial, a maximum of 168 days (+ 30 days)
General disorders Asthenia	0.00% 0/2 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/2 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/2 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/5 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	25.0% 1/4 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/3 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/3 • Baseline to end of trial, a maximum of 168 days (+ 30 days)
General disorders Chest discomfort	0.00% 0/2 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/2 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/2 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/5 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/4 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/3 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	33.3% 1/3 • Baseline to end of trial, a maximum of 168 days (+ 30 days)
General disorders Localised oedema	0.00% 0/2 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/2 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/2 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/5 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/4 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	33.3% 1/3 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/3 • Baseline to end of trial, a maximum of 168 days (+ 30 days)
General disorders Non-cardiac chest pain	0.00% 0/2 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/2 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/2 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/5 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/4 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/3 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	33.3% 1/3 • Baseline to end of trial, a maximum of 168 days (+ 30 days)
General disorders Pain	50.0% 1/2 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/2 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/2 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/5 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/4 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/3 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/3 • Baseline to end of trial, a maximum of 168 days (+ 30 days)
Hepatobiliary disorders Jaundice	0.00% 0/2 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/2 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/2 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/5 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/4 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/3 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	33.3% 1/3 • Baseline to end of trial, a maximum of 168 days (+ 30 days)
Infections and infestations Conjunctivitis	0.00% 0/2 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/2 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/2 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	60.0% 3/5 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	25.0% 1/4 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/3 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/3 • Baseline to end of trial, a maximum of 168 days (+ 30 days)
Infections and infestations Upper respiratory tract infection	0.00% 0/2 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/2 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/2 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	20.0% 1/5 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	25.0% 1/4 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/3 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/3 • Baseline to end of trial, a maximum of 168 days (+ 30 days)
Infections and infestations Body tinea	0.00% 0/2 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/2 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/2 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/5 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/4 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/3 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	33.3% 1/3 • Baseline to end of trial, a maximum of 168 days (+ 30 days)
Infections and infestations Bronchitis	0.00% 0/2 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/2 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/2 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/5 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/4 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	33.3% 1/3 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/3 • Baseline to end of trial, a maximum of 168 days (+ 30 days)
Infections and infestations Candida infection	0.00% 0/2 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/2 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/2 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/5 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	25.0% 1/4 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/3 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/3 • Baseline to end of trial, a maximum of 168 days (+ 30 days)
Infections and infestations Cellulitis	0.00% 0/2 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/2 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/2 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/5 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	25.0% 1/4 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/3 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/3 • Baseline to end of trial, a maximum of 168 days (+ 30 days)
Infections and infestations Escherichia bacteraemia	0.00% 0/2 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/2 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/2 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/5 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/4 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	33.3% 1/3 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/3 • Baseline to end of trial, a maximum of 168 days (+ 30 days)
Infections and infestations Hordeolum	0.00% 0/2 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/2 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/2 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/5 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/4 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/3 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	33.3% 1/3 • Baseline to end of trial, a maximum of 168 days (+ 30 days)
Infections and infestations Klebsiella infection	0.00% 0/2 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/2 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/2 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/5 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/4 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	33.3% 1/3 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/3 • Baseline to end of trial, a maximum of 168 days (+ 30 days)
Infections and infestations Oral fungal infection	0.00% 0/2 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/2 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/2 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	20.0% 1/5 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/4 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/3 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/3 • Baseline to end of trial, a maximum of 168 days (+ 30 days)
Infections and infestations Periorbital cellulitis	0.00% 0/2 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/2 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/2 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/5 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/4 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/3 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	33.3% 1/3 • Baseline to end of trial, a maximum of 168 days (+ 30 days)
