Trial Outcomes & Findings for Study of ADCT-301 in Patients With Relapsed/Refractory CD25-positive Acute Myeloid Leukemia (AML) or CD25-positive Acute Lymphoblastic Leukemia (ALL) (NCT NCT02588092)

Last Updated: 2020-02-26

Results Overview

A DLT is defined as any of the following events, except those that are clearly due to underlying disease or extraneous causes: A hematologic DLT is defined as: \- Grade 3 or higher event of neutropenia or thrombocytopenia, or a Grade 4 anemia, with a hypocellular bone marrow lasting for 6 weeks or more after the start of a cycle, in the absence of residual leukemia (i.e., with \<5% blasts). In case of a normocellular bone marrow with \<5% blasts, 8 weeks with ≥Grade 3 pancytopenia will be considered a DLT. A non-hematologic DLT is defined as: * Grade 4 tumor lysis syndrome. * Grade 3 or higher AE (including nausea, vomiting, diarrhea, and electrolyte imbalances lasting more than 48 hours despite optimal therapy; excluding all grades of alopecia). * CTCAE Grade 3 or higher hypersensitivity reaction (regardless of premedication). * CTCAE Grade 3 or higher skin ulceration. * Peripheral sensory or motor neuropathy ≥ Grade 2.

Recruitment status

TERMINATED

Study phase

PHASE1

Target enrollment

35 participants

Primary outcome timeframe

Day 1 to Day 21 (Cycle 1)

Results posted on

2020-02-26

Participant Flow

Participants were enrolled at 11 sites in the United States between 01 February 2016 and 29 August 2018.

Participant milestones

Participant milestones
Measure	Cohort 1: 3 μg/kg Q3W Participants received 3 μg/kg ADCT-301 formulation, intravenous infusion for 1 hour, on Day 1 of each 3-week (21-day) cycle (Q3W).	Cohort 2: 6 μg/kg Q3W Participants received 6 μg/kg ADCT-301 formulation, intravenous infusion for 1 hour, on Day 1 of each 3-week (21-day) cycle (Q3W).	Cohort 3: 12 μg/kg Q3W Participants received 12 μg/kg ADCT-301 formulation, intravenous infusion for 1 hour, on Day 1 of each 3-week (21-day) cycle (Q3W).	Cohort 4: 22 μg/kg Q3W Participants received 22 μg/kg ADCT-301 formulation, intravenous infusion for 1 hour, on Day 1 of each 3-week (21-day) cycle (Q3W).	Cohort 5: 32 μg/kg Q3W Participants received 32 μg/kg ADCT-301 formulation, intravenous infusion for 1 hour, on Day 1 of each 3-week (21-day) cycle.	Cohort 6: 52 μg/kg Q3W Participants received 52 μg/kg ADCT-301 formulation, intravenous infusion for 1 hour, on Day 1 of each 3-week (21-day) cycle (Q3W).	Cohort 7: 72 μg/kg Q3W Participants received 72 μg/kg ADCT-301 formulation, intravenous infusion for 1 hour, on Day 1 of each 3-week (21-day) cycle (Q3W).	Cohort 8: 92 μg/kg Q3W Participants received 92 μg/kg ADCT-301 formulation, intravenous infusion for 1 hour, on Day 1 of each 3-week (21-day) cycle (Q3W).	Cohort 9: 30 μg/kg QW Participants received 30 μg/kg ADCT-301 formulation, intravenous infusion for 1 hour, on Days 1, 8 and 15 (once weekly \[QW\]) of each 3-week (21 day) cycle.	Cohort 10: 37.5 μg/kg QW Participants received 37.5 μg/kg ADCT-301 formulation, intravenous infusion for 1 hour, on Days 1, 8 and 15 (once weekly \[QW\]) of each 3-week (21 day) cycle.
Overall Study STARTED	4	3	3	3	3	3	3	4	6	3
Overall Study COMPLETED	0	0	0	0	0	0	0	0	0	0
Overall Study NOT COMPLETED	4	3	3	3	3	3	3	4	6	3

Reasons for withdrawal

Reasons for withdrawal
Measure	Cohort 1: 3 μg/kg Q3W Participants received 3 μg/kg ADCT-301 formulation, intravenous infusion for 1 hour, on Day 1 of each 3-week (21-day) cycle (Q3W).	Cohort 2: 6 μg/kg Q3W Participants received 6 μg/kg ADCT-301 formulation, intravenous infusion for 1 hour, on Day 1 of each 3-week (21-day) cycle (Q3W).	Cohort 3: 12 μg/kg Q3W Participants received 12 μg/kg ADCT-301 formulation, intravenous infusion for 1 hour, on Day 1 of each 3-week (21-day) cycle (Q3W).	Cohort 4: 22 μg/kg Q3W Participants received 22 μg/kg ADCT-301 formulation, intravenous infusion for 1 hour, on Day 1 of each 3-week (21-day) cycle (Q3W).	Cohort 5: 32 μg/kg Q3W Participants received 32 μg/kg ADCT-301 formulation, intravenous infusion for 1 hour, on Day 1 of each 3-week (21-day) cycle.	Cohort 6: 52 μg/kg Q3W Participants received 52 μg/kg ADCT-301 formulation, intravenous infusion for 1 hour, on Day 1 of each 3-week (21-day) cycle (Q3W).	Cohort 7: 72 μg/kg Q3W Participants received 72 μg/kg ADCT-301 formulation, intravenous infusion for 1 hour, on Day 1 of each 3-week (21-day) cycle (Q3W).	Cohort 8: 92 μg/kg Q3W Participants received 92 μg/kg ADCT-301 formulation, intravenous infusion for 1 hour, on Day 1 of each 3-week (21-day) cycle (Q3W).	Cohort 9: 30 μg/kg QW Participants received 30 μg/kg ADCT-301 formulation, intravenous infusion for 1 hour, on Days 1, 8 and 15 (once weekly \[QW\]) of each 3-week (21 day) cycle.	Cohort 10: 37.5 μg/kg QW Participants received 37.5 μg/kg ADCT-301 formulation, intravenous infusion for 1 hour, on Days 1, 8 and 15 (once weekly \[QW\]) of each 3-week (21 day) cycle.
Overall Study Death	4	3	3	3	2	2	2	1	5	2
Overall Study Withdrawal by Subject	0	0	0	0	0	1	1	2	0	0
Overall Study Started Another Treatment	0	0	0	0	1	0	0	1	0	0
Overall Study Sponsor Decision	0	0	0	0	0	0	0	0	1	1

Baseline Characteristics

Height data was not collected for one participant because of complications during the collection of baseline measurements.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Cohort 1: 3 μg/kg Q3W n=4 Participants Participants received 3 μg/kg ADCT-301 formulation, intravenous infusion for 1 hour, on Day 1 of each 3-week (21-day) cycle (Q3W).	Cohort 2: 6 μg/kg Q3W n=3 Participants Participants received 6 μg/kg ADCT-301 formulation, intravenous infusion for 1 hour, on Day 1 of each 3-week (21-day) cycle (Q3W).	Cohort 3: 12 μg/kg Q3W n=3 Participants Participants received 12 μg/kg ADCT-301 formulation, intravenous infusion for 1 hour, on Day 1 of each 3-week (21-day) cycle (Q3W).	Cohort 4: 22 μg/kg Q3W n=3 Participants Participants received 22 μg/kg ADCT-301 formulation, intravenous infusion for 1 hour, on Day 1 of each 3-week (21-day) cycle (Q3W).	Cohort 5: 32 μg/kg Q3W n=3 Participants Participants received 32 μg/kg ADCT-301 formulation, intravenous infusion for 1 hour, on Day 1 of each 3-week (21-day) cycle (Q3W).	Cohort 6: 52 μg/kg Q3W n=3 Participants Participants received 52 μg/kg ADCT-301 formulation, intravenous infusion for 1 hour, on Day 1 of each 3-week (21-day) cycle (Q3W).	Cohort 7: 72 μg/kg Q3W n=3 Participants Participants received 72 μg/kg ADCT-301 formulation, intravenous infusion for 1 hour, on Day 1 of each 3-week (21-day) cycle (Q3W).	Cohort 8: 92 μg/kg Q3W n=4 Participants Participants received 92 μg/kg ADCT-301 formulation, intravenous infusion for 1 hour, on Day 1 of each 3-week (21-day) cycle (Q3W).	Cohort 9: 30 μg/kg QW n=6 Participants Participants received 30 μg/kg ADCT-301 formulation, intravenous infusion for 1 hour, on Days 1, 8 and 15 (once weekly \[QW\]) of each 3-week (21 day) cycle.	Cohort 10: 37.5 μg/kg QW n=3 Participants Participants received 37.5 μg/kg ADCT-301 formulation, intravenous infusion for 1 hour, on Days 1, 8 and 15 (once weekly \[QW\]) of each 3-week (21 day) cycle.	Total n=35 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=4 Participants	0 Participants n=3 Participants	0 Participants n=3 Participants	0 Participants n=3 Participants	0 Participants n=3 Participants	0 Participants n=3 Participants	0 Participants n=3 Participants	0 Participants n=4 Participants	0 Participants n=6 Participants	0 Participants n=3 Participants	0 Participants n=35 Participants
Age, Categorical Between 18 and 65 years	2 Participants n=4 Participants	0 Participants n=3 Participants	2 Participants n=3 Participants	2 Participants n=3 Participants	0 Participants n=3 Participants	1 Participants n=3 Participants	0 Participants n=3 Participants	2 Participants n=4 Participants	1 Participants n=6 Participants	2 Participants n=3 Participants	12 Participants n=35 Participants
Age, Categorical >=65 years	2 Participants n=4 Participants	3 Participants n=3 Participants	1 Participants n=3 Participants	1 Participants n=3 Participants	3 Participants n=3 Participants	2 Participants n=3 Participants	3 Participants n=3 Participants	2 Participants n=4 Participants	5 Participants n=6 Participants	1 Participants n=3 Participants	23 Participants n=35 Participants
Age, Continuous	66.8 years STANDARD_DEVIATION 11.09 • n=4 Participants	72.3 years STANDARD_DEVIATION 4.73 • n=3 Participants	51.0 years STANDARD_DEVIATION 17.78 • n=3 Participants	51.7 years STANDARD_DEVIATION 26.27 • n=3 Participants	69.3 years STANDARD_DEVIATION 2.89 • n=3 Participants	67.0 years STANDARD_DEVIATION 13.00 • n=3 Participants	75.7 years STANDARD_DEVIATION 5.69 • n=3 Participants	56.5 years STANDARD_DEVIATION 18.43 • n=4 Participants	71.0 years STANDARD_DEVIATION 10.77 • n=6 Participants	63.3 years STANDARD_DEVIATION 10.02 • n=3 Participants	64.9 years STANDARD_DEVIATION 14.21 • n=35 Participants
Sex: Female, Male Female	1 Participants n=4 Participants	1 Participants n=3 Participants	0 Participants n=3 Participants	1 Participants n=3 Participants	1 Participants n=3 Participants	1 Participants n=3 Participants	1 Participants n=3 Participants	1 Participants n=4 Participants	3 Participants n=6 Participants	0 Participants n=3 Participants	10 Participants n=35 Participants
Sex: Female, Male Male	3 Participants n=4 Participants	2 Participants n=3 Participants	3 Participants n=3 Participants	2 Participants n=3 Participants	2 Participants n=3 Participants	2 Participants n=3 Participants	2 Participants n=3 Participants	3 Participants n=4 Participants	3 Participants n=6 Participants	3 Participants n=3 Participants	25 Participants n=35 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=4 Participants	0 Participants n=3 Participants	0 Participants n=3 Participants	0 Participants n=3 Participants	0 Participants n=3 Participants	1 Participants n=3 Participants	0 Participants n=3 Participants	0 Participants n=4 Participants	0 Participants n=6 Participants	0 Participants n=3 Participants	1 Participants n=35 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	4 Participants n=4 Participants	3 Participants n=3 Participants	3 Participants n=3 Participants	3 Participants n=3 Participants	3 Participants n=3 Participants	2 Participants n=3 Participants	3 Participants n=3 Participants	4 Participants n=4 Participants	6 Participants n=6 Participants	3 Participants n=3 Participants	34 Participants n=35 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=4 Participants	0 Participants n=3 Participants	0 Participants n=3 Participants	0 Participants n=3 Participants	0 Participants n=3 Participants	0 Participants n=3 Participants	0 Participants n=3 Participants	0 Participants n=4 Participants	0 Participants n=6 Participants	0 Participants n=3 Participants	0 Participants n=35 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=4 Participants	0 Participants n=3 Participants	0 Participants n=3 Participants	0 Participants n=3 Participants	0 Participants n=3 Participants	0 Participants n=3 Participants	0 Participants n=3 Participants	0 Participants n=4 Participants	0 Participants n=6 Participants	0 Participants n=3 Participants	0 Participants n=35 Participants
Race (NIH/OMB) Asian	0 Participants n=4 Participants	0 Participants n=3 Participants	1 Participants n=3 Participants	0 Participants n=3 Participants	0 Participants n=3 Participants	0 Participants n=3 Participants	0 Participants n=3 Participants	0 Participants n=4 Participants	0 Participants n=6 Participants	0 Participants n=3 Participants	1 Participants n=35 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=4 Participants	0 Participants n=3 Participants	0 Participants n=3 Participants	0 Participants n=3 Participants	0 Participants n=3 Participants	0 Participants n=3 Participants	0 Participants n=3 Participants	0 Participants n=4 Participants	0 Participants n=6 Participants	0 Participants n=3 Participants	0 Participants n=35 Participants
Race (NIH/OMB) Black or African American	0 Participants n=4 Participants	0 Participants n=3 Participants	0 Participants n=3 Participants	0 Participants n=3 Participants	0 Participants n=3 Participants	0 Participants n=3 Participants	0 Participants n=3 Participants	0 Participants n=4 Participants	0 Participants n=6 Participants	0 Participants n=3 Participants	0 Participants n=35 Participants
Race (NIH/OMB) White	4 Participants n=4 Participants	3 Participants n=3 Participants	2 Participants n=3 Participants	3 Participants n=3 Participants	3 Participants n=3 Participants	3 Participants n=3 Participants	3 Participants n=3 Participants	3 Participants n=4 Participants	6 Participants n=6 Participants	3 Participants n=3 Participants	33 Participants n=35 Participants
Race (NIH/OMB) More than one race	0 Participants n=4 Participants	0 Participants n=3 Participants	0 Participants n=3 Participants	0 Participants n=3 Participants	0 Participants n=3 Participants	0 Participants n=3 Participants	0 Participants n=3 Participants	0 Participants n=4 Participants	0 Participants n=6 Participants	0 Participants n=3 Participants	0 Participants n=35 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=4 Participants	0 Participants n=3 Participants	0 Participants n=3 Participants	0 Participants n=3 Participants	0 Participants n=3 Participants	0 Participants n=3 Participants	0 Participants n=3 Participants	1 Participants n=4 Participants	0 Participants n=6 Participants	0 Participants n=3 Participants	1 Participants n=35 Participants
Region of Enrollment United States	4 participants n=4 Participants	3 participants n=3 Participants	3 participants n=3 Participants	3 participants n=3 Participants	3 participants n=3 Participants	3 participants n=3 Participants	3 participants n=3 Participants	4 participants n=4 Participants	6 participants n=6 Participants	3 participants n=3 Participants	35 participants n=35 Participants
Height	169.40 cm STANDARD_DEVIATION 10.641 • n=3 Participants • Height data was not collected for one participant because of complications during the collection of baseline measurements.	179.27 cm STANDARD_DEVIATION 15.255 • n=3 Participants • Height data was not collected for one participant because of complications during the collection of baseline measurements.	183.20 cm STANDARD_DEVIATION 9.354 • n=3 Participants • Height data was not collected for one participant because of complications during the collection of baseline measurements.	170.00 cm STANDARD_DEVIATION 4.359 • n=3 Participants • Height data was not collected for one participant because of complications during the collection of baseline measurements.	176.33 cm STANDARD_DEVIATION 4.856 • n=3 Participants • Height data was not collected for one participant because of complications during the collection of baseline measurements.	165.50 cm STANDARD_DEVIATION 18.007 • n=3 Participants • Height data was not collected for one participant because of complications during the collection of baseline measurements.	168.57 cm STANDARD_DEVIATION 6.562 • n=3 Participants • Height data was not collected for one participant because of complications during the collection of baseline measurements.	169.38 cm STANDARD_DEVIATION 11.762 • n=4 Participants • Height data was not collected for one participant because of complications during the collection of baseline measurements.	169.52 cm STANDARD_DEVIATION 12.478 • n=6 Participants • Height data was not collected for one participant because of complications during the collection of baseline measurements.	177.22 cm STANDARD_DEVIATION 3.586 • n=3 Participants • Height data was not collected for one participant because of complications during the collection of baseline measurements.	172.44 cm STANDARD_DEVIATION 10.774 • n=34 Participants • Height data was not collected for one participant because of complications during the collection of baseline measurements.
Weight	94.98 kg STANDARD_DEVIATION 24.758 • n=4 Participants	99.30 kg STANDARD_DEVIATION 12.644 • n=3 Participants	73.50 kg STANDARD_DEVIATION 7.988 • n=3 Participants	72.20 kg STANDARD_DEVIATION 11.722 • n=3 Participants	105.67 kg STANDARD_DEVIATION 24.509 • n=3 Participants	71.63 kg STANDARD_DEVIATION 15.053 • n=3 Participants	71.67 kg STANDARD_DEVIATION 11.395 • n=3 Participants	79.45 kg STANDARD_DEVIATION 17.436 • n=4 Participants	74.10 kg STANDARD_DEVIATION 5.686 • n=6 Participants	75.23 kg STANDARD_DEVIATION 5.200 • n=3 Participants	81.43 kg STANDARD_DEVIATION 17.597 • n=35 Participants
Body Mass Index (BMI)	29.37 kg/m^2 STANDARD_DEVIATION 3.100 • n=3 Participants • BMI could not be analyzed for one participant because height data was not collected.	31.09 kg/m^2 STANDARD_DEVIATION 4.209 • n=3 Participants • BMI could not be analyzed for one participant because height data was not collected.	21.94 kg/m^2 STANDARD_DEVIATION 2.469 • n=3 Participants • BMI could not be analyzed for one participant because height data was not collected.	24.89 kg/m^2 STANDARD_DEVIATION 3.002 • n=3 Participants • BMI could not be analyzed for one participant because height data was not collected.	33.86 kg/m^2 STANDARD_DEVIATION 7.003 • n=3 Participants • BMI could not be analyzed for one participant because height data was not collected.	25.98 kg/m^2 STANDARD_DEVIATION 1.259 • n=3 Participants • BMI could not be analyzed for one participant because height data was not collected.	25.52 kg/m^2 STANDARD_DEVIATION 6.243 • n=3 Participants • BMI could not be analyzed for one participant because height data was not collected.	27.47 kg/m^2 STANDARD_DEVIATION 3.759 • n=4 Participants • BMI could not be analyzed for one participant because height data was not collected.	26.03 kg/m^2 STANDARD_DEVIATION 3.607 • n=6 Participants • BMI could not be analyzed for one participant because height data was not collected.	23.94 kg/m^2 STANDARD_DEVIATION 0.934 • n=3 Participants • BMI could not be analyzed for one participant because height data was not collected.	26.94 kg/m^2 STANDARD_DEVIATION 4.656 • n=34 Participants • BMI could not be analyzed for one participant because height data was not collected.
Eastern Cooperative Oncology Group (ECOG) performance status 0	0 Participants n=4 Participants	0 Participants n=3 Participants	0 Participants n=3 Participants	1 Participants n=3 Participants	0 Participants n=3 Participants	0 Participants n=3 Participants	0 Participants n=3 Participants	0 Participants n=4 Participants	0 Participants n=6 Participants	0 Participants n=3 Participants	1 Participants n=35 Participants
Eastern Cooperative Oncology Group (ECOG) performance status 1	3 Participants n=4 Participants	3 Participants n=3 Participants	2 Participants n=3 Participants	2 Participants n=3 Participants	3 Participants n=3 Participants	2 Participants n=3 Participants	2 Participants n=3 Participants	3 Participants n=4 Participants	5 Participants n=6 Participants	2 Participants n=3 Participants	27 Participants n=35 Participants
Eastern Cooperative Oncology Group (ECOG) performance status 2	1 Participants n=4 Participants	0 Participants n=3 Participants	1 Participants n=3 Participants	0 Participants n=3 Participants	0 Participants n=3 Participants	1 Participants n=3 Participants	1 Participants n=3 Participants	1 Participants n=4 Participants	1 Participants n=6 Participants	1 Participants n=3 Participants	7 Participants n=35 Participants

