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Study of ADCT-301 in Patients With Relapsed or Refractory Hodgkin and Non-Hodgkin Lymphoma

Sponsor
ADC Therapeutics S.A. (Industry)
Overall Status
Completed
CT.gov ID
NCT02432235
Collaborator
(none)
133
Enrollment
12
Locations
12
Arms
48.6
Actual Duration (Months)
11.1
Patients Per Site
0.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study evaluates camidanlumab tesirine in participants with relapsed/refractory Non-Hodgkin or Hodgkin lymphoma.

Condition or Disease Intervention/Treatment Phase
  • Drug: Camidanlumab tesirine
 Phase 1

Detailed Description

This is a Phase I, first in human clinical study with camidanlumab tesirine to evaluate the safety and tolerability and pharmacokinetics of camidanlumab tesirine in participants with relapsed/refractory lymphoma.

Camidanlumab tesirine is a human monoclonal antibody attached via a cleavable linker to a pyrrolobenzodiazepine (PBD) warhead which, when internalized by antigen expressing cells, covalently cross links deoxyribonucleic acid (DNA) preventing replication.

The study will be conducted in 2 parts: Part 1 (dose escalation) and Part 2 (expansion).

Study Design

Study Type:
Interventional
Actual Enrollment :
133 participants
Allocation:
Non-Randomized
Intervention Model:
Sequential Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Phase 1 Adaptive Dose-Escalation Study to Evaluate the Tolerability, Safety, Pharmacokinetics, and Antitumor Activity of ADCT-301 in Patients With Relapsed or Refractory Hodgkin Lymphoma and Non-Hodgkin Lymphoma
Actual Study Start Date :
Oct 5, 2015
Actual Primary Completion Date :
Oct 24, 2019
Actual Study Completion Date :
Oct 24, 2019

Arms and Interventions

Arm Intervention/Treatment
Experimental: 3 μg/kg

Participants received an intravenous (IV) infusion of camidanlumab tesirine (3 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 2 cycles.

Drug: Camidanlumab tesirine
Intravenous (IV) infusion.
Other Names:
  • ADCT-301
  • Cami

    		•
    Experimental: 5 μg/kg

    Participants received an intravenous (IV) infusion of camidanlumab tesirine (5 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 4 cycles.

    Drug: Camidanlumab tesirine
    Intravenous (IV) infusion.
    Other Names:
  • ADCT-301
  • Cami

    		•
    Experimental: 8 μg/kg

    Participants received an intravenous (IV) infusion of camidanlumab tesirine (8 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 3 cycles.

    Drug: Camidanlumab tesirine
    Intravenous (IV) infusion.
    Other Names:
  • ADCT-301
  • Cami

    		•
    Experimental: 13 μg/kg

    Participants received an intravenous (IV) infusion of camidanlumab tesirine (13 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 15 cycles.

    Drug: Camidanlumab tesirine
    Intravenous (IV) infusion.
    Other Names:
  • ADCT-301
  • Cami

    		•
    Experimental: 20 μg/kg

    Participants received an intravenous (IV) infusion of camidanlumab tesirine (20 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 3 cycles.

    Drug: Camidanlumab tesirine
    Intravenous (IV) infusion.
    Other Names:
  • ADCT-301
  • Cami

    		•
    Experimental: 30 μg/kg

    Participants received an intravenous (IV) infusion of camidanlumab tesirine (30 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 10 cycles.

    Drug: Camidanlumab tesirine
    Intravenous (IV) infusion.
    Other Names:
  • ADCT-301
  • Cami

    		•
    Experimental: 45 μg/kg

    Participants received an intravenous (IV) infusion of camidanlumab tesirine (45 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 10 cycles.

    Drug: Camidanlumab tesirine
    Intravenous (IV) infusion.
    Other Names:
  • ADCT-301
  • Cami

    		•
    Experimental: 60 μg/kg

    Participants received an intravenous (IV) infusion of camidanlumab tesirine (60 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 8 cycles.

    Drug: Camidanlumab tesirine
    Intravenous (IV) infusion.
    Other Names:
  • ADCT-301
  • Cami

    		•
    Experimental: 80 μg/kg

    Participants received an intravenous (IV) infusion of camidanlumab tesirine (80 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 7 cycles.

    Drug: Camidanlumab tesirine
    Intravenous (IV) infusion.
    Other Names:
  • ADCT-301
  • Cami

    		•
    Experimental: 100 μg/kg

    Participants received an intravenous (IV) infusion of camidanlumab tesirine (100 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 5 cycles.

    Drug: Camidanlumab tesirine
    Intravenous (IV) infusion.
    Other Names:
  • ADCT-301
  • Cami

    		•
    Experimental: 150 μg/kg

    Participants received an intravenous (IV) infusion of camidanlumab tesirine (150 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 2 cycles.

    Drug: Camidanlumab tesirine
    Intravenous (IV) infusion.
    Other Names:
  • ADCT-301
  • Cami

    		•
    Experimental: 300 μg/kg

    A single participant received by error an intravenous (IV) infusion of camidanlumab tesirine (300 μg/kg) on Day 1 of Cycle 1 (planned dose was 30 μg/kg). Dosing in the subsequent cycles was 30 μg/kg (for 2 more cycles).

    Drug: Camidanlumab tesirine
    Intravenous (IV) infusion.
    Other Names:
  • ADCT-301
  • Cami

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Number of Participants Who Experienced Dose-Limiting Toxicities (DLTs) [Cycle 1 Day 1 to end of Cycle 1 or 2 (21 day cycle length)]

      A DLT defined as any of the following, except those that are clearly due to underlying disease or extraneous causes: A hematologic DLT is defined as (different considerations for Adult T-Cell Leukemia/Lymphoma (ATLL) participants): Common Terminology Criteria for Adverse Events (CTCAE) Grade 3 or 4 febrile neutropenia or neutropenic infection CTCAE Grade 4 neutropenia lasting >7 days CTCAE Grade 4 thrombocytopenia CTCAE Grade 3 thrombocytopenia with clinically significant bleeding, or Grade 3 thrombocytopenia requiring a platelet transfusion CTCAE Grade 4 anemia A non-hematologic DLT is defined as: CTCAE Grade 4 tumor lysis syndrome CTCAE Grade 3 or higher AE (including nausea, vomiting, diarrhea, electrolyte imbalances lasting ≥ 48 hours despite optimal therapy; excluding all grades of alopecia) CTCAE Grade 3 or higher hypersensitivity reaction CTCAE Grade 2 or higher skin ulceration CTCAE Grade 2 or higher peripheral sensory or motor neuropathy

    2. Recommended Dose of Camidanlumab Tesirine for Part 2 [Cycle 1 Day 1 to end of Cycle 1 or 2 (21 day cycle length)]

      The recommended dose was 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) [Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])]

      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 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) [Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])]

      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) [Day 1 to End of Study (a maximum of 12 months after treatment; median time on treatment was 43 days [min 1 day; max 354 days])]

      ORR is defined as the number of participants with a best overall response of complete response (CR) or partial response (PR) at the time each participant discontinued treatment with camidanlumab tesirine. Tumor response was assessed using the 2014 Lugano Classification. CR is defined as achieving each of the following: Complete metabolic response. Complete radiologic response (target node regress to <1.5 cm, no nonmeasured lesions, no organ enlargement, no new lesions and normal bone marrow morphology). PR is defined as achieving each of the following: Partial metabolic response (findings indicate residual disease). Partial remission (>50% decrease in target measurable nodes, regression/ absence/ no increase of nonmeasured lesions, spleen regressed by >50% in length and no new lesions).

    2. Duration of Response (DoR) [Day 1 to End of Study (a maximum of 12 months after last dose; median time on treatment was 43 days [min 1 day; max 354 days])]

      DoR is defined among responders (complete response [CR] 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. Tumor response was assessed using the 2014 Lugano Classification. Disease progression is defined as progressive metabolic disease and one of the follow: Target node progression. An individual extranodal lesion must be abnormal with length > 1.5cm and/or increase of length > 50%. New or clear progression of nonmeasured lesions. Regrowth of previously resolved lesions or new nodes >1.5 cm in length. New or recurrent bone marrow involvement. DoR is presented overall for all participants who were classed as responders among the efficacy analysis set. Data is pooled for all lymphoma participants for DoR as specified in protocol section 8.4.

    3. Progression-Free Survival (PFS) [Day 1 to End of Study (a maximum of 12 months after last dose; median time on treatment was 43 days [min 1 day; max 354 days])]

      Progression-free survival (PFS) is defined among the efficacy population as the time from first dose of study drug until either disease progression or death due to any cause. Tumor response was assessed using the 2014 Lugano Classification for response. Disease progression is defined as progressive metabolic disease and one of the following: Target node progression. An individual extranodal lesion must be abnormal with length > 1.5cm and/or increase of length > 50%. New or clear progression of nonmeasured lesions. Regrowth of previously resolved lesions or new nodes > 1.5 cm in length. New or recurrent bone marrow involvement. PFS is presented overall for all participants who received camidanlumab tesirine among the efficacy analysis set. Data is pooled for all lymphoma participants for PFS as specified in protocol section 8.4

    4. Overall Survival (OS) [Day 1 to End of Study (a maximum of 12 months after last dose; median time on treatment was 43 days [min 1 day; max 354 days])]

      Overall survival (OS) is defined as the time from the first dose of study drug treatment until the date of death due to any cause. OS is presented overall for all participants who received camidanlumab tesirine among the efficacy analysis set. Data is pooled for all lymphoma participants for OS as specified in protocol section 8.4.

    5. Maximum Observed Serum Concentration (Cmax) for Camidanlumab Tesirine [Pre-dose on Day 1 and 1 to 336 hours post-dose of Cycles 1 and 2 (21 day cycle length)]

      Cmax for HuMax-TAC, pyrrolobenzodiazepine (PBD) conjugated HuMax-TAC, and free warhead (SG3199).

    6. Time to Reach the Maximum Serum Concentration (Tmax) for Camidanlumab Tesirine [Pre-dose on Day 1 and 1 to 336 hours post-dose of Cycles 1 and 2 (21 day cycle length)]

      Tmax for HuMax-TAC, PBD-conjugated HuMax-TAC, and free warhead (SG3199).

    7. Area Under the Serum Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration (AUC0-last) for Camidanlumab Tesirine [Pre-dose on Day 1 and 1 to 336 hours post-dose of Cycles 1 and 2 (21 day cycle length)]

      AUC0-last for HuMax-TAC, PBD-conjugated HuMax-TAC, and free warhead (SG3199).

    8. Area Under the Serum Concentration-time Curve From Time 0 to the End of the Dosing Interval (AUC0-t) for Camidanlumab Tesirine [Pre-dose on Day 1 and 1 to 336 hours post-dose of Cycle 2 (21 day cycle length)]

      AUC0-tau for HuMax-TAC, PBD-conjugated HuMax-TAC, and free warhead (SG3199) for Cycle 2 only.

    9. Area Under the Serum Concentration-time Curve From Time 0 to Infinity (AUC∞) for Camidanlumab Tesirine [Pre-dose on Day 1 and 1 to 336 hours post-dose of Cycle 1 (21 day cycle length)]

      AUC∞ HuMax-TAC and PBD-conjugated HuMax-TAC for Cycle 1 only.

    10. Accumulation Index (AI) for Camidanlumab Tesirine [Pre-dose on Day 1 and 1 to 336 hours post-dose of Cycles 1 and 2 (21 day cycle length)]

      AI for HuMax-TAC, PBD-conjugated HuMax-TAC, and free warhead (SG3199). AI is the ratio of area under the serum concentration-time curve (AUC) from 0 to 21 days for Cycle 2 divided by AUC from 0 to 21 days for Cycle 1 (21 day cycle length). It is the increase in drug plasma concentration after multiple dosing until a steady state is reached.

    11. Volume of Distribution for Camidanlumab Tesirine [Pre-dose on Day 1 and 1 to 336 hours post-dose of Cycles 1 and 2 (21 day cycle length)]

      Volume of distribution for HuMax-TAC, PBD-conjugated HuMax-TAC, and free warhead (SG3199).

    12. Apparent Terminal Half-life (T1/2) of Camidanlumab Tesirine [Pre-dose on Day 1 and 1 to 336 hours post-dose of Cycles 1 and 2 (21 day cycle length)]

      T1/2 of HuMax-TAC, PBD-conjugated HuMax-TAC, and free warhead (SG3199).

    13. Clearance of Camidanlumab Tesirine [Pre-dose on Day 1 and 1 to 336 hours post-dose of Cycles 1 and 2 (21 day cycle length)]

      Clearance of HuMax-TAC, PBD-conjugated HuMax-TAC, and free warhead (SG3199).

    14. Number of Participants With Anti-drug Antibody Response (ADA) Against Camidanlumab Tesirine [Day 1 to End of Study (a maximum of 12 months after last dose; median time on treatment was 43 days [min 1 day; max 354 days])]

      An assay determines the presence of anti-ADCT-301 antibodies in human serum using a validated bridging electro chemiluminescence immunoassay (ECLIA) technique. The technique uses the drug itself to capture any anti ADCT-301 antibodies present in the serum. If anti-ADCT-301 antibodies are detected, they are confirmed to be specifically against ADCT-301 and then the level of the anti-ADCT-301 antibodies present in the serum is established using a modified version of the ECLIA technique.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    1. Male or female age 18 years or older.

    2. Refractory or relapsed lymphoma (per World Health Organization (WHO) Classification system)

    3. Pathologically confirmed relapsed or refractory lymphoma

    4. Availability of formalin-fixed paraffin-embedded (FFPE) tumor tissue block.

    5. Measurable disease, defined by the 2014 Lugano Classification Criteria and Global Response Score Grading Scales for cutaneous T-cell lymphoma (CTCL)

    6. Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2.

    7. Absolute neutrophil count ≥1500/µL. Criterion not applicable to adult T cell leukemia/lymphoma (ATLL) patients.

    8. Platelet count of ≥75000/µL. Criterion not applicable to ATLL patients.

    9. Hemoglobin ≥9.0 g/dL without transfusion within the 2 weeks prior to Day 1.

    10. Serum/plasma creatinine ≤1.5 mg/dL, or if the participant has a creatinine > 1.5 mg/dL, a measured creatinine clearance must be > 80 mL/min as calculated by the Cockcroft and Gault equation

    11. Serum alkaline phosphatase, alanine aminotransferase, and aspartate aminotransferase ≤2 times the upper limit of normal (ULN); ≤ 5 times ULN if there is liver or bone involvement.

    12. Total serum/plasma bilirubin ≤1.5 times ULN (participants with known Gilbert's syndrome may have a total bilirubin up to ≤3 times ULN)

    13. Women of childbearing potential must have a negative serum beta-human chorionic gonadotropin pregnancy test within 7 days prior to Day 1.

    14. Women of childbearing potential must agree to use a highly effective method of contraception. Men with female partners who are of childbearing potential must agree that they or their partners will use a highly effective method of contraception.

    Exclusion Criteria:

    1. Participants who have an option for any treatment with proven clinical benefit for their lymphoid malignancy at current state of disease.

    2. Active graft-versus-host disease.

    3. Autologous or allogenic transplant within the 60 days prior to Cycle 1 Day 1 (C1D1)

    4. Evidence of myelodysplasia or myeloid leukemia by morphology, immunostains, flow cytometry, or cytogenetics on a bone marrow aspirate or biopsy.

    5. Known history of positive serum human anti-drug antibody (ADA) or known allergy to any component of ADCT-301.

    6. History of symptomatic autoimmune disease (e.g., rheumatoid arthritis, systemic progressive sclerosis [scleroderma], systemic lupus erythematosus, Sjögren's syndrome, autoimmune vasculitis [e.g., Wegener's granulomatosis])

    7. History of neuropathy considered of autoimmune origin (e.g., polyradiculopathy including Guillain-Barré syndrome and myasthenia gravis); other central nervous system autoimmune disease (e.g., poliomyelitis, multiple sclerosis).

    8. History of recent infection (within 4 weeks of C1D1) considered to be caused by one of the pathogens listed: herpes simplex virus Type 1 (HSV1), herpes simplex virus Type 2 (HSV2), varicella zoster virus (VZV), Epstein-Barr virus (EBV), cytomegalovirus (CMV), measles, Influenza A, Zika virus, Chikungunya virus, mycoplasma pneumonia, Campylobacter jejuni, or enterovirus D68.

