Study of ADCT-402 in Patients With Relapsed or Refractory B-cell Lineage Acute Lymphoblastic Leukemia (B-ALL)

• Sponsor: ADC Therapeutics S.A. (Industry)
• Overall Status: Terminated
• CT.gov ID: NCT02669264
• Collaborator: (none)
• Enrollment: 35
• Locations: 10
• Arms: 2
• Duration (Months): 28.1
• Patients Per Site: 3.5
• Patients Per Site Per Month: 0.1

Study Details

Study Description

Brief Summary

This study evaluates ADCT-402 in participants with relapsed or refractory B-cell lineage acute lymphoblastic leukemia (B-ALL). Participants will participate in a dose-escalation phase (Part 1) and dose expansion (Part 2). In Part 2, participants will receive the dose level identified in Part 1.

Condition or Disease	Intervention/Treatment	Phase
Acute Lymphoblastic Leukemia	Drug: ADCT-402	Phase 1

Detailed Description

Study ADCT-402-102 is the first clinical study with ADCT-402 in participants with B-cell lineage acute lymphoblastic leukemia (B-ALL).

ADCT-402 is an antibody drug conjugate (ADC) composed of a humanized antibody directed against human cluster of differentiation 19 (CD19), stochastically conjugated via a valine-alanine cleavable, maleimide linker to a pyrrolobenzodiazepine (PBD) dimer cytotoxin.

The study will be conducted in 2 parts. In Part 1 (dose escalation) participants will receive an infusion of ADCT-402 either on weekly administration or every 3-week administration. participants on weekly administration will receive an infusion of ADCT-402 on Days 1, 8, and 15 of each 3 week treatment cycle. Participants on 3-week administration will receive an infusion of ADCT-402 on Day 1, every 3 weeks. Dose escalation will continue until the maximum tolerated dose (MTD) is determined.

In Part 2 (expansion), all participants will be assigned to the recommended dose and/or schedule of ADCT-402 identified in Part 1 by the Dose Escalation Steering Committee.

For each patient, the study will include a screening period (up to 28 days), a treatment period (until withdrawal), and a follow-up period to assess disease progression and survival for up to 12 months after the last dose of study drug. The total study duration will be dependent on overall patient tolerability to the study drug and response to treatment. It is anticipated that the duration of the entire study (Parts 1 and 2) could be approximately 3 years from first patient treated to last patient completed.

Study Design

• Study Type: Interventional
• Actual Enrollment: 35 participants
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Phase 1, Open-label, Adaptive Dose-escalation, Multicenter Study to Evaluate the Tolerability, Safety, Pharmacokinetics, and Anti-tumor Activity of ADCT-402 in Patients With Relapsed or Refractory B-cell Lineage Acute Lymphoblastic Leukemia (B-ALL)
• Study Start Date: Mar 1, 2016
• Actual Primary Completion Date: Jul 3, 2018
• Actual Study Completion Date: Jul 3, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Part 1: ADCT-402 dose escalation Weekly administration - Participants will receive an intravenous (IV) infusion of ADCT-402, on Days 1, 8, and 15 of each 3-week (21-day) cycle. 3-week administration - Participants will receive an IV infusion of ADCT-402, on Day 1 of each 3-week (21-day) cycle. The dose escalation will be conducted according to a 3+3 design.	Drug: ADCT-402; Intravenous infusion; Other Names: Loncastuximab tesirine Zynlonta
Experimental: Part 2: ADCT-402 expansion All participants will be assigned to the recommended dose and/or schedule of ADCT-402 identified in Part 1 by the Dose Escalation Steering Committee	Drug: ADCT-402; Intravenous infusion; Other Names: Loncastuximab tesirine Zynlonta

Outcome Measures

Primary Outcome Measures

1. Number of Participants Who Experienced Dose-Limiting Toxicities (DLTs) [Day 1 to End of Cycle 1 (3 weeks)]

   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 TLS will not constitute DLT unless it leads to irreversible end-organ damage). 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.

2. Recommended Dose of ADCT-402 for Part 2 [Day 1 to End of Cycle 1 (3 weeks)]

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

3. Number of Participants Reporting at Least One Treatment Emergent Adverse Event (TEAE) [From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)]

   An adverse event (AE) is defined as any untoward medical occurrence in a participants enrolled into this study regardless of its causal relationship to study drug. A TEAE is defined as any 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.

4. Number of Participants Reporting at Least One Treatment Emergent Serious Adverse Event (SAE) [From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)]

   An adverse event (AE) is defined as any untoward medical occurrence in a participant enrolled into this study regardless of its causal relationship to study drug. A treatment-emergent AE (TEAE) is defined as any 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. 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.

Secondary Outcome Measures

1. Overall Response Rate (ORR) [From 6 days prior to Day 1 of Cycle 3 and 5, and at each subsequent cycle, until discontinuation, assessed up to 12 months after last dose of study drug]

   ORR is defined as the number of participants with a best overall response of complete response (CR), complete response with incomplete blood count recovery (Cri) or partial response (PR) at the time each participant discontinues treatment with ADCT-402. CR is defined as achieving each of the following: 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 is defined as achieving each of the following: 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.

2. Duration of Response [From 6 days prior to Day 1 of Cycle 3 and 5, and at each subsequent cycle, until discontinuation, assessed up to 12 months after last dose of study drug]

   Duration of response is defined among responders (complete response [CR], complete response with incomplete blood count recovery [Cri], and 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. Disease progression is defined as: For participants with CR or CRi, the first date of reappearance of blast cells in bone marrow and/or peripheral blood to a level ≥5%, or development of extramedullary disease. For participants with PR, the first date of an increase in blast cells in bone marrow and/or peripheral blood such that the patient does not continue to meet the criteria for PR.

3. Overall Survival [From 6 days prior to Day 1 of Cycle 3 and 5, and at each subsequent cycle, until discontinuation, assessed up to 12 months after last dose of study drug]

   Overall survival is defined as the time from the first dose of study drug treatment until the date of death due to any cause.

4. Progression-free Survival [From 6 days prior to Day 1 of Cycle 3 and 5, and at each subsequent cycle, until discontinuation, assessed up to 12 months after last dose of study drug]

   Progression-free survival is defined among the efficacy population as the time from first dose of study drug until the first date of either disease progression or death due to any cause.

5. Maximum Observed Serum Concentration (Cmax) for ADCT-402 Administered Every 3 Weeks (Q3W) [Day 1 (before infusion, end of infusion, and 1, 3 and 6 hours after infusion) and Days 2, 3, 5, 8 and 15 for Cycles 1 and 2]

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

6. Maximum Observed Serum Concentration (Cmax) for ADCT-402 Administered Every Week (QW) [Day 1 (before infusion, end of infusion, and 1, 3 and 6 hours after infusion) and Days 2, 3, 5, 8 and 15 for Cycles 1 and 2]

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

7. Time to Reach the Maximum Serum Concentration (Tmax) for ADCT-402 Administered Every 3 Weeks (Q3W) [Day 1 (before infusion, end of infusion, and 1, 3 and 6 hours after infusion) and Days 2, 3, 5, 8 and 15 for Cycles 1 and 2]

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

8. Time to Reach the Maximum Serum Concentration (Tmax) for ADCT-402 Administered Every Week (QW) [Day 1 (before infusion, end of infusion, and 1, 3 and 6 hours after infusion) and Days 2, 3, 5, 8 and 15 for Cycles 1 and 2]

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

9. Area Under the Serum Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration (AUClast) for ADCT-402 Administered Every 3 Weeks (Q3W) [Day 1 (before infusion, end of infusion, and 1, 3 and 6 hours after infusion) and Days 2, 3, 5, 8 and 15 for Cycles 1 and 2]

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

10. Area Under the Serum Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration (AUClast) for ADCT-402 Administered Every Week (QW) [Day 1 (before infusion, end of infusion, and 1, 3 and 6 hours after infusion) and Days 2, 3, 5, 8 and 15 for Cycles 1 and 2]

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

11. Area Under the Serum Concentration-time Curve From Time 0 to Infinity (AUC∞) for ADCT-402 Administered Every 3 Weeks (Q3W) [Day 1 (before infusion, end of infusion, and 1, 3 and 6 hours after infusion) and Days 2, 3, 5, 8 and 15 for Cycles 1 and 2]

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

12. Area Under the Serum Concentration-time Curve From Time 0 to Infinity (AUC∞) for ADCT-402 Administered Weekly (QW) [Day 1 (before infusion, end of infusion, and 1, 3 and 6 hours after infusion) and Days 2, 3, 5, 8 and 15 for Cycles 1 and 2]

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

13. Area Under the Serum Concentration-time Curve From Time 0 to the End of the Dosing Interval (AUC0-tau) for ADCT-402 Administered Every 3 Weeks (Q3W) [Day 1 (before infusion, end of infusion, and 1, 3 and 6 hours after infusion) and Days 2, 3, 5, 8 and 15 for Cycles 1 and 2]

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

14. Area Under the Serum Concentration-time Curve From Time 0 to the End of the Dosing Interval (AUC0-tau) for ADCT-402 Administered Every Week (QW) [Day 1 (before infusion, end of infusion, and 1, 3 and 6 hours after infusion) and Days 2, 3, 5, 8 and 15 for Cycles 1 and 2]

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

15. Accumulation Index (AI) for ADCT-402 Administered Every 3 Weeks (Q3W) [Day 1 (before infusion, end of infusion, and 1, 3 and 6 hours after infusion) and Days 2, 3, 5, 8 and 15 for Cycles 1 and 2]

    AI for Pyrrolobenzodiazepine (PBD) conjugated antibody (Ab), total Ab and free warhead (SG3199) for the Q3W cohorts. AI is the ratio of AUC 0-24 after multiple doses versus a single dose. It is the increase in drug plasma concentration after multiple dosing until a steady state is reached.

16. Accumulation Index (AI) for ADCT-402 Administered Weekly (QW) [Day 1 (before infusion, end of infusion, and 1, 3 and 6 hours after infusion) and Days 2, 3, 5, 8 and 15 for Cycles 1 and 2]

    AI for Pyrrolobenzodiazepine (PBD) conjugated antibody (Ab), total Ab and free warhead (SG3199) for the QW cohort. AI is the ratio of AUC 0-24 after multiple doses versus a single dose. It is the increase in drug plasma concentration after multiple dosing until a steady state is reached.

17. Volume of Distribution at Steady State for ADCT-402 [Day 1 (before infusion, end of infusion, and 1, 3 and 6 hours after infusion) and Days 2, 3, 5, 8 and 15 for Cycles 1 and 2]

18. Mean Residence Time for ADCT-402 [Day 1 (before infusion, end of infusion, and 1, 3 and 6 hours after infusion) and Days 2, 3, 5, 8 and 15 for Cycles 1 and 2]

19. Terminal Elimination Phase Rate Constant for ADCT-402 [Day 1 (before infusion, end of infusion, and 1, 3 and 6 hours after infusion) and Days 2, 3, 5, 8 and 15 for Cycles 1 and 2]

20. Apparent Terminal Phase Elimination Half-life (T1/2) for ADCT-402 Administered Every 3 Weeks (Q3W) [Day 1 (before infusion, end of infusion, and 1, 3 and 6 hours after infusion) and Days 2, 3, 5, 8 and 15 for Cycles 1 and 2]

    T1/2 for Pyrrolobenzodiazepine (PBD) conjugated antibody (Ab), total Ab and free warhead (SG3199) for the Q3W cohorts.

21. Apparent Terminal Phase Elimination Half-life (T1/2) for ADCT-402 Administered Every Week (QW) [Day 1 (before infusion, end of infusion, and 1, 3 and 6 hours after infusion) and Days 2, 3, 5, 8 and 15 for Cycles 1 and 2]

    T1/2 for Pyrrolobenzodiazepine (PBD) conjugated antibody (Ab), total Ab and free warhead (SG3199) for the QW cohort.

22. Apparent Clearance at Steady State for ADCT-402 Administered Every 3 Weeks (Q3W) [Day 1 (before infusion, end of infusion, and 1, 3 and 6 hours after infusion) and Days 2, 3, 5, 8 and 15 for Cycles 1 and 2]

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

23. Apparent Clearance at Steady State for ADCT-402 Administered Every Week (QW) [Day 1 (before infusion, end of infusion, and 1, 3 and 6 hours after infusion) and Days 2, 3, 5, 8 and 15 for Cycles 1 and 2]

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

24. Apparent Volume of Distribution (Vd Beta) for ADCT-402 Administered Every 3 Weeks (Q3W) [Day 1 (before infusion, end of infusion, and 1, 3 and 6 hours after infusion) and Days 2, 3, 5, 8 and 15 for Cycles 1 and 2]

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

25. Apparent Volume of Distribution (Vd Beta) for ADCT-402 Administered Every Week (QW) [Day 1 (before infusion, end of infusion, and 1, 3 and 6 hours after infusion) and Days 2, 3, 5, 8 and 15 for Cycles 1 and 2]

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

26. Number of Participants With Anti-drug Antibody Response (ADA) Against ADCT-402 [Day 1 (before infusion, end of infusion, and 1, 3 and 6 hours after infusion) and Days 2, 3, 5, 8 and 15 for Cycles 1 and 2]

    Blood serum samples were collected and analysed to determine the presence or absence of ADA.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 12 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Male or female patients, ages 12 years and older, with relapsed or refractory B-ALL who have failed, or are intolerant to, any established therapy; or for whom no other treatment options are available.

• Eastern Cooperative Oncology Group (ECOG) performance status 0-2.