PRIMARY outcome

Timeframe: Day 1 to Day 21 (Cycle 1)

Outcome measures

Outcome measures
Measure	Cohort 5: 32 μg/kg Q3W n=3 Participants Participants received 32 μg/kg ADCT-301 formulation, intravenous infusion for 1 hour, on Day 1 of each 3-week (21-day) cycle (Q3W).	Cohort 6: 52 μg/kg Q3W n=3 Participants Participants received 52 μg/kg ADCT-301 formulation, intravenous infusion for 1 hour, on Day 1 of each 3-week (21-day) cycle (Q3W).	Cohort 7: 72 μg/kg Q3W n=3 Participants Participants received 72 μg/kg ADCT-301 formulation, intravenous infusion for 1 hour, on Day 1 of each 3-week (21-day) cycle (Q3W).	Cohort 8: 92 μg/kg Q3W n=4 Participants Participants received 92 μg/kg ADCT-301 formulation, intravenous infusion for 1 hour, on Day 1 of each 3-week (21-day) cycle (Q3W).	Cohort 9: 30 μg/kg QW n=6 Participants Participants received 30 μg/kg ADCT-301 formulation, intravenous infusion for 1 hour, on Days 1, 8 and 15 (once weekly \[QW\]) of each 3-week (21 day) cycle.	Cohort 10: 37.5 μg/kg QW n=3 Participants Participants received 37.5 μg/kg ADCT-301 formulation, intravenous infusion for 1 hour, on Days 1, 8 and 15 (once weekly \[QW\]) of each 3-week (21 day) cycle.	Cohort 1: 3 μg/kg Q3W n=4 Participants Participants received 3 μg/kg ADCT-301 formulation, intravenous infusion for 1 hour, on Day 1 of each 3-week (21-day) cycle (Q3W).	Cohort 2: 6 μg/kg Q3W n=3 Participants Participants received 6 μg/kg ADCT-301 formulation, intravenous infusion for 1 hour, on Day 1 of each 3-week (21-day) cycle (Q3W).	Cohort 3: 12 μg/kg Q3W n=3 Participants Participants received 12 μg/kg ADCT-301 formulation, intravenous infusion for 1 hour, on Day 1 of each 3-week (21-day) cycle (Q3W).	Cohort 4: 22 μg/kg Q3W n=3 Participants Participants received 22 μg/kg ADCT-301 formulation, intravenous infusion for 1 hour, on Day 1 of each 3-week (21-day) cycle (Q3W).
Number of Participants Who Experienced Dose-Limiting Toxicities (DLT)	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants

PRIMARY outcome

Timeframe: Day 1 to Day 21 (Cycle 1)

Population: The analysis was planned, but the data was not collected as study was terminated prematurely.

The recommended dose was to be established by the dose escalation steering committee and based on safety findings during part 1 of the study.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: Day 1 to a maximum of 24 weeks (+ 30 days)

A TEAE is defined as any adverse event not present before exposure to study drug or any event already present that worsens in either intensity or frequency after exposure to study drug.

Outcome measures

Outcome measures
Measure	Cohort 5: 32 μg/kg Q3W n=3 Participants Participants received 32 μg/kg ADCT-301 formulation, intravenous infusion for 1 hour, on Day 1 of each 3-week (21-day) cycle (Q3W).	Cohort 6: 52 μg/kg Q3W n=3 Participants Participants received 52 μg/kg ADCT-301 formulation, intravenous infusion for 1 hour, on Day 1 of each 3-week (21-day) cycle (Q3W).	Cohort 7: 72 μg/kg Q3W n=3 Participants Participants received 72 μg/kg ADCT-301 formulation, intravenous infusion for 1 hour, on Day 1 of each 3-week (21-day) cycle (Q3W).	Cohort 8: 92 μg/kg Q3W n=4 Participants Participants received 92 μg/kg ADCT-301 formulation, intravenous infusion for 1 hour, on Day 1 of each 3-week (21-day) cycle (Q3W).	Cohort 9: 30 μg/kg QW n=6 Participants Participants received 30 μg/kg ADCT-301 formulation, intravenous infusion for 1 hour, on Days 1, 8 and 15 (once weekly \[QW\]) of each 3-week (21 day) cycle.	Cohort 10: 37.5 μg/kg QW n=3 Participants Participants received 37.5 μg/kg ADCT-301 formulation, intravenous infusion for 1 hour, on Days 1, 8 and 15 (once weekly \[QW\]) of each 3-week (21 day) cycle.	Cohort 1: 3 μg/kg Q3W n=4 Participants Participants received 3 μg/kg ADCT-301 formulation, intravenous infusion for 1 hour, on Day 1 of each 3-week (21-day) cycle (Q3W).	Cohort 2: 6 μg/kg Q3W n=3 Participants Participants received 6 μg/kg ADCT-301 formulation, intravenous infusion for 1 hour, on Day 1 of each 3-week (21-day) cycle (Q3W).	Cohort 3: 12 μg/kg Q3W n=3 Participants Participants received 12 μg/kg ADCT-301 formulation, intravenous infusion for 1 hour, on Day 1 of each 3-week (21-day) cycle (Q3W).	Cohort 4: 22 μg/kg Q3W n=3 Participants Participants received 22 μg/kg ADCT-301 formulation, intravenous infusion for 1 hour, on Day 1 of each 3-week (21-day) cycle (Q3W).
Number of Participants Reporting One or More Treatment Emergent Adverse Events (TEAEs)	3 Participants	3 Participants	3 Participants	4 Participants	6 Participants	3 Participants	4 Participants	2 Participants	3 Participants	3 Participants

PRIMARY outcome

Timeframe: Day 1 to a maximum of 24 weeks (+ 30 days)

An SAE is defined as any event that results in death, is immediately life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, or is a congenital anomaly/birth defect. Hospitalization for elective procedures or for protocol compliance is not considered an SAE.

Outcome measures

Outcome measures
Measure	Cohort 5: 32 μg/kg Q3W n=3 Participants Participants received 32 μg/kg ADCT-301 formulation, intravenous infusion for 1 hour, on Day 1 of each 3-week (21-day) cycle (Q3W).	Cohort 6: 52 μg/kg Q3W n=3 Participants Participants received 52 μg/kg ADCT-301 formulation, intravenous infusion for 1 hour, on Day 1 of each 3-week (21-day) cycle (Q3W).	Cohort 7: 72 μg/kg Q3W n=3 Participants Participants received 72 μg/kg ADCT-301 formulation, intravenous infusion for 1 hour, on Day 1 of each 3-week (21-day) cycle (Q3W).	Cohort 8: 92 μg/kg Q3W n=4 Participants Participants received 92 μg/kg ADCT-301 formulation, intravenous infusion for 1 hour, on Day 1 of each 3-week (21-day) cycle (Q3W).	Cohort 9: 30 μg/kg QW n=6 Participants Participants received 30 μg/kg ADCT-301 formulation, intravenous infusion for 1 hour, on Days 1, 8 and 15 (once weekly \[QW\]) of each 3-week (21 day) cycle.	Cohort 10: 37.5 μg/kg QW n=3 Participants Participants received 37.5 μg/kg ADCT-301 formulation, intravenous infusion for 1 hour, on Days 1, 8 and 15 (once weekly \[QW\]) of each 3-week (21 day) cycle.	Cohort 1: 3 μg/kg Q3W n=4 Participants Participants received 3 μg/kg ADCT-301 formulation, intravenous infusion for 1 hour, on Day 1 of each 3-week (21-day) cycle (Q3W).	Cohort 2: 6 μg/kg Q3W n=3 Participants Participants received 6 μg/kg ADCT-301 formulation, intravenous infusion for 1 hour, on Day 1 of each 3-week (21-day) cycle (Q3W).	Cohort 3: 12 μg/kg Q3W n=3 Participants Participants received 12 μg/kg ADCT-301 formulation, intravenous infusion for 1 hour, on Day 1 of each 3-week (21-day) cycle (Q3W).	Cohort 4: 22 μg/kg Q3W n=3 Participants Participants received 22 μg/kg ADCT-301 formulation, intravenous infusion for 1 hour, on Day 1 of each 3-week (21-day) cycle (Q3W).
Number of Participants Reporting One or More Treatment Emergent Serious Adverse Event (SAE)	1 Participants	2 Participants	2 Participants	2 Participants	5 Participants	3 Participants	2 Participants	1 Participants	2 Participants	3 Participants

SECONDARY outcome

Timeframe: Screening, Day 19 visit (+/- 3 days) of Cycle 2 and each subsequent cycle up to 12 months after the last dose of study drug (1 cycle = 21 days)

Population: The analysis was planned, but the data was not collected as study was terminated prematurely.

DOR is defined among responders (complete response \[CR\], CR with incomplete blood count recover \[CRi\], or partial response \[PR\]) as the time from the earliest date of first response until the first date of either disease progression or death due to any cause. A summary of antitumor activity was not conducted due to a limited number of responders. CR: * Bone marrow differential showing ≤5% blast cells. * Absolute neutrophil count (ANC) ≥1.0 x 10\^9/L and platelet count ≥100 x 10\^9/L. * Absence of extramedullary disease. * Participant is independent of red blood cell transfusions. CRi is defined as achieving all CR criteria except that values for ANC may be \<1.0 x 10\^9/L and/or values for platelets may be \<100 x 10\^9/L. PR: * ANC ≥1.0 x 10\^9/L and platelet count ≥100 x 10\^9/L. * Bone marrow differential showing a ≥50% decrease from baseline in the percentage of bone marrow blast cells to a level \>5% and ≤25%, or bone marrow differential showing \<5% blast cells.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Screening, Day 19 visit (+/- 3 days) of Cycle 2 and each subsequent cycle up to 12 months after the last dose of study drug (1 cycle = 21 days)

Population: The analysis was planned, but the data was not collected as study was terminated prematurely.

ORR is defined as the percentage of participants with a best overall response of CR, CRi, or PR at the time each participant discontinues treatment with ADCT-301. A summary of antitumor activity was not conducted due to a limited number of responders.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Screening, Day 19 visit (+/- 3 days) of Cycle 2 and each subsequent cycle up to 12 months after the last dose of study drug (1 cycle = 21 days)

Population: The analysis was planned, but the data was not collected as study was terminated prematurely.

OS is defined as the time from the first dose of study drug treatment until the date of death due to any cause. A summary of antitumor activity was not conducted due to a limited number of responders.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Screening, Day 19 visit (+/- 3 days) of Cycle 2 and each subsequent cycle up to 12 months after the last dose of study drug (1 cycle = 21 days)

Population: The analysis was planned, but the data was not collected as study was terminated prematurely.

PFS is defined as the time from first dose of study drug until the first date of either disease progression or death due to any cause. A summary of antitumor activity was not conducted due to a limited number of responders.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Before infusion, end of infusion, 1, 3, 6, 24, 48, and 96 hours after infusion, and on Days 8 and 19 of Cycle 1 and 2 (1 cycle = 21 days)

Population: Only participants with evaluable pharmacokinetic results were included in the analysis. Where data is not presented, the pharmacokinetic profiles were nonmeasurable or short-lived in duration; therefore, no analysis could be performed.

Cmax for Pyrrolobenzodiazepine (PBD) conjugated antibody (Ab), total Ab and free warhead (SG3199) for Q3W cohorts.

Outcome measures

Outcome measures
Measure	Cohort 5: 32 μg/kg Q3W n=3 Participants Participants received 32 μg/kg ADCT-301 formulation, intravenous infusion for 1 hour, on Day 1 of each 3-week (21-day) cycle (Q3W).	Cohort 6: 52 μg/kg Q3W n=3 Participants Participants received 52 μg/kg ADCT-301 formulation, intravenous infusion for 1 hour, on Day 1 of each 3-week (21-day) cycle (Q3W).	Cohort 7: 72 μg/kg Q3W n=3 Participants Participants received 72 μg/kg ADCT-301 formulation, intravenous infusion for 1 hour, on Day 1 of each 3-week (21-day) cycle (Q3W).	Cohort 8: 92 μg/kg Q3W n=4 Participants Participants received 92 μg/kg ADCT-301 formulation, intravenous infusion for 1 hour, on Day 1 of each 3-week (21-day) cycle (Q3W).	Cohort 9: 30 μg/kg QW Participants received 30 μg/kg ADCT-301 formulation, intravenous infusion for 1 hour, on Days 1, 8 and 15 (once weekly \[QW\]) of each 3-week (21 day) cycle.	Cohort 10: 37.5 μg/kg QW Participants received 37.5 μg/kg ADCT-301 formulation, intravenous infusion for 1 hour, on Days 1, 8 and 15 (once weekly \[QW\]) of each 3-week (21 day) cycle.	Cohort 1: 3 μg/kg Q3W Participants received 3 μg/kg ADCT-301 formulation, intravenous infusion for 1 hour, on Day 1 of each 3-week (21-day) cycle (Q3W).	Cohort 2: 6 μg/kg Q3W n=2 Participants Participants received 6 μg/kg ADCT-301 formulation, intravenous infusion for 1 hour, on Day 1 of each 3-week (21-day) cycle (Q3W).	Cohort 3: 12 μg/kg Q3W n=1 Participants Participants received 12 μg/kg ADCT-301 formulation, intravenous infusion for 1 hour, on Day 1 of each 3-week (21-day) cycle (Q3W).	Cohort 4: 22 μg/kg Q3W n=3 Participants Participants received 22 μg/kg ADCT-301 formulation, intravenous infusion for 1 hour, on Day 1 of each 3-week (21-day) cycle (Q3W).
Maximum Observed Serum Concentration (Cmax) of ADCT-301 for the Q3W Dosing Schedule PBD-conjugated Ab of ADCT-301: Cycle 1	514 μg/L Geometric Coefficient of Variation 127	920 μg/L Geometric Coefficient of Variation 71.2	877 μg/L Geometric Coefficient of Variation 35.4	949 μg/L Geometric Coefficient of Variation 63.8	—	—	—	181 μg/L Geometric Coefficient of Variation 348	165 μg/L Geometric Coefficient of Variation NA Standard deviation could not be determined as only one participant had evaluable data.	186 μg/L Geometric Coefficient of Variation 117
Maximum Observed Serum Concentration (Cmax) of ADCT-301 for the Q3W Dosing Schedule PBD-conjugated Ab of ADCT-301: Cycle 2	405 μg/L Geometric Coefficient of Variation 383	284 μg/L Geometric Coefficient of Variation 102	1182 μg/L Geometric Coefficient of Variation 167	710 μg/L Geometric Coefficient of Variation 41.6	—	—	—	79.2 μg/L Geometric Coefficient of Variation 0.268	—	589 μg/L Geometric Coefficient of Variation NA Standard deviation could not be determined as only one participant had evaluable data.
Maximum Observed Serum Concentration (Cmax) of ADCT-301 for the Q3W Dosing Schedule Total Ab of ADCT-301: Cycle 1	715 μg/L Geometric Coefficient of Variation 139	960 μg/L Geometric Coefficient of Variation 82.5	1013 μg/L Geometric Coefficient of Variation 34.4	1196 μg/L Geometric Coefficient of Variation 69.3	—	—	—	278 μg/L Geometric Coefficient of Variation 355	177 μg/L Geometric Coefficient of Variation NA Standard deviation could not be determined as only one participant had evaluable data.	233 μg/L Geometric Coefficient of Variation 93.8
Maximum Observed Serum Concentration (Cmax) of ADCT-301 for the Q3W Dosing Schedule Total Ab of ADCT-301: Cycle 2	517 μg/L Geometric Coefficient of Variation 330	333 μg/L Geometric Coefficient of Variation 121	1406 μg/L Geometric Coefficient of Variation 199	910 μg/L Geometric Coefficient of Variation 41.0	—	—	—	91.4 μg/L Geometric Coefficient of Variation 17.0	—	272 μg/L Geometric Coefficient of Variation 236
Maximum Observed Serum Concentration (Cmax) of ADCT-301 for the Q3W Dosing Schedule SG3199 Free Warhead of ADCT-301: Cycle 1	—	0.0210 μg/L Geometric Coefficient of Variation NA Standard deviation could not be determined as only one participant had evaluable data.	0.0140 μg/L Geometric Coefficient of Variation NA Standard deviation could not be determined as only one participant had evaluable data.	0.0280 μg/L Geometric Coefficient of Variation 54.3	—	—	—	—	—	—
Maximum Observed Serum Concentration (Cmax) of ADCT-301 for the Q3W Dosing Schedule SG3199 Free Warhead of ADCT-301: Cycle 2	—	0.0140 μg/L Geometric Coefficient of Variation 29.7	—	0.0170 μg/L Geometric Coefficient of Variation NA Standard deviation could not be determined as only one participant had evaluable data.	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Before infusion, end of infusion, 5, 24, 48, and 96 hours after infusion on days 1 and 8, and before and after infusion on Day 15 of Cycle 1 and 2 (1 cycle = 21 days)

Cmax for Pyrrolobenzodiazepine (PBD) conjugated antibody (Ab), total Ab and free warhead (SG3199) for QW cohort.