    9. Known seropositive for human immunodeficiency virus (HIV), hepatitis B surface antigen (HbsAg), or antibody to hepatitis C virus (anti-HCV) with confirmatory testing and requiring anti-viral therapy. Note: testing is not mandatory to be eligible.

    If participant is at risk for having undiagnosed hepatitis C virus (HCV) (e.g., history of injection drug use), HCV testing should be considered.

    1. History of Steven's Johnson's syndrome or toxic epidermal necrolysis syndrome.

    2. Pregnant or breastfeeding women.

    3. 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, or electrocardiographic evidence of acute ischemia, poorly controlled diabetes, severe chronic pulmonary disease, coronary angioplasty, or myocardial infarction within 6 months prior to screening, or uncontrolled atrial or ventricular cardiac arrhythmias.

    4. 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 study treatment on Cycle 1, Day 1, except if approved by the Sponsor.

    5. Major surgery, radiotherapy, chemotherapy, or other anti-neoplastic therapy (including prednisone ≥ 40 mg/day or equivalent) within 14 days or 5 half-lives (whichever is shorter) prior to Cycle 1, Day 1 treatment, except if approved by the Sponsor.

    6. Failure to recover (to Common Terminology Criteria for Adverse Events [CTCAE Version 4.0] Grade 0 or Grade 1) from acute non-hematologic toxicity (except all grades of alopecia or Grade 2 or lower neuropathy), due to previous therapy, prior to Screening.

    7. Congenital long QT syndrome or a corrected QT interval (QTc)≥ 450 ms at screening (unless secondary to pacemaker or bundle branch block).

    8. 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 that Sponsor Medical Monitor and Investigator agree, and document should not be exclusionary.

    9. Any other significant medical illness, abnormality, or condition that would, in the Investigator's judgment, make the participant inappropriate for study participation or put the participant at risk.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 City of Hope (City of Hope National Medical Center, City of Hope Medical Center) Duarte California United States 91010
    2 Memorial Sloan-Kettering Cancer Center New York New York United States 10065
    3 University Hospitals Cleveland Medical Center Cleveland Ohio United States 44106
    4 The University of Texas/MD Anderson Cancer Center Houston Texas United States 77030-4009
    5 Cancer Therapy and Research Center at The University of Texas Health Science Center at San Antonio San Antonio Texas United States 78229
    6 Virginia Cancer Specialists, PC Fairfax Virginia United States 22031
    7 Froedtert Hospital/Medical College of Wisconsin Milwaukee Wisconsin United States 53226
    8 Guy's and St. Thomas' Hospital NHS Trust London England United Kingdom SE1 9RT
    9 The Newcastle Upon Tyne Hospitals NHS Foundation Trust Newcastle upon Tyne England United Kingdom
    10 Churchill Hospital, Oxford University Hospitals NHS Foundation Trust Oxford England United Kingdom OX3 7LE
    11 The Christie NHS Foundation Trust Manchester Greater Manchester United Kingdom M20 4BX
    12 Southampton General Hospital, University Hospital Southampton NHS Foundation Trust Southampton Hampshire United Kingdom

    Sponsors and Collaborators

    • ADC Therapeutics S.A.

    Investigators

    • Study Director: Jens Wuerthner, MD, PhD, ADC Therapeutics

    Study Documents (Full-Text)

    More Information

    Publications

    None provided.
    Responsible Party:
    ADC Therapeutics S.A.
    ClinicalTrials.gov Identifier:
    NCT02432235
    Other Study ID Numbers:
    • ADCT-301-001
    • 2015-005272-25
    • 199948
    First Posted:
    May 4, 2015
    Last Update Posted:
    Jul 13, 2021
    Last Verified:
    Jul 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Keywords provided by ADC Therapeutics S.A.
    Camidanlumab tesirine
    Additional relevant MeSH terms:
    Lymphoma
    Lymphoma, Non-Hodgkin
    Hodgkin Disease

    Study Results

    Participant Flow

    Recruitment Details There were 12 sites that screened and enrolled participants: USA: 7 sites; UK: 5 sites.
    Pre-assignment Detail Participants were included in a screening period of up to 28 days.
    Arm/Group Title 3 μg/kg 5 μg/kg 8 μg/kg 13 μg/kg 20 μg/kg 30 μg/kg 45 μg/kg 60 μg/kg 80 μg/kg 100 μg/kg 150 μg/kg 300 μg/kg
    Arm/Group Description Participants received an intravenous (IV) infusion of camidanlumab tesirine (3 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 2 cycles. Camidanlumab tesirine: Intravenous (IV) infusion. Participants received an intravenous (IV) infusion of camidanlumab tesirine (5 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 4 cycles. Camidanlumab tesirine: Intravenous (IV) infusion. Participants received an intravenous (IV) infusion of camidanlumab tesirine (8 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 3 cycles. Camidanlumab tesirine: Intravenous (IV) infusion. Participants received an intravenous (IV) infusion of camidanlumab tesirine (13 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 15 cycles. Camidanlumab tesirine: Intravenous (IV) infusion. Participants received an intravenous (IV) infusion of camidanlumab tesirine (20 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 3 cycles. Camidanlumab tesirine: Intravenous (IV) infusion. Participants received an intravenous (IV) infusion of camidanlumab tesirine (30 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 10 cycles. Camidanlumab tesirine: Intravenous (IV) infusion. Participants received an intravenous (IV) infusion of camidanlumab tesirine (45 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 10 cycles. Camidanlumab tesirine: Intravenous (IV) infusion. Participants received an intravenous (IV) infusion of camidanlumab tesirine (60 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 8 cycles. Camidanlumab tesirine: Intravenous (IV) infusion. Participants received an intravenous (IV) infusion of camidanlumab tesirine (80 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 7 cycles. Camidanlumab tesirine: Intravenous (IV) infusion. Participants received an intravenous (IV) infusion of camidanlumab tesirine (100 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 5 cycles. Camidanlumab tesirine: Intravenous (IV) infusion. Participants received an intravenous (IV) infusion of camidanlumab tesirine (150 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 2 cycles. Camidanlumab tesirine: Intravenous (IV) infusion. A single participant received by error an intravenous (IV) infusion of camidanlumab tesirine (300 μg/kg) on Day 1 of Cycle 1 (planned dose was 30 μg/kg). Dosing in the subsequent cycles was 30 μg/kg (for 2 more cycles). Camidanlumab tesirine: Intravenous (IV) infusion.
    Period Title: Overall Study
    STARTED 2 2 2 3 2 20 41 29 26 3 2 1
    COMPLETED 1 0 0 1 0 8 23 9 5 0 1 0
    NOT COMPLETED 1 2 2 2 2 12 18 20 21 3 1 1

    Baseline Characteristics

    Arm/Group Title 3 μg/kg 5 μg/kg 8 μg/kg 13 μg/kg 20 μg/kg 30 μg/kg 45 μg/kg 60 μg/kg 80 μg/kg 100 μg/kg 150 μg/kg 300 μg/kg Total
    Arm/Group Description Participants received an intravenous (IV) infusion of camidanlumab tesirine (3 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 2 cycles. Camidanlumab tesirine: Intravenous (IV) infusion. Participants received an intravenous (IV) infusion of camidanlumab tesirine (5 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 4 cycles. Camidanlumab tesirine: Intravenous (IV) infusion. Participants received an intravenous (IV) infusion of camidanlumab tesirine (8 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 3 cycles. Camidanlumab tesirine: Intravenous (IV) infusion. Participants received an intravenous (IV) infusion of camidanlumab tesirine (13 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 15 cycles. Camidanlumab tesirine: Intravenous (IV) infusion. Participants received an intravenous (IV) infusion of camidanlumab tesirine (20 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 3 cycles. Camidanlumab tesirine: Intravenous (IV) infusion. Participants received an intravenous (IV) infusion of camidanlumab tesirine (30 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 10 cycles. Camidanlumab tesirine: Intravenous (IV) infusion. Participants received an intravenous (IV) infusion of camidanlumab tesirine (45 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 10 cycles. Camidanlumab tesirine: Intravenous (IV) infusion. Participants received an intravenous (IV) infusion of camidanlumab tesirine (60 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 8 cycles. Camidanlumab tesirine: Intravenous (IV) infusion. Participants received an intravenous (IV) infusion of camidanlumab tesirine (80 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 7 cycles. Camidanlumab tesirine: Intravenous (IV) infusion. Participants received an intravenous (IV) infusion of camidanlumab tesirine (100 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 5 cycles. Camidanlumab tesirine: Intravenous (IV) infusion. Participants received an intravenous (IV) infusion of camidanlumab tesirine (150 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 2 cycles. Camidanlumab tesirine: Intravenous (IV) infusion. A single participant received by error an intravenous (IV) infusion of camidanlumab tesirine (300 μg/kg) on Day 1 of Cycle 1 (planned dose was 30 μg/kg). Dosing in the subsequent cycles was 30 μg/kg (for 2 more cycles). Camidanlumab tesirine: Intravenous (IV) infusion. Total of all reporting groups
    Overall Participants 2 2 2 3 2 20 41 29 26 3 2 1 133
    Age (years) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [years]
    73.5
    (2.12)
    44.0
    (2.83)
    64.0
    (12.73)
    51.0
    (12.53)
    38.0
    (19.80)
    42.1
    (16.32)
    45.1
    (15.48)
    56.3
    (18.16)
    58.1
    (15.69)
    58.7
    (8.08)
    44.5
    (19.09)
    64.0
    50.8
    (17.13)
    Sex: Female, Male (Count of Participants)
    Female
    1
    50%
    1
    50%
    1
    50%
    2
    66.7%
    1
    50%
    8
    40%
    14
    34.1%
    15
    51.7%
    10
    38.5%
    0
    0%
    1
    50%
    1
    100%
    55
    41.4%
    Male
    1
    50%
    1
    50%
    1
    50%
    1
    33.3%
    1
    50%
    12
    60%
    27
    65.9%
    14
    48.3%
    16
    61.5%
    3
    100%
    1
    50%
    0
    0%
    78
    58.6%
    Ethnicity (NIH/OMB) (Count of Participants)
    Hispanic or Latino
    0
    0%
    1
    50%
    0
    0%
    0
    0%
    0
    0%
    2
    10%
    5
    12.2%
    3
    10.3%
    2
    7.7%
    0
    0%
    0
    0%
    0
    0%
    13
    9.8%
    Not Hispanic or Latino
    2
    100%
    1
    50%
    2
    100%
    3
    100%
    2
    100%
    18
    90%
    36
    87.8%
    26
    89.7%
    24
    92.3%
    3
    100%
    2
    100%
    1
    100%
    120
    90.2%
    Unknown or Not Reported
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    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%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Asian
    0
    0%
    0
    0%
    0
    0%
    1
    33.3%
    0
    0%
    0
    0%
    2
    4.9%
    0
    0%
    0
    0%
    1
    33.3%
    0
    0%
    0
    0%
    4
    3%
    Native Hawaiian or Other Pacific Islander
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Black or African American
    1
    50%
    0
    0%
    0
    0%
    1
    33.3%
    0
    0%
    0
    0%
    5
    12.2%
    1
    3.4%
    9
    34.6%
    0
    0%
    0
    0%
    0
    0%
    17
    12.8%
    White
    1
    50%
    2
    100%
    2
    100%
    1
    33.3%
    1
    50%
    19
    95%
    30
    73.2%
    28
    96.6%
    17
    65.4%
    2
    66.7%
    2
    100%
    1
    100%
    106
    79.7%
    More than one race
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Unknown or Not Reported
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    1
    50%
    1
    5%
    4
    9.8%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    6
    4.5%
    Region of Enrollment (participants) [Number]
    United States
    2
    100%
    2
    100%
    2
    100%
    3
    100%
    2
    100%
    20
    100%
    27
    65.9%
    20
    69%
    16
    61.5%
    2
    66.7%
    1
    50%
    1
    100%
    98
    73.7%
    United Kingdom
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    14
    34.1%
    9
    31%
    10
    38.5%
    1
    33.3%
    1
    50%
    0
    0%
    35
    26.3%
    Eastern Cooperative Oncology Group (ECOG) Performance Status (Count of Participants)
    Grade 0
    0
    0%
    1
    50%
    0
    0%
    0
    0%
    0
    0%
    6
    30%
    16
    39%
    12
    41.4%
    7
    26.9%
    0
    0%
    1
    50%
    0
    0%
    43
    32.3%
    Grade 1
    2
    100%
    0
    0%
    2
    100%
    1
    33.3%
    2
    100%
    14
    70%
    24
    58.5%
    13
    44.8%
    16
    61.5%
    3
    100%
    1
    50%
    1
    100%
    79
    59.4%
    Grade 2
    0
    0%
    1
    50%
    0
    0%
    2
    66.7%
    0
    0%
    0
    0%
    1
    2.4%
    4
    13.8%
    3
    11.5%
    0
    0%
    0
    0%
    0
    0%
    11
    8.3%
    Grade 3
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Grade 4
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Grade 5
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Weight (kilograms (kg)) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [kilograms (kg)]
    98.05
    (26.517)
    55.25
    (12.799)
    80.40
    (19.658)
    63.57
    (4.840)
    65.05
    (14.496)
    79.18
    (19.920)
    89.10
    (31.926)
    75.15
    (18.241)
    78.19
    (15.780)
    82.67
    (15.808)
    96.50
    (12.869)
    53.20
    80.69
    (23.766)
    Height (centimeters (cm)) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [centimeters (cm)]
    176.65
    (24.961)
    158.00
    (1.414)
    176.00
    (4.243)
    170.43
    (5.811)
    170.20
    172.13
    (11.212)
    172.12
    (9.410)
    171.43
    (9.341)
    170.33
    (10.188)
    173.43
    (10.856)
    172.50
    (13.435)
    155.00
    171.37
    (9.920)
    Body Mass Index (kg/m^2) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [kg/m^2]
    33.60
    (17.816)
    22.18
    (5.524)
    25.83
    (5.100)
    21.98
    (2.829)
    25.99
    26.69
    (4.496)
    30.26
    (11.193)
    25.37
    (4.913)
    26.95
    (4.944)
    27.47
    (4.559)
    33.07
    (9.447)
    22.14
    27.52
    (7.757)

    Outcome Measures

    1. Primary Outcome
    Title Number of Participants Who Experienced Dose-Limiting Toxicities (DLTs)
    Description A DLT defined as any of the following, except those that are clearly due to underlying disease or extraneous causes: A hematologic DLT is defined as (different considerations for Adult T-Cell Leukemia/Lymphoma (ATLL) participants): Common Terminology Criteria for Adverse Events (CTCAE) Grade 3 or 4 febrile neutropenia or neutropenic infection CTCAE Grade 4 neutropenia lasting >7 days CTCAE Grade 4 thrombocytopenia CTCAE Grade 3 thrombocytopenia with clinically significant bleeding, or Grade 3 thrombocytopenia requiring a platelet transfusion CTCAE Grade 4 anemia A non-hematologic DLT is defined as: CTCAE Grade 4 tumor lysis syndrome CTCAE Grade 3 or higher AE (including nausea, vomiting, diarrhea, electrolyte imbalances lasting ≥ 48 hours despite optimal therapy; excluding all grades of alopecia) CTCAE Grade 3 or higher hypersensitivity reaction CTCAE Grade 2 or higher skin ulceration CTCAE Grade 2 or higher peripheral sensory or motor neuropathy
    Time Frame Cycle 1 Day 1 to end of Cycle 1 or 2 (21 day cycle length)