Infections and infestations Pneumonia	0.00% 0/2 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/2 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/2 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/5 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/4 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	33.3% 1/3 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/3 • Baseline to end of trial, a maximum of 168 days (+ 30 days)
Infections and infestations Sepsis	0.00% 0/2 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/2 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/2 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/5 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/4 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	33.3% 1/3 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/3 • Baseline to end of trial, a maximum of 168 days (+ 30 days)
Infections and infestations Tooth abscess	0.00% 0/2 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/2 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/2 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	20.0% 1/5 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/4 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/3 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/3 • Baseline to end of trial, a maximum of 168 days (+ 30 days)
Injury, poisoning and procedural complications Laceration	50.0% 1/2 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/2 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/2 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/5 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/4 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/3 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/3 • Baseline to end of trial, a maximum of 168 days (+ 30 days)
Investigations Blood alkaline phosphatase increased	0.00% 0/2 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/2 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/2 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	20.0% 1/5 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	25.0% 1/4 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/3 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	33.3% 1/3 • Baseline to end of trial, a maximum of 168 days (+ 30 days)
Investigations Alanine aminotransferase increased	0.00% 0/2 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/2 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/2 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	20.0% 1/5 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/4 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/3 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	33.3% 1/3 • Baseline to end of trial, a maximum of 168 days (+ 30 days)
Investigations Aspartate aminotransferase increased	0.00% 0/2 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/2 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/2 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	20.0% 1/5 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	25.0% 1/4 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/3 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/3 • Baseline to end of trial, a maximum of 168 days (+ 30 days)
Investigations Weight decreased	0.00% 0/2 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/2 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/2 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/5 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	25.0% 1/4 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/3 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	33.3% 1/3 • Baseline to end of trial, a maximum of 168 days (+ 30 days)
Investigations Weight increased	0.00% 0/2 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/2 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/2 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	20.0% 1/5 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/4 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/3 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	33.3% 1/3 • Baseline to end of trial, a maximum of 168 days (+ 30 days)
Investigations Activated partial thromboplastin time prolonged	0.00% 0/2 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/2 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/2 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	20.0% 1/5 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/4 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/3 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/3 • Baseline to end of trial, a maximum of 168 days (+ 30 days)
Investigations Blood bilirubin increased	0.00% 0/2 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/2 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/2 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/5 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/4 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/3 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	33.3% 1/3 • Baseline to end of trial, a maximum of 168 days (+ 30 days)
Investigations Electrocardiogram QT prolonged	0.00% 0/2 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/2 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/2 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/5 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	25.0% 1/4 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/3 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/3 • Baseline to end of trial, a maximum of 168 days (+ 30 days)
Investigations Lymphocyte count decreased	0.00% 0/2 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/2 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/2 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	20.0% 1/5 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/4 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/3 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/3 • Baseline to end of trial, a maximum of 168 days (+ 30 days)
Investigations Platelet count decreased	0.00% 0/2 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/2 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/2 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	20.0% 1/5 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/4 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/3 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/3 • Baseline to end of trial, a maximum of 168 days (+ 30 days)
Investigations Troponin I increased	0.00% 0/2 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/2 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/2 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/5 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/4 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/3 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	33.3% 1/3 • Baseline to end of trial, a maximum of 168 days (+ 30 days)
Metabolism and nutrition disorders Decreased appetite	0.00% 0/2 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/2 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	50.0% 1/2 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/5 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	75.0% 3/4 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	33.3% 1/3 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	33.3% 1/3 • Baseline to end of trial, a maximum of 168 days (+ 30 days)
Metabolism and nutrition disorders Hyperglycaemia	0.00% 0/2 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/2 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	50.0% 1/2 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	20.0% 1/5 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/4 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/3 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	33.3% 1/3 • Baseline to end of trial, a maximum of 168 days (+ 30 days)