Outcome measures

Outcome measures
Measure	Cohort 5: 32 μg/kg Q3W Participants received 32 μg/kg ADCT-301 formulation, intravenous infusion for 1 hour, on Day 1 of each 3-week (21-day) cycle (Q3W).	Cohort 6: 52 μg/kg Q3W Participants received 52 μg/kg ADCT-301 formulation, intravenous infusion for 1 hour, on Day 1 of each 3-week (21-day) cycle (Q3W).	Cohort 7: 72 μg/kg Q3W Participants received 72 μg/kg ADCT-301 formulation, intravenous infusion for 1 hour, on Day 1 of each 3-week (21-day) cycle (Q3W).	Cohort 8: 92 μg/kg Q3W Participants received 92 μg/kg ADCT-301 formulation, intravenous infusion for 1 hour, on Day 1 of each 3-week (21-day) cycle (Q3W).	Cohort 9: 30 μg/kg QW Participants received 30 μg/kg ADCT-301 formulation, intravenous infusion for 1 hour, on Days 1, 8 and 15 (once weekly \[QW\]) of each 3-week (21 day) cycle.	Cohort 10: 37.5 μg/kg QW Participants received 37.5 μg/kg ADCT-301 formulation, intravenous infusion for 1 hour, on Days 1, 8 and 15 (once weekly \[QW\]) of each 3-week (21 day) cycle.	Cohort 1: 3 μg/kg Q3W n=5 Participants Participants received 3 μg/kg ADCT-301 formulation, intravenous infusion for 1 hour, on Day 1 of each 3-week (21-day) cycle (Q3W).	Cohort 2: 6 μg/kg Q3W n=2 Participants Participants received 6 μg/kg ADCT-301 formulation, intravenous infusion for 1 hour, on Day 1 of each 3-week (21-day) cycle (Q3W).	Cohort 3: 12 μg/kg Q3W Participants received 12 μg/kg ADCT-301 formulation, intravenous infusion for 1 hour, on Day 1 of each 3-week (21-day) cycle (Q3W).	Cohort 4: 22 μg/kg Q3W Participants received 22 μg/kg ADCT-301 formulation, intravenous infusion for 1 hour, on Day 1 of each 3-week (21-day) cycle (Q3W).
Maximum Observed Serum Concentration (Cmax) of ADCT-301 for the QW Dosing Schedule PBD-conjugated Ab of ADCT-301: Cycle 1 Week 1	—	—	—	—	—	—	377 μg/L Geometric Coefficient of Variation 67.0	355 μg/L Geometric Coefficient of Variation 39.4	—	—
Maximum Observed Serum Concentration (Cmax) of ADCT-301 for the QW Dosing Schedule PBD-conjugated Ab of ADCT-301: Cycle 1 Week 2	—	—	—	—	—	—	350 μg/L Geometric Coefficient of Variation 32.8	13200 μg/L Geometric Coefficient of Variation NA Standard deviation could not be determined as only one participant had evaluable data.	—	—
Maximum Observed Serum Concentration (Cmax) of ADCT-301 for the QW Dosing Schedule Total Ab of ADCT-301: Cycle 1 Week 1	—	—	—	—	—	—	435 μg/L Geometric Coefficient of Variation 63.5	504 μg/L Geometric Coefficient of Variation 22.2	—	—
Maximum Observed Serum Concentration (Cmax) of ADCT-301 for the QW Dosing Schedule Total Ab of ADCT-301: Cycle 1 Week 2	—	—	—	—	—	—	416 μg/L Geometric Coefficient of Variation 33.8	15100 μg/L Geometric Coefficient of Variation NA Standard deviation could not be determined as only one participant had evaluable data.	—	—

SECONDARY outcome

Timeframe: Before infusion, end of infusion, 1, 3, 6, 24, 48, and 96 hours after infusion, and on Days 8 and 19 of Cycle 1 and 2 (1 cycle = 21 days)

Tmax for Pyrrolobenzodiazepine (PBD) conjugated antibody (Ab), total Ab and free warhead (SG3199) for Q3W cohort.

Outcome measures

Outcome measures
Measure	Cohort 5: 32 μg/kg Q3W n=3 Participants Participants received 32 μg/kg ADCT-301 formulation, intravenous infusion for 1 hour, on Day 1 of each 3-week (21-day) cycle (Q3W).	Cohort 6: 52 μg/kg Q3W n=3 Participants Participants received 52 μg/kg ADCT-301 formulation, intravenous infusion for 1 hour, on Day 1 of each 3-week (21-day) cycle (Q3W).	Cohort 7: 72 μg/kg Q3W n=3 Participants Participants received 72 μg/kg ADCT-301 formulation, intravenous infusion for 1 hour, on Day 1 of each 3-week (21-day) cycle (Q3W).	Cohort 8: 92 μg/kg Q3W n=4 Participants Participants received 92 μg/kg ADCT-301 formulation, intravenous infusion for 1 hour, on Day 1 of each 3-week (21-day) cycle (Q3W).	Cohort 9: 30 μg/kg QW Participants received 30 μg/kg ADCT-301 formulation, intravenous infusion for 1 hour, on Days 1, 8 and 15 (once weekly \[QW\]) of each 3-week (21 day) cycle.	Cohort 10: 37.5 μg/kg QW Participants received 37.5 μg/kg ADCT-301 formulation, intravenous infusion for 1 hour, on Days 1, 8 and 15 (once weekly \[QW\]) of each 3-week (21 day) cycle.	Cohort 1: 3 μg/kg Q3W Participants received 3 μg/kg ADCT-301 formulation, intravenous infusion for 1 hour, on Day 1 of each 3-week (21-day) cycle (Q3W).	Cohort 2: 6 μg/kg Q3W n=2 Participants Participants received 6 μg/kg ADCT-301 formulation, intravenous infusion for 1 hour, on Day 1 of each 3-week (21-day) cycle (Q3W).	Cohort 3: 12 μg/kg Q3W n=1 Participants Participants received 12 μg/kg ADCT-301 formulation, intravenous infusion for 1 hour, on Day 1 of each 3-week (21-day) cycle (Q3W).	Cohort 4: 22 μg/kg Q3W n=3 Participants Participants received 22 μg/kg ADCT-301 formulation, intravenous infusion for 1 hour, on Day 1 of each 3-week (21-day) cycle (Q3W).
Time to Reach the Maximum Observed Serum Concentration (Tmax) for ADCT-301 for the Q3W Dosing Schedule SG3199 Free Warhead of ADCT-301: Cycle 2	—	0.228 days Geometric Coefficient of Variation 12.8	—	0.309 days Geometric Coefficient of Variation NA Standard deviation could not be determined as only one participant had evaluable data.	—	—	—	—	—	—
Time to Reach the Maximum Observed Serum Concentration (Tmax) for ADCT-301 for the Q3W Dosing Schedule PBD-conjugated Ab of ADCT-301: Cycle 1	0.0850 days Geometric Coefficient of Variation 23.4	0.0910 days Geometric Coefficient of Variation 5.00	0.108 days Geometric Coefficient of Variation 20.1	0.108 days Geometric Coefficient of Variation 20.1	—	—	—	0.162 days Geometric Coefficient of Variation 34.6	0.0870 days Geometric Coefficient of Variation NA Standard deviation could not be determined as only one participant had evaluable data.	0.0830 days Geometric Coefficient of Variation 3.01
Time to Reach the Maximum Observed Serum Concentration (Tmax) for ADCT-301 for the Q3W Dosing Schedule PBD-conjugated Ab of ADCT-301: Cycle 2	0.0620 days Geometric Coefficient of Variation 33.9	0.0860 days Geometric Coefficient of Variation 2.45	0.0840 days Geometric Coefficient of Variation 63.1	0.0810 days Geometric Coefficient of Variation 45.1	—	—	—	0.144 days Geometric Coefficient of Variation 21.7	—	0.0490 days Geometric Coefficient of Variation NA Standard deviation could not be determined as only one participant had evaluable data.
Time to Reach the Maximum Observed Serum Concentration (Tmax) for ADCT-301 for the Q3W Dosing Schedule Total Ab of ADCT-301: Cycle 1	0.101 days Geometric Coefficient of Variation 11.7	0.0910 days Geometric Coefficient of Variation 5.00	0.119 days Geometric Coefficient of Variation 31.2	0.108 days Geometric Coefficient of Variation 20.1	—	—	—	0.162 days Geometric Coefficient of Variation 34.6	0.0870 days Geometric Coefficient of Variation NA Standard deviation could not be determined as only one participant had evaluable data.	0.0830 days Geometric Coefficient of Variation 3.01
Time to Reach the Maximum Observed Serum Concentration (Tmax) for ADCT-301 for the Q3W Dosing Schedule Total Ab of ADCT-301: Cycle 2	0.0770 days Geometric Coefficient of Variation 17.1	0.123 days Geometric Coefficient of Variation 50.2	0.0840 days Geometric Coefficient of Variation 63.1	0.0760 days Geometric Coefficient of Variation 59.1	—	—	—	0.103 days Geometric Coefficient of Variation 27.2	—	0.0490 days Geometric Coefficient of Variation NA Standard deviation could not be determined as only one participant had evaluable data.
Time to Reach the Maximum Observed Serum Concentration (Tmax) for ADCT-301 for the Q3W Dosing Schedule SG3199 Free Warhead of ADCT-301: Cycle 1	—	0.310 days Geometric Coefficient of Variation NA Standard deviation could not be determined as only one participant had evaluable data.	0.379 days Geometric Coefficient of Variation NA Standard deviation could not be determined as only one participant had evaluable data.	0.164 days Geometric Coefficient of Variation 36.1	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Before infusion, end of infusion, 5, 24, 48, and 96 hours after infusion on days 1 and 8, and before and after infusion on Day 15 of Cycle 1 and 2 (1 cycle = 21 days)

Tmax for Pyrrolobenzodiazepine (PBD) conjugated antibody (Ab), total Ab and free warhead (SG3199) for QW cohort.

Outcome measures

Outcome measures
Measure	Cohort 5: 32 μg/kg Q3W Participants received 32 μg/kg ADCT-301 formulation, intravenous infusion for 1 hour, on Day 1 of each 3-week (21-day) cycle (Q3W).	Cohort 6: 52 μg/kg Q3W Participants received 52 μg/kg ADCT-301 formulation, intravenous infusion for 1 hour, on Day 1 of each 3-week (21-day) cycle (Q3W).	Cohort 7: 72 μg/kg Q3W Participants received 72 μg/kg ADCT-301 formulation, intravenous infusion for 1 hour, on Day 1 of each 3-week (21-day) cycle (Q3W).	Cohort 8: 92 μg/kg Q3W Participants received 92 μg/kg ADCT-301 formulation, intravenous infusion for 1 hour, on Day 1 of each 3-week (21-day) cycle (Q3W).	Cohort 9: 30 μg/kg QW Participants received 30 μg/kg ADCT-301 formulation, intravenous infusion for 1 hour, on Days 1, 8 and 15 (once weekly \[QW\]) of each 3-week (21 day) cycle.	Cohort 10: 37.5 μg/kg QW Participants received 37.5 μg/kg ADCT-301 formulation, intravenous infusion for 1 hour, on Days 1, 8 and 15 (once weekly \[QW\]) of each 3-week (21 day) cycle.	Cohort 1: 3 μg/kg Q3W n=5 Participants Participants received 3 μg/kg ADCT-301 formulation, intravenous infusion for 1 hour, on Day 1 of each 3-week (21-day) cycle (Q3W).	Cohort 2: 6 μg/kg Q3W n=2 Participants Participants received 6 μg/kg ADCT-301 formulation, intravenous infusion for 1 hour, on Day 1 of each 3-week (21-day) cycle (Q3W).	Cohort 3: 12 μg/kg Q3W Participants received 12 μg/kg ADCT-301 formulation, intravenous infusion for 1 hour, on Day 1 of each 3-week (21-day) cycle (Q3W).	Cohort 4: 22 μg/kg Q3W Participants received 22 μg/kg ADCT-301 formulation, intravenous infusion for 1 hour, on Day 1 of each 3-week (21-day) cycle (Q3W).
Time to Reach the Maximum Observed Serum Concentration (Tmax) for ADCT-301 for the QW Dosing Schedule PBD-conjugated Ab of ADCT-301: Cycle 1 Week 1	—	—	—	—	—	—	0.0680 days Geometric Coefficient of Variation 19.9	0.119 days Geometric Coefficient of Variation 173	—	—
Time to Reach the Maximum Observed Serum Concentration (Tmax) for ADCT-301 for the QW Dosing Schedule PBD-conjugated Ab of ADCT-301: Cycle 1 Week 2	—	—	—	—	—	—	0.0370 days Geometric Coefficient of Variation 50.4	0.0240 days Geometric Coefficient of Variation NA Standard deviation could not be determined as only one participant had evaluable data.	—	—
Time to Reach the Maximum Observed Serum Concentration (Tmax) for ADCT-301 for the QW Dosing Schedule Total Ab of ADCT-301: Cycle 1 Week 1	—	—	—	—	—	—	0.117 days Geometric Coefficient of Variation 185	0.0590 days Geometric Coefficient of Variation 18.1	—	—
Time to Reach the Maximum Observed Serum Concentration (Tmax) for ADCT-301 for the QW Dosing Schedule Total Ab of ADCT-301: Cycle 1 Week 2	—	—	—	—	—	—	0.0370 days Geometric Coefficient of Variation 50.4	0.0240 days Geometric Coefficient of Variation NA Standard deviation could not be determined as only one participant had evaluable data.	—	—

SECONDARY outcome

Timeframe: Before infusion, end of infusion, 1, 3, 6, 24, 48, and 96 hours after infusion, and on Days 8 and 19 of Cycle 1 and 2 (1 cycle = 21 days)

AUClast for Pyrrolobenzodiazepine (PBD) conjugated antibody (Ab), total Ab and free warhead (SG3199) for Q3W cohort.

Outcome measures

Outcome measures
Measure	Cohort 5: 32 μg/kg Q3W n=3 Participants Participants received 32 μg/kg ADCT-301 formulation, intravenous infusion for 1 hour, on Day 1 of each 3-week (21-day) cycle (Q3W).	Cohort 6: 52 μg/kg Q3W n=3 Participants Participants received 52 μg/kg ADCT-301 formulation, intravenous infusion for 1 hour, on Day 1 of each 3-week (21-day) cycle (Q3W).	Cohort 7: 72 μg/kg Q3W n=3 Participants Participants received 72 μg/kg ADCT-301 formulation, intravenous infusion for 1 hour, on Day 1 of each 3-week (21-day) cycle (Q3W).	Cohort 8: 92 μg/kg Q3W n=4 Participants Participants received 92 μg/kg ADCT-301 formulation, intravenous infusion for 1 hour, on Day 1 of each 3-week (21-day) cycle (Q3W).	Cohort 9: 30 μg/kg QW Participants received 30 μg/kg ADCT-301 formulation, intravenous infusion for 1 hour, on Days 1, 8 and 15 (once weekly \[QW\]) of each 3-week (21 day) cycle.	Cohort 10: 37.5 μg/kg QW Participants received 37.5 μg/kg ADCT-301 formulation, intravenous infusion for 1 hour, on Days 1, 8 and 15 (once weekly \[QW\]) of each 3-week (21 day) cycle.	Cohort 1: 3 μg/kg Q3W Participants received 3 μg/kg ADCT-301 formulation, intravenous infusion for 1 hour, on Day 1 of each 3-week (21-day) cycle (Q3W).	Cohort 2: 6 μg/kg Q3W n=2 Participants Participants received 6 μg/kg ADCT-301 formulation, intravenous infusion for 1 hour, on Day 1 of each 3-week (21-day) cycle (Q3W).	Cohort 3: 12 μg/kg Q3W n=1 Participants Participants received 12 μg/kg ADCT-301 formulation, intravenous infusion for 1 hour, on Day 1 of each 3-week (21-day) cycle (Q3W).	Cohort 4: 22 μg/kg Q3W n=3 Participants Participants received 22 μg/kg ADCT-301 formulation, intravenous infusion for 1 hour, on Day 1 of each 3-week (21-day) cycle (Q3W).
Area Under the Serum Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration (AUClast) for ADCT-301 for the Q3W Dosing Schedule Total Ab of ADCT-301: Cycle 2	348 day*μg/L Geometric Coefficient of Variation 1389	127 day*μg/L Geometric Coefficient of Variation 452	1427 day*μg/L Geometric Coefficient of Variation 180	436 day*μg/L Geometric Coefficient of Variation 178	—	—	—	22.6 day*μg/L Geometric Coefficient of Variation 23.9	—	22.6 day*μg/L Geometric Coefficient of Variation 77.7
Area Under the Serum Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration (AUClast) for ADCT-301 for the Q3W Dosing Schedule PBD-conjugated Ab of ADCT-301: Cycle 1	317 day*μg/L Geometric Coefficient of Variation 43.3	897 day*μg/L Geometric Coefficient of Variation 67.5	1198 day*μg/L Geometric Coefficient of Variation 82.1	381 day*μg/L Geometric Coefficient of Variation 126	—	—	—	19.0 day*μg/L Geometric Coefficient of Variation 681	109 day*μg/L Geometric Coefficient of Variation NA Standard deviation could not be determined as only one participant had evaluable data.	34.9 day*μg/L Geometric Coefficient of Variation 363
Area Under the Serum Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration (AUClast) for ADCT-301 for the Q3W Dosing Schedule PBD-conjugated Ab of ADCT-301: Cycle 2	231 day*μg/L Geometric Coefficient of Variation 1225	114 day*μg/L Geometric Coefficient of Variation 332	1063 day*μg/L Geometric Coefficient of Variation 135	360 day*μg/L Geometric Coefficient of Variation 180	—	—	—	19.1 day*μg/L Geometric Coefficient of Variation 7.42	—	30.4 day*μg/L Geometric Coefficient of Variation NA Standard deviation could not be determined as only one participant had evaluable data.
Area Under the Serum Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration (AUClast) for ADCT-301 for the Q3W Dosing Schedule Total Ab of ADCT-301: Cycle 1	590 day*μg/L Geometric Coefficient of Variation 40.6	1144 day*μg/L Geometric Coefficient of Variation 66.7	1577 day*μg/L Geometric Coefficient of Variation 69.6	394 day*μg/L Geometric Coefficient of Variation 174	—	—	—	36.3 day*μg/L Geometric Coefficient of Variation 245	132 day*μg/L Geometric Coefficient of Variation NA Standard deviation could not be determined as only one participant had evaluable data.	46.4 day*μg/L Geometric Coefficient of Variation 353
Area Under the Serum Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration (AUClast) for ADCT-301 for the Q3W Dosing Schedule SG3199 Free Warhead of ADCT-301: Cycle 1	—	0.00500 day*μg/L Geometric Coefficient of Variation NA Standard deviation could not be determined as only one participant had evaluable data.	0.0120 day*μg/L Geometric Coefficient of Variation NA Standard deviation could not be determined as only one participant had evaluable data.	0.0500 day*μg/L Geometric Coefficient of Variation 81.2	—	—	—	—	—	—
Area Under the Serum Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration (AUClast) for ADCT-301 for the Q3W Dosing Schedule SG3199 Free Warhead of ADCT-301: Cycle 2	—	0.00600 day*μg/L Geometric Coefficient of Variation 110	—	0.01540 day*μg/L Geometric Coefficient of Variation NA Standard deviation could not be determined as only one participant had evaluable data.	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Before infusion, end of infusion, 5, 24, 48, and 96 hours after infusion on days 1 and 8, and before and after infusion on Day 15 of Cycle 1 and 2 (1 cycle = 21 days)

AUClast for Pyrrolobenzodiazepine (PBD) conjugated antibody (Ab), total Ab and free warhead (SG3199) for QW cohort.