    Outcome Measure Data

    Analysis Population Description
    DLT Evaluable Analysis Set: The DLT-evaluable analysis set consisted of participants who completed two cycles of ADCT-301 if enrolled prior to protocol amendment 4 and participants who completed one cycle of ADCT-301 if enrolled after protocol amendment 4. The participants with completed DLT information were included even if they discontinued early before the end of cycle 2 or cycle 1 respectively.
    Arm/Group Title 3 μg/kg 5 μg/kg 8 μg/kg 13 μg/kg 20 μg/kg 30 μg/kg 45 μg/kg 60 μg/kg 80 μg/kg 100 μg/kg 150 μg/kg 300 μg/kg
    Arm/Group Description Participants received an intravenous (IV) infusion of camidanlumab tesirine (3 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 2 cycles. Camidanlumab tesirine: Intravenous (IV) infusion. Participants received an intravenous (IV) infusion of camidanlumab tesirine (5 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 4 cycles. Camidanlumab tesirine: Intravenous (IV) infusion. Participants received an intravenous (IV) infusion of camidanlumab tesirine (8 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 3 cycles. Camidanlumab tesirine: Intravenous (IV) infusion. Participants received an intravenous (IV) infusion of camidanlumab tesirine (13 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 15 cycles. Camidanlumab tesirine: Intravenous (IV) infusion. Participants received an intravenous (IV) infusion of camidanlumab tesirine (20 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 3 cycles. Camidanlumab tesirine: Intravenous (IV) infusion. Participants received an intravenous (IV) infusion of camidanlumab tesirine (30 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 10 cycles. Camidanlumab tesirine: Intravenous (IV) infusion. Participants received an intravenous (IV) infusion of camidanlumab tesirine (45 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 10 cycles. Camidanlumab tesirine: Intravenous (IV) infusion. Participants received an intravenous (IV) infusion of camidanlumab tesirine (60 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 8 cycles. Camidanlumab tesirine: Intravenous (IV) infusion. Participants received an intravenous (IV) infusion of camidanlumab tesirine (80 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 7 cycles. Camidanlumab tesirine: Intravenous (IV) infusion. Participants received an intravenous (IV) infusion of camidanlumab tesirine (100 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 5 cycles. Camidanlumab tesirine: Intravenous (IV) infusion. Participants received an intravenous (IV) infusion of camidanlumab tesirine (150 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 2 cycles. Camidanlumab tesirine: Intravenous (IV) infusion. A single participant received by error an intravenous (IV) infusion of camidanlumab tesirine (300 μg/kg) on Day 1 of Cycle 1 (planned dose was 30 μg/kg). Dosing in the subsequent cycles was 30 μg/kg (for 2 more cycles). Camidanlumab tesirine: Intravenous (IV) infusion.
    Measure Participants 2 2 2 2 2 10 15 29 16 3 2 1
    Count of Participants [Participants]
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    1
    50%
    2
    10%
    1
    2.4%
    0
    0%
    1
    3.8%
    0
    0%
    0
    0%
    0
    0%
    2. Primary Outcome
    Title Recommended Dose of Camidanlumab Tesirine for Part 2
    Description The recommended dose was established by the dose escalation steering committee and based on safety findings during Part 1 of the study.
    Time Frame Cycle 1 Day 1 to end of Cycle 1 or 2 (21 day cycle length)

    Outcome Measure Data

    Analysis Population Description
    Number of participants analyzed presented in the outcome measure data are only those participants in the DLT evaluable analysis set who were dosed at the three dose levels recommended for Part 2.
    Arm/Group Title Dose-Limiting Toxicity (DLT) Evaluable Set Analysis Set
    Arm/Group Description DLT Evaluable Analysis Set: The DLT-evaluable analysis set consisted of participants who completed two cycles of ADCT-301 if enrolled prior to protocol amendment 4 and participants who completed one cycle of ADCT-301 if enrolled after protocol amendment 4. The participants with completed DLT information were included even if they discontinued early before the end of cycle 2 or cycle 1 respectively.
    Measure Participants 86
    Participants with Hodgkin Lymphoma (Dose level 1: 30 µg/kg)
    30
    Participants with Hodgkin Lymphoma (Dose level 2: 45 µg/kg)
    45
    Participants with T-cell Lymphoma (80 µg/kg)
    80
    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 participant 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 Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title 3 μg/kg 5 μg/kg 8 μg/kg 13 μg/kg 20 μg/kg 30 μg/kg 45 μg/kg 60 μg/kg 80 μg/kg 100 μg/kg 150 μg/kg 300 μg/kg
    Arm/Group Description Participants received an intravenous (IV) infusion of camidanlumab tesirine (3 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 2 cycles. Camidanlumab tesirine: Intravenous (IV) infusion. Participants received an intravenous (IV) infusion of camidanlumab tesirine (5 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 4 cycles. Camidanlumab tesirine: Intravenous (IV) infusion. Participants received an intravenous (IV) infusion of camidanlumab tesirine (8 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 3 cycles. Camidanlumab tesirine: Intravenous (IV) infusion. Participants received an intravenous (IV) infusion of camidanlumab tesirine (13 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 15 cycles. Camidanlumab tesirine: Intravenous (IV) infusion. Participants received an intravenous (IV) infusion of camidanlumab tesirine (20 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 3 cycles. Camidanlumab tesirine: Intravenous (IV) infusion. Participants received an intravenous (IV) infusion of camidanlumab tesirine (30 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 10 cycles. Camidanlumab tesirine: Intravenous (IV) infusion. Participants received an intravenous (IV) infusion of camidanlumab tesirine (45 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 10 cycles. Camidanlumab tesirine: Intravenous (IV) infusion. Participants received an intravenous (IV) infusion of camidanlumab tesirine (60 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 8 cycles. Camidanlumab tesirine: Intravenous (IV) infusion. Participants received an intravenous (IV) infusion of camidanlumab tesirine (80 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 7 cycles. Camidanlumab tesirine: Intravenous (IV) infusion. Participants received an intravenous (IV) infusion of camidanlumab tesirine (100 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 5 cycles. Camidanlumab tesirine: Intravenous (IV) infusion. Participants received an intravenous (IV) infusion of camidanlumab tesirine (150 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 2 cycles. Camidanlumab tesirine: Intravenous (IV) infusion. A single participant received by error an intravenous (IV) infusion of camidanlumab tesirine (300 μg/kg) on Day 1 of Cycle 1 (planned dose was 30 μg/kg). Dosing in the subsequent cycles was 30 μg/kg (for 2 more cycles). Camidanlumab tesirine: Intravenous (IV) infusion.
    Measure Participants 2 2 2 3 2 20 41 29 26 3 2 1
    Count of Participants [Participants]
    1
    50%
    2
    100%
    2
    100%
    3
    100%
    2
    100%
    20
    100%
    41
    100%
    29
    100%
    26
    100%
    3
    100%
    2
    100%
    1
    100%
    4. Primary Outcome
    Title Number of Participants Reporting at Least One Treatment Emergent Serious Adverse Event (SAE)
    Description 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 Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title 3 μg/kg 5 μg/kg 8 μg/kg 13 μg/kg 20 μg/kg 30 μg/kg 45 μg/kg 60 μg/kg 80 μg/kg 100 μg/kg 150 μg/kg 300 μg/kg
    Arm/Group Description Participants received an intravenous (IV) infusion of camidanlumab tesirine (3 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 2 cycles. Camidanlumab tesirine: Intravenous (IV) infusion. Participants received an intravenous (IV) infusion of camidanlumab tesirine (5 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 4 cycles. Camidanlumab tesirine: Intravenous (IV) infusion. Participants received an intravenous (IV) infusion of camidanlumab tesirine (8 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 3 cycles. Camidanlumab tesirine: Intravenous (IV) infusion. Participants received an intravenous (IV) infusion of camidanlumab tesirine (13 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 15 cycles. Camidanlumab tesirine: Intravenous (IV) infusion. Participants received an intravenous (IV) infusion of camidanlumab tesirine (20 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 3 cycles. Camidanlumab tesirine: Intravenous (IV) infusion. Participants received an intravenous (IV) infusion of camidanlumab tesirine (30 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 10 cycles. Camidanlumab tesirine: Intravenous (IV) infusion. Participants received an intravenous (IV) infusion of camidanlumab tesirine (45 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 10 cycles. Camidanlumab tesirine: Intravenous (IV) infusion. Participants received an intravenous (IV) infusion of camidanlumab tesirine (60 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 8 cycles. Camidanlumab tesirine: Intravenous (IV) infusion. Participants received an intravenous (IV) infusion of camidanlumab tesirine (80 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 7 cycles. Camidanlumab tesirine: Intravenous (IV) infusion. Participants received an intravenous (IV) infusion of camidanlumab tesirine (100 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 5 cycles. Camidanlumab tesirine: Intravenous (IV) infusion. Participants received an intravenous (IV) infusion of camidanlumab tesirine (150 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 2 cycles. Camidanlumab tesirine: Intravenous (IV) infusion. A single participant received by error an intravenous (IV) infusion of camidanlumab tesirine (300 μg/kg) on Day 1 of Cycle 1 (planned dose was 30 μg/kg). Dosing in the subsequent cycles was 30 μg/kg (for 2 more cycles). Camidanlumab tesirine: Intravenous (IV) infusion.
    Measure Participants 2 2 2 3 2 20 41 29 26 3 2 1
    Count of Participants [Participants]
    0
    0%
    1
    50%
    0
    0%
    3
    100%
    1
    50%
    10
    50%
    24
    58.5%
    14
    48.3%
    18
    69.2%
    1
    33.3%
    1
    50%
    1
    100%
    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) or partial response (PR) at the time each participant discontinued treatment with camidanlumab tesirine. Tumor response was assessed using the 2014 Lugano Classification. CR is defined as achieving each of the following: Complete metabolic response. Complete radiologic response (target node regress to <1.5 cm, no nonmeasured lesions, no organ enlargement, no new lesions and normal bone marrow morphology). PR is defined as achieving each of the following: Partial metabolic response (findings indicate residual disease). Partial remission (>50% decrease in target measurable nodes, regression/ absence/ no increase of nonmeasured lesions, spleen regressed by >50% in length and no new lesions).
    Time Frame Day 1 to End of Study (a maximum of 12 months after treatment; median time on treatment was 43 days [min 1 day; max 354 days])

    Outcome Measure Data

    Analysis Population Description
    Efficacy Analysis Set: The efficacy analysis set consisted of participants who received at least one dose of camidanlumab tesirine with a valid baseline and at least one valid post-baseline disease assessment or participants who had documented progression of disease or death at any time after the first dose of study.
    Arm/Group Title 3 μg/kg 5 μg/kg 8 μg/kg 13 μg/kg 20 μg/kg 30 μg/kg 45 μg/kg 60 μg/kg 80 μg/kg 100 μg/kg 150 μg/kg 300 μg/kg
    Arm/Group Description Participants received an intravenous (IV) infusion of camidanlumab tesirine (3 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 2 cycles. Camidanlumab tesirine: Intravenous (IV) infusion. Participants received an intravenous (IV) infusion of camidanlumab tesirine (5 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 4 cycles. Camidanlumab tesirine: Intravenous (IV) infusion. Participants received an intravenous (IV) infusion of camidanlumab tesirine (8 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 3 cycles. Camidanlumab tesirine: Intravenous (IV) infusion. Participants received an intravenous (IV) infusion of camidanlumab tesirine (13 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 15 cycles. Camidanlumab tesirine: Intravenous (IV) infusion. Participants received an intravenous (IV) infusion of camidanlumab tesirine (20 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 3 cycles. Camidanlumab tesirine: Intravenous (IV) infusion. Participants received an intravenous (IV) infusion of camidanlumab tesirine (30 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 10 cycles. Camidanlumab tesirine: Intravenous (IV) infusion. Participants received an intravenous (IV) infusion of camidanlumab tesirine (45 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 10 cycles. Camidanlumab tesirine: Intravenous (IV) infusion. Participants received an intravenous (IV) infusion of camidanlumab tesirine (60 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 8 cycles. Camidanlumab tesirine: Intravenous (IV) infusion. Participants received an intravenous (IV) infusion of camidanlumab tesirine (80 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 7 cycles. Camidanlumab tesirine: Intravenous (IV) infusion. Participants received an intravenous (IV) infusion of camidanlumab tesirine (100 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 5 cycles. Camidanlumab tesirine: Intravenous (IV) infusion. Participants received an intravenous (IV) infusion of camidanlumab tesirine (150 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 2 cycles. Camidanlumab tesirine: Intravenous (IV) infusion. A single participant received by error an intravenous (IV) infusion of camidanlumab tesirine (300 μg/kg) on Day 1 of Cycle 1 (planned dose was 30 μg/kg). Dosing in the subsequent cycles was 30 μg/kg (for 2 more cycles). Camidanlumab tesirine: Intravenous (IV) infusion.
    Measure Participants 2 2 2 3 2 20 41 28 24 3 2 1
    Count of Participants [Participants]
    0
    0%
    0
    0%
    0
    0%
    1
    33.3%
    0
    0%
    11
    55%
    32
    78%
    15
    51.7%
    12
    46.2%
    2
    66.7%
    1
    50%
    1
    100%
    6. Secondary Outcome
    Title Duration of Response (DoR)
    Description DoR is defined among responders (complete response [CR] 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. Tumor response was assessed using the 2014 Lugano Classification. Disease progression is defined as progressive metabolic disease and one of the follow: Target node progression. An individual extranodal lesion must be abnormal with length > 1.5cm and/or increase of length > 50%. New or clear progression of nonmeasured lesions. Regrowth of previously resolved lesions or new nodes >1.5 cm in length. New or recurrent bone marrow involvement. DoR is presented overall for all participants who were classed as responders among the efficacy analysis set. Data is pooled for all lymphoma participants for DoR as specified in protocol section 8.4.
    Time Frame Day 1 to End of Study (a maximum of 12 months after last dose; median time on treatment was 43 days [min 1 day; max 354 days])

    Outcome Measure Data

    Analysis Population Description
    Efficacy Analysis Set: The efficacy analysis set consisted of participants who received at least one dose of camidanlumab tesirine with a valid baseline and at least one valid post-baseline disease assessment or participants who had documented progression of disease or death at any time after the first dose of study.
    Arm/Group Title Efficacy Analysis Set
    Arm/Group Description Participants received an intravenous (IV) infusion of camidanlumab tesirine at any dose (doses ranging from 3 μg/kg to 300 μg/kg) on Day 1 of each 3-week treatment cycle. The maximum number of cycles received was 15.
    Measure Participants 130
    Median (95% Confidence Interval) [Months]
    5.19
    7. Secondary Outcome
    Title Progression-Free Survival (PFS)
    Description Progression-free survival (PFS) is defined among the efficacy population as the time from first dose of study drug until either disease progression or death due to any cause. Tumor response was assessed using the 2014 Lugano Classification for response. Disease progression is defined as progressive metabolic disease and one of the following: Target node progression. An individual extranodal lesion must be abnormal with length > 1.5cm and/or increase of length > 50%. New or clear progression of nonmeasured lesions. Regrowth of previously resolved lesions or new nodes > 1.5 cm in length. New or recurrent bone marrow involvement. PFS is presented overall for all participants who received camidanlumab tesirine among the efficacy analysis set. Data is pooled for all lymphoma participants for PFS as specified in protocol section 8.4
    Time Frame Day 1 to End of Study (a maximum of 12 months after last dose; median time on treatment was 43 days [min 1 day; max 354 days])

    Outcome Measure Data

    Analysis Population Description
    Efficacy Analysis Set: The efficacy analysis set consisted of participants who received at least one dose of camidanlumab tesirine with a valid baseline and at least one valid post-baseline disease assessment or participants who had documented progression of disease or death at any time after the first dose of study.
    Arm/Group Title Efficacy Analysis Set
    Arm/Group Description Participants received an intravenous (IV) infusion of camidanlumab tesirine at any dose (doses ranging from 3 μg/kg to 300 μg/kg) on Day 1 of each 3-week treatment cycle. The maximum number of cycles received was 15.
    Measure Participants 130
    Median (95% Confidence Interval) [Months]
    5.22
    8. Secondary Outcome
    Title Overall Survival (OS)
    Description Overall survival (OS) is defined as the time from the first dose of study drug treatment until the date of death due to any cause. OS is presented overall for all participants who received camidanlumab tesirine among the efficacy analysis set. Data is pooled for all lymphoma participants for OS as specified in protocol section 8.4.
    Time Frame Day 1 to End of Study (a maximum of 12 months after last dose; median time on treatment was 43 days [min 1 day; max 354 days])

    Outcome Measure Data

    Analysis Population Description
    Efficacy Analysis Set: The efficacy analysis set consisted of participants who received at least one dose of camidanlumab tesirine with a valid baseline and at least one valid post-baseline disease assessment or participants who had documented progression of disease or death at any time after the first dose of study.
    Arm/Group Title Efficacy Analysis Set
    Arm/Group Description Participants received an intravenous (IV) infusion of camidanlumab tesirine at any dose (doses ranging from 3 μg/kg to 300 μg/kg) on Day 1 of each 3-week treatment cycle. The maximum number of cycles received was 15.
    Measure Participants 130
    Median (95% Confidence Interval) [Months]
    16.26
    9. Secondary Outcome
    Title Maximum Observed Serum Concentration (Cmax) for Camidanlumab Tesirine
    Description Cmax for HuMax-TAC, pyrrolobenzodiazepine (PBD) conjugated HuMax-TAC, and free warhead (SG3199).
    Time Frame Pre-dose on Day 1 and 1 to 336 hours post-dose of Cycles 1 and 2 (21 day cycle length)