• Serum/plasma creatinine ≤1.5mg/dL.

• Serum/plasma alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2 times the upper limit of normal (ULN); ≤5 times ULN if there is liver or bone involvement.

• Total serum/plasma bilirubin ≤1.5 times ULN.

• White Blood Cell Count value of <15,000 cells/μL prior to Cycle 1 Day 1.

• Negative urine or serum beta-human chorionic gonadotropin (β-HCG) pregnancy test within 7 days prior to the Cycle 1, Day 1 visit, for women of childbearing potential.

• Males, and female patients who are biologically capable of having children, must agree to use a medically acceptable method of birth control.

Exclusion Criteria:

• Patients who have an option for other treatment for B-ALL at the current state of disease.

• Known active central nervous system (CNS) leukemia.

• Patients with Burkitt's leukemia/lymphoma.

• Active graft-versus-host disease.

• Autologous or allogenic transplant within the 60 days prior to Screening.

• Known history of immunogenicity or hypersensitivity to a CD19 antibody.

• Known history of positive serum human ADA.

• Active autoimmune disease, motor neuropathy considered of autoimmune origin, or other central nervous system autoimmune disease.

• Known seropositive for human immunodeficiency (HIV) virus, hepatitis B surface antigen (HbsAg), or antibody to hepatitis C virus (anti-HCV).

• History of Stevens-Johnson syndrome or toxic epidermal necrolysis syndrome.

• Pregnant or breastfeeding women.

• Significant medical comorbidities, including uncontrolled hypertension (diastolic blood pressure >115 mm Hg), unstable angina, congestive heart failure (greater than New York Heart Association class II), severe uncontrolled ventricular arrhythmias, electrocardiographic evidence of acute ischemia, poorly controlled diabetes, severe chronic pulmonary disease, coronary angioplasty, myocardial infarction within 6 months prior to Screening, or uncontrolled atrial or ventricular cardiac arrhythmias.

• Use of any other experimental medication(s) within 14 days or 5 half-lives, but in no case <14 days prior to the start of treatment on Cycle 1, Day 1, except if approved by the Sponsor.

• Major surgery, chemotherapy, systemic therapy (excluding hydroxyurea,steroids and any targeted small molecules or biologics), or radiotherapy, within 14 days or 5 half-lives (whichever is shorter) prior to the Cycle 1, Day 1 treatment, except if approved by the Sponsor.

• Failure to recover from acute non hematologic toxicity (except alopecia or Grade 2 or lower neuropathy), due to previous therapy, prior to Screening.

• Isolated extramedullary relapse.

• Congenital long QT syndrome or a corrected QTc interval of ≥450 ms at the Screening visit.

• Active second primary malignancy other than non-melanoma skin cancers, nonmetastatic prostate cancer, in situ cervical cancer, ductal or lobular carcinoma in situ of the breast, or other malignancy determined not be exclusionary.

• Any other significant medical illness, abnormality, or condition that would make the patient inappropriate for study participation or put the patient at risk.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	UC San Diego Moores Cancer Center	La Jolla	California	United States	92093
2	Smilow Cancer Hospital at Yale-New Haven	New Haven	Connecticut	United States	06510
3	Emory University Hospital	Atlanta	Georgia	United States	30322
4	The University of Chicago Medical Center	Chicago	Illinois	United States	60637
5	John Theurer Cancer Center at Hackensack University Medical Center	Hackensack	New Jersey	United States	07601
6	Rutgers Cancer Institute of New Jersey	New Brunswick	New Jersey	United States	08903
7	University Hospital of Cleveland	Cleveland	Ohio	United States	44106
8	The Ohio State University Wexner Medical Center, James Cancer Hospital	Columbus	Ohio	United States	43210
9	The University of Texas MD Anderson Cancer Center	Houston	Texas	United States	77030
10	Froedtert Hospital & the Medical College of Wisconsin	Milwaukee	Wisconsin	United States	53226

Sponsors and Collaborators

• ADC Therapeutics S.A.

Investigators

None specified.

Study Documents (Full-Text)

• Study Protocol - Apr 19, 2017
• Statistical Analysis Plan - Apr 19, 2017

More Information

Publications

None provided.

• Responsible Party: ADC Therapeutics S.A.
• ClinicalTrials.gov Identifier: NCT02669264
• Other Study ID Numbers: ADCT-402-102
• First Posted: Feb 1, 2016
• Last Update Posted: May 24, 2021
• Last Verified: Apr 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Keywords provided by ADC Therapeutics S.A.: Loncastuximab tesirine
• Additional relevant MeSH terms: Leukemia; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Leukemia, Lymphoid; Loncastuximab tesirine

Study Results

Participant Flow

Arm/Group Title	15 μg/kg Q3W	30 μg/kg Q3W	60 μg/kg Q3W	90 μg/kg Q3W	120 μg/kg Q3W	150 μg/kg Q3W	50 μg/kg QW
Arm/Group Description	Participants received 15 μg/kg ADCT-402 on Day 1 of each 3-week treatment cycle.	Participants received 30 μg/kg ADCT-402 on Day 1 of each 3-week treatment cycle.	Participants received 60 μg/kg ADCT-402 on Day 1 of each 3-week treatment cycle.	Participants received 90 μg/kg ADCT-402 on Day 1 of each 3-week treatment cycle.	Participants received 120 μg/kg ADCT-402 on Day 1 of each 3-week treatment cycle.	Participants received 150 μg/kg ADCT-402 on Day 1 of each 3-week treatment cycle.	Participants received 50 μg/kg ADCT-402 weekly on Days 1, 8 and 15 of each 3-week (21-day) treatment cycle. This dose level for the weekly (QW) dosing schedule was based on the safety and tolerability of participants who had been treated on the every 3-week (Q3W) schedule.
Period Title: Overall Study
STARTED	5	7	3	4	5	6	5
COMPLETED	0	1	0	1	0	0	0
NOT COMPLETED	5	6	3	3	5	6	5

Baseline Characteristics

Arm/Group Title	15 μg/kg Q3W	30 μg/kg Q3W	60 μg/kg Q3W	90 μg/kg Q3W	120 μg/kg Q3W	150 μg/kg Q3W	50 μg/kg QW	Total
Arm/Group Description	Participants received 15 μg/kg ADCT-402 on Day 1 of each 3-week treatment cycle.	Participants received 30 μg/kg ADCT-402 on Day 1 of each 3-week treatment cycle.	Participants received 60 μg/kg ADCT-402 on Day 1 of each 3-week treatment cycle.	Participants received 90 μg/kg ADCT-402 on Day 1 of each 3-week treatment cycle.	Participants received 120 μg/kg ADCT-402 on Day 1 of each 3-week treatment cycle.	Participants received 150 μg/kg ADCT-402 on Day 1 of each 3-week treatment cycle.	Participants received 50 μg/kg ADCT-402 on Days 1, 8 and 15 of each 3-week (21-day) treatment cycle. This dose level for the QW dosing was based on the safety and tolerability of participants who have been treated on the every 3-week (Q3W) schedule.	Total of all reporting groups
Overall Participants	5	7	3	4	5	6	5	35
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	43.6 (21.22)	49.6 (21.95)	50.3 (6.51)	63.8 (7.09)	46.8 (18.14)	45.2 (19.61)	42.8 (24.30)	48.3 (18.66)
Sex: Female, Male (Count of Participants)
Female	3 60%	1 14.3%	1 33.3%	1 25%	2 40%	4 66.7%	4 80%	16 45.7%
Male	2 40%	6 85.7%	2 66.7%	3 75%	3 60%	2 33.3%	1 20%	19 54.3%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	2 40%	3 42.9%	1 33.3%	0 0%	2 40%	5 83.3%	2 40%	15 42.9%
Not Hispanic or Latino	3 60%	4 57.1%	2 66.7%	4 100%	3 60%	1 16.7%	3 60%	20 57.1%
Unknown or Not Reported	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Asian	1 20%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	1 2.9%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	1 33.3%	0 0%	0 0%	0 0%	0 0%	1 2.9%
Black or African American	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	1 20%	1 2.9%
White	4 80%	7 100%	1 33.3%	4 100%	5 100%	3 50%	3 60%	27 77.1%
More than one race	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Unknown or Not Reported	0 0%	0 0%	1 33.3%	0 0%	0 0%	3 50%	1 20%	5 14.3%
Region of Enrollment (Count of Participants)
United States	5 100%	7 100%	3 100%	4 100%	5 100%	6 100%	5 100%	35 100%
Height (cm) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [cm]	162.40 (8.510)	167.97 (17.050)	162.60 (0.000)	164.78 (11.943)	172.32 (10.146)	163.58 (7.398)	155.75 (5.072)	164.83 (11.211)
Weight (kg) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [kg]	76.44 (26.043)	93.80 (31.551)	87.13 (13.301)	58.33 (15.745)	78.00 (11.663)	83.05 (38.842)	70.58 (11.576)	79.28 (25.631)
Body Mass Index (BMI) (kg/m^2) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [kg/m^2]	28.62 (7.192)	34.05 (13.059)	30.43 (3.504)	21.07 (3.356)	26.22 (2.949)	32.70 (12.605)	27.93 (5.741)	29.15 (9.142)
Eastern Cooperative Oncology Group (ECOG) Performance Status (Score on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Score on a scale]	1.00 (0.000)	1.29 (0.488)	0.67 (0.577)	1.50 (0.577)	1.60 (0.548)	1.33 (1.033)	1.40 (0.548)	1.29 (0.622)

Outcome Measures

1. Primary Outcome

Title	Number of Participants Who Experienced Dose-Limiting Toxicities (DLTs)
Description	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 TLS will not constitute DLT unless it leads to irreversible end-organ damage). 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.
Time Frame	Day 1 to End of Cycle 1 (3 weeks)

Outcome Measure Data

Analysis Population Description

Safety analysis set

Arm/Group Title	15 μg/kg Q3W	30 μg/kg Q3W	60 μg/kg Q3W	90 μg/kg Q3W	120 μg/kg Q3W	150 μg/kg Q3W	50 μg/kg QW
Arm/Group Description	Participants received 15 μg/kg ADCT-402 on Day 1 of each 3-week treatment cycle.	Participants received 30 μg/kg ADCT-402 on Day 1 of each 3-week treatment cycle.	Participants received 60 μg/kg ADCT-402 on Day 1 of each 3-week treatment cycle.	Participants received 90 μg/kg ADCT-402 on Day 1 of each 3-week treatment cycle.	Participants received 120 μg/kg ADCT-402 on Day 1 of each 3-week treatment cycle.	Participants received 150 μg/kg ADCT-402 on Day 1 of each 3-week treatment cycle.	Participants received 50 μg/kg ADCT-402 weekly on Days 1, 8 and 15 of each 3-week (21-day) treatment cycle. This dose level for the weekly (QW) dosing schedule was based on the safety and tolerability of participants who had been treated on the every 3-week (Q3W) schedule.
Measure Participants	5	7	3	4	5	6	5
Count of Participants [Participants]	0 0%	0 0%	0 0%	0 0%	0 0%	1 16.7%	0 0%

2. Primary Outcome

Title	Recommended Dose of ADCT-402 for Part 2
Description	The recommended dose was to be established by the dose escalation steering committee and based on safety findings during part 1 of the study.
Time Frame	Day 1 to End of Cycle 1 (3 weeks)

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Part 1: ADCT-402 Dose Escalation
Arm/Group Description	Weekly administration (QW) - Participants received an intravenous (IV) infusion of ADCT-402, on Days 1, 8, and 15 of each 3- week (21-day) cycle. 3-week administration (Q3W) - Participants received an IV infusion of ADCT-402, on Day 1 of each 3-week (21-day) cycle. The dose escalation was conducted according to a 3+3 design.
Measure Participants	0

3. Primary Outcome

Title	Number of Participants Reporting at Least One Treatment Emergent Adverse Event (TEAE)
Description	An adverse event (AE) is defined as any untoward medical occurrence in a participants enrolled into this study regardless of its causal relationship to study drug. A TEAE is defined as any 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.
Time Frame	From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)

Outcome Measure Data

Analysis Population Description

Safety analysis set

Arm/Group Title	15 μg/kg Q3W	30 μg/kg Q3W	60 μg/kg Q3W	90 μg/kg Q3W	120 μg/kg Q3W	150 μg/kg Q3W	50 μg/kg QW
Arm/Group Description	Participants received 15 μg/kg ADCT-402 on Day 1 of each 3-week treatment cycle.	Participants received 30 μg/kg ADCT-402 on Day 1 of each 3-week treatment cycle.	Participants received 60 μg/kg ADCT-402 on Day 1 of each 3-week treatment cycle.	Participants received 90 μg/kg ADCT-402 on Day 1 of each 3-week treatment cycle.	Participants received 120 μg/kg ADCT-402 on Day 1 of each 3-week treatment cycle.	Participants received 150 μg/kg ADCT-402 on Day 1 of each 3-week treatment cycle.	Participants received 50 μg/kg ADCT-402 weekly on Days 1, 8 and 15 of each 3-week (21-day) treatment cycle. This dose level for the weekly (QW) dosing schedule was based on the safety and tolerability of participants who had been treated on the every 3-week (Q3W) schedule.
Measure Participants	5	7	3	4	5	6	5
Count of Participants [Participants]	5 100%	7 100%	3 100%	4 100%	5 100%	6 100%	5 100%