Outcome measures

Outcome measures
Measure	Cohort 5: 32 μg/kg Q3W Participants received 32 μg/kg ADCT-301 formulation, intravenous infusion for 1 hour, on Day 1 of each 3-week (21-day) cycle (Q3W).	Cohort 6: 52 μg/kg Q3W Participants received 52 μg/kg ADCT-301 formulation, intravenous infusion for 1 hour, on Day 1 of each 3-week (21-day) cycle (Q3W).	Cohort 7: 72 μg/kg Q3W Participants received 72 μg/kg ADCT-301 formulation, intravenous infusion for 1 hour, on Day 1 of each 3-week (21-day) cycle (Q3W).	Cohort 8: 92 μg/kg Q3W Participants received 92 μg/kg ADCT-301 formulation, intravenous infusion for 1 hour, on Day 1 of each 3-week (21-day) cycle (Q3W).	Cohort 9: 30 μg/kg QW Participants received 30 μg/kg ADCT-301 formulation, intravenous infusion for 1 hour, on Days 1, 8 and 15 (once weekly \[QW\]) of each 3-week (21 day) cycle.	Cohort 10: 37.5 μg/kg QW Participants received 37.5 μg/kg ADCT-301 formulation, intravenous infusion for 1 hour, on Days 1, 8 and 15 (once weekly \[QW\]) of each 3-week (21 day) cycle.	Cohort 1: 3 μg/kg Q3W n=5 Participants Participants received 3 μg/kg ADCT-301 formulation, intravenous infusion for 1 hour, on Day 1 of each 3-week (21-day) cycle (Q3W).	Cohort 2: 6 μg/kg Q3W n=2 Participants Participants received 6 μg/kg ADCT-301 formulation, intravenous infusion for 1 hour, on Day 1 of each 3-week (21-day) cycle (Q3W).	Cohort 3: 12 μg/kg Q3W Participants received 12 μg/kg ADCT-301 formulation, intravenous infusion for 1 hour, on Day 1 of each 3-week (21-day) cycle (Q3W).	Cohort 4: 22 μg/kg Q3W Participants received 22 μg/kg ADCT-301 formulation, intravenous infusion for 1 hour, on Day 1 of each 3-week (21-day) cycle (Q3W).
Area Under the Serum Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration (AUClast) for ADCT-301 for the QW Dosing Schedule PBD-conjugated Ab of ADCT-301: Cycle 1 Week 1	—	—	—	—	—	—	331 day*μg/L Geometric Coefficient of Variation 114	113 day*μg/L Geometric Coefficient of Variation 86.8	—	—
Area Under the Serum Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration (AUClast) for ADCT-301 for the QW Dosing Schedule PBD-conjugated Ab of ADCT-301: Cycle 1 Week 2	—	—	—	—	—	—	378 day*μg/L Geometric Coefficient of Variation 103	2319 day*μg/L Geometric Coefficient of Variation NA Standard deviation could not be determined as only one participant had evaluable data.	—	—
Area Under the Serum Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration (AUClast) for ADCT-301 for the QW Dosing Schedule Total Ab of ADCT-301: Cycle 1 Week 1	—	—	—	—	—	—	476 day*μg/L Geometric Coefficient of Variation 116	152 day*μg/L Geometric Coefficient of Variation 103	—	—
Area Under the Serum Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration (AUClast) for ADCT-301 for the QW Dosing Schedule Total Ab of ADCT-301: Cycle 1 Week 2	—	—	—	—	—	—	584 day*μg/L Geometric Coefficient of Variation 86.8	3099 day*μg/L Geometric Coefficient of Variation NA Standard deviation could not be determined as only one participant had evaluable data.	—	—

SECONDARY outcome

Timeframe: Before infusion, end of infusion, 1, 3, 6, 24, 48, and 96 hours after infusion, and on Days 8 and 19 of Cycle 1 and 2 (1 cycle = 21 days)

AUCtau for Pyrrolobenzodiazepine (PBD) conjugated antibody (Ab), total Ab and free warhead (SG3199) for Q3W cohort.

Outcome measures

Outcome measures
Measure	Cohort 5: 32 μg/kg Q3W n=2 Participants Participants received 32 μg/kg ADCT-301 formulation, intravenous infusion for 1 hour, on Day 1 of each 3-week (21-day) cycle (Q3W).	Cohort 6: 52 μg/kg Q3W n=2 Participants Participants received 52 μg/kg ADCT-301 formulation, intravenous infusion for 1 hour, on Day 1 of each 3-week (21-day) cycle (Q3W).	Cohort 7: 72 μg/kg Q3W n=2 Participants Participants received 72 μg/kg ADCT-301 formulation, intravenous infusion for 1 hour, on Day 1 of each 3-week (21-day) cycle (Q3W).	Cohort 8: 92 μg/kg Q3W n=3 Participants Participants received 92 μg/kg ADCT-301 formulation, intravenous infusion for 1 hour, on Day 1 of each 3-week (21-day) cycle (Q3W).	Cohort 9: 30 μg/kg QW Participants received 30 μg/kg ADCT-301 formulation, intravenous infusion for 1 hour, on Days 1, 8 and 15 (once weekly \[QW\]) of each 3-week (21 day) cycle.	Cohort 10: 37.5 μg/kg QW Participants received 37.5 μg/kg ADCT-301 formulation, intravenous infusion for 1 hour, on Days 1, 8 and 15 (once weekly \[QW\]) of each 3-week (21 day) cycle.	Cohort 1: 3 μg/kg Q3W Participants received 3 μg/kg ADCT-301 formulation, intravenous infusion for 1 hour, on Day 1 of each 3-week (21-day) cycle (Q3W).	Cohort 2: 6 μg/kg Q3W Participants received 6 μg/kg ADCT-301 formulation, intravenous infusion for 1 hour, on Day 1 of each 3-week (21-day) cycle (Q3W).	Cohort 3: 12 μg/kg Q3W Participants received 12 μg/kg ADCT-301 formulation, intravenous infusion for 1 hour, on Day 1 of each 3-week (21-day) cycle (Q3W).	Cohort 4: 22 μg/kg Q3W Participants received 22 μg/kg ADCT-301 formulation, intravenous infusion for 1 hour, on Day 1 of each 3-week (21-day) cycle (Q3W).
Area Under the Serum Concentration-time Curve From Time 0 to the End of the Dosing Interval (AUCtau) for ADCT-301 for the Q3W Dosing Schedule PBD-conjugated Ab of ADCT-301: Cycle 2	1061 day*μg/L Geometric Coefficient of Variation 72.3	186 day*μg/L Geometric Coefficient of Variation 240	1248 day*μg/L Geometric Coefficient of Variation 114	826 day*μg/L Geometric Coefficient of Variation 151	—	—	—	—	—	—
Area Under the Serum Concentration-time Curve From Time 0 to the End of the Dosing Interval (AUCtau) for ADCT-301 for the Q3W Dosing Schedule Total Ab of ADCT-301: Cycle 2	1700 day*μg/L Geometric Coefficient of Variation 89.6	60.2 day*μg/L Geometric Coefficient of Variation NA Standard deviation could not be determined as only one participant had evaluable data.	1751 day*μg/L Geometric Coefficient of Variation 146	622 day*μg/L Geometric Coefficient of Variation 167	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Before infusion, end of infusion, 5, 24, 48, and 96 hours after infusion on days 1 and 8, and before and after infusion on Day 15 of Cycle 1 and 2 (1 cycle = 21 days)

Population: The analysis was planned, but the data was not collected as study was terminated prematurely.

AUCtau for Pyrrolobenzodiazepine (PBD) conjugated antibody (Ab), total Ab and free warhead (SG3199) for QW cohort.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Before infusion, end of infusion, 1, 3, 6, 24, 48, and 96 hours after infusion, and on Days 8 and 19 of Cycle 1 and 2 (1 cycle = 21 days)

AUCinf for Pyrrolobenzodiazepine (PBD) conjugated antibody (Ab), total Ab and free warhead (SG3199) for Q3W cohort.

Outcome measures

Outcome measures
Measure	Cohort 5: 32 μg/kg Q3W n=2 Participants Participants received 32 μg/kg ADCT-301 formulation, intravenous infusion for 1 hour, on Day 1 of each 3-week (21-day) cycle (Q3W).	Cohort 6: 52 μg/kg Q3W n=1 Participants Participants received 52 μg/kg ADCT-301 formulation, intravenous infusion for 1 hour, on Day 1 of each 3-week (21-day) cycle (Q3W).	Cohort 7: 72 μg/kg Q3W n=1 Participants Participants received 72 μg/kg ADCT-301 formulation, intravenous infusion for 1 hour, on Day 1 of each 3-week (21-day) cycle (Q3W).	Cohort 8: 92 μg/kg Q3W n=2 Participants Participants received 92 μg/kg ADCT-301 formulation, intravenous infusion for 1 hour, on Day 1 of each 3-week (21-day) cycle (Q3W).	Cohort 9: 30 μg/kg QW Participants received 30 μg/kg ADCT-301 formulation, intravenous infusion for 1 hour, on Days 1, 8 and 15 (once weekly \[QW\]) of each 3-week (21 day) cycle.	Cohort 10: 37.5 μg/kg QW Participants received 37.5 μg/kg ADCT-301 formulation, intravenous infusion for 1 hour, on Days 1, 8 and 15 (once weekly \[QW\]) of each 3-week (21 day) cycle.	Cohort 1: 3 μg/kg Q3W Participants received 3 μg/kg ADCT-301 formulation, intravenous infusion for 1 hour, on Day 1 of each 3-week (21-day) cycle (Q3W).	Cohort 2: 6 μg/kg Q3W Participants received 6 μg/kg ADCT-301 formulation, intravenous infusion for 1 hour, on Day 1 of each 3-week (21-day) cycle (Q3W).	Cohort 3: 12 μg/kg Q3W Participants received 12 μg/kg ADCT-301 formulation, intravenous infusion for 1 hour, on Day 1 of each 3-week (21-day) cycle (Q3W).	Cohort 4: 22 μg/kg Q3W Participants received 22 μg/kg ADCT-301 formulation, intravenous infusion for 1 hour, on Day 1 of each 3-week (21-day) cycle (Q3W).
Area Under the Serum Concentration-time Curve From Time 0 to Infinity (AUCinf) for ADCT-301 for the Q3W Dosing Schedule PBD-conjugated Ab of ADCT-301: Cycle 1	—	—	2846 day*μg/L Geometric Coefficient of Variation NA Standard deviation could not be determined as only one participant had evaluable data.	440 day*μg/L Geometric Coefficient of Variation 139	—	—	—	—	—	—
Area Under the Serum Concentration-time Curve From Time 0 to Infinity (AUCinf) for ADCT-301 for the Q3W Dosing Schedule Total Ab of ADCT-301: Cycle 1	667 day*μg/L Geometric Coefficient of Variation 56.3	1631 day*μg/L Geometric Coefficient of Variation NA Standard deviation could not be determined as only one participant had evaluable data.	3434 day*μg/L Geometric Coefficient of Variation NA Standard deviation could not be determined as only one participant had evaluable data.	1019 day*μg/L Geometric Coefficient of Variation NA Standard deviation could not be determined as only one participant had evaluable data.	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Before infusion, end of infusion, 5, 24, 48, and 96 hours after infusion on days 1 and 8, and before and after infusion on Day 15 of Cycle 1 and 2 (1 cycle = 21 days)

AUCinf for Pyrrolobenzodiazepine (PBD) conjugated antibody (Ab), total Ab and free warhead (SG3199) for QW cohort.

Outcome measures

Outcome measures
Measure	Cohort 5: 32 μg/kg Q3W Participants received 32 μg/kg ADCT-301 formulation, intravenous infusion for 1 hour, on Day 1 of each 3-week (21-day) cycle (Q3W).	Cohort 6: 52 μg/kg Q3W Participants received 52 μg/kg ADCT-301 formulation, intravenous infusion for 1 hour, on Day 1 of each 3-week (21-day) cycle (Q3W).	Cohort 7: 72 μg/kg Q3W Participants received 72 μg/kg ADCT-301 formulation, intravenous infusion for 1 hour, on Day 1 of each 3-week (21-day) cycle (Q3W).	Cohort 8: 92 μg/kg Q3W Participants received 92 μg/kg ADCT-301 formulation, intravenous infusion for 1 hour, on Day 1 of each 3-week (21-day) cycle (Q3W).	Cohort 9: 30 μg/kg QW Participants received 30 μg/kg ADCT-301 formulation, intravenous infusion for 1 hour, on Days 1, 8 and 15 (once weekly \[QW\]) of each 3-week (21 day) cycle.	Cohort 10: 37.5 μg/kg QW Participants received 37.5 μg/kg ADCT-301 formulation, intravenous infusion for 1 hour, on Days 1, 8 and 15 (once weekly \[QW\]) of each 3-week (21 day) cycle.	Cohort 1: 3 μg/kg Q3W n=1 Participants Participants received 3 μg/kg ADCT-301 formulation, intravenous infusion for 1 hour, on Day 1 of each 3-week (21-day) cycle (Q3W).	Cohort 2: 6 μg/kg Q3W Participants received 6 μg/kg ADCT-301 formulation, intravenous infusion for 1 hour, on Day 1 of each 3-week (21-day) cycle (Q3W).	Cohort 3: 12 μg/kg Q3W Participants received 12 μg/kg ADCT-301 formulation, intravenous infusion for 1 hour, on Day 1 of each 3-week (21-day) cycle (Q3W).	Cohort 4: 22 μg/kg Q3W Participants received 22 μg/kg ADCT-301 formulation, intravenous infusion for 1 hour, on Day 1 of each 3-week (21-day) cycle (Q3W).
Area Under the Serum Concentration-time Curve From Time 0 to Infinity (AUCinf) for ADCT-301 for the QW Dosing Schedule Total Ab of ADCT-301: Cycle 1 Week 1	—	—	—	—	—	—	366 day*μg/L Geometric Coefficient of Variation NA Standard deviation could not be determined as only one participant had evaluable data.	—	—	—

SECONDARY outcome

Timeframe: Before infusion, end of infusion, 1, 3, 6, 24, 48, and 96 hours after infusion, and on Days 8 and 19 of Cycle 1 and 2 (1 cycle = 21 days)

AI for Pyrrolobenzodiazepine (PBD) conjugated antibody (Ab), total Ab and free warhead (SG3199) for Q3W cohort. AI is the ratio of area under the serum concentration-time curve (AUC) from 0 to 21 days for Cycle 2 divided by AUC from 0 to 21 days for Cycle 1.

Outcome measures

Outcome measures
Measure	Cohort 5: 32 μg/kg Q3W n=2 Participants Participants received 32 μg/kg ADCT-301 formulation, intravenous infusion for 1 hour, on Day 1 of each 3-week (21-day) cycle (Q3W).	Cohort 6: 52 μg/kg Q3W n=2 Participants Participants received 52 μg/kg ADCT-301 formulation, intravenous infusion for 1 hour, on Day 1 of each 3-week (21-day) cycle (Q3W).	Cohort 7: 72 μg/kg Q3W n=2 Participants Participants received 72 μg/kg ADCT-301 formulation, intravenous infusion for 1 hour, on Day 1 of each 3-week (21-day) cycle (Q3W).	Cohort 8: 92 μg/kg Q3W n=3 Participants Participants received 92 μg/kg ADCT-301 formulation, intravenous infusion for 1 hour, on Day 1 of each 3-week (21-day) cycle (Q3W).	Cohort 9: 30 μg/kg QW Participants received 30 μg/kg ADCT-301 formulation, intravenous infusion for 1 hour, on Days 1, 8 and 15 (once weekly \[QW\]) of each 3-week (21 day) cycle.	Cohort 10: 37.5 μg/kg QW Participants received 37.5 μg/kg ADCT-301 formulation, intravenous infusion for 1 hour, on Days 1, 8 and 15 (once weekly \[QW\]) of each 3-week (21 day) cycle.	Cohort 1: 3 μg/kg Q3W Participants received 3 μg/kg ADCT-301 formulation, intravenous infusion for 1 hour, on Day 1 of each 3-week (21-day) cycle (Q3W).	Cohort 2: 6 μg/kg Q3W Participants received 6 μg/kg ADCT-301 formulation, intravenous infusion for 1 hour, on Day 1 of each 3-week (21-day) cycle (Q3W).	Cohort 3: 12 μg/kg Q3W Participants received 12 μg/kg ADCT-301 formulation, intravenous infusion for 1 hour, on Day 1 of each 3-week (21-day) cycle (Q3W).	Cohort 4: 22 μg/kg Q3W Participants received 22 μg/kg ADCT-301 formulation, intravenous infusion for 1 hour, on Day 1 of each 3-week (21-day) cycle (Q3W).
Accumulation Index (AI) for ADCT-301 for the Q3W Dosing Schedule PBD-conjugated Ab of ADCT-301: Cycle 2	1.00 ratio Geometric Coefficient of Variation 0.373	1.00 ratio Geometric Coefficient of Variation 0	1.00 ratio Geometric Coefficient of Variation 0.0434	1.00 ratio Geometric Coefficient of Variation NA Standard deviation could not be determined as only one participant had evaluable data.	—	—	—	—	—	—
Accumulation Index (AI) for ADCT-301 for the Q3W Dosing Schedule Total Ab of ADCT-301: Cycle 2	1.00 ratio Geometric Coefficient of Variation 0.416	1.00 ratio Geometric Coefficient of Variation NA Standard deviation could not be determined as only one participant had evaluable data.	1.00 ratio Geometric Coefficient of Variation 0.113	1.00 ratio Geometric Coefficient of Variation 0.000222	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Before infusion, end of infusion, 5, 24, 48, and 96 hours after infusion on days 1 and 8, and before and after infusion on Day 15 of Cycle 1 and 2 (1 cycle = 21 days)

AI for Pyrrolobenzodiazepine (PBD) conjugated antibody (Ab), total Ab and free warhead (SG3199) for QW cohort. AI is the ratio of area under the serum concentration-time curve (AUC) from 0 to 7 days divided by AUC from 7 to 14 days for Cycle 1.