    Outcome Measure Data

    Analysis Population Description
    Pharmacokinetic (PK) analysis set consisted of all participants who received study drug and have sufficient concentration data for PK analysis.
    Arm/Group Title 3 μg/kg 5 μg/kg 8 μg/kg 13 μg/kg 20 μg/kg 30 μg/kg 45 μg/kg 60 μg/kg 80 μg/kg 100 μg/kg 150 μg/kg 300 μg/kg
    Arm/Group Description Participants received an intravenous (IV) infusion of camidanlumab tesirine (3 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 2 cycles. Camidanlumab tesirine: Intravenous (IV) infusion. Participants received an intravenous (IV) infusion of camidanlumab tesirine (5 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 4 cycles. Camidanlumab tesirine: Intravenous (IV) infusion. Participants received an intravenous (IV) infusion of camidanlumab tesirine (8 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 3 cycles. Camidanlumab tesirine: Intravenous (IV) infusion. Participants received an intravenous (IV) infusion of camidanlumab tesirine (13 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 15 cycles. Camidanlumab tesirine: Intravenous (IV) infusion. Participants received an intravenous (IV) infusion of camidanlumab tesirine (20 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 3 cycles. Camidanlumab tesirine: Intravenous (IV) infusion. Participants received an intravenous (IV) infusion of camidanlumab tesirine (30 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 10 cycles. Camidanlumab tesirine: Intravenous (IV) infusion. Participants received an intravenous (IV) infusion of camidanlumab tesirine (45 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 10 cycles. Camidanlumab tesirine: Intravenous (IV) infusion. Participants received an intravenous (IV) infusion of camidanlumab tesirine (60 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 8 cycles. Camidanlumab tesirine: Intravenous (IV) infusion. Participants received an intravenous (IV) infusion of camidanlumab tesirine (80 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 7 cycles. Camidanlumab tesirine: Intravenous (IV) infusion. Participants received an intravenous (IV) infusion of camidanlumab tesirine (100 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 5 cycles. Camidanlumab tesirine: Intravenous (IV) infusion. Participants received an intravenous (IV) infusion of camidanlumab tesirine (150 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 2 cycles. Camidanlumab tesirine: Intravenous (IV) infusion. A single participant received by error an intravenous (IV) infusion of camidanlumab tesirine (300 μg/kg) on Day 1 of Cycle 1 (planned dose was 30 μg/kg). Dosing in the subsequent cycles was 30 μg/kg (for 2 more cycles). Camidanlumab tesirine: Intravenous (IV) infusion.
    Measure Participants 1 1 2 3 2 20 41 29 25 3 2 1
    Cycle 1 - HuMax-TAC
    109
    62.5
    131
    (20.7)
    189
    (98.4)
    318
    (82.9)
    603
    (31.8)
    803
    (54.4)
    1120
    (82.8)
    1325
    (43.1)
    1494
    (26.1)
    2671
    (32.9)
    5020
    Cycle 2 - HuMax-TAC
    67.5
    177
    (39.4)
    254
    (13.1)
    224
    554
    (48.1)
    1040
    (60.0)
    1402
    (56.1)
    1379
    (32.2)
    800
    (726)
    3251
    (37.8)
    497
    Cycle 1 - PBD-conjugated HuMax-TAC
    79.5
    127
    (27.6)
    152
    (95.1)
    241
    (76.7)
    455
    (38.5)
    648
    (51.0)
    881
    (78.8)
    1055
    (45.9)
    1154
    (26.4)
    2097
    (21.1)
    4020
    Cycle 2 - PBD-conjugated HuMax-TAC
    61.5
    151
    (23.2)
    208
    (18.4)
    164
    424
    (47.8)
    808
    (55.8)
    1084
    (59.9)
    1084
    (32.0)
    645
    (655)
    2090
    (31.6)
    497
    Cycle 1 - Free warhead (SG3199)
    0.0120
    (8.04)
    0.0310
    (102)
    0.0150
    (34.6)
    0.0110
    0.0170
    0.0240
    Cycle 2 - Free warhead (SG3199)
    0.0170
    (46.9)
    0.132
    (413)
    0.0140
    (4.21)
    0.0270
    0.0170
    (20.1)
    10. Secondary Outcome
    Title Time to Reach the Maximum Serum Concentration (Tmax) for Camidanlumab Tesirine
    Description Tmax for HuMax-TAC, PBD-conjugated HuMax-TAC, and free warhead (SG3199).
    Time Frame Pre-dose on Day 1 and 1 to 336 hours post-dose of Cycles 1 and 2 (21 day cycle length)

    Outcome Measure Data

    Analysis Population Description
    Pharmacokinetic (PK) analysis set consisted of all participants who received study drug and have sufficient concentration data for PK analysis.
    Arm/Group Title 3 μg/kg 5 μg/kg 8 μg/kg 13 μg/kg 20 μg/kg 30 μg/kg 45 μg/kg 60 μg/kg 80 μg/kg 100 μg/kg 150 μg/kg 300 μg/kg
    Arm/Group Description Participants received an intravenous (IV) infusion of camidanlumab tesirine (3 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 2 cycles. Camidanlumab tesirine: Intravenous (IV) infusion. Participants received an intravenous (IV) infusion of camidanlumab tesirine (5 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 4 cycles. Camidanlumab tesirine: Intravenous (IV) infusion. Participants received an intravenous (IV) infusion of camidanlumab tesirine (8 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 3 cycles. Camidanlumab tesirine: Intravenous (IV) infusion. Participants received an intravenous (IV) infusion of camidanlumab tesirine (13 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 15 cycles. Camidanlumab tesirine: Intravenous (IV) infusion. Participants received an intravenous (IV) infusion of camidanlumab tesirine (20 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 3 cycles. Camidanlumab tesirine: Intravenous (IV) infusion. Participants received an intravenous (IV) infusion of camidanlumab tesirine (30 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 10 cycles. Camidanlumab tesirine: Intravenous (IV) infusion. Participants received an intravenous (IV) infusion of camidanlumab tesirine (45 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 10 cycles. Camidanlumab tesirine: Intravenous (IV) infusion. Participants received an intravenous (IV) infusion of camidanlumab tesirine (60 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 8 cycles. Camidanlumab tesirine: Intravenous (IV) infusion. Participants received an intravenous (IV) infusion of camidanlumab tesirine (80 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 7 cycles. Camidanlumab tesirine: Intravenous (IV) infusion. Participants received an intravenous (IV) infusion of camidanlumab tesirine (100 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 5 cycles. Camidanlumab tesirine: Intravenous (IV) infusion. Participants received an intravenous (IV) infusion of camidanlumab tesirine (150 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 2 cycles. Camidanlumab tesirine: Intravenous (IV) infusion. A single participant received by error an intravenous (IV) infusion of camidanlumab tesirine (300 μg/kg) on Day 1 of Cycle 1 (planned dose was 30 μg/kg). Dosing in the subsequent cycles was 30 μg/kg (for 2 more cycles). Camidanlumab tesirine: Intravenous (IV) infusion.
    Measure Participants 1 1 2 3 2 20 41 29 25 3 2 1
    Cycle 1 - HuMax-TAC
    0.155
    0.0830
    0.0970
    (22.4)
    0.149
    (75.3)
    0.103
    (26.4)
    0.0820
    (38.5)
    0.0950
    (67.5)
    0.106
    (58.3)
    0.105
    (45.1)
    0.111
    (22.3)
    0.157
    (0.937)
    0.172
    Cycle 2 - HuMax-TAC
    0.149
    0.110
    (32.2)
    0.137
    (69.8)
    0.130
    0.0640
    (105)
    0.0790
    (81.6)
    0.0910
    (100)
    0.0830
    (71.7)
    0.0700
    (31.4)
    0.145
    (21.1)
    0.0310
    Cycle 1 - PBD-conjugated HuMax-TAC
    0.155
    0.114
    (46.4)
    0.110
    (24.6)
    0.131
    (64.3)
    0.0910
    (47.1)
    0.0950
    (62.4)
    0.0970
    (44.6)
    0.118
    (83.0)
    0.111
    (22.3)
    0.114
    (46.7)
    0.0830
    Cycle 2 - PBD-conjugated HuMax-TAC
    0.336
    0.126
    (37.9)
    0.0860
    (1.70)
    0.0920
    0.0640
    (121)
    0.0660
    (64.3)
    0.0690
    (110)
    0.0720
    (79.3)
    0.0850
    (2.89)
    0.0940
    (160)
    0.0310
    Cycle 1 - Free warhead (SG3199)
    0.119
    (75.0)
    0.124
    (83.6)
    0.206
    (69.8)
    0.211
    0.240
    0.172
    Cycle 2 - Free warhead (SG3199)
    0.192
    (42.6)
    0.0970
    (119)
    0.201
    (24.8)
    0.167
    0.156
    (109)
    11. Secondary Outcome
    Title Area Under the Serum Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration (AUC0-last) for Camidanlumab Tesirine
    Description AUC0-last for HuMax-TAC, PBD-conjugated HuMax-TAC, and free warhead (SG3199).
    Time Frame Pre-dose on Day 1 and 1 to 336 hours post-dose of Cycles 1 and 2 (21 day cycle length)

    Outcome Measure Data

    Analysis Population Description
    Pharmacokinetic (PK) analysis set consisted of all participants who received study drug and have sufficient concentration data for PK analysis.
    Arm/Group Title 3 μg/kg 5 μg/kg 8 μg/kg 13 μg/kg 20 μg/kg 30 μg/kg 45 μg/kg 60 μg/kg 80 μg/kg 100 μg/kg 150 μg/kg 300 μg/kg
    Arm/Group Description Participants received an intravenous (IV) infusion of camidanlumab tesirine (3 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 2 cycles. Camidanlumab tesirine: Intravenous (IV) infusion. Participants received an intravenous (IV) infusion of camidanlumab tesirine (5 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 4 cycles. Camidanlumab tesirine: Intravenous (IV) infusion. Participants received an intravenous (IV) infusion of camidanlumab tesirine (8 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 3 cycles. Camidanlumab tesirine: Intravenous (IV) infusion. Participants received an intravenous (IV) infusion of camidanlumab tesirine (13 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 15 cycles. Camidanlumab tesirine: Intravenous (IV) infusion. Participants received an intravenous (IV) infusion of camidanlumab tesirine (20 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 3 cycles. Camidanlumab tesirine: Intravenous (IV) infusion. Participants received an intravenous (IV) infusion of camidanlumab tesirine (30 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 10 cycles. Camidanlumab tesirine: Intravenous (IV) infusion. Participants received an intravenous (IV) infusion of camidanlumab tesirine (45 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 10 cycles. Camidanlumab tesirine: Intravenous (IV) infusion. Participants received an intravenous (IV) infusion of camidanlumab tesirine (60 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 8 cycles. Camidanlumab tesirine: Intravenous (IV) infusion. Participants received an intravenous (IV) infusion of camidanlumab tesirine (80 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 7 cycles. Camidanlumab tesirine: Intravenous (IV) infusion. Participants received an intravenous (IV) infusion of camidanlumab tesirine (100 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 5 cycles. Camidanlumab tesirine: Intravenous (IV) infusion. Participants received an intravenous (IV) infusion of camidanlumab tesirine (150 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 2 cycles. Camidanlumab tesirine: Intravenous (IV) infusion. A single participant received by error an intravenous (IV) infusion of camidanlumab tesirine (300 μg/kg) on Day 1 of Cycle 1 (planned dose was 30 μg/kg). Dosing in the subsequent cycles was 30 μg/kg (for 2 more cycles). Camidanlumab tesirine: Intravenous (IV) infusion.
    Measure Participants 1 1 2 3 2 20 41 29 25 3 2 1
    Cycle 1 - HuMax-TAC
    82.7
    2.60
    48.2
    (207)
    76.3
    (1444)
    660
    (93.7)
    967
    (60.4)
    1715
    (128)
    2491
    (132)
    2751
    (109)
    4091
    (84.6)
    12919
    (14.6)
    30759
    Cycle 2 - HuMax-TAC
    21.0
    111
    (35.0)
    453
    (35.3)
    473
    1004
    (66.8)
    2476
    (117)
    3665
    (127)
    4190
    (123)
    921
    (1700356)
    12767
    (13.1)
    919
    Cycle 1 - PBD-conjugated HuMax-TAC
    12.0
    58.8
    (458)
    76.8
    (470)
    262
    (276)
    625
    (53.1)
    1173
    (113)
    1623
    (102)
    1630
    (155)
    2849
    (68.0)
    7727
    (11.2)
    18915
    Cycle 2 - PBD-conjugated HuMax-TAC
    18.6
    85.8
    (15.9)
    237
    (23.1)
    330
    655
    (53.3)
    1514
    (103)
    2283
    (94.5)
    3038
    (97.7)
    1482
    (13082)
    8992
    (28.3)
    634
    Cycle 1 - Free warhead (SG3199)
    0.00200
    (331)
    0.00200
    (127)
    0.00300
    (290)
    0.0100
    0.00400
    0.0360
    Cycle 2 - Free warhead (SG3199)
    0.00300
    (74.6)
    0.0330
    (183)
    0.00600
    (79.8)
    0.00300
    0.0130
    (5.60)
    12. Secondary Outcome
    Title Area Under the Serum Concentration-time Curve From Time 0 to the End of the Dosing Interval (AUC0-t) for Camidanlumab Tesirine
    Description AUC0-tau for HuMax-TAC, PBD-conjugated HuMax-TAC, and free warhead (SG3199) for Cycle 2 only.
    Time Frame Pre-dose on Day 1 and 1 to 336 hours post-dose of Cycle 2 (21 day cycle length)

    Outcome Measure Data

    Analysis Population Description
    Pharmacokinetic (PK) analysis set consisted of all participants who received study drug and have sufficient concentration data for PK analysis.
    Arm/Group Title 3 μg/kg 5 μg/kg 8 μg/kg 13 μg/kg 20 μg/kg 30 μg/kg 45 μg/kg 60 μg/kg 80 μg/kg 100 μg/kg 150 μg/kg 300 μg/kg
    Arm/Group Description Participants received an intravenous (IV) infusion of camidanlumab tesirine (3 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 2 cycles. Camidanlumab tesirine: Intravenous (IV) infusion. Participants received an intravenous (IV) infusion of camidanlumab tesirine (5 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 4 cycles. Camidanlumab tesirine: Intravenous (IV) infusion. Participants received an intravenous (IV) infusion of camidanlumab tesirine (8 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 3 cycles. Camidanlumab tesirine: Intravenous (IV) infusion. Participants received an intravenous (IV) infusion of camidanlumab tesirine (13 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 15 cycles. Camidanlumab tesirine: Intravenous (IV) infusion. Participants received an intravenous (IV) infusion of camidanlumab tesirine (20 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 3 cycles. Camidanlumab tesirine: Intravenous (IV) infusion. Participants received an intravenous (IV) infusion of camidanlumab tesirine (30 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 10 cycles. Camidanlumab tesirine: Intravenous (IV) infusion. Participants received an intravenous (IV) infusion of camidanlumab tesirine (45 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 10 cycles. Camidanlumab tesirine: Intravenous (IV) infusion. Participants received an intravenous (IV) infusion of camidanlumab tesirine (60 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 8 cycles. Camidanlumab tesirine: Intravenous (IV) infusion. Participants received an intravenous (IV) infusion of camidanlumab tesirine (80 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 7 cycles. Camidanlumab tesirine: Intravenous (IV) infusion. Participants received an intravenous (IV) infusion of camidanlumab tesirine (100 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 5 cycles. Camidanlumab tesirine: Intravenous (IV) infusion. Participants received an intravenous (IV) infusion of camidanlumab tesirine (150 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 2 cycles. Camidanlumab tesirine: Intravenous (IV) infusion. A single participant received by error an intravenous (IV) infusion of camidanlumab tesirine (300 μg/kg) on Day 1 of Cycle 1 (planned dose was 30 μg/kg). Dosing in the subsequent cycles was 30 μg/kg (for 2 more cycles). Camidanlumab tesirine: Intravenous (IV) infusion.
    Measure Participants 0 0 2 2 1 18 33 23 17 2 2 1
    Cycle 2 - HuMax-TAC
    195
    (22.3)
    596
    (25.9)
    747
    1384
    (62.6)
    3604
    (68.9)
    4688
    (98.3)
    5689
    (58.2)
    18830
    17031
    (45.1)
    1074
    Cycle 2 - PBD-conjugated HuMax-TAC
    185
    385
    (28.5)
    489
    939
    (53.6)
    2183
    (61.6)
    2811
    (76.7)
    3469
    (91.3)
    1809
    (4154)
    9851
    (28.3)
    763
    Cycle 2 - Free warhead (SG3199)
    0.0310
    13. Secondary Outcome
    Title Area Under the Serum Concentration-time Curve From Time 0 to Infinity (AUC∞) for Camidanlumab Tesirine
    Description AUC∞ HuMax-TAC and PBD-conjugated HuMax-TAC for Cycle 1 only.
    Time Frame Pre-dose on Day 1 and 1 to 336 hours post-dose of Cycle 1 (21 day cycle length)