4. Primary Outcome

Title	Number of Participants Reporting at Least One Treatment Emergent Serious Adverse Event (SAE)
Description	An adverse event (AE) is defined as any untoward medical occurrence in a participant enrolled into this study regardless of its causal relationship to study drug. A treatment-emergent AE (TEAE) is defined as any 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. 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.
Time Frame	From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	15 μg/kg Q3W	30 μg/kg Q3W	60 μg/kg Q3W	90 μg/kg Q3W	120 μg/kg Q3W	150 μg/kg Q3W	50 μg/kg QW
Arm/Group Description	Participants received 15 μg/kg ADCT-402 on Day 1 of each 3-week treatment cycle.	Participants received 30 μg/kg ADCT-402 on Day 1 of each 3-week treatment cycle.	Participants received 60 μg/kg ADCT-402 on Day 1 of each 3-week treatment cycle.	Participants received 90 μg/kg ADCT-402 on Day 1 of each 3-week treatment cycle.	Participants received 120 μg/kg ADCT-402 on Day 1 of each 3-week treatment cycle.	Participants received 150 μg/kg ADCT-402 on Day 1 of each 3-week treatment cycle.	Participants received 50 μg/kg ADCT-402 weekly on Days 1, 8 and 15 of each 3-week (21-day) treatment cycle. This dose level for the weekly (QW) dosing schedule was based on the safety and tolerability of participants who had been treated on the every 3-week (Q3W) schedule.
Measure Participants	5	7	3	4	5	6	5
Count of Participants [Participants]	5 100%	4 57.1%	2 66.7%	3 75%	5 100%	5 83.3%	4 80%

5. Secondary Outcome

Title	Overall Response Rate (ORR)
Description	ORR is defined as the number of participants with a best overall response of complete response (CR), complete response with incomplete blood count recovery (Cri) or partial response (PR) at the time each participant discontinues treatment with ADCT-402. CR is defined as achieving each of the following: 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 is defined as achieving each of the following: 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.
Time Frame	From 6 days prior to Day 1 of Cycle 3 and 5, and at each subsequent cycle, until discontinuation, assessed up to 12 months after last dose of study drug

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	15 μg/kg Q3W	30 μg/kg Q3W	60 μg/kg Q3W	90 μg/kg Q3W	120 μg/kg Q3W	150 μg/kg Q3W	50 μg/kg QW
Arm/Group Description	Participants received 15 μg/kg ADCT-402 on Day 1 of each 3-week treatment cycle.	Participants received 30 μg/kg ADCT-402 on Day 1 of each 3-week treatment cycle.	Participants received 60 μg/kg ADCT-402 on Day 1 of each 3-week treatment cycle.	Participants received 90 μg/kg ADCT-402 on Day 1 of each 3-week treatment cycle.	Participants received 120 μg/kg ADCT-402 on Day 1 of each 3-week treatment cycle.	Participants received 150 μg/kg ADCT-402 on Day 1 of each 3-week treatment cycle.	Participants received 50 μg/kg ADCT-402 weekly on Days 1, 8 and 15 of each 3-week (21-day) treatment cycle. This dose level for the weekly (QW) dosing schedule was based on the safety and tolerability of participants who had been treated on the every 3-week (Q3W) schedule.
Measure Participants	0	0	0	0	0	0	0

6. Secondary Outcome

Title	Duration of Response
Description	Duration of response is defined among responders (complete response [CR], complete response with incomplete blood count recovery [Cri], and 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. Disease progression is defined as: For participants with CR or CRi, the first date of reappearance of blast cells in bone marrow and/or peripheral blood to a level ≥5%, or development of extramedullary disease. For participants with PR, the first date of an increase in blast cells in bone marrow and/or peripheral blood such that the patient does not continue to meet the criteria for PR.
Time Frame	From 6 days prior to Day 1 of Cycle 3 and 5, and at each subsequent cycle, until discontinuation, assessed up to 12 months after last dose of study drug

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	15 μg/kg Q3W	30 μg/kg Q3W	60 μg/kg Q3W	90 μg/kg Q3W	120 μg/kg Q3W	150 μg/kg Q3W	50 μg/kg QW
Arm/Group Description	Participants received 15 μg/kg ADCT-402 on Day 1 of each 3-week treatment cycle.	Participants received 30 μg/kg ADCT-402 on Day 1 of each 3-week treatment cycle.	Participants received 60 μg/kg ADCT-402 on Day 1 of each 3-week treatment cycle.	Participants received 90 μg/kg ADCT-402 on Day 1 of each 3-week treatment cycle.	Participants received 120 μg/kg ADCT-402 on Day 1 of each 3-week treatment cycle.	Participants received 150 μg/kg ADCT-402 on Day 1 of each 3-week treatment cycle.	Participants received 50 μg/kg ADCT-402 weekly on Days 1, 8 and 15 of each 3-week (21-day) treatment cycle. This dose level for the weekly (QW) dosing schedule was based on the safety and tolerability of participants who had been treated on the every 3-week (Q3W) schedule.
Measure Participants	0	0	0	0	0	0	0

7. Secondary Outcome

Title	Overall Survival
Description	Overall survival is defined as the time from the first dose of study drug treatment until the date of death due to any cause.
Time Frame	From 6 days prior to Day 1 of Cycle 3 and 5, and at each subsequent cycle, until discontinuation, assessed up to 12 months after last dose of study drug

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	15 μg/kg Q3W	30 μg/kg Q3W	60 μg/kg Q3W	90 μg/kg Q3W	120 μg/kg Q3W	150 μg/kg Q3W	50 μg/kg QW
Arm/Group Description	Participants received 15 μg/kg ADCT-402 on Day 1 of each 3-week treatment cycle.	Participants received 30 μg/kg ADCT-402 on Day 1 of each 3-week treatment cycle.	Participants received 60 μg/kg ADCT-402 on Day 1 of each 3-week treatment cycle.	Participants received 90 μg/kg ADCT-402 on Day 1 of each 3-week treatment cycle.	Participants received 120 μg/kg ADCT-402 on Day 1 of each 3-week treatment cycle.	Participants received 150 μg/kg ADCT-402 on Day 1 of each 3-week treatment cycle.	Participants received 50 μg/kg ADCT-402 weekly on Days 1, 8 and 15 of each 3-week (21-day) treatment cycle. This dose level for the weekly (QW) dosing schedule was based on the safety and tolerability of participants who had been treated on the every 3-week (Q3W) schedule.
Measure Participants	0	0	0	0	0	0	0

8. Secondary Outcome

Title	Progression-free Survival
Description	Progression-free survival is defined among the efficacy population as the time from first dose of study drug until the first date of either disease progression or death due to any cause.
Time Frame	From 6 days prior to Day 1 of Cycle 3 and 5, and at each subsequent cycle, until discontinuation, assessed up to 12 months after last dose of study drug

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	15 μg/kg Q3W	30 μg/kg Q3W	60 μg/kg Q3W	90 μg/kg Q3W	120 μg/kg Q3W	150 μg/kg Q3W	50 μg/kg QW
Arm/Group Description	Participants received 15 μg/kg ADCT-402 on Day 1 of each 3-week treatment cycle.	Participants received 30 μg/kg ADCT-402 on Day 1 of each 3-week treatment cycle.	Participants received 60 μg/kg ADCT-402 on Day 1 of each 3-week treatment cycle.	Participants received 90 μg/kg ADCT-402 on Day 1 of each 3-week treatment cycle.	Participants received 120 μg/kg ADCT-402 on Day 1 of each 3-week treatment cycle.	Participants received 150 μg/kg ADCT-402 on Day 1 of each 3-week treatment cycle.	Participants received 50 μg/kg ADCT-402 weekly on Days 1, 8 and 15 of each 3-week (21-day) treatment cycle. This dose level for the weekly (QW) dosing schedule was based on the safety and tolerability of participants who had been treated on the every 3-week (Q3W) schedule.
Measure Participants	0	0	0	0	0	0	0

9. Secondary Outcome

Title	Maximum Observed Serum Concentration (Cmax) for ADCT-402 Administered Every 3 Weeks (Q3W)
Description	Cmax for Pyrrolobenzodiazepine (PBD) conjugated antibody (Ab), total Ab and free warhead (SG3199) for the Q3W cohorts.
Time Frame	Day 1 (before infusion, end of infusion, and 1, 3 and 6 hours after infusion) and Days 2, 3, 5, 8 and 15 for Cycles 1 and 2

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	15 μg/kg Q3W	30 μg/kg Q3W	60 μg/kg Q3W	90 μg/kg Q3W	120 μg/kg Q3W	150 μg/kg Q3W
Arm/Group Description	Participants received 15 μg/kg ADCT-402 on Day 1 of each 3-week treatment cycle.	Participants received 30 μg/kg ADCT-402 on Day 1 of each 3-week treatment cycle.	Participants received 60 μg/kg ADCT-402 on Day 1 of each 3-week treatment cycle.	Participants received 90 μg/kg ADCT-402 on Day 1 of each 3-week treatment cycle.	Participants received 120 μg/kg ADCT-402 on Day 1 of each 3-week treatment cycle.	Participants received 150 μg/kg ADCT-402 on Day 1 of each 3-week treatment cycle.
Measure Participants	5	7	3	4	5	6
PBD-Conjugated Ab : Cycle 1	178 (128)	258 (162)	449 (282)	1058 (893)	1291 (1020)	2145 (1054)
PBD-Conjugated Ab : Cycle 2	2150 (NA)	339 (276)	661 (412)	1813 (1650)	1515 (1001)	3033 (1458)
Total Ab (ADCT-402) : Cycle 1	205 (162)	317 (194)	717 (429)	1049 (892)	1722 (785)	2761 (1718)
Total Ab (ADCT-402) : Cycle 2	1251 (1724)	366 (251)	689 (382)	1845 (1676)	2125 (944)	4338 (2460)
SG3199 : Cycle 1	0.0428 (0.0000707)	0.0617 (0.0238)	0.0810 (0.0288)	0.0907 (0.0500)
SG3199 : Cycle 2	0.0459 (NA)	0.0697 (NA)	0.0551 (NA)	0.108 (0.0239)	0.0550 (0.0277)

10. Secondary Outcome

Title	Maximum Observed Serum Concentration (Cmax) for ADCT-402 Administered Every Week (QW)
Description	Cmax for Pyrrolobenzodiazepine (PBD) conjugated antibody (Ab), total Ab and free warhead (SG3199) for the QW cohort.
Time Frame	Day 1 (before infusion, end of infusion, and 1, 3 and 6 hours after infusion) and Days 2, 3, 5, 8 and 15 for Cycles 1 and 2

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	50 μg/kg QW
Arm/Group Description	Participants received 50 μg/kg ADCT-402 weekly on Days 1, 8 and 15 of each 3-week (21-day) treatment cycle. This dose level for the weekly (QW) dosing schedule was based on the safety and tolerability of participants who had been treated on the every 3-week (Q3W) schedule.
Measure Participants	3
PBD-Conjugated Ab : Cycle 1 Week 1	777 (NA)
PBD-Conjugated Ab : Cycle 1 Week 2	788 (456)
PBD-Conjugated Ab : Cycle 2 Week 1	444 (NA)
PBD-Conjugated Ab : Cycle 2 Week 2	757 (NA)
PBD-Conjugated Ab : Cycle 2 Week 3	773 (NA)
Total Ab (ADCT-402): Cycle 1 Week 1	363 (390)
Total Ab (ADCT-402): Cycle 1 Week 2	544 (492)
Total Ab (ADCT-402): Cycle 1 Week 3	293 (313)
Total Ab (ADCT-402): Cycle 2 Week 1	300 (294)
Total Ab (ADCT-402): Cycle 2 Week 2	480 (414)
Total Ab (ADCT-402): Cycle 2 Week 3	730 (NA)

11. Secondary Outcome

Title	Time to Reach the Maximum Serum Concentration (Tmax) for ADCT-402 Administered Every 3 Weeks (Q3W)
Description	Tmax for Pyrrolobenzodiazepine (PBD) conjugated antibody (Ab), total Ab and free warhead (SG3199) for the Q3W cohorts.
Time Frame	Day 1 (before infusion, end of infusion, and 1, 3 and 6 hours after infusion) and Days 2, 3, 5, 8 and 15 for Cycles 1 and 2

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	15 μg/kg Q3W	30 μg/kg Q3W	60 μg/kg Q3W	90 μg/kg Q3W	120 μg/kg Q3W	150 μg/kg Q3W
Arm/Group Description	Participants received 15 μg/kg ADCT-402 on Day 1 of each 3-week treatment cycle.	Participants received 30 μg/kg ADCT-402 on Day 1 of each 3-week treatment cycle.	Participants received 60 μg/kg ADCT-402 on Day 1 of each 3-week treatment cycle.	Participants received 90 μg/kg ADCT-402 on Day 1 of each 3-week treatment cycle.	Participants received 120 μg/kg ADCT-402 on Day 1 of each 3-week treatment cycle.	Participants received 150 μg/kg ADCT-402 on Day 1 of each 3-week treatment cycle.
Measure Participants	4	7	3	3	5	6
PBD-Conjugated Ab : Cycle 1	0.0525 (0.00957)	0.0671 (0.0547)	0.0433 (0.00577)	0.0567 (0.0208)	0.0460 (0.00548)	0.0517 (0.00983)
PBD-Conjugated Ab: Cycle 2	0.0600 (NA)	0.0475 (0.0250)	0.0300 (0.0141)	0.0500 (0.0424)	0.0500 (0.0212)	0.0525 (0.0250)
Total Ab (ADCT-402) : Cycle 1	0.0600 (0.0216)	0.0729 (0.0547)	0.0450 (0.00707)	0.0433 (0.00577)	0.0450 (0.00577)	0.0517 (0.00983)
Total Ab (ADCT-402) : Cycle 2	0.0600 (NA)	0.0700 (0.0678)	0.0300 (0.0141)	0.0500 (0.0424)	0.0600 (0.0141)	0.0625 (0.0263)
SG3199 : Cycle 1	0.0600 (0.0283)	0.125 (0.0636)	0.0867 (0.00577)	0.395 (0.777)
SG3199 : Cycle 2	0.0600 (NA)	0.0600 (NA)	0.0400 (NA)	0.0867 (0.00577)	0.0600 (0.0283)