Outcome measures

Outcome measures
Measure	Cohort 5: 32 μg/kg Q3W Participants received 32 μg/kg ADCT-301 formulation, intravenous infusion for 1 hour, on Day 1 of each 3-week (21-day) cycle (Q3W).	Cohort 6: 52 μg/kg Q3W Participants received 52 μg/kg ADCT-301 formulation, intravenous infusion for 1 hour, on Day 1 of each 3-week (21-day) cycle (Q3W).	Cohort 7: 72 μg/kg Q3W Participants received 72 μg/kg ADCT-301 formulation, intravenous infusion for 1 hour, on Day 1 of each 3-week (21-day) cycle (Q3W).	Cohort 8: 92 μg/kg Q3W Participants received 92 μg/kg ADCT-301 formulation, intravenous infusion for 1 hour, on Day 1 of each 3-week (21-day) cycle (Q3W).	Cohort 9: 30 μg/kg QW Participants received 30 μg/kg ADCT-301 formulation, intravenous infusion for 1 hour, on Days 1, 8 and 15 (once weekly \[QW\]) of each 3-week (21 day) cycle.	Cohort 10: 37.5 μg/kg QW Participants received 37.5 μg/kg ADCT-301 formulation, intravenous infusion for 1 hour, on Days 1, 8 and 15 (once weekly \[QW\]) of each 3-week (21 day) cycle.	Cohort 1: 3 μg/kg Q3W n=4 Participants Participants received 3 μg/kg ADCT-301 formulation, intravenous infusion for 1 hour, on Day 1 of each 3-week (21-day) cycle (Q3W).	Cohort 2: 6 μg/kg Q3W n=1 Participants Participants received 6 μg/kg ADCT-301 formulation, intravenous infusion for 1 hour, on Day 1 of each 3-week (21-day) cycle (Q3W).	Cohort 3: 12 μg/kg Q3W Participants received 12 μg/kg ADCT-301 formulation, intravenous infusion for 1 hour, on Day 1 of each 3-week (21-day) cycle (Q3W).	Cohort 4: 22 μg/kg Q3W Participants received 22 μg/kg ADCT-301 formulation, intravenous infusion for 1 hour, on Day 1 of each 3-week (21-day) cycle (Q3W).
Accumulation Index (AI) for ADCT-301 for the QW Dosing Schedule PBD-conjugated Ab of ADCT-301: Cycle 1 Week 2	—	—	—	—	—	—	1.13 ratio Geometric Coefficient of Variation 9.77	1.00 ratio Geometric Coefficient of Variation NA Standard deviation could not be determined as only one participant had evaluable data.	—	—
Accumulation Index (AI) for ADCT-301 for the QW Dosing Schedule Total Ab of ADCT-301: Cycle 1 Week 2	—	—	—	—	—	—	1.12 ratio Geometric Coefficient of Variation 14.3	1.00 ratio Geometric Coefficient of Variation NA Standard deviation could not be determined as only one participant had evaluable data.	—	—

SECONDARY outcome

Timeframe: Before infusion, end of infusion, 1, 3, 6, 24, 48, and 96 hours after infusion, and on Days 8 and 19 of Cycle 1 and 2 (1 cycle = 21 days)

Vss for Pyrrolobenzodiazepine (PBD) conjugated antibody (Ab), total Ab and free warhead (SG3199) for Q3W cohort.

Outcome measures

Outcome measures
Measure	Cohort 5: 32 μg/kg Q3W n=2 Participants Participants received 32 μg/kg ADCT-301 formulation, intravenous infusion for 1 hour, on Day 1 of each 3-week (21-day) cycle (Q3W).	Cohort 6: 52 μg/kg Q3W n=2 Participants Participants received 52 μg/kg ADCT-301 formulation, intravenous infusion for 1 hour, on Day 1 of each 3-week (21-day) cycle (Q3W).	Cohort 7: 72 μg/kg Q3W n=2 Participants Participants received 72 μg/kg ADCT-301 formulation, intravenous infusion for 1 hour, on Day 1 of each 3-week (21-day) cycle (Q3W).	Cohort 8: 92 μg/kg Q3W n=3 Participants Participants received 92 μg/kg ADCT-301 formulation, intravenous infusion for 1 hour, on Day 1 of each 3-week (21-day) cycle (Q3W).	Cohort 9: 30 μg/kg QW Participants received 30 μg/kg ADCT-301 formulation, intravenous infusion for 1 hour, on Days 1, 8 and 15 (once weekly \[QW\]) of each 3-week (21 day) cycle.	Cohort 10: 37.5 μg/kg QW Participants received 37.5 μg/kg ADCT-301 formulation, intravenous infusion for 1 hour, on Days 1, 8 and 15 (once weekly \[QW\]) of each 3-week (21 day) cycle.	Cohort 1: 3 μg/kg Q3W Participants received 3 μg/kg ADCT-301 formulation, intravenous infusion for 1 hour, on Day 1 of each 3-week (21-day) cycle (Q3W).	Cohort 2: 6 μg/kg Q3W Participants received 6 μg/kg ADCT-301 formulation, intravenous infusion for 1 hour, on Day 1 of each 3-week (21-day) cycle (Q3W).	Cohort 3: 12 μg/kg Q3W Participants received 12 μg/kg ADCT-301 formulation, intravenous infusion for 1 hour, on Day 1 of each 3-week (21-day) cycle (Q3W).	Cohort 4: 22 μg/kg Q3W Participants received 22 μg/kg ADCT-301 formulation, intravenous infusion for 1 hour, on Day 1 of each 3-week (21-day) cycle (Q3W).
Volume of Distribution at Steady-state (Vss) for ADCT-301 for the Q3W Dosing Schedule PBD-conjugated Ab of ADCT-301: Cycle 1	—	—	4.27 liters Geometric Coefficient of Variation NA Standard deviation could not be determined as only one participant had evaluable data.	7.34 liters Geometric Coefficient of Variation 120	—	—	—	—	—	—
Volume of Distribution at Steady-state (Vss) for ADCT-301 for the Q3W Dosing Schedule PBD-conjugated Ab of ADCT-301: Cycle 2	6.46 liters Geometric Coefficient of Variation 13.9	7.58 liters Geometric Coefficient of Variation 168	5.94 liters Geometric Coefficient of Variation 25.7	5.29 liters Geometric Coefficient of Variation NA Standard deviation could not be determined as only one participant had evaluable data.	—	—	—	—	—	—
Volume of Distribution at Steady-state (Vss) for ADCT-301 for the Q3W Dosing Schedule Total Ab of ADCT-301: Cycle 1	5.69 liters Geometric Coefficient of Variation 28.9	7.04 liters Geometric Coefficient of Variation NA Standard deviation could not be determined as only one participant had evaluable data.	4.54 liters Geometric Coefficient of Variation NA Standard deviation could not be determined as only one participant had evaluable data.	3.88 liters Geometric Coefficient of Variation NA Standard deviation could not be determined as only one participant had evaluable data.	—	—	—	—	—	—
Volume of Distribution at Steady-state (Vss) for ADCT-301 for the Q3W Dosing Schedule Total Ab of ADCT-301: Cycle 2	5.74 liters Geometric Coefficient of Variation 2.99	—	6.22 liters Geometric Coefficient of Variation 43.3	7.83 liters Geometric Coefficient of Variation 37.1	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Before infusion, end of infusion, 5, 24, 48, and 96 hours after infusion on days 1 and 8, and before and after infusion on Day 15 of Cycle 1 and 2 (1 cycle = 21 days)

Vss for Pyrrolobenzodiazepine (PBD) conjugated antibody (Ab), total Ab and free warhead (SG3199) for QW cohort.

Outcome measures

Outcome measures
Measure	Cohort 5: 32 μg/kg Q3W Participants received 32 μg/kg ADCT-301 formulation, intravenous infusion for 1 hour, on Day 1 of each 3-week (21-day) cycle (Q3W).	Cohort 6: 52 μg/kg Q3W Participants received 52 μg/kg ADCT-301 formulation, intravenous infusion for 1 hour, on Day 1 of each 3-week (21-day) cycle (Q3W).	Cohort 7: 72 μg/kg Q3W Participants received 72 μg/kg ADCT-301 formulation, intravenous infusion for 1 hour, on Day 1 of each 3-week (21-day) cycle (Q3W).	Cohort 8: 92 μg/kg Q3W Participants received 92 μg/kg ADCT-301 formulation, intravenous infusion for 1 hour, on Day 1 of each 3-week (21-day) cycle (Q3W).	Cohort 9: 30 μg/kg QW Participants received 30 μg/kg ADCT-301 formulation, intravenous infusion for 1 hour, on Days 1, 8 and 15 (once weekly \[QW\]) of each 3-week (21 day) cycle.	Cohort 10: 37.5 μg/kg QW Participants received 37.5 μg/kg ADCT-301 formulation, intravenous infusion for 1 hour, on Days 1, 8 and 15 (once weekly \[QW\]) of each 3-week (21 day) cycle.	Cohort 1: 3 μg/kg Q3W n=1 Participants Participants received 3 μg/kg ADCT-301 formulation, intravenous infusion for 1 hour, on Day 1 of each 3-week (21-day) cycle (Q3W).	Cohort 2: 6 μg/kg Q3W Participants received 6 μg/kg ADCT-301 formulation, intravenous infusion for 1 hour, on Day 1 of each 3-week (21-day) cycle (Q3W).	Cohort 3: 12 μg/kg Q3W Participants received 12 μg/kg ADCT-301 formulation, intravenous infusion for 1 hour, on Day 1 of each 3-week (21-day) cycle (Q3W).	Cohort 4: 22 μg/kg Q3W Participants received 22 μg/kg ADCT-301 formulation, intravenous infusion for 1 hour, on Day 1 of each 3-week (21-day) cycle (Q3W).
Volume of Distribution at Steady-state (Vss) for ADCT-301 for the QW Dosing Schedule Total Ab of ADCT-301: Cycle 1 Week 1	—	—	—	—	—	—	6.07 liters Geometric Coefficient of Variation NA Standard deviation could not be determined as only one participant had evaluable data.	—	—	—

SECONDARY outcome

Timeframe: Before infusion, end of infusion, 1, 3, 6, 24, 48, and 96 hours after infusion, and on Days 8 and 19 of Cycle 1 and 2 (1 cycle = 21 days)

Population: This analysis was planned, but data was not collected as the study was terminated prematurely.

MRT analysis was planned for Pyrrolobenzodiazepine (PBD) conjugated antibody (Ab), total Ab and free warhead (SG3199) for Q3W cohort.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Before infusion, end of infusion, 5, 24, 48, and 96 hours after infusion on days 1 and 8, and before and after infusion on Day 15 of Cycle 1 and 2 (1 cycle = 21 days)

Population: This analysis was planned, but data was not collected as the study was terminated prematurely.

MRT analysis was planned for Pyrrolobenzodiazepine (PBD) conjugated antibody (Ab), total Ab and free warhead (SG3199) for QW cohort.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Before infusion, end of infusion, 1, 3, 6, 24, 48, and 96 hours after infusion, and on Days 8 and 19 of Cycle 1 and 2 (1 cycle = 21 days)

Population: This analysis was planned, but data was not collected as the study was terminated prematurely.

λz analysis was planned for Pyrrolobenzodiazepine (PBD) conjugated antibody (Ab), total Ab and free warhead (SG3199) for Q3W cohort.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Before infusion, end of infusion, 5, 24, 48, and 96 hours after infusion on days 1 and 8, and before and after infusion on Day 15 of Cycle 1 and 2 (1 cycle = 21 days)

Population: This analysis was planned, but data was not collected as the study was terminated prematurely.

λz analysis was planned for Pyrrolobenzodiazepine (PBD) conjugated antibody (Ab), total Ab and free warhead (SG3199) for QW cohort.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Before infusion, end of infusion, 1, 3, 6, 24, 48, and 96 hours after infusion, and on Days 8 and 19 of Cycle 1 and 2 (1 cycle = 21 days)

Thalf for Pyrrolobenzodiazepine (PBD) conjugated antibody (Ab), total Ab and free warhead (SG3199) for Q3W cohort.

Outcome measures

Outcome measures
Measure	Cohort 5: 32 μg/kg Q3W n=2 Participants Participants received 32 μg/kg ADCT-301 formulation, intravenous infusion for 1 hour, on Day 1 of each 3-week (21-day) cycle (Q3W).	Cohort 6: 52 μg/kg Q3W n=2 Participants Participants received 52 μg/kg ADCT-301 formulation, intravenous infusion for 1 hour, on Day 1 of each 3-week (21-day) cycle (Q3W).	Cohort 7: 72 μg/kg Q3W n=2 Participants Participants received 72 μg/kg ADCT-301 formulation, intravenous infusion for 1 hour, on Day 1 of each 3-week (21-day) cycle (Q3W).	Cohort 8: 92 μg/kg Q3W n=3 Participants Participants received 92 μg/kg ADCT-301 formulation, intravenous infusion for 1 hour, on Day 1 of each 3-week (21-day) cycle (Q3W).	Cohort 9: 30 μg/kg QW Participants received 30 μg/kg ADCT-301 formulation, intravenous infusion for 1 hour, on Days 1, 8 and 15 (once weekly \[QW\]) of each 3-week (21 day) cycle.	Cohort 10: 37.5 μg/kg QW Participants received 37.5 μg/kg ADCT-301 formulation, intravenous infusion for 1 hour, on Days 1, 8 and 15 (once weekly \[QW\]) of each 3-week (21 day) cycle.	Cohort 1: 3 μg/kg Q3W Participants received 3 μg/kg ADCT-301 formulation, intravenous infusion for 1 hour, on Day 1 of each 3-week (21-day) cycle (Q3W).	Cohort 2: 6 μg/kg Q3W Participants received 6 μg/kg ADCT-301 formulation, intravenous infusion for 1 hour, on Day 1 of each 3-week (21-day) cycle (Q3W).	Cohort 3: 12 μg/kg Q3W Participants received 12 μg/kg ADCT-301 formulation, intravenous infusion for 1 hour, on Day 1 of each 3-week (21-day) cycle (Q3W).	Cohort 4: 22 μg/kg Q3W Participants received 22 μg/kg ADCT-301 formulation, intravenous infusion for 1 hour, on Day 1 of each 3-week (21-day) cycle (Q3W).
Apparent Terminal Phase Elimination Half-life (Thalf) for ADCT-301 for the Q3W Dosing Schedule PBD-conjugated Ab of ADCT-301: Cycle 1	—	—	2.28 days Geometric Coefficient of Variation NA Standard deviation could not be determined as only one participant had evaluable data.	0.446 days Geometric Coefficient of Variation 45.6	—	—	—	—	—	—
Apparent Terminal Phase Elimination Half-life (Thalf) for ADCT-301 for the Q3W Dosing Schedule PBD-conjugated Ab of ADCT-301: Cycle 2	1.80 days Geometric Coefficient of Variation 67.7	0.379 days Geometric Coefficient of Variation 63.9	1.36 days Geometric Coefficient of Variation 56.0	1.02 days Geometric Coefficient of Variation NA Standard deviation could not be determined as only one participant had evaluable data.	—	—	—	—	—	—
Apparent Terminal Phase Elimination Half-life (Thalf) for ADCT-301 for the Q3W Dosing Schedule Total Ab of ADCT-301: Cycle 1	0.995 days Geometric Coefficient of Variation 45.8	2.28 days Geometric Coefficient of Variation NA Standard deviation could not be determined as only one participant had evaluable data.	2.18 days Geometric Coefficient of Variation NA Standard deviation could not be determined as only one participant had evaluable data.	0.587 days Geometric Coefficient of Variation NA Standard deviation could not be determined as only one participant had evaluable data.	—	—	—	—	—	—
Apparent Terminal Phase Elimination Half-life (Thalf) for ADCT-301 for the Q3W Dosing Schedule Total Ab of ADCT-301: Cycle 2	1.96 days Geometric Coefficient of Variation 55.8	—	1.57 days Geometric Coefficient of Variation 55.5	0.451 days Geometric Coefficient of Variation 111	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Before infusion, end of infusion, 5, 24, 48, and 96 hours after infusion on days 1 and 8, and before and after infusion on Day 15 of Cycle 1 and 2 (1 cycle = 21 days)

Thalf for Pyrrolobenzodiazepine (PBD) conjugated antibody (Ab), total Ab and free warhead (SG3199) for QW cohort.

Outcome measures

Outcome measures
Measure	Cohort 5: 32 μg/kg Q3W Participants received 32 μg/kg ADCT-301 formulation, intravenous infusion for 1 hour, on Day 1 of each 3-week (21-day) cycle (Q3W).	Cohort 6: 52 μg/kg Q3W Participants received 52 μg/kg ADCT-301 formulation, intravenous infusion for 1 hour, on Day 1 of each 3-week (21-day) cycle (Q3W).	Cohort 7: 72 μg/kg Q3W Participants received 72 μg/kg ADCT-301 formulation, intravenous infusion for 1 hour, on Day 1 of each 3-week (21-day) cycle (Q3W).	Cohort 8: 92 μg/kg Q3W Participants received 92 μg/kg ADCT-301 formulation, intravenous infusion for 1 hour, on Day 1 of each 3-week (21-day) cycle (Q3W).	Cohort 9: 30 μg/kg QW Participants received 30 μg/kg ADCT-301 formulation, intravenous infusion for 1 hour, on Days 1, 8 and 15 (once weekly \[QW\]) of each 3-week (21 day) cycle.	Cohort 10: 37.5 μg/kg QW Participants received 37.5 μg/kg ADCT-301 formulation, intravenous infusion for 1 hour, on Days 1, 8 and 15 (once weekly \[QW\]) of each 3-week (21 day) cycle.	Cohort 1: 3 μg/kg Q3W n=1 Participants Participants received 3 μg/kg ADCT-301 formulation, intravenous infusion for 1 hour, on Day 1 of each 3-week (21-day) cycle (Q3W).	Cohort 2: 6 μg/kg Q3W Participants received 6 μg/kg ADCT-301 formulation, intravenous infusion for 1 hour, on Day 1 of each 3-week (21-day) cycle (Q3W).	Cohort 3: 12 μg/kg Q3W Participants received 12 μg/kg ADCT-301 formulation, intravenous infusion for 1 hour, on Day 1 of each 3-week (21-day) cycle (Q3W).	Cohort 4: 22 μg/kg Q3W Participants received 22 μg/kg ADCT-301 formulation, intravenous infusion for 1 hour, on Day 1 of each 3-week (21-day) cycle (Q3W).
Apparent Terminal Phase Elimination Half-life (Thalf) for ADCT-301 for the QW Dosing Schedule Total Ab of ADCT-301: Cycle 1 Week 1	—	—	—	—	—	—	0.719 days Geometric Coefficient of Variation NA Standard deviation could not be determined as only one participant had evaluable data.	—	—	—

SECONDARY outcome

Timeframe: Before infusion, end of infusion, 1, 3, 6, 24, 48, and 96 hours after infusion, and on Days 8 and 19 of Cycle 1 and 2 (1 cycle = 21 days)

CL for Pyrrolobenzodiazepine (PBD) conjugated antibody (Ab), total Ab and free warhead (SG3199) for Q3W cohort.