Metabolism and nutrition disorders Hyponatraemia	0.00% 0/2 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/2 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/2 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	20.0% 1/5 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/4 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/3 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	33.3% 1/3 • Baseline to end of trial, a maximum of 168 days (+ 30 days)
Metabolism and nutrition disorders Hypophosphataemia	0.00% 0/2 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/2 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/2 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/5 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	25.0% 1/4 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/3 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	33.3% 1/3 • Baseline to end of trial, a maximum of 168 days (+ 30 days)
Metabolism and nutrition disorders Dehydration	0.00% 0/2 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/2 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	50.0% 1/2 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/5 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/4 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/3 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/3 • Baseline to end of trial, a maximum of 168 days (+ 30 days)
Metabolism and nutrition disorders Hypercalcaemia	0.00% 0/2 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	50.0% 1/2 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/2 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/5 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/4 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/3 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/3 • Baseline to end of trial, a maximum of 168 days (+ 30 days)
Metabolism and nutrition disorders Hypoalbuminaemia	0.00% 0/2 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/2 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/2 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/5 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/4 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/3 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	33.3% 1/3 • Baseline to end of trial, a maximum of 168 days (+ 30 days)
Musculoskeletal and connective tissue disorders Myalgia	0.00% 0/2 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/2 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/2 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	60.0% 3/5 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	25.0% 1/4 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/3 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/3 • Baseline to end of trial, a maximum of 168 days (+ 30 days)
Musculoskeletal and connective tissue disorders Neck pain	100.0% 2/2 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/2 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/2 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/5 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/4 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	33.3% 1/3 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/3 • Baseline to end of trial, a maximum of 168 days (+ 30 days)
Musculoskeletal and connective tissue disorders Muscular weakness	0.00% 0/2 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/2 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/2 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/5 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	25.0% 1/4 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/3 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	33.3% 1/3 • Baseline to end of trial, a maximum of 168 days (+ 30 days)
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/2 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	50.0% 1/2 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/2 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/5 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/4 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/3 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/3 • Baseline to end of trial, a maximum of 168 days (+ 30 days)
Musculoskeletal and connective tissue disorders Bone disorder	0.00% 0/2 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/2 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/2 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/5 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	25.0% 1/4 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/3 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/3 • Baseline to end of trial, a maximum of 168 days (+ 30 days)
Musculoskeletal and connective tissue disorders Bone pain	0.00% 0/2 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/2 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/2 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/5 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	25.0% 1/4 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/3 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/3 • Baseline to end of trial, a maximum of 168 days (+ 30 days)
Musculoskeletal and connective tissue disorders Myositis	0.00% 0/2 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/2 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/2 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	20.0% 1/5 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/4 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/3 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/3 • Baseline to end of trial, a maximum of 168 days (+ 30 days)
Musculoskeletal and connective tissue disorders Pain in extremity	0.00% 0/2 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/2 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/2 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/5 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	25.0% 1/4 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/3 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/3 • Baseline to end of trial, a maximum of 168 days (+ 30 days)
Nervous system disorders Dizziness	0.00% 0/2 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/2 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/2 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	20.0% 1/5 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	25.0% 1/4 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/3 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	33.3% 1/3 • Baseline to end of trial, a maximum of 168 days (+ 30 days)
Nervous system disorders Dysgeusia	0.00% 0/2 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/2 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/2 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/5 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/4 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/3 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	33.3% 1/3 • Baseline to end of trial, a maximum of 168 days (+ 30 days)
Nervous system disorders Hyperaesthesia	0.00% 0/2 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/2 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/2 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/5 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	25.0% 1/4 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/3 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/3 • Baseline to end of trial, a maximum of 168 days (+ 30 days)
Nervous system disorders Peripheral sensory neuropathy	0.00% 0/2 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/2 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/2 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/5 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	25.0% 1/4 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/3 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/3 • Baseline to end of trial, a maximum of 168 days (+ 30 days)