    Outcome Measure Data

    Analysis Population Description
    Pharmacokinetic (PK) analysis set consisted of all participants who received study drug and have sufficient concentration data for PK analysis.
    Arm/Group Title 3 μg/kg 5 μg/kg 8 μg/kg 13 μg/kg 20 μg/kg 30 μg/kg 45 μg/kg 60 μg/kg 80 μg/kg 100 μg/kg 150 μg/kg 300 μg/kg
    Arm/Group Description Participants received an intravenous (IV) infusion of camidanlumab tesirine (3 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 2 cycles. Camidanlumab tesirine: Intravenous (IV) infusion. Participants received an intravenous (IV) infusion of camidanlumab tesirine (5 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 4 cycles. Camidanlumab tesirine: Intravenous (IV) infusion. Participants received an intravenous (IV) infusion of camidanlumab tesirine (8 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 3 cycles. Camidanlumab tesirine: Intravenous (IV) infusion. Participants received an intravenous (IV) infusion of camidanlumab tesirine (13 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 15 cycles. Camidanlumab tesirine: Intravenous (IV) infusion. Participants received an intravenous (IV) infusion of camidanlumab tesirine (20 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 3 cycles. Camidanlumab tesirine: Intravenous (IV) infusion. Participants received an intravenous (IV) infusion of camidanlumab tesirine (30 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 10 cycles. Camidanlumab tesirine: Intravenous (IV) infusion. Participants received an intravenous (IV) infusion of camidanlumab tesirine (45 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 10 cycles. Camidanlumab tesirine: Intravenous (IV) infusion. Participants received an intravenous (IV) infusion of camidanlumab tesirine (60 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 8 cycles. Camidanlumab tesirine: Intravenous (IV) infusion. Participants received an intravenous (IV) infusion of camidanlumab tesirine (80 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 7 cycles. Camidanlumab tesirine: Intravenous (IV) infusion. Participants received an intravenous (IV) infusion of camidanlumab tesirine (100 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 5 cycles. Camidanlumab tesirine: Intravenous (IV) infusion. Participants received an intravenous (IV) infusion of camidanlumab tesirine (150 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 2 cycles. Camidanlumab tesirine: Intravenous (IV) infusion. A single participant received by error an intravenous (IV) infusion of camidanlumab tesirine (300 μg/kg) on Day 1 of Cycle 1 (planned dose was 30 μg/kg). Dosing in the subsequent cycles was 30 μg/kg (for 2 more cycles). Camidanlumab tesirine: Intravenous (IV) infusion.
    Measure Participants 0 0 0 0 1 14 29 23 18 2 2 1
    Cycle 1 - HuMax-TAC
    1283
    (63.1)
    3001
    (75.0)
    3618
    (52.9)
    3261
    (83.9)
    4972
    (116)
    13842
    (9.45)
    33153
    Cycle 1 - PBD-conjugated HuMax-TAC
    917
    1019
    (54.9)
    1846
    (59.9)
    2284
    (50.8)
    2797
    (81.7)
    3734
    (82.7)
    8730
    (5.31)
    20144
    14. Secondary Outcome
    Title Accumulation Index (AI) for Camidanlumab Tesirine
    Description AI for HuMax-TAC, PBD-conjugated HuMax-TAC, and free warhead (SG3199). AI is the ratio of area under the serum concentration-time curve (AUC) from 0 to 21 days for Cycle 2 divided by AUC from 0 to 21 days for Cycle 1 (21 day cycle length). It is the increase in drug plasma concentration after multiple dosing until a steady state is reached.
    Time Frame Pre-dose on Day 1 and 1 to 336 hours post-dose of Cycles 1 and 2 (21 day cycle length)

    Outcome Measure Data

    Analysis Population Description
    Pharmacokinetic (PK) analysis set consisted of all participants who received study drug and have sufficient concentration data for PK analysis.
    Arm/Group Title 3 μg/kg 5 μg/kg 8 μg/kg 13 μg/kg 20 μg/kg 30 μg/kg 45 μg/kg 60 μg/kg 80 μg/kg 100 μg/kg 150 μg/kg 300 μg/kg
    Arm/Group Description Participants received an intravenous (IV) infusion of camidanlumab tesirine (3 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 2 cycles. Camidanlumab tesirine: Intravenous (IV) infusion. Participants received an intravenous (IV) infusion of camidanlumab tesirine (5 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 4 cycles. Camidanlumab tesirine: Intravenous (IV) infusion. Participants received an intravenous (IV) infusion of camidanlumab tesirine (8 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 3 cycles. Camidanlumab tesirine: Intravenous (IV) infusion. Participants received an intravenous (IV) infusion of camidanlumab tesirine (13 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 15 cycles. Camidanlumab tesirine: Intravenous (IV) infusion. Participants received an intravenous (IV) infusion of camidanlumab tesirine (20 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 3 cycles. Camidanlumab tesirine: Intravenous (IV) infusion. Participants received an intravenous (IV) infusion of camidanlumab tesirine (30 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 10 cycles. Camidanlumab tesirine: Intravenous (IV) infusion. Participants received an intravenous (IV) infusion of camidanlumab tesirine (45 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 10 cycles. Camidanlumab tesirine: Intravenous (IV) infusion. Participants received an intravenous (IV) infusion of camidanlumab tesirine (60 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 8 cycles. Camidanlumab tesirine: Intravenous (IV) infusion. Participants received an intravenous (IV) infusion of camidanlumab tesirine (80 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 7 cycles. Camidanlumab tesirine: Intravenous (IV) infusion. Participants received an intravenous (IV) infusion of camidanlumab tesirine (100 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 5 cycles. Camidanlumab tesirine: Intravenous (IV) infusion. Participants received an intravenous (IV) infusion of camidanlumab tesirine (150 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 2 cycles. Camidanlumab tesirine: Intravenous (IV) infusion. A single participant received by error an intravenous (IV) infusion of camidanlumab tesirine (300 μg/kg) on Day 1 of Cycle 1 (planned dose was 30 μg/kg). Dosing in the subsequent cycles was 30 μg/kg (for 2 more cycles). Camidanlumab tesirine: Intravenous (IV) infusion.
    Measure Participants 0 0 2 2 1 18 33 22 17 2 2 1
    HuMax-TAC
    1.00
    (0.0000132)
    1.00
    (0.000584)
    1.00
    1.01
    (3.41)
    1.02
    (2.59)
    1.03
    (4.24)
    1.04
    (3.48)
    1.23
    1.08
    (6.58)
    1.00
    PBD-conjugated HuMax-TAC
    1.00
    1.00
    (0.00153)
    1.00
    1.00
    (0.234)
    1.01
    (1.48)
    1.03
    (4.94)
    1.03
    (2.38)
    1.06
    (8.36)
    1.06
    (0.381)
    1.00
    Free warhead (SG3199)
    1.00
    15. Secondary Outcome
    Title Volume of Distribution for Camidanlumab Tesirine
    Description Volume of distribution for HuMax-TAC, PBD-conjugated HuMax-TAC, and free warhead (SG3199).
    Time Frame Pre-dose on Day 1 and 1 to 336 hours post-dose of Cycles 1 and 2 (21 day cycle length)

    Outcome Measure Data

    Analysis Population Description
    Pharmacokinetic (PK) analysis set consisted of all participants who received study drug and have sufficient concentration data for PK analysis.
    Arm/Group Title 3 μg/kg 5 μg/kg 8 μg/kg 13 μg/kg 20 μg/kg 30 μg/kg 45 μg/kg 60 μg/kg 80 μg/kg 100 μg/kg 150 μg/kg 300 μg/kg
    Arm/Group Description Participants received an intravenous (IV) infusion of camidanlumab tesirine (3 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 2 cycles. Camidanlumab tesirine: Intravenous (IV) infusion. Participants received an intravenous (IV) infusion of camidanlumab tesirine (5 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 4 cycles. Camidanlumab tesirine: Intravenous (IV) infusion. Participants received an intravenous (IV) infusion of camidanlumab tesirine (8 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 3 cycles. Camidanlumab tesirine: Intravenous (IV) infusion. Participants received an intravenous (IV) infusion of camidanlumab tesirine (13 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 15 cycles. Camidanlumab tesirine: Intravenous (IV) infusion. Participants received an intravenous (IV) infusion of camidanlumab tesirine (20 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 3 cycles. Camidanlumab tesirine: Intravenous (IV) infusion. Participants received an intravenous (IV) infusion of camidanlumab tesirine (30 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 10 cycles. Camidanlumab tesirine: Intravenous (IV) infusion. Participants received an intravenous (IV) infusion of camidanlumab tesirine (45 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 10 cycles. Camidanlumab tesirine: Intravenous (IV) infusion. Participants received an intravenous (IV) infusion of camidanlumab tesirine (60 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 8 cycles. Camidanlumab tesirine: Intravenous (IV) infusion. Participants received an intravenous (IV) infusion of camidanlumab tesirine (80 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 7 cycles. Camidanlumab tesirine: Intravenous (IV) infusion. Participants received an intravenous (IV) infusion of camidanlumab tesirine (100 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 5 cycles. Camidanlumab tesirine: Intravenous (IV) infusion. Participants received an intravenous (IV) infusion of camidanlumab tesirine (150 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 2 cycles. Camidanlumab tesirine: Intravenous (IV) infusion. A single participant received by error an intravenous (IV) infusion of camidanlumab tesirine (300 μg/kg) on Day 1 of Cycle 1 (planned dose was 30 μg/kg). Dosing in the subsequent cycles was 30 μg/kg (for 2 more cycles). Camidanlumab tesirine: Intravenous (IV) infusion.
    Measure Participants 0 0 2 2 1 18 33 23 18 2 2 1
    Cycle 1 - HuMax-TAC
    3.93
    (43.2)
    4.57
    (26.9)
    4.55
    (27.0)
    4.28
    (159)
    6.11
    (8.73)
    7.01
    (46.4)
    4.84
    Cycle 2 - HuMax-TAC
    3.71
    (70.3)
    3.26
    (19.9)
    7.72
    4.28
    (60.1)
    4.54
    (36.0)
    4.64
    (26.5)
    5.23
    (24.8)
    5.55
    6.13
    (6.58)
    2.44
    Cycle 1 - PBD-conjugated HuMax-TAC
    2.23
    3.28
    (56.7)
    5.08
    (23.3)
    5.05
    (25.5)
    5.15
    (34.5)
    6.91
    (14.4)
    9.03
    (71.7)
    5.84
    Cycle 2 - PBD-conjugated HuMax-TAC
    5.89
    3.56
    (14.7)
    8.39
    4.81
    (53.0)
    4.91
    (29.9)
    5.10
    (30.2)
    5.89
    (25.7)
    14.5
    (257)
    7.55
    (8.86)
    2.90
    Cycle 2 - Free warhead (SG3199)
    7246
    16. Secondary Outcome
    Title Apparent Terminal Half-life (T1/2) of Camidanlumab Tesirine
    Description T1/2 of HuMax-TAC, PBD-conjugated HuMax-TAC, and free warhead (SG3199).
    Time Frame Pre-dose on Day 1 and 1 to 336 hours post-dose of Cycles 1 and 2 (21 day cycle length)

    Outcome Measure Data

    Analysis Population Description
    Pharmacokinetic (PK) analysis set consisted of all participants who received study drug and have sufficient concentration data for PK analysis.
    Arm/Group Title 3 μg/kg 5 μg/kg 8 μg/kg 13 μg/kg 20 μg/kg 30 μg/kg 45 μg/kg 60 μg/kg 80 μg/kg 100 μg/kg 150 μg/kg 300 μg/kg
    Arm/Group Description Participants received an intravenous (IV) infusion of camidanlumab tesirine (3 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 2 cycles. Camidanlumab tesirine: Intravenous (IV) infusion. Participants received an intravenous (IV) infusion of camidanlumab tesirine (5 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 4 cycles. Camidanlumab tesirine: Intravenous (IV) infusion. Participants received an intravenous (IV) infusion of camidanlumab tesirine (8 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 3 cycles. Camidanlumab tesirine: Intravenous (IV) infusion. Participants received an intravenous (IV) infusion of camidanlumab tesirine (13 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 15 cycles. Camidanlumab tesirine: Intravenous (IV) infusion. Participants received an intravenous (IV) infusion of camidanlumab tesirine (20 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 3 cycles. Camidanlumab tesirine: Intravenous (IV) infusion. Participants received an intravenous (IV) infusion of camidanlumab tesirine (30 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 10 cycles. Camidanlumab tesirine: Intravenous (IV) infusion. Participants received an intravenous (IV) infusion of camidanlumab tesirine (45 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 10 cycles. Camidanlumab tesirine: Intravenous (IV) infusion. Participants received an intravenous (IV) infusion of camidanlumab tesirine (60 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 8 cycles. Camidanlumab tesirine: Intravenous (IV) infusion. Participants received an intravenous (IV) infusion of camidanlumab tesirine (80 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 7 cycles. Camidanlumab tesirine: Intravenous (IV) infusion. Participants received an intravenous (IV) infusion of camidanlumab tesirine (100 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 5 cycles. Camidanlumab tesirine: Intravenous (IV) infusion. Participants received an intravenous (IV) infusion of camidanlumab tesirine (150 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 2 cycles. Camidanlumab tesirine: Intravenous (IV) infusion. A single participant received by error an intravenous (IV) infusion of camidanlumab tesirine (300 μg/kg) on Day 1 of Cycle 1 (planned dose was 30 μg/kg). Dosing in the subsequent cycles was 30 μg/kg (for 2 more cycles). Camidanlumab tesirine: Intravenous (IV) infusion.
    Measure Participants 0 0 2 2 1 18 33 23 18 2 2 1
    Cycle 1 - HuMax-TAC
    1.58
    (58.9)
    2.62
    (44.1)
    2.76
    (51.9)
    1.98
    (78.1)
    2.49
    (131)
    4.42
    (0.622)
    7.68
    Cycle 2 - HuMax-TAC
    0.835
    (16.9)
    1.63
    (0.507)
    2.61
    1.87
    (50.7)
    3.26
    (38.0)
    3.26
    (59.5)
    3.65
    (42.4)
    8.74
    5.38
    (34.4)
    1.43
    Cycle 1 - PBD-conjugated HuMax-TAC
    1.75
    1.39
    (49.8)
    2.31
    (45.5)
    2.43
    (44.7)
    2.11
    (78.6)
    2.92
    (152)
    5.59
    (50.9)
    7.16
    Cycle 2 - PBD-conjugated HuMax-TAC
    1.30
    1.37
    (5.69)
    2.24
    1.78
    (28.4)
    2.69
    (40.2)
    2.93
    (62.2)
    3.06
    (67.2)
    3.03
    (156)
    5.02
    (2.26)
    1.67
    Cycle 2 - Free warhead (SG3199)
    1.18
    17. Secondary Outcome
    Title Clearance of Camidanlumab Tesirine
    Description Clearance of HuMax-TAC, PBD-conjugated HuMax-TAC, and free warhead (SG3199).
    Time Frame Pre-dose on Day 1 and 1 to 336 hours post-dose of Cycles 1 and 2 (21 day cycle length)