Outcome measures

Outcome measures
Measure	Cohort 5: 32 μg/kg Q3W n=2 Participants Participants received 32 μg/kg ADCT-301 formulation, intravenous infusion for 1 hour, on Day 1 of each 3-week (21-day) cycle (Q3W).	Cohort 6: 52 μg/kg Q3W n=2 Participants Participants received 52 μg/kg ADCT-301 formulation, intravenous infusion for 1 hour, on Day 1 of each 3-week (21-day) cycle (Q3W).	Cohort 7: 72 μg/kg Q3W n=2 Participants Participants received 72 μg/kg ADCT-301 formulation, intravenous infusion for 1 hour, on Day 1 of each 3-week (21-day) cycle (Q3W).	Cohort 8: 92 μg/kg Q3W n=3 Participants Participants received 92 μg/kg ADCT-301 formulation, intravenous infusion for 1 hour, on Day 1 of each 3-week (21-day) cycle (Q3W).	Cohort 9: 30 μg/kg QW Participants received 30 μg/kg ADCT-301 formulation, intravenous infusion for 1 hour, on Days 1, 8 and 15 (once weekly \[QW\]) of each 3-week (21 day) cycle.	Cohort 10: 37.5 μg/kg QW Participants received 37.5 μg/kg ADCT-301 formulation, intravenous infusion for 1 hour, on Days 1, 8 and 15 (once weekly \[QW\]) of each 3-week (21 day) cycle.	Cohort 1: 3 μg/kg Q3W Participants received 3 μg/kg ADCT-301 formulation, intravenous infusion for 1 hour, on Day 1 of each 3-week (21-day) cycle (Q3W).	Cohort 2: 6 μg/kg Q3W Participants received 6 μg/kg ADCT-301 formulation, intravenous infusion for 1 hour, on Day 1 of each 3-week (21-day) cycle (Q3W).	Cohort 3: 12 μg/kg Q3W Participants received 12 μg/kg ADCT-301 formulation, intravenous infusion for 1 hour, on Day 1 of each 3-week (21-day) cycle (Q3W).	Cohort 4: 22 μg/kg Q3W Participants received 22 μg/kg ADCT-301 formulation, intravenous infusion for 1 hour, on Day 1 of each 3-week (21-day) cycle (Q3W).
Clearance (CL) for ADCT-301 for the Q3W Dosing Schedule Total Ab of ADCT-301: Cycle 1	4.22 L/day Geometric Coefficient of Variation 86.9	2.21 L/day Geometric Coefficient of Variation NA Standard deviation could not be determined as only one participant had evaluable data.	1.75 L/day Geometric Coefficient of Variation NA Standard deviation could not be determined as only one participant had evaluable data.	5.36 L/day Geometric Coefficient of Variation NA Standard deviation could not be determined as only one participant had evaluable data.	—	—	—	—	—	—
Clearance (CL) for ADCT-301 for the Q3W Dosing Schedule PBD-conjugated Ab of ADCT-301: Cycle 1	—	—	1.67 L/day Geometric Coefficient of Variation NA Standard deviation could not be determined as only one participant had evaluable data.	12.5 L/day Geometric Coefficient of Variation 237	—	—	—	—	—	—
Clearance (CL) for ADCT-301 for the Q3W Dosing Schedule PBD-conjugated Ab of ADCT-301: Cycle 2	2.68 L/day Geometric Coefficient of Variation 40.6	14.5 L/day Geometric Coefficient of Variation 423	3.28 L/day Geometric Coefficient of Variation 84.1	8.20 L/day Geometric Coefficient of Variation 163	—	—	—	—	—	—
Clearance (CL) for ADCT-301 for the Q3W Dosing Schedule Total Ab of ADCT-301: Cycle 2	2.12 L/day Geometric Coefficient of Variation 54.5	—	2.96 L/day Geometric Coefficient of Variation 109	12.6 L/day Geometric Coefficient of Variation 151	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Before infusion, end of infusion, 5, 24, 48, and 96 hours after infusion on days 1 and 8, and before and after infusion on Day 15 of Cycle 1 and 2 (1 cycle = 21 days)

CL for Pyrrolobenzodiazepine (PBD) conjugated antibody (Ab), total Ab and free warhead (SG3199) for QW cohort.

Outcome measures

Outcome measures
Measure	Cohort 5: 32 μg/kg Q3W Participants received 32 μg/kg ADCT-301 formulation, intravenous infusion for 1 hour, on Day 1 of each 3-week (21-day) cycle (Q3W).	Cohort 6: 52 μg/kg Q3W Participants received 52 μg/kg ADCT-301 formulation, intravenous infusion for 1 hour, on Day 1 of each 3-week (21-day) cycle (Q3W).	Cohort 7: 72 μg/kg Q3W Participants received 72 μg/kg ADCT-301 formulation, intravenous infusion for 1 hour, on Day 1 of each 3-week (21-day) cycle (Q3W).	Cohort 8: 92 μg/kg Q3W Participants received 92 μg/kg ADCT-301 formulation, intravenous infusion for 1 hour, on Day 1 of each 3-week (21-day) cycle (Q3W).	Cohort 9: 30 μg/kg QW Participants received 30 μg/kg ADCT-301 formulation, intravenous infusion for 1 hour, on Days 1, 8 and 15 (once weekly \[QW\]) of each 3-week (21 day) cycle.	Cohort 10: 37.5 μg/kg QW Participants received 37.5 μg/kg ADCT-301 formulation, intravenous infusion for 1 hour, on Days 1, 8 and 15 (once weekly \[QW\]) of each 3-week (21 day) cycle.	Cohort 1: 3 μg/kg Q3W n=1 Participants Participants received 3 μg/kg ADCT-301 formulation, intravenous infusion for 1 hour, on Day 1 of each 3-week (21-day) cycle (Q3W).	Cohort 2: 6 μg/kg Q3W Participants received 6 μg/kg ADCT-301 formulation, intravenous infusion for 1 hour, on Day 1 of each 3-week (21-day) cycle (Q3W).	Cohort 3: 12 μg/kg Q3W Participants received 12 μg/kg ADCT-301 formulation, intravenous infusion for 1 hour, on Day 1 of each 3-week (21-day) cycle (Q3W).	Cohort 4: 22 μg/kg Q3W Participants received 22 μg/kg ADCT-301 formulation, intravenous infusion for 1 hour, on Day 1 of each 3-week (21-day) cycle (Q3W).
Clearance (CL) for ADCT-301 for the QW Dosing Schedule Total Ab of ADCT-301: Cycle 1 Week 1	—	—	—	—	—	—	6.59 L/day Geometric Coefficient of Variation NA Standard deviation could not be determined as only one participant had evaluable data.	—	—	—

SECONDARY outcome

Timeframe: Day 1 to the end of Cycle 2 (6 weeks)

Blood serum samples were collected and analysed to determine the presence or absence of ADA. Results were pooled for Part 1 participants as specified in the protocol.

Outcome measures

Outcome measures
Measure	Cohort 5: 32 μg/kg Q3W Participants received 32 μg/kg ADCT-301 formulation, intravenous infusion for 1 hour, on Day 1 of each 3-week (21-day) cycle (Q3W).	Cohort 6: 52 μg/kg Q3W Participants received 52 μg/kg ADCT-301 formulation, intravenous infusion for 1 hour, on Day 1 of each 3-week (21-day) cycle (Q3W).	Cohort 7: 72 μg/kg Q3W Participants received 72 μg/kg ADCT-301 formulation, intravenous infusion for 1 hour, on Day 1 of each 3-week (21-day) cycle (Q3W).	Cohort 8: 92 μg/kg Q3W Participants received 92 μg/kg ADCT-301 formulation, intravenous infusion for 1 hour, on Day 1 of each 3-week (21-day) cycle (Q3W).	Cohort 9: 30 μg/kg QW Participants received 30 μg/kg ADCT-301 formulation, intravenous infusion for 1 hour, on Days 1, 8 and 15 (once weekly \[QW\]) of each 3-week (21 day) cycle.	Cohort 10: 37.5 μg/kg QW Participants received 37.5 μg/kg ADCT-301 formulation, intravenous infusion for 1 hour, on Days 1, 8 and 15 (once weekly \[QW\]) of each 3-week (21 day) cycle.	Cohort 1: 3 μg/kg Q3W n=34 Participants Participants received 3 μg/kg ADCT-301 formulation, intravenous infusion for 1 hour, on Day 1 of each 3-week (21-day) cycle (Q3W).	Cohort 2: 6 μg/kg Q3W Participants received 6 μg/kg ADCT-301 formulation, intravenous infusion for 1 hour, on Day 1 of each 3-week (21-day) cycle (Q3W).	Cohort 3: 12 μg/kg Q3W Participants received 12 μg/kg ADCT-301 formulation, intravenous infusion for 1 hour, on Day 1 of each 3-week (21-day) cycle (Q3W).	Cohort 4: 22 μg/kg Q3W Participants received 22 μg/kg ADCT-301 formulation, intravenous infusion for 1 hour, on Day 1 of each 3-week (21-day) cycle (Q3W).
Number of Participants With Anti-drug Antibody Response (Against ADCT-301)	—	—	—	—	—	—	2 Participants	—	—	—

Adverse Events

Cohort 1: 3 μg/kg Q3W

Serious events: 2 serious events

Other events: 4 other events

Deaths: 4 deaths

Cohort 2: 6 μg/kg Q3W

Serious events: 1 serious events

Other events: 2 other events

Deaths: 3 deaths

Cohort 3: 12 μg/kg Q3W

Serious events: 2 serious events

Other events: 3 other events

Deaths: 3 deaths

Cohort 4: 22 μg/kg Q3W

Serious events: 3 serious events

Other events: 3 other events

Deaths: 3 deaths

Cohort 5: 32 μg/kg Q3W

Serious events: 1 serious events

Other events: 3 other events

Deaths: 2 deaths

Cohort 6: 52 μg/kg Q3W

Serious events: 2 serious events

Other events: 3 other events

Deaths: 2 deaths

Cohort 7: 72 μg/kg Q3W

Serious events: 2 serious events

Other events: 3 other events

Deaths: 2 deaths

Cohort 8: 92 μg/kg Q3W

Serious events: 2 serious events

Other events: 4 other events

Deaths: 1 deaths

Cohort 9: 30 μg/kg QW

Serious events: 5 serious events

Other events: 6 other events

Deaths: 5 deaths

Cohort 10: 37.5 μg/kg QW

Serious events: 3 serious events

Other events: 3 other events

Deaths: 2 deaths

Serious adverse events

Serious adverse events
Measure	Cohort 1: 3 μg/kg Q3W n=4 participants at risk Participants received 3 μg/kg ADCT-301 formulation, intravenous infusion for 1 hour, on Day 1 of each 3-week (21-day) cycle (Q3W).	Cohort 2: 6 μg/kg Q3W n=3 participants at risk Participants received 6 μg/kg ADCT-301 formulation, intravenous infusion for 1 hour, on Day 1 of each 3-week (21-day) cycle (Q3W).	Cohort 3: 12 μg/kg Q3W n=3 participants at risk Participants received 12 μg/kg ADCT-301 formulation, intravenous infusion for 1 hour, on Day 1 of each 3-week (21-day) cycle (Q3W).	Cohort 4: 22 μg/kg Q3W n=3 participants at risk Participants received 22 μg/kg ADCT-301 formulation, intravenous infusion for 1 hour, on Day 1 of each 3-week (21-day) cycle (Q3W).	Cohort 5: 32 μg/kg Q3W n=3 participants at risk Participants received 32 μg/kg ADCT-301 formulation, intravenous infusion for 1 hour, on Day 1 of each 3-week (21-day) cycle (Q3W).	Cohort 6: 52 μg/kg Q3W n=3 participants at risk Participants received 52 μg/kg ADCT-301 formulation, intravenous infusion for 1 hour, on Day 1 of each 3-week (21-day) cycle (Q3W).	Cohort 7: 72 μg/kg Q3W n=3 participants at risk Participants received 72 μg/kg ADCT-301 formulation, intravenous infusion for 1 hour, on Day 1 of each 3-week (21-day) cycle (Q3W).	Cohort 8: 92 μg/kg Q3W n=4 participants at risk Participants received 92 μg/kg ADCT-301 formulation, intravenous infusion for 1 hour, on Day 1 of each 3-week (21-day) cycle (Q3W).	Cohort 9: 30 μg/kg QW n=6 participants at risk Participants received 30 μg/kg ADCT-301 formulation, intravenous infusion for 1 hour, on Days 1, 8 and 15 (once weekly \[QW\]) of each 3-week (21 day) cycle.	Cohort 10: 37.5 μg/kg QW n=3 participants at risk Participants received 37.5 μg/kg ADCT-301 formulation, intravenous infusion for 1 hour, on Days 1, 8 and 15 (once weekly \[QW\]) of each 3-week (21 day) cycle.
Blood and lymphatic system disorders Febrile Neutropenia	0.00% 0/4 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	66.7% 2/3 • Number of events 2 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	33.3% 1/3 • Number of events 1 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	33.3% 1/3 • Number of events 2 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/4 • Day 1 to a maximum of 24 weeks (+ 30 days)	33.3% 2/6 • Number of events 2 • Day 1 to a maximum of 24 weeks (+ 30 days)	66.7% 2/3 • Number of events 3 • Day 1 to a maximum of 24 weeks (+ 30 days)
Cardiac disorders Atrial Fibrillation	0.00% 0/4 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	33.3% 1/3 • Number of events 1 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/4 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/6 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)
Cardiac disorders Cardiac Arrest	25.0% 1/4 • Number of events 1 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/4 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/6 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)
Cardiac disorders Pericarditis	0.00% 0/4 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	33.3% 1/3 • Number of events 1 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/4 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/6 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)
Cardiac disorders Supraventricular Tachycardia	0.00% 0/4 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	25.0% 1/4 • Number of events 1 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/6 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)
Gastrointestinal disorders Abdominal Pain	0.00% 0/4 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/4 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/6 • Day 1 to a maximum of 24 weeks (+ 30 days)	33.3% 1/3 • Number of events 1 • Day 1 to a maximum of 24 weeks (+ 30 days)
Gastrointestinal disorders Intra-abdominal Haemorrhage	0.00% 0/4 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	33.3% 1/3 • Number of events 1 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/4 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/6 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)
Gastrointestinal disorders Stomatitis	0.00% 0/4 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	33.3% 1/3 • Number of events 1 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/4 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/6 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)
General disorders Disease Progression	0.00% 0/4 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	66.7% 2/3 • Number of events 2 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/4 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/6 • Day 1 to a maximum of 24 weeks (+ 30 days)	33.3% 1/3 • Number of events 1 • Day 1 to a maximum of 24 weeks (+ 30 days)
General disorders Non-cardiac Chest Pain	0.00% 0/4 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	33.3% 1/3 • Number of events 1 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/4 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/6 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)
General disorders Pain	0.00% 0/4 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	33.3% 1/3 • Number of events 1 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/4 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/6 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)
General disorders Pyrexia	0.00% 0/4 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	33.3% 1/3 • Number of events 1 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/4 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/6 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)
Infections and infestations Lung Infection	0.00% 0/4 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	33.3% 1/3 • Number of events 1 • Day 1 to a maximum of 24 weeks (+ 30 days)	33.3% 1/3 • Number of events 1 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/4 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/6 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)
Infections and infestations Pneumonia	0.00% 0/4 • Day 1 to a maximum of 24 weeks (+ 30 days)	33.3% 1/3 • Number of events 1 • Day 1 to a maximum of 24 weeks (+ 30 days)	33.3% 1/3 • Number of events 1 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	33.3% 1/3 • Number of events 1 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/4 • Day 1 to a maximum of 24 weeks (+ 30 days)	33.3% 2/6 • Number of events 2 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)
Infections and infestations Streptococcal Bacteraemia	0.00% 0/4 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/4 • Day 1 to a maximum of 24 weeks (+ 30 days)	16.7% 1/6 • Number of events 1 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)
Infections and infestations Urinary Tract Infection	0.00% 0/4 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/4 • Day 1 to a maximum of 24 weeks (+ 30 days)	16.7% 1/6 • Number of events 1 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)
Infections and infestations Urinary Tract Infection Enterococcal	0.00% 0/4 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/4 • Day 1 to a maximum of 24 weeks (+ 30 days)	16.7% 1/6 • Number of events 1 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)
Injury, poisoning and procedural complications Subdural Haemorrhage	0.00% 0/4 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/4 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/6 • Day 1 to a maximum of 24 weeks (+ 30 days)	33.3% 1/3 • Number of events 1 • Day 1 to a maximum of 24 weeks (+ 30 days)
Metabolism and nutrition disorders Decreased Appetite	0.00% 0/4 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/4 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/6 • Day 1 to a maximum of 24 weeks (+ 30 days)	33.3% 1/3 • Number of events 1 • Day 1 to a maximum of 24 weeks (+ 30 days)
Metabolism and nutrition disorders Failure to Thrive	0.00% 0/4 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/4 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/6 • Day 1 to a maximum of 24 weeks (+ 30 days)	33.3% 1/3 • Number of events 2 • Day 1 to a maximum of 24 weeks (+ 30 days)
Metabolism and nutrition disorders Hyperglycaemia	0.00% 0/4 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/4 • Day 1 to a maximum of 24 weeks (+ 30 days)	16.7% 1/6 • Number of events 1 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)
Musculoskeletal and connective tissue disorders Arthralgia	25.0% 1/4 • Number of events 1 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/4 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/6 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)
Musculoskeletal and connective tissue disorders Back Pain	0.00% 0/4 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	33.3% 1/3 • Number of events 2 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/4 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/6 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Acute Lymphocytic Leukaemia	0.00% 0/4 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/4 • Day 1 to a maximum of 24 weeks (+ 30 days)	16.7% 1/6 • Number of events 1 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Acute Myeloid Leukaemia	0.00% 0/4 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	33.3% 1/3 • Number of events 1 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	66.7% 2/3 • Number of events 2 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/4 • Day 1 to a maximum of 24 weeks (+ 30 days)	16.7% 1/6 • Number of events 1 • Day 1 to a maximum of 24 weeks (+ 30 days)	33.3% 1/3 • Number of events 1 • Day 1 to a maximum of 24 weeks (+ 30 days)
Nervous system disorders Subarachnoid Haemorrhage	0.00% 0/4 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/4 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/6 • Day 1 to a maximum of 24 weeks (+ 30 days)	33.3% 1/3 • Number of events 1 • Day 1 to a maximum of 24 weeks (+ 30 days)
Psychiatric disorders Anxiety	0.00% 0/4 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	33.3% 1/3 • Number of events 1 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/4 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/6 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)
Renal and urinary disorders Haematuria	0.00% 0/4 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/4 • Day 1 to a maximum of 24 weeks (+ 30 days)	16.7% 1/6 • Number of events 1 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/4 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	25.0% 1/4 • Number of events 1 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/6 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)
Skin and subcutaneous tissue disorders Rash Maculo-papular	0.00% 0/4 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	33.3% 1/3 • Number of events 1 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/4 • Day 1 to a maximum of 24 weeks (+ 30 days)	33.3% 2/6 • Number of events 2 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)
Vascular disorders Hypotension	0.00% 0/4 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	33.3% 1/3 • Number of events 1 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/4 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/6 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)