12. Secondary Outcome

Title	Time to Reach the Maximum Serum Concentration (Tmax) for ADCT-402 Administered Every Week (QW)
Description	Tmax for Pyrrolobenzodiazepine (PBD) conjugated antibody (Ab), total Ab and free warhead (SG3199) for the QW cohort.
Time Frame	Day 1 (before infusion, end of infusion, and 1, 3 and 6 hours after infusion) and Days 2, 3, 5, 8 and 15 for Cycles 1 and 2

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	50 μg/kg QW
Arm/Group Description	Participants received 50 μg/kg ADCT-402 weekly on Days 1, 8 and 15 of each 3-week (21-day) treatment cycle. This dose level for the weekly (QW) dosing schedule was based on the safety and tolerability of participants who had been treated on the every 3-week (Q3W) schedule.
Measure Participants	3
PBD-Conjugated Ab : Cycle 1 Week 1	0.0500 (NA)
PBD-Conjugated Ab : Cycle 1 Week 2	0.0400 (0.0141)
PBD-Conjugated Ab : Cycle 2 Week 1	0.0400 (NA)
PBD-Conjugated Ab : Cycle 2 Week 2	0.0400 (NA)
PBD-Conjugated Ab : Cycle 2 Week 3	0.0400 (NA)
Total Ab (ADCT-402): Cycle 1 Week 1	0.0500 (0.0100)
Total Ab (ADCT-402): Cycle 1 Week 2	0.697 (1.14)
Total Ab (ADCT-402): Cycle 1 Week 3	0.110 (0.0849)
Total Ab (ADCT-402): Cycle 2 Week 1	0.0400 (0)
Total Ab (ADCT-402): Cycle 2 Week 2	0.0300 (0.0141)
Total Ab (ADCT-402): Cycle 2 Week 3	0.0400 (NA)

13. Secondary Outcome

Title	Area Under the Serum Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration (AUClast) for ADCT-402 Administered Every 3 Weeks (Q3W)
Description	AUClast for Pyrrolobenzodiazepine (PBD) conjugated antibody (Ab), total Ab and free warhead (SG3199) for the Q3W cohorts.
Time Frame	Day 1 (before infusion, end of infusion, and 1, 3 and 6 hours after infusion) and Days 2, 3, 5, 8 and 15 for Cycles 1 and 2

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	15 μg/kg Q3W	30 μg/kg Q3W	60 μg/kg Q3W	90 μg/kg Q3W	120 μg/kg Q3W	150 μg/kg Q3W
Arm/Group Description	Participants received 15 μg/kg ADCT-402 on Day 1 of each 3-week treatment cycle.	Participants received 30 μg/kg ADCT-402 on Day 1 of each 3-week treatment cycle.	Participants received 60 μg/kg ADCT-402 on Day 1 of each 3-week treatment cycle.	Participants received 90 μg/kg ADCT-402 on Day 1 of each 3-week treatment cycle.	Participants received 120 μg/kg ADCT-402 on Day 1 of each 3-week treatment cycle.	Participants received 150 μg/kg ADCT-402 on Day 1 of each 3-week treatment cycle.
Measure Participants	4	7	3	3	5	6
PBD-Conjugated Ab : Cycle 1	337 (651)	127 (229)	43.0 (37.3)	671 (1083)	3907 (8159)	688 (570)
PBD-Conjugated Ab : Cycle 2	1596 (NA)	735 (1400)	50.6 (9.08)	3370 (4562)	8744 (17745)	7553 (727)
Total Ab (ADCT-402) : Cycle 1	610 (1190)	408 (623)	59.9 (43.5)	558 (899)	5718 (9648)	1091 (673)
Total Ab (ADCT-402) : Cycle 2	1012 (1301)	1140 (2096)	40.2 (0.0244)	3671 (5062)	13519 (22799)	10493 (2021)
SG3199 : Cycle 1	0.00355 (0.00147)	0.00930 (0.00675)	0.0194 (0.0231)	0.0338 (0.0150)
SG3199 : Cycle 2	0.00522 (NA)	0.0129 (NA)	0.00830 (NA)	0.0433 (0.0316)	0.00927 (0.00881)

14. Secondary Outcome

Title	Area Under the Serum Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration (AUClast) for ADCT-402 Administered Every Week (QW)
Description	AUClast for Pyrrolobenzodiazepine (PBD) conjugated antibody (Ab), total Ab and free warhead (SG3199) for the QW cohort.
Time Frame	Day 1 (before infusion, end of infusion, and 1, 3 and 6 hours after infusion) and Days 2, 3, 5, 8 and 15 for Cycles 1 and 2

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	50 μg/kg QW
Arm/Group Description	Participants received 50 μg/kg ADCT-402 weekly on Days 1, 8 and 15 of each 3-week (21-day) treatment cycle. This dose level for the weekly (QW) dosing schedule was based on the safety and tolerability of participants who had been treated on the every 3-week (Q3W) schedule.
Measure Participants	3
PBD-Conjugated Ab : Cycle 1 Week 1	518 (NA)
PBD-Conjugated Ab : Cycle 1 Week 2	1063 (1334)
PBD-Conjugated Ab : Cycle 2 Week 1	1548 (NA)
PBD-Conjugated Ab : Cycle 2 Week 2	2631 (NA)
PBD-Conjugated Ab : Cycle 2 Week 3	3918 (NA)
Total Ab (ADCT-402): Cycle 1 Week 1	464 (290)
Total Ab (ADCT-402): Cycle 1 Week 2	821 (886)
Total Ab (ADCT-402): Cycle 1 Week 3	1286 (1158)
Total Ab (ADCT-402): Cycle 2 Week 1	1157 (962)
Total Ab (ADCT-402): Cycle 2 Week 2	9.08 (9.78)
Total Ab (ADCT-402): Cycle 2 Week 3	3927 (NA)

15. Secondary Outcome

Title	Area Under the Serum Concentration-time Curve From Time 0 to Infinity (AUC∞) for ADCT-402 Administered Every 3 Weeks (Q3W)
Description	AUC∞ for Pyrrolobenzodiazepine (PBD) conjugated antibody (Ab), total Ab and free warhead (SG3199) for the Q3W cohorts.
Time Frame	Day 1 (before infusion, end of infusion, and 1, 3 and 6 hours after infusion) and Days 2, 3, 5, 8 and 15 for Cycles 1 and 2

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	15 μg/kg Q3W	30 μg/kg Q3W	60 μg/kg Q3W	90 μg/kg Q3W	120 μg/kg Q3W	150 μg/kg Q3W
Arm/Group Description	Participants received 15 μg/kg ADCT-402 on Day 1 of each 3-week treatment cycle.	Participants received 30 μg/kg ADCT-402 on Day 1 of each 3-week treatment cycle.	Participants received 60 μg/kg ADCT-402 on Day 1 of each 3-week treatment cycle.	Participants received 90 μg/kg ADCT-402 on Day 1 of each 3-week treatment cycle.	Participants received 120 μg/kg ADCT-402 on Day 1 of each 3-week treatment cycle.	Participants received 150 μg/kg ADCT-402 on Day 1 of each 3-week treatment cycle.
Measure Participants	1	2	1	3	2	5
PBD-Conjugated Ab : Cycle 1	1378 (NA)	395 (371)	677 (1091)	282 (324)	486 (259)
Total Ab (ADCT-402) : Cycle 1	535 (668)	94.1 (NA)	1634 (NA)	1140 (1283)

16. Secondary Outcome

Title	Area Under the Serum Concentration-time Curve From Time 0 to Infinity (AUC∞) for ADCT-402 Administered Weekly (QW)
Description	AUC∞ for Pyrrolobenzodiazepine (PBD) conjugated antibody (Ab), total Ab and free warhead (SG3199) for the QW cohort.
Time Frame	Day 1 (before infusion, end of infusion, and 1, 3 and 6 hours after infusion) and Days 2, 3, 5, 8 and 15 for Cycles 1 and 2

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	50 μg/kg QW
Arm/Group Description	Participants received 50 μg/kg ADCT-402 weekly on Days 1, 8 and 15 of each 3-week (21-day) treatment cycle. This dose level for the weekly (QW) dosing schedule was based on the safety and tolerability of participants who had been treated on the every 3-week (Q3W) schedule.
Measure Participants	1
PBD-Conjugated Ab : Cycle 1 Week 1	545 (NA)

17. Secondary Outcome

Title	Area Under the Serum Concentration-time Curve From Time 0 to the End of the Dosing Interval (AUC0-tau) for ADCT-402 Administered Every 3 Weeks (Q3W)
Description	AUCtau for Pyrrolobenzodiazepine (PBD) conjugated antibody (Ab), total Ab and free warhead (SG3199) for the Q3W cohorts.
Time Frame	Day 1 (before infusion, end of infusion, and 1, 3 and 6 hours after infusion) and Days 2, 3, 5, 8 and 15 for Cycles 1 and 2

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	15 μg/kg Q3W	30 μg/kg Q3W	60 μg/kg Q3W	90 μg/kg Q3W	120 μg/kg Q3W	150 μg/kg Q3W
Arm/Group Description	Participants received 15 μg/kg ADCT-402 on Day 1 of each 3-week treatment cycle.	Participants received 30 μg/kg ADCT-402 on Day 1 of each 3-week treatment cycle.	Participants received 60 μg/kg ADCT-402 on Day 1 of each 3-week treatment cycle.	Participants received 90 μg/kg ADCT-402 on Day 1 of each 3-week treatment cycle.	Participants received 120 μg/kg ADCT-402 on Day 1 of each 3-week treatment cycle.	Participants received 150 μg/kg ADCT-402 on Day 1 of each 3-week treatment cycle.
Measure Participants	1	3	2	2	4	4
PBD-Conjugated Ab : Cycle 2	1810 (NA)	985 (1606)	53.3 (9.99)	3595 (4876)	8282 (14386)	7444 (831)
Total Ab (ADCT-402) : Cycle 2	2500 (NA)	1607 (2330)	41.2 (NA)	7820 (NA)	10198 (15433)	10112 (1753)
SG3199 : Cycle 2	0.104 (NA)

18. Secondary Outcome

Title	Area Under the Serum Concentration-time Curve From Time 0 to the End of the Dosing Interval (AUC0-tau) for ADCT-402 Administered Every Week (QW)
Description	AUCtau for Pyrrolobenzodiazepine (PBD) conjugated antibody (Ab), total Ab and free warhead (SG3199) for the QW cohort.
Time Frame	Day 1 (before infusion, end of infusion, and 1, 3 and 6 hours after infusion) and Days 2, 3, 5, 8 and 15 for Cycles 1 and 2

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	50 μg/kg QW
Arm/Group Description	Participants received 50 μg/kg ADCT-402 weekly on Days 1, 8 and 15 of each 3-week (21-day) treatment cycle. This dose level for the weekly (QW) dosing schedule was based on the safety and tolerability of participants who had been treated on the every 3-week (Q3W) schedule.
Measure Participants	2
PBD-Conjugated Ab : Cycle 1 Week 2	1293 (1640)
PBD-Conjugated Ab : Cycle 2 Week 3	3542 (NA)
Total Ab (ADCT-402): Cycle 1 Week 2	1402 (1314)
Total Ab (ADCT-402): Cycle 1 Week 3	2066 (NA)
Total Ab (ADCT-402): Cycle 2 Week 1	449 (NA)
Total Ab (ADCT-402): Cycle 2 Week 3	3463 (NA)

19. Secondary Outcome

Title	Accumulation Index (AI) for ADCT-402 Administered Every 3 Weeks (Q3W)
Description	AI for Pyrrolobenzodiazepine (PBD) conjugated antibody (Ab), total Ab and free warhead (SG3199) for the Q3W cohorts. AI is the ratio of AUC 0-24 after multiple doses versus a single dose. It is the increase in drug plasma concentration after multiple dosing until a steady state is reached.
Time Frame	Day 1 (before infusion, end of infusion, and 1, 3 and 6 hours after infusion) and Days 2, 3, 5, 8 and 15 for Cycles 1 and 2

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	15 μg/kg Q3W	30 μg/kg Q3W	60 μg/kg Q3W	90 μg/kg Q3W	120 μg/kg Q3W	150 μg/kg Q3W
Arm/Group Description	Participants received 15 μg/kg ADCT-402 on Day 1 of each 3-week treatment cycle.	Participants received 30 μg/kg ADCT-402 on Day 1 of each 3-week treatment cycle.	Participants received 60 μg/kg ADCT-402 on Day 1 of each 3-week treatment cycle.	Participants received 90 μg/kg ADCT-402 on Day 1 of each 3-week treatment cycle.	Participants received 120 μg/kg ADCT-402 on Day 1 of each 3-week treatment cycle.	Participants received 150 μg/kg ADCT-402 on Day 1 of each 3-week treatment cycle.
Measure Participants	1	3	1	1	3	4
PBD-Conjugated Ab : Cycle 2	1.01 (NA)	1.14 (0.242)	1.00 (NA)	1.06 (NA)	1.30 (0.509)	1.03 (0.0187)
Total Ab (ADCT-402) : Cycle 2	1.04 (NA)	1.62 (0.433)	1.00 (NA)	1.08 (NA)	1.67 (0.939)	1.06 (0.0532)