    Outcome Measure Data

    Analysis Population Description
    Pharmacokinetic (PK) analysis set consisted of all participants who received study drug and have sufficient concentration data for PK analysis.
    Arm/Group Title 3 μg/kg 5 μg/kg 8 μg/kg 13 μg/kg 20 μg/kg 30 μg/kg 45 μg/kg 60 μg/kg 80 μg/kg 100 μg/kg 150 μg/kg 300 μg/kg
    Arm/Group Description Participants received an intravenous (IV) infusion of camidanlumab tesirine (3 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 2 cycles. Camidanlumab tesirine: Intravenous (IV) infusion. Participants received an intravenous (IV) infusion of camidanlumab tesirine (5 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 4 cycles. Camidanlumab tesirine: Intravenous (IV) infusion. Participants received an intravenous (IV) infusion of camidanlumab tesirine (8 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 3 cycles. Camidanlumab tesirine: Intravenous (IV) infusion. Participants received an intravenous (IV) infusion of camidanlumab tesirine (13 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 15 cycles. Camidanlumab tesirine: Intravenous (IV) infusion. Participants received an intravenous (IV) infusion of camidanlumab tesirine (20 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 3 cycles. Camidanlumab tesirine: Intravenous (IV) infusion. Participants received an intravenous (IV) infusion of camidanlumab tesirine (30 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 10 cycles. Camidanlumab tesirine: Intravenous (IV) infusion. Participants received an intravenous (IV) infusion of camidanlumab tesirine (45 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 10 cycles. Camidanlumab tesirine: Intravenous (IV) infusion. Participants received an intravenous (IV) infusion of camidanlumab tesirine (60 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 8 cycles. Camidanlumab tesirine: Intravenous (IV) infusion. Participants received an intravenous (IV) infusion of camidanlumab tesirine (80 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 7 cycles. Camidanlumab tesirine: Intravenous (IV) infusion. Participants received an intravenous (IV) infusion of camidanlumab tesirine (100 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 5 cycles. Camidanlumab tesirine: Intravenous (IV) infusion. Participants received an intravenous (IV) infusion of camidanlumab tesirine (150 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 2 cycles. Camidanlumab tesirine: Intravenous (IV) infusion. A single participant received by error an intravenous (IV) infusion of camidanlumab tesirine (300 μg/kg) on Day 1 of Cycle 1 (planned dose was 30 μg/kg). Dosing in the subsequent cycles was 30 μg/kg (for 2 more cycles). Camidanlumab tesirine: Intravenous (IV) infusion.
    Measure Participants 0 0 2 2 1 18 33 23 18 2 2 1
    Cycle 1 - HuMax-TAC
    1.82
    (69.0)
    1.29
    (64.0)
    1.24
    (54.5)
    1.60
    (184)
    1.82
    (136)
    1.05
    (22.6)
    0.489
    Cycle 2 - HuMax-TAC
    3.23
    (50.1)
    1.44
    (22.5)
    2.01
    1.60
    (66.5)
    1.03
    (61.2)
    0.950
    (85.9)
    1.10
    (46.2)
    0.446
    0.849
    (30.8)
    1.23
    Cycle 1 - PBD-conjugated HuMax-TAC
    0.943
    1.75
    (55.6)
    1.68
    (50.3)
    1.65
    (48.9)
    1.87
    (99.0)
    1.94
    (98.7)
    1.33
    (18.4)
    0.643
    Cycle 2 - PBD-conjugated HuMax-TAC
    3.27
    1.79
    (25.1)
    2.46
    1.93
    (57.2)
    1.37
    (55.3)
    1.27
    (62.8)
    1.44
    (86.9)
    3.28
    (2602)
    1.17
    (15.0)
    1.38
    Cycle 2 - Free warhead (SG3199)
    4302
    18. Secondary Outcome
    Title Number of Participants With Anti-drug Antibody Response (ADA) Against Camidanlumab Tesirine
    Description An assay determines the presence of anti-ADCT-301 antibodies in human serum using a validated bridging electro chemiluminescence immunoassay (ECLIA) technique. The technique uses the drug itself to capture any anti ADCT-301 antibodies present in the serum. If anti-ADCT-301 antibodies are detected, they are confirmed to be specifically against ADCT-301 and then the level of the anti-ADCT-301 antibodies present in the serum is established using a modified version of the ECLIA technique.
    Time Frame Day 1 to End of Study (a maximum of 12 months after last dose; median time on treatment was 43 days [min 1 day; max 354 days])

    Outcome Measure Data

    Analysis Population Description
    Safety Analysis Set - The safety analysis set consisted of all participants who received camidanlumab tesirine.
    Arm/Group Title 3 μg/kg 5 μg/kg 8 μg/kg 13 μg/kg 20 μg/kg 30 μg/kg 45 μg/kg 60 μg/kg 80 μg/kg 100 μg/kg 150 μg/kg 300 μg/kg
    Arm/Group Description Participants received an intravenous (IV) infusion of camidanlumab tesirine (3 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 2 cycles. Camidanlumab tesirine: Intravenous (IV) infusion. Participants received an intravenous (IV) infusion of camidanlumab tesirine (5 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 4 cycles. Camidanlumab tesirine: Intravenous (IV) infusion. Participants received an intravenous (IV) infusion of camidanlumab tesirine (8 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 3 cycles. Camidanlumab tesirine: Intravenous (IV) infusion. Participants received an intravenous (IV) infusion of camidanlumab tesirine (13 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 15 cycles. Camidanlumab tesirine: Intravenous (IV) infusion. Participants received an intravenous (IV) infusion of camidanlumab tesirine (20 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 3 cycles. Camidanlumab tesirine: Intravenous (IV) infusion. Participants received an intravenous (IV) infusion of camidanlumab tesirine (30 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 10 cycles. Camidanlumab tesirine: Intravenous (IV) infusion. Participants received an intravenous (IV) infusion of camidanlumab tesirine (45 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 10 cycles. Camidanlumab tesirine: Intravenous (IV) infusion. Participants received an intravenous (IV) infusion of camidanlumab tesirine (60 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 8 cycles. Camidanlumab tesirine: Intravenous (IV) infusion. Participants received an intravenous (IV) infusion of camidanlumab tesirine (80 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 7 cycles. Camidanlumab tesirine: Intravenous (IV) infusion. Participants received an intravenous (IV) infusion of camidanlumab tesirine (100 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 5 cycles. Camidanlumab tesirine: Intravenous (IV) infusion. Participants received an intravenous (IV) infusion of camidanlumab tesirine (150 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 2 cycles. Camidanlumab tesirine: Intravenous (IV) infusion. A single participant received by error an intravenous (IV) infusion of camidanlumab tesirine (300 μg/kg) on Day 1 of Cycle 1 (planned dose was 30 μg/kg). Dosing in the subsequent cycles was 30 μg/kg (for 2 more cycles). Camidanlumab tesirine: Intravenous (IV) infusion.
    Measure Participants 2 2 2 3 2 20 41 29 26 3 2 1
    Confirmed positive ADA pre-dose
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Confirmed positive ADA post-dose only
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Confirmed positive ADA at any time
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%