Other adverse events

Other adverse events
Measure	Cohort 1: 3 μg/kg Q3W n=4 participants at risk Participants received 3 μg/kg ADCT-301 formulation, intravenous infusion for 1 hour, on Day 1 of each 3-week (21-day) cycle (Q3W).	Cohort 2: 6 μg/kg Q3W n=3 participants at risk Participants received 6 μg/kg ADCT-301 formulation, intravenous infusion for 1 hour, on Day 1 of each 3-week (21-day) cycle (Q3W).	Cohort 3: 12 μg/kg Q3W n=3 participants at risk Participants received 12 μg/kg ADCT-301 formulation, intravenous infusion for 1 hour, on Day 1 of each 3-week (21-day) cycle (Q3W).	Cohort 4: 22 μg/kg Q3W n=3 participants at risk Participants received 22 μg/kg ADCT-301 formulation, intravenous infusion for 1 hour, on Day 1 of each 3-week (21-day) cycle (Q3W).	Cohort 5: 32 μg/kg Q3W n=3 participants at risk Participants received 32 μg/kg ADCT-301 formulation, intravenous infusion for 1 hour, on Day 1 of each 3-week (21-day) cycle (Q3W).	Cohort 6: 52 μg/kg Q3W n=3 participants at risk Participants received 52 μg/kg ADCT-301 formulation, intravenous infusion for 1 hour, on Day 1 of each 3-week (21-day) cycle (Q3W).	Cohort 7: 72 μg/kg Q3W n=3 participants at risk Participants received 72 μg/kg ADCT-301 formulation, intravenous infusion for 1 hour, on Day 1 of each 3-week (21-day) cycle (Q3W).	Cohort 8: 92 μg/kg Q3W n=4 participants at risk Participants received 92 μg/kg ADCT-301 formulation, intravenous infusion for 1 hour, on Day 1 of each 3-week (21-day) cycle (Q3W).	Cohort 9: 30 μg/kg QW n=6 participants at risk Participants received 30 μg/kg ADCT-301 formulation, intravenous infusion for 1 hour, on Days 1, 8 and 15 (once weekly \[QW\]) of each 3-week (21 day) cycle.	Cohort 10: 37.5 μg/kg QW n=3 participants at risk Participants received 37.5 μg/kg ADCT-301 formulation, intravenous infusion for 1 hour, on Days 1, 8 and 15 (once weekly \[QW\]) of each 3-week (21 day) cycle.
Gastrointestinal disorders Dry Mouth	0.00% 0/4 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	33.3% 1/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	33.3% 1/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/4 • Day 1 to a maximum of 24 weeks (+ 30 days)	16.7% 1/6 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)
Injury, poisoning and procedural complications Head Injury	0.00% 0/4 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	33.3% 1/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/4 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/6 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)
Vascular disorders Hypertension	0.00% 0/4 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	33.3% 1/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	25.0% 1/4 • Day 1 to a maximum of 24 weeks (+ 30 days)	16.7% 1/6 • Day 1 to a maximum of 24 weeks (+ 30 days)	33.3% 1/3 • Day 1 to a maximum of 24 weeks (+ 30 days)
Reproductive system and breast disorders Balanoposthitis	0.00% 0/4 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	33.3% 1/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/4 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/6 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)
Injury, poisoning and procedural complications Laceration	0.00% 0/4 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/4 • Day 1 to a maximum of 24 weeks (+ 30 days)	16.7% 1/6 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)
Skin and subcutaneous tissue disorders Skin Exfoliation	0.00% 0/4 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	33.3% 1/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/4 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/6 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)
Skin and subcutaneous tissue disorders Skin Lesion	0.00% 0/4 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	33.3% 1/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/4 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/6 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)
Skin and subcutaneous tissue disorders Skin Mass	25.0% 1/4 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/4 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/6 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)
Respiratory, thoracic and mediastinal disorders Oropharyngeal Pain	25.0% 1/4 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	33.3% 1/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/4 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/6 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)
Respiratory, thoracic and mediastinal disorders Pleural Effusion	0.00% 0/4 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/4 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/6 • Day 1 to a maximum of 24 weeks (+ 30 days)	66.7% 2/3 • Day 1 to a maximum of 24 weeks (+ 30 days)
Respiratory, thoracic and mediastinal disorders Atelectasis	0.00% 0/4 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/4 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/6 • Day 1 to a maximum of 24 weeks (+ 30 days)	33.3% 1/3 • Day 1 to a maximum of 24 weeks (+ 30 days)
Respiratory, thoracic and mediastinal disorders Hypoxia	0.00% 0/4 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	33.3% 1/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/4 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/6 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)
Respiratory, thoracic and mediastinal disorders Nasal Congestion	0.00% 0/4 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	25.0% 1/4 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/6 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)
Respiratory, thoracic and mediastinal disorders Pneumonitis	0.00% 0/4 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	33.3% 1/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/4 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/6 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)
Respiratory, thoracic and mediastinal disorders Productive Cough	0.00% 0/4 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	33.3% 1/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/4 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/6 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)
Respiratory, thoracic and mediastinal disorders Rhinitis Allergic	0.00% 0/4 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/4 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/6 • Day 1 to a maximum of 24 weeks (+ 30 days)	33.3% 1/3 • Day 1 to a maximum of 24 weeks (+ 30 days)
Respiratory, thoracic and mediastinal disorders Rhinorrhoea	0.00% 0/4 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/4 • Day 1 to a maximum of 24 weeks (+ 30 days)	16.7% 1/6 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)
Respiratory, thoracic and mediastinal disorders Sinus Congestion	0.00% 0/4 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	33.3% 1/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/4 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/6 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)
Respiratory, thoracic and mediastinal disorders Wheezing	0.00% 0/4 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	33.3% 1/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/4 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/6 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)
Skin and subcutaneous tissue disorders Rash Maculo-papular	0.00% 0/4 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	33.3% 1/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	33.3% 1/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/4 • Day 1 to a maximum of 24 weeks (+ 30 days)	16.7% 1/6 • Day 1 to a maximum of 24 weeks (+ 30 days)	33.3% 1/3 • Day 1 to a maximum of 24 weeks (+ 30 days)
Skin and subcutaneous tissue disorders Dry Skin	0.00% 0/4 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	33.3% 1/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	33.3% 1/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/4 • Day 1 to a maximum of 24 weeks (+ 30 days)	16.7% 1/6 • Day 1 to a maximum of 24 weeks (+ 30 days)	33.3% 1/3 • Day 1 to a maximum of 24 weeks (+ 30 days)
Skin and subcutaneous tissue disorders Rash	25.0% 1/4 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	33.3% 1/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/4 • Day 1 to a maximum of 24 weeks (+ 30 days)	16.7% 1/6 • Day 1 to a maximum of 24 weeks (+ 30 days)	33.3% 1/3 • Day 1 to a maximum of 24 weeks (+ 30 days)
Skin and subcutaneous tissue disorders Pruritus	0.00% 0/4 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	33.3% 1/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/4 • Day 1 to a maximum of 24 weeks (+ 30 days)	16.7% 1/6 • Day 1 to a maximum of 24 weeks (+ 30 days)	33.3% 1/3 • Day 1 to a maximum of 24 weeks (+ 30 days)
Skin and subcutaneous tissue disorders Urticaria	0.00% 0/4 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/4 • Day 1 to a maximum of 24 weeks (+ 30 days)	16.7% 1/6 • Day 1 to a maximum of 24 weeks (+ 30 days)	33.3% 1/3 • Day 1 to a maximum of 24 weeks (+ 30 days)
Skin and subcutaneous tissue disorders Alopecia	0.00% 0/4 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/4 • Day 1 to a maximum of 24 weeks (+ 30 days)	16.7% 1/6 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)
Skin and subcutaneous tissue disorders Blister	0.00% 0/4 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	33.3% 1/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/4 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/6 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)
Skin and subcutaneous tissue disorders Cold Sweat	0.00% 0/4 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/4 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/6 • Day 1 to a maximum of 24 weeks (+ 30 days)	33.3% 1/3 • Day 1 to a maximum of 24 weeks (+ 30 days)
Skin and subcutaneous tissue disorders Decubitus Ulcer	0.00% 0/4 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	33.3% 1/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/4 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/6 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)
Skin and subcutaneous tissue disorders Dermal Cyst	0.00% 0/4 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	33.3% 1/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/4 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/6 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)
Skin and subcutaneous tissue disorders Ecchymosis	0.00% 0/4 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	33.3% 1/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/4 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/6 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)
Skin and subcutaneous tissue disorders Erythema	0.00% 0/4 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/4 • Day 1 to a maximum of 24 weeks (+ 30 days)	16.7% 1/6 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)
Skin and subcutaneous tissue disorders Hypersensitivity Vasculitis	0.00% 0/4 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/4 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/6 • Day 1 to a maximum of 24 weeks (+ 30 days)	33.3% 1/3 • Day 1 to a maximum of 24 weeks (+ 30 days)
Skin and subcutaneous tissue disorders Petechiae	0.00% 0/4 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/4 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/6 • Day 1 to a maximum of 24 weeks (+ 30 days)	33.3% 1/3 • Day 1 to a maximum of 24 weeks (+ 30 days)
Skin and subcutaneous tissue disorders Rash Pruritic	0.00% 0/4 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	33.3% 1/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/4 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/6 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)
Skin and subcutaneous tissue disorders Skin Discolouration	0.00% 0/4 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	33.3% 1/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/4 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/6 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)
Skin and subcutaneous tissue disorders Capillary Leak Syndrome	0.00% 0/4 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/4 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/6 • Day 1 to a maximum of 24 weeks (+ 30 days)	33.3% 1/3 • Day 1 to a maximum of 24 weeks (+ 30 days)
Skin and subcutaneous tissue disorders Lymphoedema	0.00% 0/4 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/4 • Day 1 to a maximum of 24 weeks (+ 30 days)	16.7% 1/6 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)
Gastrointestinal disorders Abdominal Pain Lower	0.00% 0/4 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	33.3% 1/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/4 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/6 • Day 1 to a maximum of 24 weeks (+ 30 days)	33.3% 1/3 • Day 1 to a maximum of 24 weeks (+ 30 days)
Gastrointestinal disorders Flatulence	0.00% 0/4 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/4 • Day 1 to a maximum of 24 weeks (+ 30 days)	16.7% 1/6 • Day 1 to a maximum of 24 weeks (+ 30 days)	33.3% 1/3 • Day 1 to a maximum of 24 weeks (+ 30 days)
Gastrointestinal disorders Oral Pain	0.00% 0/4 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	66.7% 2/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/4 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/6 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)
Gastrointestinal disorders Stomatitis	0.00% 0/4 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	33.3% 1/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	33.3% 1/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/4 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/6 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)
Blood and lymphatic system disorders Febrile Neutropenia	0.00% 0/4 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	33.3% 1/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/4 • Day 1 to a maximum of 24 weeks (+ 30 days)	16.7% 1/6 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)
Blood and lymphatic system disorders Anaemia	0.00% 0/4 • Day 1 to a maximum of 24 weeks (+ 30 days)	33.3% 1/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	33.3% 1/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/4 • Day 1 to a maximum of 24 weeks (+ 30 days)	33.3% 2/6 • Day 1 to a maximum of 24 weeks (+ 30 days)	33.3% 1/3 • Day 1 to a maximum of 24 weeks (+ 30 days)
Blood and lymphatic system disorders Lymphopenia	0.00% 0/4 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	33.3% 1/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/4 • Day 1 to a maximum of 24 weeks (+ 30 days)	33.3% 2/6 • Day 1 to a maximum of 24 weeks (+ 30 days)	66.7% 2/3 • Day 1 to a maximum of 24 weeks (+ 30 days)
Blood and lymphatic system disorders Thrombocytopenia	0.00% 0/4 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	33.3% 1/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	33.3% 1/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	33.3% 1/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/4 • Day 1 to a maximum of 24 weeks (+ 30 days)	33.3% 2/6 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)
Blood and lymphatic system disorders Leukocytosis	0.00% 0/4 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	33.3% 1/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/4 • Day 1 to a maximum of 24 weeks (+ 30 days)	16.7% 1/6 • Day 1 to a maximum of 24 weeks (+ 30 days)	33.3% 1/3 • Day 1 to a maximum of 24 weeks (+ 30 days)
Blood and lymphatic system disorders Leukopenia	0.00% 0/4 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	33.3% 1/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	25.0% 1/4 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/6 • Day 1 to a maximum of 24 weeks (+ 30 days)	33.3% 1/3 • Day 1 to a maximum of 24 weeks (+ 30 days)
Blood and lymphatic system disorders Neutropenia	0.00% 0/4 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	33.3% 1/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/4 • Day 1 to a maximum of 24 weeks (+ 30 days)	16.7% 1/6 • Day 1 to a maximum of 24 weeks (+ 30 days)	33.3% 1/3 • Day 1 to a maximum of 24 weeks (+ 30 days)
Blood and lymphatic system disorders Lymphocytosis	0.00% 0/4 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	33.3% 1/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/4 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/6 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)
Cardiac disorders Palpitations	0.00% 0/4 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	25.0% 1/4 • Day 1 to a maximum of 24 weeks (+ 30 days)	16.7% 1/6 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)
Cardiac disorders Tachycardia	0.00% 0/4 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	33.3% 1/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/4 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/6 • Day 1 to a maximum of 24 weeks (+ 30 days)	33.3% 1/3 • Day 1 to a maximum of 24 weeks (+ 30 days)
Cardiac disorders Angina Pectoris	0.00% 0/4 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/4 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/6 • Day 1 to a maximum of 24 weeks (+ 30 days)	33.3% 1/3 • Day 1 to a maximum of 24 weeks (+ 30 days)
Cardiac disorders Pericarditis	0.00% 0/4 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	33.3% 1/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/4 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/6 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)
Cardiac disorders Sinus Tachycardia	0.00% 0/4 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/4 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/6 • Day 1 to a maximum of 24 weeks (+ 30 days)	33.3% 1/3 • Day 1 to a maximum of 24 weeks (+ 30 days)
Eye disorders Vision Blurred	0.00% 0/4 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	33.3% 1/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/4 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/6 • Day 1 to a maximum of 24 weeks (+ 30 days)	33.3% 1/3 • Day 1 to a maximum of 24 weeks (+ 30 days)
Eye disorders Dry Eye	0.00% 0/4 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	33.3% 1/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/4 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/6 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)
Eye disorders Eye Pain	0.00% 0/4 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/4 • Day 1 to a maximum of 24 weeks (+ 30 days)	16.7% 1/6 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)
Eye disorders Ocular Hyperaemia	0.00% 0/4 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/4 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/6 • Day 1 to a maximum of 24 weeks (+ 30 days)	33.3% 1/3 • Day 1 to a maximum of 24 weeks (+ 30 days)
Eye disorders Pupillary Reflex Impaired	0.00% 0/4 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/4 • Day 1 to a maximum of 24 weeks (+ 30 days)	16.7% 1/6 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)
Gastrointestinal disorders Nausea	0.00% 0/4 • Day 1 to a maximum of 24 weeks (+ 30 days)	33.3% 1/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	66.7% 2/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	33.3% 1/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	50.0% 2/4 • Day 1 to a maximum of 24 weeks (+ 30 days)	16.7% 1/6 • Day 1 to a maximum of 24 weeks (+ 30 days)	33.3% 1/3 • Day 1 to a maximum of 24 weeks (+ 30 days)
Gastrointestinal disorders Diarrhoea	0.00% 0/4 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	33.3% 1/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	33.3% 1/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	33.3% 1/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	33.3% 1/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	25.0% 1/4 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/6 • Day 1 to a maximum of 24 weeks (+ 30 days)	66.7% 2/3 • Day 1 to a maximum of 24 weeks (+ 30 days)
Gastrointestinal disorders Constipation	0.00% 0/4 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	33.3% 1/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	33.3% 1/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	66.7% 2/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	33.3% 1/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/4 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/6 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)
Gastrointestinal disorders Vomiting	0.00% 0/4 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	33.3% 1/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	33.3% 1/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	33.3% 1/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/4 • Day 1 to a maximum of 24 weeks (+ 30 days)	16.7% 1/6 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)
Gastrointestinal disorders Abdominal Distension	0.00% 0/4 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/4 • Day 1 to a maximum of 24 weeks (+ 30 days)	16.7% 1/6 • Day 1 to a maximum of 24 weeks (+ 30 days)	33.3% 1/3 • Day 1 to a maximum of 24 weeks (+ 30 days)
Gastrointestinal disorders Abdominal Pain	0.00% 0/4 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	33.3% 1/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/4 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/6 • Day 1 to a maximum of 24 weeks (+ 30 days)	33.3% 1/3 • Day 1 to a maximum of 24 weeks (+ 30 days)
Gastrointestinal disorders Abdominal Pain Upper	0.00% 0/4 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	33.3% 1/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/4 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/6 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)
Gastrointestinal disorders Ascites	0.00% 0/4 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/4 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/6 • Day 1 to a maximum of 24 weeks (+ 30 days)	33.3% 1/3 • Day 1 to a maximum of 24 weeks (+ 30 days)
Gastrointestinal disorders Dysphagia	0.00% 0/4 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	25.0% 1/4 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/6 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)
Gastrointestinal disorders Enteritis	0.00% 0/4 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/4 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/6 • Day 1 to a maximum of 24 weeks (+ 30 days)	33.3% 1/3 • Day 1 to a maximum of 24 weeks (+ 30 days)
Gastrointestinal disorders Eructation	0.00% 0/4 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/4 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/6 • Day 1 to a maximum of 24 weeks (+ 30 days)	33.3% 1/3 • Day 1 to a maximum of 24 weeks (+ 30 days)
Gastrointestinal disorders Gastrooesophageal Reflux Disease	0.00% 0/4 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	33.3% 1/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/4 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/6 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)
Gastrointestinal disorders Lip Ulceration	0.00% 0/4 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	33.3% 1/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/4 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/6 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)
Gastrointestinal disorders Melaena	0.00% 0/4 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	33.3% 1/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/4 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/6 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)
Gastrointestinal disorders Mouth Ulceration	0.00% 0/4 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/4 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/6 • Day 1 to a maximum of 24 weeks (+ 30 days)	33.3% 1/3 • Day 1 to a maximum of 24 weeks (+ 30 days)
Gastrointestinal disorders Oral Mucosa Haematoma	0.00% 0/4 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/4 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/6 • Day 1 to a maximum of 24 weeks (+ 30 days)	33.3% 1/3 • Day 1 to a maximum of 24 weeks (+ 30 days)
Gastrointestinal disorders Tongue Coated	0.00% 0/4 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	33.3% 1/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/4 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/6 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)
General disorders Fatigue	0.00% 0/4 • Day 1 to a maximum of 24 weeks (+ 30 days)	33.3% 1/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	33.3% 1/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	33.3% 1/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	33.3% 1/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	33.3% 1/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	50.0% 2/4 • Day 1 to a maximum of 24 weeks (+ 30 days)	50.0% 3/6 • Day 1 to a maximum of 24 weeks (+ 30 days)	33.3% 1/3 • Day 1 to a maximum of 24 weeks (+ 30 days)
General disorders Pyrexia	0.00% 0/4 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	33.3% 1/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	66.7% 2/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	33.3% 1/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	25.0% 1/4 • Day 1 to a maximum of 24 weeks (+ 30 days)	16.7% 1/6 • Day 1 to a maximum of 24 weeks (+ 30 days)	33.3% 1/3 • Day 1 to a maximum of 24 weeks (+ 30 days)