20. Secondary Outcome

Title	Accumulation Index (AI) for ADCT-402 Administered Weekly (QW)
Description	AI for Pyrrolobenzodiazepine (PBD) conjugated antibody (Ab), total Ab and free warhead (SG3199) for the QW cohort. AI is the ratio of AUC 0-24 after multiple doses versus a single dose. It is the increase in drug plasma concentration after multiple dosing until a steady state is reached.
Time Frame	Day 1 (before infusion, end of infusion, and 1, 3 and 6 hours after infusion) and Days 2, 3, 5, 8 and 15 for Cycles 1 and 2

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	50 μg/kg QW
Arm/Group Description	Participants received 50 μg/kg ADCT-402 weekly on Days 1, 8 and 15 of each 3-week (21-day) treatment cycle. This dose level for the weekly (QW) dosing schedule was based on the safety and tolerability of participants who had been treated on the every 3-week (Q3W) schedule.
Measure Participants	2
PBD-Conjugated Ab : Cycle 1 Week 2	1.13 (0.0410)
Total Ab (ADCT-402) : Cycle 1 Week 2	2.52 (1.92)

21. Secondary Outcome

Title	Volume of Distribution at Steady State for ADCT-402
Time Frame	Day 1 (before infusion, end of infusion, and 1, 3 and 6 hours after infusion) and Days 2, 3, 5, 8 and 15 for Cycles 1 and 2

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	15 μg/kg Q3W	30 μg/kg Q3W	60 μg/kg Q3W	90 μg/kg Q3W	120 μg/kg Q3W	150 μg/kg Q3W	50 μg/kg QW
Arm/Group Description	Participants received 15 μg/kg ADCT-402 on Day 1 of each 3-week treatment cycle.	Participants received 30 μg/kg ADCT-402 on Day 1 of each 3-week treatment cycle.	Participants received 60 μg/kg ADCT-402 on Day 1 of each 3-week treatment cycle.	Participants received 90 μg/kg ADCT-402 on Day 1 of each 3-week treatment cycle.	Participants received 120 μg/kg ADCT-402 on Day 1 of each 3-week treatment cycle.	Participants received 150 μg/kg ADCT-402 on Day 1 of each 3-week treatment cycle.	Participants received 50 μg/kg ADCT-402 weekly on Days 1, 8 and 15 of each 3-week (21-day) treatment cycle. This dose level for the weekly (QW) dosing schedule was based on the safety and tolerability of participants who had been treated on the every 3-week (Q3W) schedule.
Measure Participants	0	0	0	0	0	0	0

22. Secondary Outcome

Title	Mean Residence Time for ADCT-402
Time Frame	Day 1 (before infusion, end of infusion, and 1, 3 and 6 hours after infusion) and Days 2, 3, 5, 8 and 15 for Cycles 1 and 2

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	15 μg/kg Q3W	30 μg/kg Q3W	60 μg/kg Q3W	90 μg/kg Q3W	120 μg/kg Q3W	150 μg/kg Q3W	50 μg/kg QW
Arm/Group Description	Participants received 15 μg/kg ADCT-402 on Day 1 of each 3-week treatment cycle.	Participants received 30 μg/kg ADCT-402 on Day 1 of each 3-week treatment cycle.	Participants received 60 μg/kg ADCT-402 on Day 1 of each 3-week treatment cycle.	Participants received 90 μg/kg ADCT-402 on Day 1 of each 3-week treatment cycle.	Participants received 120 μg/kg ADCT-402 on Day 1 of each 3-week treatment cycle.	Participants received 150 μg/kg ADCT-402 on Day 1 of each 3-week treatment cycle.	Participants received 50 μg/kg ADCT-402 weekly on Days 1, 8 and 15 of each 3-week (21-day) treatment cycle. This dose level for the weekly (QW) dosing schedule was based on the safety and tolerability of participants who had been treated on the every 3-week (Q3W) schedule.
Measure Participants	0	0	0	0	0	0	0

23. Secondary Outcome

Title	Terminal Elimination Phase Rate Constant for ADCT-402
Time Frame	Day 1 (before infusion, end of infusion, and 1, 3 and 6 hours after infusion) and Days 2, 3, 5, 8 and 15 for Cycles 1 and 2

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	15 μg/kg Q3W	30 μg/kg Q3W	60 μg/kg Q3W	90 μg/kg Q3W	120 μg/kg Q3W	150 μg/kg Q3W	50 μg/kg QW
Arm/Group Description	Participants received 15 μg/kg ADCT-402 on Day 1 of each 3-week treatment cycle.	Participants received 30 μg/kg ADCT-402 on Day 1 of each 3-week treatment cycle.	Participants received 60 μg/kg ADCT-402 on Day 1 of each 3-week treatment cycle.	Participants received 90 μg/kg ADCT-402 on Day 1 of each 3-week treatment cycle.	Participants received 120 μg/kg ADCT-402 on Day 1 of each 3-week treatment cycle.	Participants received 150 μg/kg ADCT-402 on Day 1 of each 3-week treatment cycle.	Participants received 50 μg/kg ADCT-402 weekly on Days 1, 8 and 15 of each 3-week (21-day) treatment cycle. This dose level for the weekly (QW) dosing schedule was based on the safety and tolerability of participants who had been treated on the every 3-week (Q3W) schedule.
Measure Participants	0	0	0	0	0	0	0

24. Secondary Outcome

Title	Apparent Terminal Phase Elimination Half-life (T1/2) for ADCT-402 Administered Every 3 Weeks (Q3W)
Description	T1/2 for Pyrrolobenzodiazepine (PBD) conjugated antibody (Ab), total Ab and free warhead (SG3199) for the Q3W cohorts.
Time Frame	Day 1 (before infusion, end of infusion, and 1, 3 and 6 hours after infusion) and Days 2, 3, 5, 8 and 15 for Cycles 1 and 2

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	15 μg/kg Q3W	30 μg/kg Q3W	60 μg/kg Q3W	90 μg/kg Q3W	120 μg/kg Q3W	150 μg/kg Q3W
Arm/Group Description	Participants received 15 μg/kg ADCT-402 on Day 1 of each 3-week treatment cycle.	Participants received 30 μg/kg ADCT-402 on Day 1 of each 3-week treatment cycle.	Participants received 60 μg/kg ADCT-402 on Day 1 of each 3-week treatment cycle.	Participants received 90 μg/kg ADCT-402 on Day 1 of each 3-week treatment cycle.	Participants received 120 μg/kg ADCT-402 on Day 1 of each 3-week treatment cycle.	Participants received 150 μg/kg ADCT-402 on Day 1 of each 3-week treatment cycle.
Measure Participants	1	3	1	3	3	5
PBD-Conjugated Ab : Cycle 1	5.23 (NA)	1.87 (0.287)	0.355 (0.501)	0.156 (0.164)	0.713 (0.596)
PBD-Conjugated Ab : Cycle 2	2.91 (NA)	4.31 (6.62)	0.282 (NA)	4.96 (NA)	7.55 (10.3)	3.99 (0.723)
Total Ab (ADCT-402) : Cycle 1	1.28 (1.66)	0.0538 (NA)	0.784 (NA)	0.275 (0.306)
Total Ab (ADCT-402) : Cycle 2	4.42 (NA)	15.0 (6.88)	0.0342 (NA)	5.59 (NA)	14.5 (16.4)	4.67 (1.68)
SG3199 : Cycle 2	0.508 (NA)

25. Secondary Outcome

Title	Apparent Terminal Phase Elimination Half-life (T1/2) for ADCT-402 Administered Every Week (QW)
Description	T1/2 for Pyrrolobenzodiazepine (PBD) conjugated antibody (Ab), total Ab and free warhead (SG3199) for the QW cohort.
Time Frame	Day 1 (before infusion, end of infusion, and 1, 3 and 6 hours after infusion) and Days 2, 3, 5, 8 and 15 for Cycles 1 and 2

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	50 μg/kg QW
Arm/Group Description	Participants received 50 μg/kg ADCT-402 weekly on Days 1, 8 and 15 of each 3-week (21-day) treatment cycle. This dose level for the weekly (QW) dosing schedule was based on the safety and tolerability of participants who had been treated on the every 3-week (Q3W) schedule.
Measure Participants	2
PBD-Conjugated Ab : Cycle 1 Week 1	2.29 (NA)
PBD-Conjugated Ab : Cycle 1 Week 2	2.26 (0.288)
Total Ab (ADCT-402): Cycle 1 Week 2	9.39 (9.77)

26. Secondary Outcome

Title	Apparent Clearance at Steady State for ADCT-402 Administered Every 3 Weeks (Q3W)
Description	Apparent clearance for Pyrrolobenzodiazepine (PBD) conjugated antibody (Ab), total Ab and free warhead (SG3199) for the Q3W cohorts.
Time Frame	Day 1 (before infusion, end of infusion, and 1, 3 and 6 hours after infusion) and Days 2, 3, 5, 8 and 15 for Cycles 1 and 2

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	15 μg/kg Q3W	30 μg/kg Q3W	60 μg/kg Q3W	90 μg/kg Q3W	120 μg/kg Q3W	150 μg/kg Q3W
Arm/Group Description	Participants received 15 μg/kg ADCT-402 on Day 1 of each 3-week treatment cycle.	Participants received 30 μg/kg ADCT-402 on Day 1 of each 3-week treatment cycle.	Participants received 60 μg/kg ADCT-402 on Day 1 of each 3-week treatment cycle.	Participants received 90 μg/kg ADCT-402 on Day 1 of each 3-week treatment cycle.	Participants received 120 μg/kg ADCT-402 on Day 1 of each 3-week treatment cycle.	Participants received 150 μg/kg ADCT-402 on Day 1 of each 3-week treatment cycle.
Measure Participants	1	3	2	3	4	5
PBD-Conjugated Ab : Cycle 1	0.650 (NA)	14.0 (14.3)	80.8 (106)	84.3 (102)	27.4 (12.4)
PBD-Conjugated Ab : Cycle 2	0.495 (NA)	69.3 (92.3)	86.4 (34.6)	9.63 (12.5)	31.1 (37.0)	1.57 (0.726)
Total Ab (ADCT-402) : Cycle 1	31.3 (40.0)	55.5 (NA)	3.98 (NA)	18.9 (21.8)
Total Ab (ADCT-402) : Cycle 2	0.422 (NA)	16.4 (19.9)	146 (NA)	0.831 (NA)	10.3 (16.7)	1.37 (0.656)
SG3199 : Cycle 2	838 (NA)

27. Secondary Outcome

Title	Apparent Clearance at Steady State for ADCT-402 Administered Every Week (QW)
Description	Apparent clearance for Pyrrolobenzodiazepine (PBD) conjugated antibody (Ab), total Ab and free warhead (SG3199) for the QW cohort.
Time Frame	Day 1 (before infusion, end of infusion, and 1, 3 and 6 hours after infusion) and Days 2, 3, 5, 8 and 15 for Cycles 1 and 2

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	50 μg/kg QW
Arm/Group Description	Participants received 50 μg/kg ADCT-402 weekly on Days 1, 8 and 15 of each 3-week (21-day) treatment cycle. This dose level for the weekly (QW) dosing schedule was based on the safety and tolerability of participants who had been treated on the every 3-week (Q3W) schedule.
Measure Participants	2
PBD-Conjugated Ab : Cycle 1 Week 1	5.77 (NA)
PBD-Conjugated Ab : Cycle 1 Week 2	14.0 (18.0)
PBD-Conjugated Ab : Cycle 2 Week 3	1.01 (NA)
Total Ab (ADCT-402): Cycle 1 Week 2	5.23 (5.16)
Total Ab (ADCT-402): Cycle 1 Week 3	2.03 (NA)
Total Ab (ADCT-402): Cycle 2 Week 1	8.46 (NA)
Total Ab (ADCT-402): Cycle 2 Week 3	1.21 (NA)

28. Secondary Outcome

Title	Apparent Volume of Distribution (Vd Beta) for ADCT-402 Administered Every 3 Weeks (Q3W)
Description	Vd beta for Pyrrolobenzodiazepine (PBD) conjugated antibody (Ab), total Ab and free warhead (SG3199) for the Q3W cohorts.
Time Frame	Day 1 (before infusion, end of infusion, and 1, 3 and 6 hours after infusion) and Days 2, 3, 5, 8 and 15 for Cycles 1 and 2

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	15 μg/kg Q3W	30 μg/kg Q3W	60 μg/kg Q3W	90 μg/kg Q3W	120 μg/kg Q3W	150 μg/kg Q3W
Arm/Group Description	Participants received 15 μg/kg ADCT-402 on Day 1 of each 3-week treatment cycle.	Participants received 30 μg/kg ADCT-402 on Day 1 of each 3-week treatment cycle.	Participants received 60 μg/kg ADCT-402 on Day 1 of each 3-week treatment cycle.	Participants received 90 μg/kg ADCT-402 on Day 1 of each 3-week treatment cycle.	Participants received 120 μg/kg ADCT-402 on Day 1 of each 3-week treatment cycle.	Participants received 150 μg/kg ADCT-402 on Day 1 of each 3-week treatment cycle.
Measure Participants	1	3	1	3	3	5
PBD-Conjugated Ab : Cycle 1	4.91 (NA)	40.7 (44.3)	10.5 (12.6)	6.89 (3.13)	34.2 (35.5)
PBD-Conjugated Ab : Cycle 2	2.08 (NA)	24.0 (18.1)	45.1 (NA)	5.61 (NA)	8.33 (5.43)	9.45 (5.27)
Total Ab (ADCT-402) : Cycle 1	9.77 (1.09)	4.31 (NA)	4.50 (NA)	2.68 (0.309)
Total Ab (ADCT-402) : Cycle 2	2.69 (NA)	145 (190)	7.22 (NA)	6.71 (NA)	11.4 (0.101)	9.14 (5.96)
SG3199 : Cycle 2	614 (NA)