    Adverse Events

    Time Frame Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
    Adverse Event Reporting Description AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days [min 1 day; max 354 days]).
    Arm/Group Title 3 μg/kg 5 μg/kg 8 μg/kg 13 μg/kg 20 μg/kg 30 μg/kg 45 μg/kg 60 μg/kg 80 μg/kg 100 μg/kg 150 μg/kg 300 μg/kg
    Arm/Group Description Participants received an intravenous (IV) infusion of camidanlumab tesirine (3 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 2 cycles. Camidanlumab tesirine: Intravenous (IV) infusion. Participants received an intravenous (IV) infusion of camidanlumab tesirine (5 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 4 cycles. Camidanlumab tesirine: Intravenous (IV) infusion. Participants received an intravenous (IV) infusion of camidanlumab tesirine (8 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 3 cycles. Camidanlumab tesirine: Intravenous (IV) infusion. Participants received an intravenous (IV) infusion of camidanlumab tesirine (13 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 15 cycles. Camidanlumab tesirine: Intravenous (IV) infusion. Participants received an intravenous (IV) infusion of camidanlumab tesirine (20 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 3 cycles. Camidanlumab tesirine: Intravenous (IV) infusion. Participants received an intravenous (IV) infusion of camidanlumab tesirine (30 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 10 cycles. Camidanlumab tesirine: Intravenous (IV) infusion. Participants received an intravenous (IV) infusion of camidanlumab tesirine (45 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 10 cycles. Camidanlumab tesirine: Intravenous (IV) infusion. Participants received an intravenous (IV) infusion of camidanlumab tesirine (60 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 8 cycles. Camidanlumab tesirine: Intravenous (IV) infusion. Participants received an intravenous (IV) infusion of camidanlumab tesirine (80 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 7 cycles. Camidanlumab tesirine: Intravenous (IV) infusion. Participants received an intravenous (IV) infusion of camidanlumab tesirine (100 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 5 cycles. Camidanlumab tesirine: Intravenous (IV) infusion. Participants received an intravenous (IV) infusion of camidanlumab tesirine (150 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 2 cycles. Camidanlumab tesirine: Intravenous (IV) infusion. A single participant received by error an intravenous (IV) infusion of camidanlumab tesirine (300 μg/kg) on Day 1 of Cycle 1 (planned dose was 30 μg/kg). Dosing in the subsequent cycles was 30 μg/kg (for 2 more cycles). Camidanlumab tesirine: Intravenous (IV) infusion.
    All Cause Mortality
    3 μg/kg 5 μg/kg 8 μg/kg 13 μg/kg 20 μg/kg 30 μg/kg 45 μg/kg 60 μg/kg 80 μg/kg 100 μg/kg 150 μg/kg 300 μg/kg
    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 Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 1/2 (50%) 1/2 (50%) 2/2 (100%) 2/3 (66.7%) 1/2 (50%) 3/20 (15%) 11/41 (26.8%) 15/29 (51.7%) 15/26 (57.7%) 3/3 (100%) 1/2 (50%) 0/1 (0%)
    Serious Adverse Events
    3 μg/kg 5 μg/kg 8 μg/kg 13 μg/kg 20 μg/kg 30 μg/kg 45 μg/kg 60 μg/kg 80 μg/kg 100 μg/kg 150 μg/kg 300 μg/kg
    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 Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 0/2 (0%) 1/2 (50%) 0/2 (0%) 3/3 (100%) 1/2 (50%) 10/20 (50%) 24/41 (58.5%) 14/29 (48.3%) 18/26 (69.2%) 1/3 (33.3%) 1/2 (50%) 1/1 (100%)
    Blood and lymphatic system disorders
    Febrile neutropenia 0/2 (0%) 0 0/2 (0%) 0 0/2 (0%) 0 0/3 (0%) 0 0/2 (0%) 0 0/20 (0%) 0 2/41 (4.9%) 2 0/29 (0%) 0 2/26 (7.7%) 2 0/3 (0%) 0 0/2 (0%) 0 0/1 (0%) 0
    Anaemia 0/2 (0%) 0 0/2 (0%) 0 0/2 (0%) 0 0/3 (0%) 0 1/2 (50%) 1 0/20 (0%) 0 0/41 (0%) 0 0/29 (0%) 0 1/26 (3.8%) 1 0/3 (0%) 0 0/2 (0%) 0 0/1 (0%) 0
    Pancytopenia 0/2 (0%) 0 0/2 (0%) 0 0/2 (0%) 0 0/3 (0%) 0 0/2 (0%) 0 1/20 (5%) 1 1/41 (2.4%) 1 0/29 (0%) 0 0/26 (0%) 0 0/3 (0%) 0 0/2 (0%) 0 0/1 (0%) 0
    Neutropenia 0/2 (0%) 0 0/2 (0%) 0 0/2 (0%) 0 0/3 (0%) 0 0/2 (0%) 0 0/20 (0%) 0 1/41 (2.4%) 1 0/29 (0%) 0 0/26 (0%) 0 0/3 (0%) 0 0/2 (0%) 0 0/1 (0%) 0
    Spleen disorder 0/2 (0%) 0 0/2 (0%) 0 0/2 (0%) 0 0/3 (0%) 0 0/2 (0%) 0 0/20 (0%) 0 1/41 (2.4%) 1 0/29 (0%) 0 0/26 (0%) 0 0/3 (0%) 0 0/2 (0%) 0 0/1 (0%) 0
    Cardiac disorders
    Atrial fibrillation 0/2 (0%) 0 0/2 (0%) 0 0/2 (0%) 0 0/3 (0%) 0 0/2 (0%) 0 0/20 (0%) 0 1/41 (2.4%) 1 0/29 (0%) 0 1/26 (3.8%) 1 0/3 (0%) 0 0/2 (0%) 0 0/1 (0%) 0
    Atrial flutter 0/2 (0%) 0 0/2 (0%) 0 0/2 (0%) 0 0/3 (0%) 0 0/2 (0%) 0 0/20 (0%) 0 1/41 (2.4%) 1 0/29 (0%) 0 0/26 (0%) 0 0/3 (0%) 0 0/2 (0%) 0 0/1 (0%) 0
    Cardiac arrest 0/2 (0%) 0 1/2 (50%) 1 0/2 (0%) 0 0/3 (0%) 0 0/2 (0%) 0 0/20 (0%) 0 0/41 (0%) 0 0/29 (0%) 0 0/26 (0%) 0 0/3 (0%) 0 0/2 (0%) 0 0/1 (0%) 0
    Cardiac failure 0/2 (0%) 0 0/2 (0%) 0 0/2 (0%) 0 0/3 (0%) 0 0/2 (0%) 0 0/20 (0%) 0 0/41 (0%) 0 1/29 (3.4%) 1 0/26 (0%) 0 0/3 (0%) 0 0/2 (0%) 0 0/1 (0%) 0
    Myocardial infarction 0/2 (0%) 0 0/2 (0%) 0 0/2 (0%) 0 0/3 (0%) 0 0/2 (0%) 0 0/20 (0%) 0 0/41 (0%) 0 0/29 (0%) 0 1/26 (3.8%) 1 0/3 (0%) 0 0/2 (0%) 0 0/1 (0%) 0
    Pericardial effusion 0/2 (0%) 0 0/2 (0%) 0 0/2 (0%) 0 0/3 (0%) 0 0/2 (0%) 0 1/20 (5%) 1 0/41 (0%) 0 0/29 (0%) 0 0/26 (0%) 0 0/3 (0%) 0 0/2 (0%) 0 0/1 (0%) 0
    Sinus tachycardia 0/2 (0%) 0 0/2 (0%) 0 0/2 (0%) 0 0/3 (0%) 0 0/2 (0%) 0 0/20 (0%) 0 1/41 (2.4%) 1 0/29 (0%) 0 0/26 (0%) 0 0/3 (0%) 0 0/2 (0%) 0 0/1 (0%) 0
    Supraventricular tachycardia 0/2 (0%) 0 0/2 (0%) 0 0/2 (0%) 0 0/3 (0%) 0 0/2 (0%) 0 0/20 (0%) 0 0/41 (0%) 0 0/29 (0%) 0 1/26 (3.8%) 1 0/3 (0%) 0 0/2 (0%) 0 0/1 (0%) 0
    Ear and labyrinth disorders
    Ear pain 0/2 (0%) 0 0/2 (0%) 0 0/2 (0%) 0 0/3 (0%) 0 0/2 (0%) 0 0/20 (0%) 0 0/41 (0%) 0 1/29 (3.4%) 1 0/26 (0%) 0 0/3 (0%) 0 0/2 (0%) 0 0/1 (0%) 0
    Endocrine disorders
    Thyroiditis 0/2 (0%) 0 0/2 (0%) 0 0/2 (0%) 0 0/3 (0%) 0 0/2 (0%) 0 0/20 (0%) 0 0/41 (0%) 0 1/29 (3.4%) 1 0/26 (0%) 0 0/3 (0%) 0 0/2 (0%) 0 0/1 (0%) 0
    Gastrointestinal disorders
    Abdominal pain 0/2 (0%) 0 0/2 (0%) 0 0/2 (0%) 0 0/3 (0%) 0 0/2 (0%) 0 0/20 (0%) 0 1/41 (2.4%) 1 0/29 (0%) 0 2/26 (7.7%) 2 0/3 (0%) 0 0/2 (0%) 0 0/1 (0%) 0
    Diarrhoea 0/2 (0%) 0 0/2 (0%) 0 0/2 (0%) 0 0/3 (0%) 0 0/2 (0%) 0 0/20 (0%) 0 0/41 (0%) 0 0/29 (0%) 0 2/26 (7.7%) 2 0/3 (0%) 0 0/2 (0%) 0 0/1 (0%) 0
    Nausea 0/2 (0%) 0 0/2 (0%) 0 0/2 (0%) 0 0/3 (0%) 0 0/2 (0%) 0 0/20 (0%) 0 2/41 (4.9%) 2 0/29 (0%) 0 0/26 (0%) 0 0/3 (0%) 0 0/2 (0%) 0 0/1 (0%) 0
    Stomatitis 0/2 (0%) 0 0/2 (0%) 0 0/2 (0%) 0 0/3 (0%) 0 1/2 (50%) 1 0/20 (0%) 0 1/41 (2.4%) 1 0/29 (0%) 0 0/26 (0%) 0 0/3 (0%) 0 0/2 (0%) 0 0/1 (0%) 0
    Vomiting 0/2 (0%) 0 0/2 (0%) 0 0/2 (0%) 0 0/3 (0%) 0 0/2 (0%) 0 0/20 (0%) 0 1/41 (2.4%) 1 0/29 (0%) 0 0/26 (0%) 0 0/3 (0%) 0 0/2 (0%) 0 1/1 (100%) 1
    Abdominal pain lower 0/2 (0%) 0 0/2 (0%) 0 0/2 (0%) 0 0/3 (0%) 0 0/2 (0%) 0 0/20 (0%) 0 0/41 (0%) 0 1/29 (3.4%) 1 0/26 (0%) 0 0/3 (0%) 0 0/2 (0%) 0 0/1 (0%) 0
    Ascites 0/2 (0%) 0 0/2 (0%) 0 0/2 (0%) 0 0/3 (0%) 0 0/2 (0%) 0 0/20 (0%) 0 1/41 (2.4%) 1 0/29 (0%) 0 0/26 (0%) 0 0/3 (0%) 0 0/2 (0%) 0 0/1 (0%) 0
    Colitis 0/2 (0%) 0 0/2 (0%) 0 0/2 (0%) 0 0/3 (0%) 0 0/2 (0%) 0 0/20 (0%) 0 1/41 (2.4%) 1 0/29 (0%) 0 0/26 (0%) 0 0/3 (0%) 0 0/2 (0%) 0 0/1 (0%) 0
    Dysphagia 0/2 (0%) 0 0/2 (0%) 0 0/2 (0%) 0 0/3 (0%) 0 0/2 (0%) 0 0/20 (0%) 0 1/41 (2.4%) 1 0/29 (0%) 0 0/26 (0%) 0 0/3 (0%) 0 0/2 (0%) 0 0/1 (0%) 0
    Enteritis 0/2 (0%) 0 0/2 (0%) 0 0/2 (0%) 0 0/3 (0%) 0 1/2 (50%) 1 0/20 (0%) 0 0/41 (0%) 0 0/29 (0%) 0 0/26 (0%) 0 0/3 (0%) 0 0/2 (0%) 0 0/1 (0%) 0
    Oesophagitis 0/2 (0%) 0 0/2 (0%) 0 0/2 (0%) 0 0/3 (0%) 0 0/2 (0%) 0 0/20 (0%) 0 0/41 (0%) 0 0/29 (0%) 0 1/26 (3.8%) 1 0/3 (0%) 0 0/2 (0%) 0 0/1 (0%) 0
    Oral pain 0/2 (0%) 0 0/2 (0%) 0 0/2 (0%) 0 0/3 (0%) 0 0/2 (0%) 0 0/20 (0%) 0 1/41 (2.4%) 1 0/29 (0%) 0 0/26 (0%) 0 0/3 (0%) 0 0/2 (0%) 0 0/1 (0%) 0
    Proctalgia 0/2 (0%) 0 0/2 (0%) 0 0/2 (0%) 0 0/3 (0%) 0 0/2 (0%) 0 0/20 (0%) 0 0/41 (0%) 0 1/29 (3.4%) 1 0/26 (0%) 0 0/3 (0%) 0 0/2 (0%) 0 0/1 (0%) 0
    General disorders
    Pyrexia 0/2 (0%) 0 0/2 (0%) 0 0/2 (0%) 0 1/3 (33.3%) 1 1/2 (50%) 1 1/20 (5%) 1 4/41 (9.8%) 4 3/29 (10.3%) 3 6/26 (23.1%) 7 0/3 (0%) 0 0/2 (0%) 0 0/1 (0%) 0
    Disease progression 0/2 (0%) 0 0/2 (0%) 0 0/2 (0%) 0 0/3 (0%) 0 0/2 (0%) 0 0/20 (0%) 0 1/41 (2.4%) 1 1/29 (3.4%) 1 2/26 (7.7%) 2 0/3 (0%) 0 0/2 (0%) 0 0/1 (0%) 0
    Fatigue 0/2 (0%) 0 0/2 (0%) 0 0/2 (0%) 0 0/3 (0%) 0 0/2 (0%) 0 0/20 (0%) 0 2/41 (4.9%) 2 0/29 (0%) 0 0/26 (0%) 0 0/3 (0%) 0 0/2 (0%) 0 0/1 (0%) 0
    Non-cardiac chest pain 0/2 (0%) 0 0/2 (0%) 0 0/2 (0%) 0 0/3 (0%) 0 0/2 (0%) 0 0/20 (0%) 0 2/41 (4.9%) 2 0/29 (0%) 0 0/26 (0%) 0 0/3 (0%) 0 0/2 (0%) 0 0/1 (0%) 0
    Oedema peripheral 0/2 (0%) 0 0/2 (0%) 0 0/2 (0%) 0 0/3 (0%) 0 0/2 (0%) 0 0/20 (0%) 0 2/41 (4.9%) 2 0/29 (0%) 0 0/26 (0%) 0 0/3 (0%) 0 0/2 (0%) 0 0/1 (0%) 0
    Chills 0/2 (0%) 0 0/2 (0%) 0 0/2 (0%) 0 0/3 (0%) 0 0/2 (0%) 0 0/20 (0%) 0 0/41 (0%) 0 0/29 (0%) 0 1/26 (3.8%) 1 0/3 (0%) 0 0/2 (0%) 0 0/1 (0%) 0
    Death 0/2 (0%) 0 0/2 (0%) 0 0/2 (0%) 0 0/3 (0%) 0 0/2 (0%) 0 0/20 (0%) 0 1/41 (2.4%) 1 0/29 (0%) 0 0/26 (0%) 0 0/3 (0%) 0 0/2 (0%) 0 0/1 (0%) 0
    Infusion site extravasation 0/2 (0%) 0 0/2 (0%) 0 0/2 (0%) 0 0/3 (0%) 0 0/2 (0%) 0 1/20 (5%) 1 0/41 (0%) 0 0/29 (0%) 0 0/26 (0%) 0 0/3 (0%) 0 0/2 (0%) 0 0/1 (0%) 0
    Mucosal inflammation 0/2 (0%) 0 0/2 (0%) 0 0/2 (0%) 0 0/3 (0%) 0 0/2 (0%) 0 0/20 (0%) 0 1/41 (2.4%) 1 0/29 (0%) 0 0/26 (0%) 0 0/3 (0%) 0 0/2 (0%) 0 0/1 (0%) 0
    Hepatobiliary disorders
    Hepatic failure 0/2 (0%) 0 0/2 (0%) 0 0/2 (0%) 0 0/3 (0%) 0 0/2 (0%) 0 1/20 (5%) 1 0/41 (0%) 0 0/29 (0%) 0 0/26 (0%) 0 0/3 (0%) 0 0/2 (0%) 0 0/1 (0%) 0
    Infections and infestations
    Lung infection 0/2 (0%) 0 0/2 (0%) 0 0/2 (0%) 0 0/3 (0%) 0 0/2 (0%) 0 0/20 (0%) 0 1/41 (2.4%) 1 1/29 (3.4%) 1 2/26 (7.7%) 2 0/3 (0%) 0 0/2 (0%) 0 0/1 (0%) 0
    Pneumocystis jirovecii pneumonia 0/2 (0%) 0 0/2 (0%) 0 0/2 (0%) 0 0/3 (0%) 0 0/2 (0%) 0 0/20 (0%) 0 2/41 (4.9%) 2 1/29 (3.4%) 1 0/26 (0%) 0 1/3 (33.3%) 1 0/2 (0%) 0 0/1 (0%) 0
    Neutropenic sepsis 0/2 (0%) 0 0/2 (0%) 0 0/2 (0%) 0 0/3 (0%) 0 0/2 (0%) 0 0/20 (0%) 0 1/41 (2.4%) 1 0/29 (0%) 0 1/26 (3.8%) 1 0/3 (0%) 0 1/2 (50%) 1 0/1 (0%) 0
    Rhinovirus infection 0/2 (0%) 0 0/2 (0%) 0 0/2 (0%) 0 0/3 (0%) 0 0/2 (0%) 0 0/20 (0%) 0 2/41 (4.9%) 2 1/29 (3.4%) 1 0/26 (0%) 0 0/3 (0%) 0 0/2 (0%) 0 0/1 (0%) 0
    Sepsis 0/2 (0%) 0 0/2 (0%) 0 0/2 (0%) 0 0/3 (0%) 0 0/2 (0%) 0 1/20 (5%) 1 0/41 (0%) 0 0/29 (0%) 0 2/26 (7.7%) 2 0/3 (0%) 0 0/2 (0%) 0 0/1 (0%) 0
    Clostridium difficile colitis 0/2 (0%) 0 0/2 (0%) 0 0/2 (0%) 0 0/3 (0%) 0 0/2 (0%) 0 0/20 (0%) 0 0/41 (0%) 0 1/29 (3.4%) 1 0/26 (0%) 0 0/3 (0%) 0 0/2 (0%) 0 1/1 (100%) 1
    Rash pustular 0/2 (0%) 0 0/2 (0%) 0 0/2 (0%) 0 0/3 (0%) 0 0/2 (0%) 0 0/20 (0%) 0 0/41 (0%) 0 1/29 (3.4%) 1 1/26 (3.8%) 1 0/3 (0%) 0 0/2 (0%) 0 0/1 (0%) 0