General disorders Oedema Peripheral	25.0% 1/4 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	33.3% 1/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	33.3% 1/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	33.3% 1/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/4 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/6 • Day 1 to a maximum of 24 weeks (+ 30 days)	33.3% 1/3 • Day 1 to a maximum of 24 weeks (+ 30 days)
General disorders Mucosal Inflammation	0.00% 0/4 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	33.3% 1/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	33.3% 1/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	33.3% 1/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/4 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/6 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)
General disorders Asthenia	0.00% 0/4 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	33.3% 1/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/4 • Day 1 to a maximum of 24 weeks (+ 30 days)	16.7% 1/6 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)
General disorders Catheter Site Pain	0.00% 0/4 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/4 • Day 1 to a maximum of 24 weeks (+ 30 days)	33.3% 2/6 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)
General disorders Chills	0.00% 0/4 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/4 • Day 1 to a maximum of 24 weeks (+ 30 days)	33.3% 2/6 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)
General disorders Non-cardiac Chest Pain	0.00% 0/4 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	33.3% 1/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/4 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/6 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)
General disorders Pain	0.00% 0/4 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/4 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/6 • Day 1 to a maximum of 24 weeks (+ 30 days)	33.3% 1/3 • Day 1 to a maximum of 24 weeks (+ 30 days)
General disorders Gait Disturbance	25.0% 1/4 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/4 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/6 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)
General disorders Peripheral Swelling	0.00% 0/4 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	33.3% 1/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/4 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/6 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)
Hepatobiliary disorders Hyperbilirubinaemia	0.00% 0/4 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/4 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/6 • Day 1 to a maximum of 24 weeks (+ 30 days)	66.7% 2/3 • Day 1 to a maximum of 24 weeks (+ 30 days)
Immune system disorders Graft versus Host Disease	0.00% 0/4 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/4 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/6 • Day 1 to a maximum of 24 weeks (+ 30 days)	33.3% 1/3 • Day 1 to a maximum of 24 weeks (+ 30 days)
Infections and infestations Pneumonia	0.00% 0/4 • Day 1 to a maximum of 24 weeks (+ 30 days)	33.3% 1/3 • Number of events 1 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	33.3% 1/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	25.0% 1/4 • Day 1 to a maximum of 24 weeks (+ 30 days)	16.7% 1/6 • Day 1 to a maximum of 24 weeks (+ 30 days)	33.3% 1/3 • Day 1 to a maximum of 24 weeks (+ 30 days)
Infections and infestations Anorectal Infection	0.00% 0/4 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	33.3% 1/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/4 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/6 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)
Infections and infestations Device Related Infection	0.00% 0/4 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/4 • Day 1 to a maximum of 24 weeks (+ 30 days)	16.7% 1/6 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)
Infections and infestations Diverticulitis	0.00% 0/4 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	33.3% 1/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/4 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/6 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)
Infections and infestations Epiglottitis	0.00% 0/4 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	25.0% 1/4 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/6 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)
Infections and infestations Otitis Externa	0.00% 0/4 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/4 • Day 1 to a maximum of 24 weeks (+ 30 days)	16.7% 1/6 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)
Infections and infestations Pharyngitis	0.00% 0/4 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	33.3% 1/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/4 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/6 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)
Infections and infestations Sinusitis	0.00% 0/4 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/4 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/6 • Day 1 to a maximum of 24 weeks (+ 30 days)	33.3% 1/3 • Day 1 to a maximum of 24 weeks (+ 30 days)
Injury, poisoning and procedural complications Contusion	0.00% 0/4 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	33.3% 1/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/4 • Day 1 to a maximum of 24 weeks (+ 30 days)	33.3% 2/6 • Day 1 to a maximum of 24 weeks (+ 30 days)	33.3% 1/3 • Day 1 to a maximum of 24 weeks (+ 30 days)
Injury, poisoning and procedural complications Fall	25.0% 1/4 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/4 • Day 1 to a maximum of 24 weeks (+ 30 days)	33.3% 2/6 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)
Investigations Gamma-glutamyltransferase Increased	0.00% 0/4 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	33.3% 1/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	25.0% 1/4 • Day 1 to a maximum of 24 weeks (+ 30 days)	66.7% 4/6 • Day 1 to a maximum of 24 weeks (+ 30 days)	66.7% 2/3 • Day 1 to a maximum of 24 weeks (+ 30 days)
Investigations Aspartate Aminotransferase Increased	0.00% 0/4 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	33.3% 1/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	33.3% 1/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/4 • Day 1 to a maximum of 24 weeks (+ 30 days)	33.3% 2/6 • Day 1 to a maximum of 24 weeks (+ 30 days)	66.7% 2/3 • Day 1 to a maximum of 24 weeks (+ 30 days)
Investigations Alanine Aminotransferase Increased	0.00% 0/4 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	33.3% 1/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	33.3% 1/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/4 • Day 1 to a maximum of 24 weeks (+ 30 days)	16.7% 1/6 • Day 1 to a maximum of 24 weeks (+ 30 days)	66.7% 2/3 • Day 1 to a maximum of 24 weeks (+ 30 days)
Investigations Neutrophil Count Decreased	0.00% 0/4 • Day 1 to a maximum of 24 weeks (+ 30 days)	33.3% 1/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	66.7% 2/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	33.3% 1/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/4 • Day 1 to a maximum of 24 weeks (+ 30 days)	16.7% 1/6 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)
Investigations Blood Alkaline Phosphatase Increased	0.00% 0/4 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/4 • Day 1 to a maximum of 24 weeks (+ 30 days)	33.3% 2/6 • Day 1 to a maximum of 24 weeks (+ 30 days)	66.7% 2/3 • Day 1 to a maximum of 24 weeks (+ 30 days)
Investigations Electrocardiogram QT Prolonged	25.0% 1/4 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	33.3% 1/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	25.0% 1/4 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/6 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)
Investigations Activated Partial Thromboplastin Time Prolonged	0.00% 0/4 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	33.3% 1/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/4 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/6 • Day 1 to a maximum of 24 weeks (+ 30 days)	33.3% 1/3 • Day 1 to a maximum of 24 weeks (+ 30 days)
Investigations Blood Creatinine Increased	0.00% 0/4 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	33.3% 1/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/4 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/6 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)
Investigations Ejection Fraction Decreased	0.00% 0/4 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/4 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/6 • Day 1 to a maximum of 24 weeks (+ 30 days)	33.3% 1/3 • Day 1 to a maximum of 24 weeks (+ 30 days)
Investigations Enterococcus Test Positive	0.00% 0/4 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	33.3% 1/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/4 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/6 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)
Investigations International Normalised Ratio Increased	0.00% 0/4 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/4 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/6 • Day 1 to a maximum of 24 weeks (+ 30 days)	33.3% 1/3 • Day 1 to a maximum of 24 weeks (+ 30 days)
Investigations Liver Function Test Abnormal	0.00% 0/4 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	33.3% 1/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/4 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/6 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)
Investigations Platelet Count Decreased	0.00% 0/4 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/4 • Day 1 to a maximum of 24 weeks (+ 30 days)	16.7% 1/6 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)
Investigations Troponin I Increased	0.00% 0/4 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	33.3% 1/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/4 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/6 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)
Investigations Weight Decreased	0.00% 0/4 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	33.3% 1/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/4 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/6 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)
Investigations White Blood Cell Count Decreased	0.00% 0/4 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/4 • Day 1 to a maximum of 24 weeks (+ 30 days)	16.7% 1/6 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)
Investigations White Blood Cell Count Increased	0.00% 0/4 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	33.3% 1/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/4 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/6 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)
Metabolism and nutrition disorders Decreased Appetite	0.00% 0/4 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	33.3% 1/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	33.3% 1/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	33.3% 1/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	25.0% 1/4 • Day 1 to a maximum of 24 weeks (+ 30 days)	33.3% 2/6 • Day 1 to a maximum of 24 weeks (+ 30 days)	66.7% 2/3 • Day 1 to a maximum of 24 weeks (+ 30 days)
Metabolism and nutrition disorders Hypocalcaemia	0.00% 0/4 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	33.3% 1/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	33.3% 1/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	33.3% 1/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	25.0% 1/4 • Day 1 to a maximum of 24 weeks (+ 30 days)	16.7% 1/6 • Day 1 to a maximum of 24 weeks (+ 30 days)	66.7% 2/3 • Day 1 to a maximum of 24 weeks (+ 30 days)
Metabolism and nutrition disorders Hyperglycaemia	0.00% 0/4 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	33.3% 1/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/4 • Day 1 to a maximum of 24 weeks (+ 30 days)	33.3% 2/6 • Day 1 to a maximum of 24 weeks (+ 30 days)	66.7% 2/3 • Day 1 to a maximum of 24 weeks (+ 30 days)
Metabolism and nutrition disorders Hyperkalaemia	0.00% 0/4 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	33.3% 1/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	33.3% 1/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	25.0% 1/4 • Day 1 to a maximum of 24 weeks (+ 30 days)	33.3% 2/6 • Day 1 to a maximum of 24 weeks (+ 30 days)	33.3% 1/3 • Day 1 to a maximum of 24 weeks (+ 30 days)
Metabolism and nutrition disorders Hypoalbuminaemia	0.00% 0/4 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	33.3% 1/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/4 • Day 1 to a maximum of 24 weeks (+ 30 days)	16.7% 1/6 • Day 1 to a maximum of 24 weeks (+ 30 days)	66.7% 2/3 • Day 1 to a maximum of 24 weeks (+ 30 days)
Metabolism and nutrition disorders Hypophosphataemia	0.00% 0/4 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	33.3% 1/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	33.3% 1/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/4 • Day 1 to a maximum of 24 weeks (+ 30 days)	16.7% 1/6 • Day 1 to a maximum of 24 weeks (+ 30 days)	33.3% 1/3 • Day 1 to a maximum of 24 weeks (+ 30 days)
Metabolism and nutrition disorders Fluid Overload	0.00% 0/4 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	33.3% 1/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/4 • Day 1 to a maximum of 24 weeks (+ 30 days)	16.7% 1/6 • Day 1 to a maximum of 24 weeks (+ 30 days)	33.3% 1/3 • Day 1 to a maximum of 24 weeks (+ 30 days)
Metabolism and nutrition disorders Hypokalaemia	0.00% 0/4 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	33.3% 1/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	33.3% 1/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/4 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/6 • Day 1 to a maximum of 24 weeks (+ 30 days)	33.3% 1/3 • Day 1 to a maximum of 24 weeks (+ 30 days)
Metabolism and nutrition disorders Hypomagnesaemia	0.00% 0/4 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	33.3% 1/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/4 • Day 1 to a maximum of 24 weeks (+ 30 days)	16.7% 1/6 • Day 1 to a maximum of 24 weeks (+ 30 days)	33.3% 1/3 • Day 1 to a maximum of 24 weeks (+ 30 days)
Metabolism and nutrition disorders Hyponatraemia	0.00% 0/4 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	33.3% 1/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/4 • Day 1 to a maximum of 24 weeks (+ 30 days)	16.7% 1/6 • Day 1 to a maximum of 24 weeks (+ 30 days)	33.3% 1/3 • Day 1 to a maximum of 24 weeks (+ 30 days)
Metabolism and nutrition disorders Hypermagnesaemia	0.00% 0/4 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/4 • Day 1 to a maximum of 24 weeks (+ 30 days)	16.7% 1/6 • Day 1 to a maximum of 24 weeks (+ 30 days)	33.3% 1/3 • Day 1 to a maximum of 24 weeks (+ 30 days)
Metabolism and nutrition disorders Hypertriglyceridaemia	0.00% 0/4 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	33.3% 1/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/4 • Day 1 to a maximum of 24 weeks (+ 30 days)	16.7% 1/6 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)
Metabolism and nutrition disorders Hyperphosphataemia	0.00% 0/4 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/4 • Day 1 to a maximum of 24 weeks (+ 30 days)	16.7% 1/6 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)
Metabolism and nutrition disorders Hyperuricaemia	0.00% 0/4 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	33.3% 1/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/4 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/6 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)
Metabolism and nutrition disorders Vitamin D Deficiency	0.00% 0/4 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/4 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/6 • Day 1 to a maximum of 24 weeks (+ 30 days)	33.3% 1/3 • Day 1 to a maximum of 24 weeks (+ 30 days)
Musculoskeletal and connective tissue disorders Arthralgia	25.0% 1/4 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/4 • Day 1 to a maximum of 24 weeks (+ 30 days)	33.3% 2/6 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)
Musculoskeletal and connective tissue disorders Back Pain	0.00% 0/4 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	33.3% 1/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	33.3% 1/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/4 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/6 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)
Musculoskeletal and connective tissue disorders Muscular Weakness	0.00% 0/4 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	33.3% 1/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/4 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/6 • Day 1 to a maximum of 24 weeks (+ 30 days)	33.3% 1/3 • Day 1 to a maximum of 24 weeks (+ 30 days)
Musculoskeletal and connective tissue disorders Flank Pain	0.00% 0/4 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/4 • Day 1 to a maximum of 24 weeks (+ 30 days)	16.7% 1/6 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)
Musculoskeletal and connective tissue disorders Hypercreatinaemia	0.00% 0/4 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/4 • Day 1 to a maximum of 24 weeks (+ 30 days)	16.7% 1/6 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)
Musculoskeletal and connective tissue disorders Myalgia	0.00% 0/4 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/4 • Day 1 to a maximum of 24 weeks (+ 30 days)	16.7% 1/6 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)
Musculoskeletal and connective tissue disorders Myositis	0.00% 0/4 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/4 • Day 1 to a maximum of 24 weeks (+ 30 days)	16.7% 1/6 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)
Musculoskeletal and connective tissue disorders Neck Pain	0.00% 0/4 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/4 • Day 1 to a maximum of 24 weeks (+ 30 days)	16.7% 1/6 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)
Musculoskeletal and connective tissue disorders Pain in Extremity	0.00% 0/4 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	33.3% 1/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/4 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/6 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)
Musculoskeletal and connective tissue disorders Synovial Cyst	25.0% 1/4 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/4 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/6 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)
Nervous system disorders Dizziness	0.00% 0/4 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	33.3% 1/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	33.3% 1/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	25.0% 1/4 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/6 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)
Nervous system disorders Paraesthesia	0.00% 0/4 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	33.3% 1/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	33.3% 1/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	25.0% 1/4 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/6 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)
Nervous system disorders Headache	0.00% 0/4 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/4 • Day 1 to a maximum of 24 weeks (+ 30 days)	33.3% 2/6 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)
Nervous system disorders Autonomic Nervous System Imbalance	0.00% 0/4 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	33.3% 1/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/4 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/6 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/4 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	33.3% 1/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	33.3% 1/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	33.3% 1/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	25.0% 1/4 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/6 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)
Nervous system disorders Cognitive Disorder	0.00% 0/4 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/4 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/6 • Day 1 to a maximum of 24 weeks (+ 30 days)	33.3% 1/3 • Day 1 to a maximum of 24 weeks (+ 30 days)
Nervous system disorders Dizziness Postural	0.00% 0/4 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/4 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/6 • Day 1 to a maximum of 24 weeks (+ 30 days)	33.3% 1/3 • Day 1 to a maximum of 24 weeks (+ 30 days)
Nervous system disorders Dysgeusia	0.00% 0/4 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/4 • Day 1 to a maximum of 24 weeks (+ 30 days)	16.7% 1/6 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)
Nervous system disorders Presyncope	0.00% 0/4 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/4 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/6 • Day 1 to a maximum of 24 weeks (+ 30 days)	33.3% 1/3 • Day 1 to a maximum of 24 weeks (+ 30 days)
Nervous system disorders Sinus Headache	0.00% 0/4 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	33.3% 1/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/4 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/6 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)
Psychiatric disorders Anxiety	0.00% 0/4 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	33.3% 1/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/4 • Day 1 to a maximum of 24 weeks (+ 30 days)	16.7% 1/6 • Day 1 to a maximum of 24 weeks (+ 30 days)	33.3% 1/3 • Day 1 to a maximum of 24 weeks (+ 30 days)
Psychiatric disorders Insomnia	0.00% 0/4 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	33.3% 1/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/4 • Day 1 to a maximum of 24 weeks (+ 30 days)	16.7% 1/6 • Day 1 to a maximum of 24 weeks (+ 30 days)	33.3% 1/3 • Day 1 to a maximum of 24 weeks (+ 30 days)
Psychiatric disorders Depression	0.00% 0/4 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	33.3% 1/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/4 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/6 • Day 1 to a maximum of 24 weeks (+ 30 days)	33.3% 1/3 • Day 1 to a maximum of 24 weeks (+ 30 days)
Psychiatric disorders Mental Status Changes	0.00% 0/4 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/4 • Day 1 to a maximum of 24 weeks (+ 30 days)	16.7% 1/6 • Day 1 to a maximum of 24 weeks (+ 30 days)	33.3% 1/3 • Day 1 to a maximum of 24 weeks (+ 30 days)
Psychiatric disorders Confusional State	0.00% 0/4 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/4 • Day 1 to a maximum of 24 weeks (+ 30 days)	16.7% 1/6 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)
Psychiatric disorders Hallucination	0.00% 0/4 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/4 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/6 • Day 1 to a maximum of 24 weeks (+ 30 days)	33.3% 1/3 • Day 1 to a maximum of 24 weeks (+ 30 days)
Psychiatric disorders Irritability	0.00% 0/4 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/4 • Day 1 to a maximum of 24 weeks (+ 30 days)	16.7% 1/6 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)
Renal and urinary disorders Proteinuria	0.00% 0/4 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	33.3% 1/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	33.3% 1/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/4 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/6 • Day 1 to a maximum of 24 weeks (+ 30 days)	33.3% 1/3 • Day 1 to a maximum of 24 weeks (+ 30 days)
Renal and urinary disorders Haematuria	0.00% 0/4 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/4 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/6 • Day 1 to a maximum of 24 weeks (+ 30 days)	33.3% 1/3 • Day 1 to a maximum of 24 weeks (+ 30 days)
Renal and urinary disorders Acute Kidney Injury	0.00% 0/4 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	33.3% 1/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/4 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/6 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)
Renal and urinary disorders Chronic Kidney Disease	0.00% 0/4 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	33.3% 1/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/4 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/6 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)
Respiratory, thoracic and mediastinal disorders Cough	0.00% 0/4 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	33.3% 1/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	33.3% 1/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	33.3% 1/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/4 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/6 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)
Respiratory, thoracic and mediastinal disorders Epistaxis	0.00% 0/4 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	33.3% 1/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	33.3% 1/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/4 • Day 1 to a maximum of 24 weeks (+ 30 days)	16.7% 1/6 • Day 1 to a maximum of 24 weeks (+ 30 days)	0.00% 0/3 • Day 1 to a maximum of 24 weeks (+ 30 days)

Additional Information

ADC Therapeutics

Phone: 954-903-7994

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place