29. Secondary Outcome

Title	Apparent Volume of Distribution (Vd Beta) for ADCT-402 Administered Every Week (QW)
Description	Vd beta for Pyrrolobenzodiazepine (PBD) conjugated antibody (Ab), total Ab and free warhead (SG3199) for the QW cohort.
Time Frame	Day 1 (before infusion, end of infusion, and 1, 3 and 6 hours after infusion) and Days 2, 3, 5, 8 and 15 for Cycles 1 and 2

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	50 μg/kg QW
Arm/Group Description	Participants received 50 μg/kg ADCT-402 weekly on Days 1, 8 and 15 of each 3-week (21-day) treatment cycle. This dose level for the weekly (QW) dosing schedule was based on the safety and tolerability of participants who had been treated on the every 3-week (Q3W) schedule.
Measure Participants	2
PBD-Conjugated Ab : Cycle 1 Week 1	19.1 (NA)
PBD-Conjugated Ab : Cycle 1 Week 2	49.5 (64.6)
Total Ab (ADCT-402): Cycle 1 Week 2	107 (144)

30. Secondary Outcome

Title	Number of Participants With Anti-drug Antibody Response (ADA) Against ADCT-402
Description	Blood serum samples were collected and analysed to determine the presence or absence of ADA.
Time Frame	Day 1 (before infusion, end of infusion, and 1, 3 and 6 hours after infusion) and Days 2, 3, 5, 8 and 15 for Cycles 1 and 2

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Part 1: ADCT-402 Dose Escalation
Arm/Group Description	Weekly administration (QW) - Participants received an intravenous (IV) infusion of ADCT-402, on Days 1, 8, and 15 of each 3- week (21-day) cycle. 3-week administration (Q3W) - Participants received an IV infusion of ADCT-402, on Day 1 of each 3-week (21-day) cycle. The dose escalation was conducted according to a 3+3 design.
Measure Participants	35
Confirmed positive ADA pre-dose	1 20%
Confirmed positive ADA post-dose	0 0%
Confirmed positive ADA at any time	1 20%