Psychiatric disorders Anxiety	50.0% 1/2 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/2 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/2 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/5 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/4 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/3 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/3 • Baseline to end of trial, a maximum of 168 days (+ 30 days)
Psychiatric disorders Insomnia	0.00% 0/2 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/2 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/2 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/5 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/4 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/3 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	33.3% 1/3 • Baseline to end of trial, a maximum of 168 days (+ 30 days)
Renal and urinary disorders Urinary retention	0.00% 0/2 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/2 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/2 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	20.0% 1/5 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/4 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/3 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	33.3% 1/3 • Baseline to end of trial, a maximum of 168 days (+ 30 days)
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/2 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/2 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	50.0% 1/2 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	20.0% 1/5 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	25.0% 1/4 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	33.3% 1/3 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	66.7% 2/3 • Baseline to end of trial, a maximum of 168 days (+ 30 days)
Respiratory, thoracic and mediastinal disorders Cough	0.00% 0/2 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/2 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/2 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	40.0% 2/5 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	25.0% 1/4 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	33.3% 1/3 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	33.3% 1/3 • Baseline to end of trial, a maximum of 168 days (+ 30 days)
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.00% 0/2 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/2 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/2 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	60.0% 3/5 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	25.0% 1/4 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/3 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	33.3% 1/3 • Baseline to end of trial, a maximum of 168 days (+ 30 days)
Respiratory, thoracic and mediastinal disorders Nasal congestion	50.0% 1/2 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/2 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/2 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/5 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	25.0% 1/4 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/3 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/3 • Baseline to end of trial, a maximum of 168 days (+ 30 days)
Respiratory, thoracic and mediastinal disorders Dysphonia	0.00% 0/2 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/2 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/2 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	20.0% 1/5 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/4 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/3 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/3 • Baseline to end of trial, a maximum of 168 days (+ 30 days)
Respiratory, thoracic and mediastinal disorders Dyspnoea exertional	0.00% 0/2 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/2 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/2 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	20.0% 1/5 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/4 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/3 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/3 • Baseline to end of trial, a maximum of 168 days (+ 30 days)
Respiratory, thoracic and mediastinal disorders Epistaxis	0.00% 0/2 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/2 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/2 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	20.0% 1/5 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/4 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/3 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/3 • Baseline to end of trial, a maximum of 168 days (+ 30 days)
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	50.0% 1/2 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/2 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/2 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/5 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/4 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/3 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/3 • Baseline to end of trial, a maximum of 168 days (+ 30 days)
Respiratory, thoracic and mediastinal disorders Pleuritic pain	0.00% 0/2 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/2 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/2 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/5 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/4 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/3 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	33.3% 1/3 • Baseline to end of trial, a maximum of 168 days (+ 30 days)
Respiratory, thoracic and mediastinal disorders Pneumonitis	0.00% 0/2 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/2 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/2 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	20.0% 1/5 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/4 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/3 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/3 • Baseline to end of trial, a maximum of 168 days (+ 30 days)
Respiratory, thoracic and mediastinal disorders Productive cough	0.00% 0/2 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/2 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/2 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	20.0% 1/5 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/4 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/3 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/3 • Baseline to end of trial, a maximum of 168 days (+ 30 days)
Skin and subcutaneous tissue disorders Rash maculo-papular	50.0% 1/2 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	100.0% 2/2 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	50.0% 1/2 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	40.0% 2/5 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	25.0% 1/4 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/3 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/3 • Baseline to end of trial, a maximum of 168 days (+ 30 days)
Skin and subcutaneous tissue disorders Skin hyperpigmentation	50.0% 1/2 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/2 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/2 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	60.0% 3/5 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/4 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	33.3% 1/3 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	33.3% 1/3 • Baseline to end of trial, a maximum of 168 days (+ 30 days)
Skin and subcutaneous tissue disorders Erythema	0.00% 0/2 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	50.0% 1/2 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/2 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	40.0% 2/5 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	25.0% 1/4 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/3 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/3 • Baseline to end of trial, a maximum of 168 days (+ 30 days)