Adverse Events

Time Frame	From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
Arm/Group Title	15 μg/kg Q3W		30 μg/kg Q3W		60 μg/kg Q3W		90 μg/kg Q3W		120 μg/kg Q3W		150 μg/kg Q3W		50 μg/kg QW
Arm/Group Description	Participants received 15 μg/kg ADCT-402 on Day 1 of each 3-week treatment cycle.		Participants received 30 μg/kg ADCT-402 on Day 1 of each 3-week treatment cycle.		Participants received 60 μg/kg ADCT-402 on Day 1 of each 3-week treatment cycle.		Participants received 90 μg/kg ADCT-402 on Day 1 of each 3-week treatment cycle.		Participants received 120 μg/kg ADCT-402 on Day 1 of each 3-week treatment cycle.		Participants received 150 μg/kg ADCT-402 on Day 1 of each 3-week treatment cycle.		Participants received 50 μg/kg ADCT-402 weekly on Days 1, 8 and 15 of each 3-week (21-day) treatment cycle. This dose level for the weekly (QW) dosing schedule was based on the safety and tolerability of participants who had been treated on the every 3-week (Q3W) schedule.
All Cause Mortality
	15 μg/kg Q3W		30 μg/kg Q3W		60 μg/kg Q3W		90 μg/kg Q3W		120 μg/kg Q3W		150 μg/kg Q3W		50 μg/kg QW
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	5/5 (100%)		5/7 (71.4%)		3/3 (100%)		3/4 (75%)		3/5 (60%)		6/6 (100%)		3/5 (60%)
Serious Adverse Events
	15 μg/kg Q3W		30 μg/kg Q3W		60 μg/kg Q3W		90 μg/kg Q3W		120 μg/kg Q3W		150 μg/kg Q3W		50 μg/kg QW
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	5/5 (100%)		4/7 (57.1%)		2/3 (66.7%)		3/4 (75%)		5/5 (100%)		5/6 (83.3%)		4/5 (80%)
Blood and lymphatic system disorders
Febrile neutropenia	0/5 (0%)		1/7 (14.3%)		1/3 (33.3%)		1/4 (25%)		2/5 (40%)		2/6 (33.3%)		1/5 (20%)
Leukocytosis	1/5 (20%)		1/7 (14.3%)		0/3 (0%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)
Cardiac disorders
Pericarditis	0/5 (0%)		0/7 (0%)		0/3 (0%)		0/4 (0%)		1/5 (20%)		0/6 (0%)		0/5 (0%)
Ear and labyrinth disorders
Ear pain	1/5 (20%)		0/7 (0%)		0/3 (0%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)
Gastrointestinal disorders
Abdominal pain	0/5 (0%)		1/7 (14.3%)		0/3 (0%)		1/4 (25%)		0/5 (0%)		0/6 (0%)		1/5 (20%)
Diarrhoea	1/5 (20%)		0/7 (0%)		0/3 (0%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)
Lip oedema	0/5 (0%)		0/7 (0%)		0/3 (0%)		0/4 (0%)		0/5 (0%)		1/6 (16.7%)		0/5 (0%)
Proctalgia	0/5 (0%)		0/7 (0%)		0/3 (0%)		0/4 (0%)		0/5 (0%)		1/6 (16.7%)		0/5 (0%)
Upper gastrointestinal haemorrhage	0/5 (0%)		0/7 (0%)		0/3 (0%)		0/4 (0%)		1/5 (20%)		0/6 (0%)		0/5 (0%)
General disorders
Asthenia	0/5 (0%)		1/7 (14.3%)		0/3 (0%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)
Disease progression	0/5 (0%)		0/7 (0%)		0/3 (0%)		0/4 (0%)		1/5 (20%)		0/6 (0%)		0/5 (0%)
Fatigue	0/5 (0%)		0/7 (0%)		0/3 (0%)		0/4 (0%)		1/5 (20%)		0/6 (0%)		0/5 (0%)
Localised oedema	0/5 (0%)		0/7 (0%)		0/3 (0%)		0/4 (0%)		0/5 (0%)		1/6 (16.7%)		0/5 (0%)
Non-cardiac chest pain	0/5 (0%)		0/7 (0%)		0/3 (0%)		0/4 (0%)		0/5 (0%)		1/6 (16.7%)		0/5 (0%)
Pain	0/5 (0%)		0/7 (0%)		0/3 (0%)		0/4 (0%)		1/5 (20%)		0/6 (0%)		0/5 (0%)
Pyrexia	1/5 (20%)		0/7 (0%)		0/3 (0%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)
Immune system disorders
Cytokine release syndrome	0/5 (0%)		0/7 (0%)		0/3 (0%)		0/4 (0%)		1/5 (20%)		0/6 (0%)		0/5 (0%)
Infections and infestations
Acute sinusitis	1/5 (20%)		0/7 (0%)		0/3 (0%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)
Bacteraemia	0/5 (0%)		0/7 (0%)		0/3 (0%)		2/4 (50%)		0/5 (0%)		0/6 (0%)		1/5 (20%)
Bacterial infection	0/5 (0%)		0/7 (0%)		0/3 (0%)		1/4 (25%)		0/5 (0%)		0/6 (0%)		0/5 (0%)
Candida sepsis	0/5 (0%)		0/7 (0%)		0/3 (0%)		0/4 (0%)		0/5 (0%)		1/6 (16.7%)		0/5 (0%)
Enterococcal bacteraemia	0/5 (0%)		0/7 (0%)		0/3 (0%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		1/5 (20%)
Fungaemia	0/5 (0%)		0/7 (0%)		0/3 (0%)		1/4 (25%)		0/5 (0%)		0/6 (0%)		0/5 (0%)
Lung infection	0/5 (0%)		1/7 (14.3%)		1/3 (33.3%)		0/4 (0%)		1/5 (20%)		0/6 (0%)		0/5 (0%)
Pneumonia	0/5 (0%)		1/7 (14.3%)		0/3 (0%)		0/4 (0%)		1/5 (20%)		1/6 (16.7%)		0/5 (0%)
Sepsis	0/5 (0%)		2/7 (28.6%)		0/3 (0%)		0/4 (0%)		1/5 (20%)		0/6 (0%)		1/5 (20%)
Injury, poisoning and procedural complications
Hip fracture	0/5 (0%)		0/7 (0%)		0/3 (0%)		0/4 (0%)		1/5 (20%)		0/6 (0%)		0/5 (0%)
Subdural haematoma	0/5 (0%)		0/7 (0%)		0/3 (0%)		0/4 (0%)		0/5 (0%)		1/6 (16.7%)		0/5 (0%)
Investigations
Alanine aminotransferase increased	0/5 (0%)		0/7 (0%)		0/3 (0%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		1/5 (20%)
Aspartate aminotransferase increased	0/5 (0%)		0/7 (0%)		0/3 (0%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		1/5 (20%)
Blast cells present	1/5 (20%)		0/7 (0%)		0/3 (0%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)
Metabolism and nutrition disorders
Fluid overload	0/5 (0%)		0/7 (0%)		0/3 (0%)		0/4 (0%)		0/5 (0%)		1/6 (16.7%)		0/5 (0%)
Tumour lysis syndrome	1/5 (20%)		0/7 (0%)		0/3 (0%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)
Musculoskeletal and connective tissue disorders
Back pain	0/5 (0%)		0/7 (0%)		0/3 (0%)		0/4 (0%)		1/5 (20%)		0/6 (0%)		0/5 (0%)
Bone pain	1/5 (20%)		0/7 (0%)		0/3 (0%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acute lymphocytic leukaemia	0/5 (0%)		0/7 (0%)		0/3 (0%)		0/4 (0%)		0/5 (0%)		1/6 (16.7%)		0/5 (0%)
Nervous system disorders
Haemorrhage intracranial	0/5 (0%)		0/7 (0%)		0/3 (0%)		0/4 (0%)		0/5 (0%)		1/6 (16.7%)		0/5 (0%)
Headache	1/5 (20%)		0/7 (0%)		0/3 (0%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)
Seizure	0/5 (0%)		0/7 (0%)		0/3 (0%)		0/4 (0%)		0/5 (0%)		1/6 (16.7%)		0/5 (0%)
Subarachnoid haemorrhage	0/5 (0%)		1/7 (14.3%)		0/3 (0%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)
Respiratory, thoracic and mediastinal disorders
Hypoxia	0/5 (0%)		0/7 (0%)		0/3 (0%)		0/4 (0%)		0/5 (0%)		2/6 (33.3%)		0/5 (0%)
Skin and subcutaneous tissue disorders
Rash maculo-papular	0/5 (0%)		0/7 (0%)		1/3 (33.3%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)
Other (Not Including Serious) Adverse Events
	15 μg/kg Q3W		30 μg/kg Q3W		60 μg/kg Q3W		90 μg/kg Q3W		120 μg/kg Q3W		150 μg/kg Q3W		50 μg/kg QW
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	5/5 (100%)		7/7 (100%)		3/3 (100%)		4/4 (100%)		5/5 (100%)		6/6 (100%)		5/5 (100%)
Blood and lymphatic system disorders
Febrile neutropenia	0/5 (0%)		0/7 (0%)		0/3 (0%)		2/4 (50%)		1/5 (20%)		3/6 (50%)		1/5 (20%)
Anaemia	0/5 (0%)		2/7 (28.6%)		1/3 (33.3%)		1/4 (25%)		0/5 (0%)		0/6 (0%)		1/5 (20%)
Neutropenia	0/5 (0%)		0/7 (0%)		0/3 (0%)		0/4 (0%)		0/5 (0%)		1/6 (16.7%)		0/5 (0%)
Thrombocytopenia	0/5 (0%)		0/7 (0%)		0/3 (0%)		1/4 (25%)		0/5 (0%)		0/6 (0%)		0/5 (0%)
Cardiac disorders
Atrial fibrillation	0/5 (0%)		1/7 (14.3%)		0/3 (0%)		0/4 (0%)		1/5 (20%)		0/6 (0%)		0/5 (0%)
Bradycardia	0/5 (0%)		1/7 (14.3%)		1/3 (33.3%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)
Ischaemic cardiomyopathy	0/5 (0%)		0/7 (0%)		0/3 (0%)		0/4 (0%)		1/5 (20%)		0/6 (0%)		0/5 (0%)
Pericardial effusion	0/5 (0%)		0/7 (0%)		0/3 (0%)		0/4 (0%)		0/5 (0%)		1/6 (16.7%)		0/5 (0%)
Sinus bradycardia	0/5 (0%)		0/7 (0%)		0/3 (0%)		0/4 (0%)		1/5 (20%)		0/6 (0%)		0/5 (0%)
Sinus tachycardia	0/5 (0%)		0/7 (0%)		0/3 (0%)		0/4 (0%)		1/5 (20%)		0/6 (0%)		0/5 (0%)
Tachycardia	1/5 (20%)		0/7 (0%)		0/3 (0%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)
Ear and labyrinth disorders
External ear inflammation	0/5 (0%)		1/7 (14.3%)		0/3 (0%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)
Hypoacusis	0/5 (0%)		0/7 (0%)		0/3 (0%)		1/4 (25%)		0/5 (0%)		0/6 (0%)		0/5 (0%)
Tinnitus	0/5 (0%)		0/7 (0%)		0/3 (0%)		0/4 (0%)		0/5 (0%)		1/6 (16.7%)		0/5 (0%)
Eye disorders
Vision blurred	0/5 (0%)		0/7 (0%)		0/3 (0%)		1/4 (25%)		1/5 (20%)		0/6 (0%)		0/5 (0%)
Conjunctival haemorrhage	0/5 (0%)		0/7 (0%)		0/3 (0%)		0/4 (0%)		1/5 (20%)		0/6 (0%)		0/5 (0%)
Eye pain	0/5 (0%)		0/7 (0%)		0/3 (0%)		0/4 (0%)		1/5 (20%)		0/6 (0%)		0/5 (0%)
Eye pruritus	0/5 (0%)		1/7 (14.3%)		0/3 (0%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)
Gastrointestinal disorders
Nausea	1/5 (20%)		2/7 (28.6%)		1/3 (33.3%)		2/4 (50%)		3/5 (60%)		5/6 (83.3%)		1/5 (20%)
Vomiting	0/5 (0%)		1/7 (14.3%)		0/3 (0%)		1/4 (25%)		3/5 (60%)		3/6 (50%)		1/5 (20%)
Abdominal pain	0/5 (0%)		0/7 (0%)		1/3 (33.3%)		1/4 (25%)		0/5 (0%)		3/6 (50%)		2/5 (40%)
Diarrhoea	0/5 (0%)		1/7 (14.3%)		1/3 (33.3%)		2/4 (50%)		0/5 (0%)		1/6 (16.7%)		1/5 (20%)
Dyspepsia	0/5 (0%)		2/7 (28.6%)		1/3 (33.3%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)
Ascites	0/5 (0%)		0/7 (0%)		0/3 (0%)		0/4 (0%)		0/5 (0%)		2/6 (33.3%)		0/5 (0%)
Colitis	0/5 (0%)		0/7 (0%)		0/3 (0%)		0/4 (0%)		0/5 (0%)		1/6 (16.7%)		1/5 (20%)
Constipation	0/5 (0%)		0/7 (0%)		0/3 (0%)		0/4 (0%)		1/5 (20%)		1/6 (16.7%)		0/5 (0%)
Tongue ulceration	0/5 (0%)		0/7 (0%)		0/3 (0%)		0/4 (0%)		1/5 (20%)		0/6 (0%)		1/5 (20%)
Abdominal pain lower	0/5 (0%)		0/7 (0%)		0/3 (0%)		1/4 (25%)		0/5 (0%)		0/6 (0%)		0/5 (0%)
Abdominal pain upper	0/5 (0%)		0/7 (0%)		1/3 (33.3%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)
Anal incontinence	0/5 (0%)		0/7 (0%)		0/3 (0%)		0/4 (0%)		0/5 (0%)		1/6 (16.7%)		0/5 (0%)
Angina bullosa haemorrhagica	0/5 (0%)		0/7 (0%)		0/3 (0%)		0/4 (0%)		1/5 (20%)		0/6 (0%)		0/5 (0%)
Gastritis	0/5 (0%)		0/7 (0%)		0/3 (0%)		1/4 (25%)		0/5 (0%)		0/6 (0%)		0/5 (0%)
Gingival pain	0/5 (0%)		0/7 (0%)		0/3 (0%)		1/4 (25%)		0/5 (0%)		0/6 (0%)		0/5 (0%)
Mouth haemorrhage	0/5 (0%)		0/7 (0%)		0/3 (0%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		1/5 (20%)
Mouth ulceration	0/5 (0%)		0/7 (0%)		0/3 (0%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		1/5 (20%)
Rectal haemorrhage	0/5 (0%)		0/7 (0%)		0/3 (0%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		1/5 (20%)
Stomatitis	0/5 (0%)		0/7 (0%)		0/3 (0%)		0/4 (0%)		0/5 (0%)		1/6 (16.7%)		0/5 (0%)
General disorders
Fatigue	0/5 (0%)		3/7 (42.9%)		1/3 (33.3%)		3/4 (75%)		1/5 (20%)		0/6 (0%)		0/5 (0%)
Pyrexia	0/5 (0%)		1/7 (14.3%)		0/3 (0%)		0/4 (0%)		1/5 (20%)		3/6 (50%)		0/5 (0%)
Oedema peripheral	0/5 (0%)		1/7 (14.3%)		0/3 (0%)		1/4 (25%)		2/5 (40%)		1/6 (16.7%)		0/5 (0%)
Asthenia	0/5 (0%)		0/7 (0%)		0/3 (0%)		0/4 (0%)		0/5 (0%)		2/6 (33.3%)		0/5 (0%)
Chills	0/5 (0%)		0/7 (0%)		1/3 (33.3%)		0/4 (0%)		1/5 (20%)		1/6 (16.7%)		0/5 (0%)
Non-cardiac chest pain	0/5 (0%)		0/7 (0%)		0/3 (0%)		0/4 (0%)		1/5 (20%)		0/6 (0%)		0/5 (0%)
Pain	0/5 (0%)		0/7 (0%)		1/3 (33.3%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)
Catheter site erythema	0/5 (0%)		0/7 (0%)		0/3 (0%)		0/4 (0%)		0/5 (0%)		1/6 (16.7%)		0/5 (0%)
Chest discomfort	0/5 (0%)		0/7 (0%)		0/3 (0%)		0/4 (0%)		0/5 (0%)		1/6 (16.7%)		0/5 (0%)
Face oedema	0/5 (0%)		0/7 (0%)		0/3 (0%)		0/4 (0%)		0/5 (0%)		1/6 (16.7%)		0/5 (0%)
Malaise	0/5 (0%)		0/7 (0%)		0/3 (0%)		1/4 (25%)		0/5 (0%)		0/6 (0%)		0/5 (0%)
Multiple organ dysfunction syndrome	0/5 (0%)		0/7 (0%)		0/3 (0%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		1/5 (20%)
Oedema	0/5 (0%)		0/7 (0%)		1/3 (33.3%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)
Localised oedema	0/5 (0%)		0/7 (0%)		0/3 (0%)		0/4 (0%)		0/5 (0%)		1/6 (16.7%)		0/5 (0%)
Hepatobiliary disorders
Cholecystitis acute	0/5 (0%)		0/7 (0%)		0/3 (0%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		1/5 (20%)
Immune system disorders
Graft versus host disease	0/5 (0%)		0/7 (0%)		0/3 (0%)		1/4 (25%)		0/5 (0%)		0/6 (0%)		0/5 (0%)
Infections and infestations
Bacteraemia	0/5 (0%)		0/7 (0%)		0/3 (0%)		0/4 (0%)		1/5 (20%)		1/6 (16.7%)		1/5 (20%)
Pneumonia	0/5 (0%)		0/7 (0%)		0/3 (0%)		0/4 (0%)		1/5 (20%)		2/6 (33.3%)		0/5 (0%)
Cellulitis	0/5 (0%)		0/7 (0%)		1/3 (33.3%)		1/4 (25%)		0/5 (0%)		2/6 (33.3%)		0/5 (0%)
Candida infection	0/5 (0%)		0/7 (0%)		0/3 (0%)		0/4 (0%)		1/5 (20%)		2/6 (33.3%)		0/5 (0%)
Staphylococcal infection	0/5 (0%)		0/7 (0%)		0/3 (0%)		0/4 (0%)		1/5 (20%)		1/6 (16.7%)		0/5 (0%)