Skin and subcutaneous tissue disorders Photosensitivity reaction	50.0% 1/2 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/2 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/2 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	40.0% 2/5 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/4 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/3 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/3 • Baseline to end of trial, a maximum of 168 days (+ 30 days)
Skin and subcutaneous tissue disorders Dry skin	0.00% 0/2 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/2 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/2 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	20.0% 1/5 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/4 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/3 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	33.3% 1/3 • Baseline to end of trial, a maximum of 168 days (+ 30 days)
Skin and subcutaneous tissue disorders Nail discolouration	0.00% 0/2 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/2 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/2 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	20.0% 1/5 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/4 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/3 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	33.3% 1/3 • Baseline to end of trial, a maximum of 168 days (+ 30 days)
Skin and subcutaneous tissue disorders Pruritus	0.00% 0/2 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	50.0% 1/2 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/2 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/5 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/4 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/3 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	33.3% 1/3 • Baseline to end of trial, a maximum of 168 days (+ 30 days)
Skin and subcutaneous tissue disorders Rash	0.00% 0/2 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/2 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	50.0% 1/2 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/5 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	25.0% 1/4 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/3 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/3 • Baseline to end of trial, a maximum of 168 days (+ 30 days)
Skin and subcutaneous tissue disorders Alopecia	0.00% 0/2 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/2 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/2 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/5 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/4 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/3 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	33.3% 1/3 • Baseline to end of trial, a maximum of 168 days (+ 30 days)
Skin and subcutaneous tissue disorders Blister	0.00% 0/2 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/2 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/2 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/5 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	25.0% 1/4 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/3 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/3 • Baseline to end of trial, a maximum of 168 days (+ 30 days)
Skin and subcutaneous tissue disorders Dermatitis	0.00% 0/2 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/2 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/2 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/5 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/4 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/3 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	33.3% 1/3 • Baseline to end of trial, a maximum of 168 days (+ 30 days)
Skin and subcutaneous tissue disorders Dermatitis contact	0.00% 0/2 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/2 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/2 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/5 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/4 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/3 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	33.3% 1/3 • Baseline to end of trial, a maximum of 168 days (+ 30 days)
Skin and subcutaneous tissue disorders Nail ridging	0.00% 0/2 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	50.0% 1/2 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/2 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/5 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/4 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/3 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/3 • Baseline to end of trial, a maximum of 168 days (+ 30 days)
Skin and subcutaneous tissue disorders Palmar-plantar erythrodysaesthesia syndrome	0.00% 0/2 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/2 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/2 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	20.0% 1/5 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/4 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/3 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/3 • Baseline to end of trial, a maximum of 168 days (+ 30 days)
Skin and subcutaneous tissue disorders Skin exfoliation	0.00% 0/2 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/2 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/2 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/5 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	25.0% 1/4 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/3 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/3 • Baseline to end of trial, a maximum of 168 days (+ 30 days)
Vascular disorders Hypotension	0.00% 0/2 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/2 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/2 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	20.0% 1/5 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/4 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	33.3% 1/3 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/3 • Baseline to end of trial, a maximum of 168 days (+ 30 days)
Vascular disorders Embolism	0.00% 0/2 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/2 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/2 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/5 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	25.0% 1/4 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/3 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/3 • Baseline to end of trial, a maximum of 168 days (+ 30 days)
Vascular disorders Flushing	0.00% 0/2 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/2 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/2 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	20.0% 1/5 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/4 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/3 • Baseline to end of trial, a maximum of 168 days (+ 30 days)	0.00% 0/3 • Baseline to end of trial, a maximum of 168 days (+ 30 days)

Additional Information

ADC Therapeutics

ADC Therapeutics

Phone: 954-903-7994

Email: clinical.trials@adctherapeutics.com

Results disclosure agreements

• Principal investigator is a sponsor employee PI can publish after first multi-site publication, or if no multi-site publication is made within 18 months of study completion/termination. The only disclosure restriction on the PI is the sponsor can review results comms. prior to public release and can embargo comms. regarding trial results for a period that is more than 60 but less than or equal to 180 days from the time submitted to sponsor for review. The sponsor can't require changes to the communication and can't extend the embargo.
• Publication restrictions are in place

Restriction type: OTHER