Urinary tract infection	0/5 (0%)		1/7 (14.3%)		0/3 (0%)		0/4 (0%)		0/5 (0%)		1/6 (16.7%)		0/5 (0%)
Cytomegalovirus infection	0/5 (0%)		0/7 (0%)		0/3 (0%)		0/4 (0%)		0/5 (0%)		1/6 (16.7%)		0/5 (0%)
Escherichia infection	0/5 (0%)		0/7 (0%)		0/3 (0%)		0/4 (0%)		0/5 (0%)		1/6 (16.7%)		0/5 (0%)
Gingivitis	0/5 (0%)		0/7 (0%)		0/3 (0%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		1/5 (20%)
Otitis externa	0/5 (0%)		0/7 (0%)		0/3 (0%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		1/5 (20%)
Periorbital cellulitis	0/5 (0%)		0/7 (0%)		0/3 (0%)		0/4 (0%)		1/5 (20%)		0/6 (0%)		0/5 (0%)
Rectal abscess	0/5 (0%)		0/7 (0%)		0/3 (0%)		0/4 (0%)		0/5 (0%)		1/6 (16.7%)		0/5 (0%)
Sinusitis	0/5 (0%)		0/7 (0%)		0/3 (0%)		0/4 (0%)		1/5 (20%)		0/6 (0%)		0/5 (0%)
Injury, poisoning and procedural complications
Infusion related reaction	0/5 (0%)		0/7 (0%)		0/3 (0%)		0/4 (0%)		2/5 (40%)		1/6 (16.7%)		1/5 (20%)
Fall	0/5 (0%)		0/7 (0%)		1/3 (33.3%)		1/4 (25%)		0/5 (0%)		0/6 (0%)		0/5 (0%)
Subdural haematoma	0/5 (0%)		0/7 (0%)		0/3 (0%)		0/4 (0%)		1/5 (20%)		1/6 (16.7%)		0/5 (0%)
Contusion	0/5 (0%)		0/7 (0%)		0/3 (0%)		1/4 (25%)		0/5 (0%)		0/6 (0%)		0/5 (0%)
Tongue injury	0/5 (0%)		1/7 (14.3%)		0/3 (0%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)
Investigations
Aspartate aminotransferase increased	0/5 (0%)		0/7 (0%)		2/3 (66.7%)		2/4 (50%)		2/5 (40%)		4/6 (66.7%)		0/5 (0%)
Gamma-glutamyltransferase increased	1/5 (20%)		0/7 (0%)		0/3 (0%)		2/4 (50%)		3/5 (60%)		3/6 (50%)		1/5 (20%)
Alanine aminotransferase increased	0/5 (0%)		0/7 (0%)		1/3 (33.3%)		2/4 (50%)		2/5 (40%)		2/6 (33.3%)		2/5 (40%)
Blood alkaline phosphatase increased	0/5 (0%)		0/7 (0%)		2/3 (66.7%)		1/4 (25%)		1/5 (20%)		3/6 (50%)		2/5 (40%)
Blood bilirubin increased	0/5 (0%)		0/7 (0%)		1/3 (33.3%)		0/4 (0%)		2/5 (40%)		2/6 (33.3%)		1/5 (20%)
Blood lactate dehydrogenase increased	1/5 (20%)		0/7 (0%)		0/3 (0%)		0/4 (0%)		2/5 (40%)		1/6 (16.7%)		0/5 (0%)
Neutrophil count decreased	0/5 (0%)		2/7 (28.6%)		0/3 (0%)		0/4 (0%)		1/5 (20%)		1/6 (16.7%)		0/5 (0%)
Blood creatinine increased	1/5 (20%)		0/7 (0%)		1/3 (33.3%)		0/4 (0%)		0/5 (0%)		1/6 (16.7%)		0/5 (0%)
Lipase increased	0/5 (0%)		0/7 (0%)		1/3 (33.3%)		0/4 (0%)		1/5 (20%)		1/6 (16.7%)		0/5 (0%)
Platelet count decreased	0/5 (0%)		0/7 (0%)		0/3 (0%)		1/4 (25%)		0/5 (0%)		1/6 (16.7%)		1/5 (20%)
White blood cell count decreased	0/5 (0%)		2/7 (28.6%)		0/3 (0%)		0/4 (0%)		0/5 (0%)		1/6 (16.7%)		0/5 (0%)
International normalised ratio increased	0/5 (0%)		0/7 (0%)		1/3 (33.3%)		0/4 (0%)		1/5 (20%)		0/6 (0%)		0/5 (0%)
Amylase decreased	0/5 (0%)		1/7 (14.3%)		0/3 (0%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)
Amylase increased	0/5 (0%)		0/7 (0%)		0/3 (0%)		0/4 (0%)		1/5 (20%)		0/6 (0%)		0/5 (0%)
Aspergillus test positive	0/5 (0%)		0/7 (0%)		0/3 (0%)		0/4 (0%)		1/5 (20%)		0/6 (0%)		0/5 (0%)
Blood bilirubin decreased	0/5 (0%)		0/7 (0%)		0/3 (0%)		1/4 (25%)		0/5 (0%)		0/6 (0%)		0/5 (0%)
Blood cholesterol increased	0/5 (0%)		0/7 (0%)		0/3 (0%)		0/4 (0%)		1/5 (20%)		0/6 (0%)		0/5 (0%)
Blood creatine phosphokinase decreased	0/5 (0%)		0/7 (0%)		0/3 (0%)		0/4 (0%)		1/5 (20%)		0/6 (0%)		0/5 (0%)
Body temperature increased	0/5 (0%)		0/7 (0%)		0/3 (0%)		1/4 (25%)		0/5 (0%)		0/6 (0%)		0/5 (0%)
Electrocardiogram QT prolonged	0/5 (0%)		1/7 (14.3%)		0/3 (0%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)
Hepatic enzyme increased	0/5 (0%)		0/7 (0%)		0/3 (0%)		0/4 (0%)		0/5 (0%)		1/6 (16.7%)		0/5 (0%)
High density lipoprotein decreased	0/5 (0%)		0/7 (0%)		0/3 (0%)		1/4 (25%)		0/5 (0%)		0/6 (0%)		0/5 (0%)
Lipase decreased	0/5 (0%)		1/7 (14.3%)		0/3 (0%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)
Lymphocyte count increased	0/5 (0%)		1/7 (14.3%)		0/3 (0%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)
Protein total decreased	0/5 (0%)		0/7 (0%)		0/3 (0%)		1/4 (25%)		0/5 (0%)		0/6 (0%)		0/5 (0%)
Prothrombin time prolonged	0/5 (0%)		0/7 (0%)		0/3 (0%)		0/4 (0%)		1/5 (20%)		0/6 (0%)		0/5 (0%)
Troponin I increased	0/5 (0%)		0/7 (0%)		0/3 (0%)		0/4 (0%)		1/5 (20%)		0/6 (0%)		0/5 (0%)
Metabolism and nutrition disorders
Hypocalcaemia	0/5 (0%)		0/7 (0%)		0/3 (0%)		1/4 (25%)		1/5 (20%)		3/6 (50%)		0/5 (0%)
Hypomagnesaemia	1/5 (20%)		0/7 (0%)		0/3 (0%)		1/4 (25%)		2/5 (40%)		0/6 (0%)		1/5 (20%)
Hyponatraemia	1/5 (20%)		0/7 (0%)		0/3 (0%)		1/4 (25%)		0/5 (0%)		2/6 (33.3%)		0/5 (0%)
Hyperglycaemia	0/5 (0%)		0/7 (0%)		0/3 (0%)		0/4 (0%)		1/5 (20%)		2/6 (33.3%)		0/5 (0%)
Hypertriglyceridaemia	1/5 (20%)		1/7 (14.3%)		0/3 (0%)		1/4 (25%)		0/5 (0%)		0/6 (0%)		0/5 (0%)
Hypophosphataemia	0/5 (0%)		0/7 (0%)		1/3 (33.3%)		1/4 (25%)		0/5 (0%)		1/6 (16.7%)		0/5 (0%)
Decreased appetite	0/5 (0%)		0/7 (0%)		0/3 (0%)		1/4 (25%)		0/5 (0%)		1/6 (16.7%)		0/5 (0%)
Fluid overload	0/5 (0%)		0/7 (0%)		0/3 (0%)		0/4 (0%)		0/5 (0%)		2/6 (33.3%)		0/5 (0%)
Hypoalbuminaemia	0/5 (0%)		0/7 (0%)		0/3 (0%)		1/4 (25%)		0/5 (0%)		1/6 (16.7%)		0/5 (0%)
Hypokalaemia	0/5 (0%)		0/7 (0%)		0/3 (0%)		0/4 (0%)		0/5 (0%)		2/6 (33.3%)		0/5 (0%)
Dehydration	0/5 (0%)		0/7 (0%)		0/3 (0%)		1/4 (25%)		0/5 (0%)		0/6 (0%)		0/5 (0%)
Hypercalcaemia	1/5 (20%)		0/7 (0%)		0/3 (0%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)
Hyperkalaemia	0/5 (0%)		1/7 (14.3%)		0/3 (0%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)
Hypernatraemia	0/5 (0%)		0/7 (0%)		0/3 (0%)		0/4 (0%)		0/5 (0%)		1/6 (16.7%)		0/5 (0%)
Hypervolaemia	0/5 (0%)		0/7 (0%)		0/3 (0%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		1/5 (20%)
Metabolic acidosis	0/5 (0%)		0/7 (0%)		0/3 (0%)		0/4 (0%)		1/5 (20%)		0/6 (0%)		0/5 (0%)
Musculoskeletal and connective tissue disorders
Arthralgia	0/5 (0%)		1/7 (14.3%)		0/3 (0%)		0/4 (0%)		1/5 (20%)		0/6 (0%)		1/5 (20%)
Back pain	0/5 (0%)		0/7 (0%)		0/3 (0%)		1/4 (25%)		0/5 (0%)		0/6 (0%)		1/5 (20%)
Bone pain	0/5 (0%)		1/7 (14.3%)		0/3 (0%)		0/4 (0%)		0/5 (0%)		1/6 (16.7%)		0/5 (0%)
Muscle spasms	1/5 (20%)		0/7 (0%)		0/3 (0%)		0/4 (0%)		1/5 (20%)		1/6 (16.7%)		0/5 (0%)
Musculoskeletal pain	0/5 (0%)		0/7 (0%)		1/3 (33.3%)		0/4 (0%)		1/5 (20%)		0/6 (0%)		1/5 (20%)
Myalgia	0/5 (0%)		0/7 (0%)		0/3 (0%)		0/4 (0%)		0/5 (0%)		2/6 (33.3%)		1/5 (20%)
Flank pain	0/5 (0%)		0/7 (0%)		0/3 (0%)		1/4 (25%)		0/5 (0%)		1/6 (16.7%)		0/5 (0%)
Pain in extremity	0/5 (0%)		0/7 (0%)		1/3 (33.3%)		0/4 (0%)		0/5 (0%)		1/6 (16.7%)		0/5 (0%)
Neck pain	0/5 (0%)		0/7 (0%)		0/3 (0%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		1/5 (20%)
Pain in jaw	0/5 (0%)		0/7 (0%)		0/3 (0%)		0/4 (0%)		0/5 (0%)		1/6 (16.7%)		0/5 (0%)
Nervous system disorders
Headache	0/5 (0%)		2/7 (28.6%)		1/3 (33.3%)		0/4 (0%)		2/5 (40%)		2/6 (33.3%)		1/5 (20%)
Dizziness	0/5 (0%)		0/7 (0%)		1/3 (33.3%)		1/4 (25%)		2/5 (40%)		2/6 (33.3%)		2/5 (40%)
Haemorrhage intracranial	0/5 (0%)		0/7 (0%)		0/3 (0%)		0/4 (0%)		1/5 (20%)		1/6 (16.7%)		0/5 (0%)
Neuropathy peripheral	0/5 (0%)		0/7 (0%)		0/3 (0%)		2/4 (50%)		0/5 (0%)		0/6 (0%)		0/5 (0%)
Cerebrovascular accident	0/5 (0%)		0/7 (0%)		0/3 (0%)		0/4 (0%)		0/5 (0%)		1/6 (16.7%)		0/5 (0%)
Lethargy	0/5 (0%)		0/7 (0%)		0/3 (0%)		0/4 (0%)		0/5 (0%)		1/6 (16.7%)		0/5 (0%)
Seizure	0/5 (0%)		0/7 (0%)		0/3 (0%)		0/4 (0%)		0/5 (0%)		1/6 (16.7%)		0/5 (0%)
Somnolence	0/5 (0%)		0/7 (0%)		0/3 (0%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		1/5 (20%)
Syncope	0/5 (0%)		0/7 (0%)		1/3 (33.3%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)
Tremor	0/5 (0%)		0/7 (0%)		0/3 (0%)		0/4 (0%)		0/5 (0%)		1/6 (16.7%)		0/5 (0%)
Psychiatric disorders
Insomnia	0/5 (0%)		1/7 (14.3%)		0/3 (0%)		0/4 (0%)		0/5 (0%)		2/6 (33.3%)		1/5 (20%)
Anxiety	0/5 (0%)		1/7 (14.3%)		0/3 (0%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		1/5 (20%)
Delirium	0/5 (0%)		1/7 (14.3%)		0/3 (0%)		0/4 (0%)		0/5 (0%)		1/6 (16.7%)		0/5 (0%)
Confusional state	0/5 (0%)		1/7 (14.3%)		0/3 (0%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)
Depression	0/5 (0%)		1/7 (14.3%)		0/3 (0%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)
Mental status changes	0/5 (0%)		0/7 (0%)		0/3 (0%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		1/5 (20%)
Renal and urinary disorders
Acute kidney injury	1/5 (20%)		0/7 (0%)		0/3 (0%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		1/5 (20%)
Haematuria	0/5 (0%)		1/7 (14.3%)		0/3 (0%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)
Reproductive system and breast disorders
Vaginal haemorrhage	0/5 (0%)		0/7 (0%)		0/3 (0%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		1/5 (20%)
Respiratory, thoracic and mediastinal disorders
Dyspnoea	0/5 (0%)		1/7 (14.3%)		1/3 (33.3%)		3/4 (75%)		0/5 (0%)		1/6 (16.7%)		1/5 (20%)
Cough	0/5 (0%)		2/7 (28.6%)		1/3 (33.3%)		0/4 (0%)		1/5 (20%)		1/6 (16.7%)		1/5 (20%)
Epistaxis	0/5 (0%)		0/7 (0%)		1/3 (33.3%)		1/4 (25%)		0/5 (0%)		1/6 (16.7%)		0/5 (0%)
Hypoxia	0/5 (0%)		0/7 (0%)		0/3 (0%)		0/4 (0%)		1/5 (20%)		1/6 (16.7%)		0/5 (0%)
Oropharyngeal pain	0/5 (0%)		1/7 (14.3%)		0/3 (0%)		0/4 (0%)		0/5 (0%)		1/6 (16.7%)		1/5 (20%)
Hiccups	0/5 (0%)		0/7 (0%)		0/3 (0%)		0/4 (0%)		1/5 (20%)		1/6 (16.7%)		0/5 (0%)
Dyspnoea exertional	0/5 (0%)		0/7 (0%)		0/3 (0%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		1/5 (20%)
Haemoptysis	0/5 (0%)		0/7 (0%)		0/3 (0%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		1/5 (20%)
Lung infiltration	0/5 (0%)		0/7 (0%)		0/3 (0%)		0/4 (0%)		0/5 (0%)		1/6 (16.7%)		0/5 (0%)
Pleural effusion	0/5 (0%)		0/7 (0%)		0/3 (0%)		0/4 (0%)		0/5 (0%)		1/6 (16.7%)		0/5 (0%)
Pneumonitis	0/5 (0%)		0/7 (0%)		0/3 (0%)		0/4 (0%)		0/5 (0%)		1/6 (16.7%)		0/5 (0%)
Rhinalgia	0/5 (0%)		0/7 (0%)		0/3 (0%)		0/4 (0%)		0/5 (0%)		1/6 (16.7%)		0/5 (0%)
Sneezing	0/5 (0%)		0/7 (0%)		0/3 (0%)		0/4 (0%)		0/5 (0%)		1/6 (16.7%)		0/5 (0%)
Wheezing	0/5 (0%)		0/7 (0%)		0/3 (0%)		0/4 (0%)		0/5 (0%)		1/6 (16.7%)		0/5 (0%)
Skin and subcutaneous tissue disorders
Rash maculo-papular	0/5 (0%)		1/7 (14.3%)		0/3 (0%)		1/4 (25%)		2/5 (40%)		2/6 (33.3%)		2/5 (40%)
Erythema	0/5 (0%)		0/7 (0%)		1/3 (33.3%)		0/4 (0%)		0/5 (0%)		1/6 (16.7%)		0/5 (0%)
Pruritus	0/5 (0%)		1/7 (14.3%)		0/3 (0%)		0/4 (0%)		0/5 (0%)		1/6 (16.7%)		0/5 (0%)
Rash	0/5 (0%)		0/7 (0%)		1/3 (33.3%)		0/4 (0%)		1/5 (20%)		0/6 (0%)		0/5 (0%)
Skin hyperpigmentation	0/5 (0%)		1/7 (14.3%)		0/3 (0%)		0/4 (0%)		0/5 (0%)		1/6 (16.7%)		0/5 (0%)
Skin mass	0/5 (0%)		0/7 (0%)		0/3 (0%)		1/4 (25%)		0/5 (0%)		0/6 (0%)		1/5 (20%)
Alopecia	0/5 (0%)		1/7 (14.3%)		0/3 (0%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)
Decubitus ulcer	0/5 (0%)		0/7 (0%)		0/3 (0%)		1/4 (25%)		0/5 (0%)		0/6 (0%)		0/5 (0%)
Penile ulceration	0/5 (0%)		1/7 (14.3%)		0/3 (0%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)
Petechiae	0/5 (0%)		0/7 (0%)		0/3 (0%)		1/4 (25%)		0/5 (0%)		0/6 (0%)		0/5 (0%)
Photosensitivity reaction	0/5 (0%)		1/7 (14.3%)		0/3 (0%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)
Purpura	0/5 (0%)		0/7 (0%)		0/3 (0%)		0/4 (0%)		0/5 (0%)		1/6 (16.7%)		0/5 (0%)
Rash erythematous	0/5 (0%)		0/7 (0%)		0/3 (0%)		0/4 (0%)		0/5 (0%)		1/6 (16.7%)		0/5 (0%)
Vascular disorders
Hypertension	2/5 (40%)		1/7 (14.3%)		0/3 (0%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		3/5 (60%)
Hypotension	0/5 (0%)		0/7 (0%)		0/3 (0%)		0/4 (0%)		0/5 (0%)		2/6 (33.3%)		1/5 (20%)
Embolism	0/5 (0%)		1/7 (14.3%)		0/3 (0%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)
Pallor	0/5 (0%)		0/7 (0%)		0/3 (0%)		0/4 (0%)		1/5 (20%)		0/6 (0%)		0/5 (0%)

Limitations/Caveats

The study was early terminated prior to part 2 because of slow accrual. Formal assessment of potential anti-leukemic effect was not undertaken because of the early termination of the study.

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

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