    Skin infection 0/2 (0%) 0 0/2 (0%) 0 0/2 (0%) 0 0/3 (0%) 0 0/2 (0%) 0 1/20 (5%) 1 0/41 (0%) 0 0/29 (0%) 0 1/26 (3.8%) 1 0/3 (0%) 0 0/2 (0%) 0 0/1 (0%) 0
    Arthritis bacterial 0/2 (0%) 0 0/2 (0%) 0 0/2 (0%) 0 0/3 (0%) 0 0/2 (0%) 0 0/20 (0%) 0 0/41 (0%) 0 0/29 (0%) 0 1/26 (3.8%) 1 0/3 (0%) 0 0/2 (0%) 0 0/1 (0%) 0
    Arthritis infective 0/2 (0%) 0 0/2 (0%) 0 0/2 (0%) 0 0/3 (0%) 0 0/2 (0%) 0 1/20 (5%) 1 0/41 (0%) 0 0/29 (0%) 0 0/26 (0%) 0 0/3 (0%) 0 0/2 (0%) 0 0/1 (0%) 0
    Bacteraemia 0/2 (0%) 0 0/2 (0%) 0 0/2 (0%) 0 0/3 (0%) 0 0/2 (0%) 0 0/20 (0%) 0 0/41 (0%) 0 0/29 (0%) 0 0/26 (0%) 0 0/3 (0%) 0 0/2 (0%) 0 1/1 (100%) 1
    Cellulitis 0/2 (0%) 0 0/2 (0%) 0 0/2 (0%) 0 0/3 (0%) 0 0/2 (0%) 0 0/20 (0%) 0 0/41 (0%) 0 0/29 (0%) 0 1/26 (3.8%) 1 0/3 (0%) 0 0/2 (0%) 0 0/1 (0%) 0
    Herpes virus infection 0/2 (0%) 0 0/2 (0%) 0 0/2 (0%) 0 0/3 (0%) 0 0/2 (0%) 0 0/20 (0%) 0 1/41 (2.4%) 1 0/29 (0%) 0 0/26 (0%) 0 0/3 (0%) 0 0/2 (0%) 0 0/1 (0%) 0
    Influenza 0/2 (0%) 0 0/2 (0%) 0 0/2 (0%) 0 0/3 (0%) 0 0/2 (0%) 0 0/20 (0%) 0 1/41 (2.4%) 1 0/29 (0%) 0 0/26 (0%) 0 0/3 (0%) 0 0/2 (0%) 0 0/1 (0%) 0
    Pneumonia 0/2 (0%) 0 0/2 (0%) 0 0/2 (0%) 0 0/3 (0%) 0 0/2 (0%) 0 0/20 (0%) 0 0/41 (0%) 0 0/29 (0%) 0 1/26 (3.8%) 1 0/3 (0%) 0 0/2 (0%) 0 0/1 (0%) 0
    Respiratory syncytial virus infection 0/2 (0%) 0 0/2 (0%) 0 0/2 (0%) 0 0/3 (0%) 0 0/2 (0%) 0 0/20 (0%) 0 1/41 (2.4%) 1 0/29 (0%) 0 0/26 (0%) 0 0/3 (0%) 0 0/2 (0%) 0 0/1 (0%) 0
    Soft tissue infection 0/2 (0%) 0 0/2 (0%) 0 0/2 (0%) 0 0/3 (0%) 0 0/2 (0%) 0 0/20 (0%) 0 0/41 (0%) 0 0/29 (0%) 0 0/26 (0%) 0 0/3 (0%) 0 1/2 (50%) 1 0/1 (0%) 0
    Wound infection 0/2 (0%) 0 0/2 (0%) 0 0/2 (0%) 0 0/3 (0%) 0 0/2 (0%) 0 0/20 (0%) 0 0/41 (0%) 0 1/29 (3.4%) 1 0/26 (0%) 0 0/3 (0%) 0 0/2 (0%) 0 0/1 (0%) 0
    Injury, poisoning and procedural complications
    Fall 0/2 (0%) 0 0/2 (0%) 0 0/2 (0%) 0 0/3 (0%) 0 0/2 (0%) 0 1/20 (5%) 1 0/41 (0%) 0 1/29 (3.4%) 1 0/26 (0%) 0 0/3 (0%) 0 0/2 (0%) 0 0/1 (0%) 0
    Femur fracture 0/2 (0%) 0 0/2 (0%) 0 0/2 (0%) 0 0/3 (0%) 0 0/2 (0%) 0 0/20 (0%) 0 0/41 (0%) 0 0/29 (0%) 0 1/26 (3.8%) 1 0/3 (0%) 0 0/2 (0%) 0 0/1 (0%) 0
    Investigations
    Blood creatine phosphokinase increased 0/2 (0%) 0 0/2 (0%) 0 0/2 (0%) 0 0/3 (0%) 0 0/2 (0%) 0 0/20 (0%) 0 1/41 (2.4%) 1 1/29 (3.4%) 2 0/26 (0%) 0 0/3 (0%) 0 0/2 (0%) 0 0/1 (0%) 0
    Platelet count decreased 0/2 (0%) 0 0/2 (0%) 0 0/2 (0%) 0 0/3 (0%) 0 0/2 (0%) 0 0/20 (0%) 0 1/41 (2.4%) 1 0/29 (0%) 0 0/26 (0%) 0 0/3 (0%) 0 1/2 (50%) 1 0/1 (0%) 0
    Transaminases increased 0/2 (0%) 0 0/2 (0%) 0 0/2 (0%) 0 0/3 (0%) 0 0/2 (0%) 0 0/20 (0%) 0 0/41 (0%) 0 2/29 (6.9%) 2 0/26 (0%) 0 0/3 (0%) 0 0/2 (0%) 0 0/1 (0%) 0
    Alanine aminotransferase increased 0/2 (0%) 0 0/2 (0%) 0 0/2 (0%) 0 0/3 (0%) 0 0/2 (0%) 0 0/20 (0%) 0 0/41 (0%) 0 1/29 (3.4%) 1 0/26 (0%) 0 0/3 (0%) 0 0/2 (0%) 0 0/1 (0%) 0
    Aspartate aminotransferase increased 0/2 (0%) 0 0/2 (0%) 0 0/2 (0%) 0 0/3 (0%) 0 0/2 (0%) 0 0/20 (0%) 0 0/41 (0%) 0 1/29 (3.4%) 1 0/26 (0%) 0 0/3 (0%) 0 0/2 (0%) 0 0/1 (0%) 0
    Blood bilirubin increased 0/2 (0%) 0 0/2 (0%) 0 0/2 (0%) 0 0/3 (0%) 0 0/2 (0%) 0 1/20 (5%) 1 0/41 (0%) 0 0/29 (0%) 0 0/26 (0%) 0 0/3 (0%) 0 0/2 (0%) 0 0/1 (0%) 0
    Blood creatinine increased 0/2 (0%) 0 0/2 (0%) 0 0/2 (0%) 0 0/3 (0%) 0 0/2 (0%) 0 0/20 (0%) 0 0/41 (0%) 0 1/29 (3.4%) 1 0/26 (0%) 0 0/3 (0%) 0 0/2 (0%) 0 0/1 (0%) 0
    Metabolism and nutrition disorders
    Hypercalcaemia 0/2 (0%) 0 0/2 (0%) 0 0/2 (0%) 0 1/3 (33.3%) 1 0/2 (0%) 0 0/20 (0%) 0 2/41 (4.9%) 2 1/29 (3.4%) 2 2/26 (7.7%) 4 0/3 (0%) 0 0/2 (0%) 0 0/1 (0%) 0
    Dehydration 0/2 (0%) 0 0/2 (0%) 0 0/2 (0%) 0 0/3 (0%) 0 0/2 (0%) 0 1/20 (5%) 1 1/41 (2.4%) 1 0/29 (0%) 0 0/26 (0%) 0 0/3 (0%) 0 0/2 (0%) 0 0/1 (0%) 0
    Hypokalaemia 0/2 (0%) 0 0/2 (0%) 0 0/2 (0%) 0 0/3 (0%) 0 0/2 (0%) 0 1/20 (5%) 1 0/41 (0%) 0 0/29 (0%) 0 0/26 (0%) 0 0/3 (0%) 0 0/2 (0%) 0 0/1 (0%) 0
    Hyponatraemia 0/2 (0%) 0 0/2 (0%) 0 0/2 (0%) 0 0/3 (0%) 0 0/2 (0%) 0 0/20 (0%) 0 0/41 (0%) 0 0/29 (0%) 0 1/26 (3.8%) 1 0/3 (0%) 0 0/2 (0%) 0 0/1 (0%) 0
    Musculoskeletal and connective tissue disorders
    Back pain 0/2 (0%) 0 0/2 (0%) 0 0/2 (0%) 0 1/3 (33.3%) 1 0/2 (0%) 0 0/20 (0%) 0 1/41 (2.4%) 1 0/29 (0%) 0 1/26 (3.8%) 1 0/3 (0%) 0 0/2 (0%) 0 0/1 (0%) 0
    Muscular weakness 0/2 (0%) 0 0/2 (0%) 0 0/2 (0%) 0 1/3 (33.3%) 1 0/2 (0%) 0 1/20 (5%) 1 0/41 (0%) 0 0/29 (0%) 0 0/26 (0%) 0 0/3 (0%) 0 0/2 (0%) 0 0/1 (0%) 0
    Flank pain 0/2 (0%) 0 0/2 (0%) 0 0/2 (0%) 0 0/3 (0%) 0 0/2 (0%) 0 0/20 (0%) 0 0/41 (0%) 0 1/29 (3.4%) 1 0/26 (0%) 0 0/3 (0%) 0 0/2 (0%) 0 0/1 (0%) 0
    Musculoskeletal chest pain 0/2 (0%) 0 0/2 (0%) 0 0/2 (0%) 0 0/3 (0%) 0 0/2 (0%) 0 0/20 (0%) 0 0/41 (0%) 0 0/29 (0%) 0 1/26 (3.8%) 1 0/3 (0%) 0 0/2 (0%) 0 0/1 (0%) 0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Lymphoma 0/2 (0%) 0 0/2 (0%) 0 0/2 (0%) 0 0/3 (0%) 0 0/2 (0%) 0 0/20 (0%) 0 0/41 (0%) 0 1/29 (3.4%) 1 1/26 (3.8%) 1 0/3 (0%) 0 0/2 (0%) 0 0/1 (0%) 0
    Hodgkins disease 0/2 (0%) 0 0/2 (0%) 0 0/2 (0%) 0 0/3 (0%) 0 0/2 (0%) 0 1/20 (5%) 1 0/41 (0%) 0 0/29 (0%) 0 0/26 (0%) 0 0/3 (0%) 0 0/2 (0%) 0 0/1 (0%) 0
    Metastases to meninges 0/2 (0%) 0 0/2 (0%) 0 0/2 (0%) 0 0/3 (0%) 0 0/2 (0%) 0 0/20 (0%) 0 0/41 (0%) 0 0/29 (0%) 0 1/26 (3.8%) 1 0/3 (0%) 0 0/2 (0%) 0 0/1 (0%) 0
    Nervous system disorders
    Guillain-Barre syndrome 0/2 (0%) 0 0/2 (0%) 0 0/2 (0%) 0 0/3 (0%) 0 0/2 (0%) 0 1/20 (5%) 1 2/41 (4.9%) 2 1/29 (3.4%) 1 0/26 (0%) 0 0/3 (0%) 0 0/2 (0%) 0 0/1 (0%) 0
    Aphasia 0/2 (0%) 0 0/2 (0%) 0 0/2 (0%) 0 0/3 (0%) 0 0/2 (0%) 0 0/20 (0%) 0 0/41 (0%) 0 1/29 (3.4%) 1 0/26 (0%) 0 0/3 (0%) 0 0/2 (0%) 0 0/1 (0%) 0
    Autonomic nervous system imbalance 0/2 (0%) 0 0/2 (0%) 0 0/2 (0%) 0 0/3 (0%) 0 0/2 (0%) 0 0/20 (0%) 0 1/41 (2.4%) 1 0/29 (0%) 0 0/26 (0%) 0 0/3 (0%) 0 0/2 (0%) 0 0/1 (0%) 0
    Dysaesthesia 0/2 (0%) 0 0/2 (0%) 0 0/2 (0%) 0 0/3 (0%) 0 0/2 (0%) 0 0/20 (0%) 0 1/41 (2.4%) 1 0/29 (0%) 0 0/26 (0%) 0 0/3 (0%) 0 0/2 (0%) 0 0/1 (0%) 0
    Facial nerve disorder 0/2 (0%) 0 0/2 (0%) 0 0/2 (0%) 0 0/3 (0%) 0 0/2 (0%) 0 0/20 (0%) 0 0/41 (0%) 0 0/29 (0%) 0 1/26 (3.8%) 1 0/3 (0%) 0 0/2 (0%) 0 0/1 (0%) 0
    Haemorrhage intracranial 0/2 (0%) 0 0/2 (0%) 0 0/2 (0%) 0 0/3 (0%) 0 0/2 (0%) 0 0/20 (0%) 0 0/41 (0%) 0 1/29 (3.4%) 1 0/26 (0%) 0 0/3 (0%) 0 0/2 (0%) 0 0/1 (0%) 0
    Paraesthesia 0/2 (0%) 0 0/2 (0%) 0 0/2 (0%) 0 1/3 (33.3%) 1 0/2 (0%) 0 0/20 (0%) 0 0/41 (0%) 0 0/29 (0%) 0 0/26 (0%) 0 0/3 (0%) 0 0/2 (0%) 0 0/1 (0%) 0
    Peripheral sensory neuropathy 0/2 (0%) 0 0/2 (0%) 0 0/2 (0%) 0 0/3 (0%) 0 0/2 (0%) 0 0/20 (0%) 0 1/41 (2.4%) 1 0/29 (0%) 0 0/26 (0%) 0 0/3 (0%) 0 0/2 (0%) 0 0/1 (0%) 0
    Posterior reversible encephalopathy syndrome 0/2 (0%) 0 0/2 (0%) 0 0/2 (0%) 0 0/3 (0%) 0 0/2 (0%) 0 0/20 (0%) 0 0/41 (0%) 0 0/29 (0%) 0 0/26 (0%) 0 0/3 (0%) 0 0/2 (0%) 0 1/1 (100%) 1
    Radiculopathy 0/2 (0%) 0 0/2 (0%) 0 0/2 (0%) 0 0/3 (0%) 0 0/2 (0%) 0 0/20 (0%) 0 1/41 (2.4%) 1 0/29 (0%) 0 0/26 (0%) 0 0/3 (0%) 0 0/2 (0%) 0 0/1 (0%) 0
    Seizure 0/2 (0%) 0 0/2 (0%) 0 0/2 (0%) 0 0/3 (0%) 0 0/2 (0%) 0 0/20 (0%) 0 0/41 (0%) 0 0/29 (0%) 0 0/26 (0%) 0 0/3 (0%) 0 1/2 (50%) 1 0/1 (0%) 0
    Syncope 0/2 (0%) 0 0/2 (0%) 0 0/2 (0%) 0 0/3 (0%) 0 0/2 (0%) 0 0/20 (0%) 0 0/41 (0%) 0 0/29 (0%) 0 1/26 (3.8%) 1 0/3 (0%) 0 0/2 (0%) 0 0/1 (0%) 0
    Transient ischaemic attack 0/2 (0%) 0 0/2 (0%) 0 0/2 (0%) 0 1/3 (33.3%) 1 0/2 (0%) 0 0/20 (0%) 0 0/41 (0%) 0 0/29 (0%) 0 0/26 (0%) 0 0/3 (0%) 0 0/2 (0%) 0 0/1 (0%) 0
    VIIth nerve paralysis 0/2 (0%) 0 0/2 (0%) 0 0/2 (0%) 0 0/3 (0%) 0 0/2 (0%) 0 0/20 (0%) 0 1/41 (2.4%) 1 0/29 (0%) 0 0/26 (0%) 0 0/3 (0%) 0 0/2 (0%) 0 0/1 (0%) 0
    Renal and urinary disorders
    Acute kidney injury 0/2 (0%) 0 0/2 (0%) 0 0/2 (0%) 0 0/3 (0%) 0 0/2 (0%) 0 0/20 (0%) 0 3/41 (7.3%) 3 2/29 (6.9%) 2 2/26 (7.7%) 2 0/3 (0%) 0 0/2 (0%) 0 0/1 (0%) 0
    Dysuria 0/2 (0%) 0 0/2 (0%) 0 0/2 (0%) 0 0/3 (0%) 0 0/2 (0%) 0 0/20 (0%) 0 0/41 (0%) 0 1/29 (3.4%) 1 0/26 (0%) 0 0/3 (0%) 0 0/2 (0%) 0 0/1 (0%) 0
    Respiratory, thoracic and mediastinal disorders
    Dyspnoea 0/2 (0%) 0 0/2 (0%) 0 0/2 (0%) 0 0/3 (0%) 0 0/2 (0%) 0 1/20 (5%) 1 3/41 (7.3%) 4 0/29 (0%) 0 3/26 (11.5%) 4 0/3 (0%) 0 0/2 (0%) 0 0/1 (0%) 0
    Pleural effusion 0/2 (0%) 0 0/2 (0%) 0 0/2 (0%) 0 0/3 (0%) 0 0/2 (0%) 0 2/20 (10%) 2 3/41 (7.3%) 5 0/29 (0%) 0 2/26 (7.7%) 3 0/3 (0%) 0 0/2 (0%) 0 0/1 (0%) 0
    Cough 0/2 (0%) 0 0/2 (0%) 0 0/2 (0%) 0 0/3 (0%) 0 0/2 (0%) 0 0/20 (0%) 0 1/41 (2.4%) 1 0/29 (0%) 0 2/26 (7.7%) 3 0/3 (0%) 0 0/2 (0%) 0 0/1 (0%) 0
    Hypoxia 0/2 (0%) 0 0/2 (0%) 0 0/2 (0%) 0 0/3 (0%) 0 0/2 (0%) 0 2/20 (10%) 2 0/41 (0%) 0 1/29 (3.4%) 2 0/26 (0%) 0 0/3 (0%) 0 0/2 (0%) 0 0/1 (0%) 0
    Pulmonary embolism 0/2 (0%) 0 0/2 (0%) 0 0/2 (0%) 0 1/3 (33.3%) 1 0/2 (0%) 0 1/20 (5%) 1 0/41 (0%) 0 0/29 (0%) 0 0/26 (0%) 0 0/3 (0%) 0 0/2 (0%) 0 0/1 (0%) 0
    Acute respiratory distress syndrome 0/2 (0%) 0 0/2 (0%) 0 0/2 (0%) 0 0/3 (0%) 0 0/2 (0%) 0 1/20 (5%) 1 0/41 (0%) 0 0/29 (0%) 0 0/26 (0%) 0 0/3 (0%) 0 0/2 (0%) 0 0/1 (0%) 0
    Pulmonary oedema 0/2 (0%) 0 0/2 (0%) 0 0/2 (0%) 0 0/3 (0%) 0 0/2 (0%) 0 0/20 (0%) 0 0/41 (0%) 0 0/29 (0%) 0 1/26 (3.8%) 1 0/3 (0%) 0 0/2 (0%) 0 0/1 (0%) 0
    Respiratory failure 0/2 (0%) 0 0/2 (0%) 0 0/2 (0%) 0 0/3 (0%) 0 0/2 (0%) 0 0/20 (0%) 0 0/41 (0%) 0 0/29 (0%) 0 0/26 (0%) 0 1/3 (33.3%) 1 0/2 (0%) 0 0/1 (0%) 0
    Skin and subcutaneous tissue disorders
    Rash 0/2 (0%) 0 0/2 (0%) 0 0/2 (0%) 0 0/3 (0%) 0 0/2 (0%) 0 0/20 (0%) 0 1/41 (2.4%) 1 1/29 (3.4%) 1 2/26 (7.7%) 2 0/3 (0%) 0 0/2 (0%) 0 0/1 (0%) 0
    Rash maculo-papular 0/2 (0%) 0 0/2 (0%) 0 0/2 (0%) 0 0/3 (0%) 0 0/2 (0%) 0 1/20 (5%) 1 1/41 (2.4%) 1 0/29 (0%) 0 0/26 (0%) 0 0/3 (0%) 0 0/2 (0%) 0 0/1 (0%) 0
    Rash generalised 0/2 (0%) 0 0/2 (0%) 0 0/2 (0%) 0 0/3 (0%) 0 0/2 (0%) 0 0/20 (0%) 0 0/41 (0%) 0 0/29 (0%) 0 1/26 (3.8%) 1 0/3 (0%) 0 0/2 (0%) 0 0/1 (0%) 0
    Vascular disorders
    Embolism 0/2 (0%) 0 0/2 (0%) 0 0/2 (0%) 0 0/3 (0%) 0 0/2 (0%) 0 0/20 (0%) 0 0/41 (0%) 0 0/29 (0%) 0 1/26 (3.8%) 1 0/3 (0%) 0 0/2 (0%) 0 0/1 (0%) 0
    Other (Not Including Serious) Adverse Events
    3 μg/kg 5 μg/kg 8 μg/kg 13 μg/kg 20 μg/kg 30 μg/kg 45 μg/kg 60 μg/kg 80 μg/kg 100 μg/kg 150 μg/kg 300 μg/kg
    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 Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 1/2 (50%) 2/2 (100%) 2/2 (100%) 3/3 (100%) 2/2 (100%) 20/20 (100%) 41/41 (100%) 29/29 (100%) 26/26 (100%) 3/3 (100%) 2/2 (100%) 1/1 (100%)
    Blood and lymphatic system disorders
    Anaemia 0/2 (0%) 1/2 (50%) 0/2 (0%) 1/3 (33.3%) 1/2 (50%) 6/20 (30%) 8/41 (19.5%) 2/29 (6.9%) 5/26 (19.2%) 0/3 (0%) 1/2 (50%) 1/1 (100%)
    Thrombocytopenia 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/3 (0%) 0/2 (0%) 1/20 (5%) 3/41 (7.3%) 1/29 (3.4%) 2/26 (7.7%) 0/3 (0%) 0/2 (0%) 0/1 (0%)
    Neutropenia 1/2 (50%) 0/2 (0%) 0/2 (0%) 0/3 (0%) 0/2 (0%) 1/20 (5%) 2/41 (4.9%) 1/29 (3.4%) 1/26 (3.8%) 0/3 (0%) 0/2 (0%) 0/1 (0%)
    Lymph node pain 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/3 (0%) 0/2 (0%) 1/20 (5%) 0/41 (0%) 1/29 (3.4%) 1/26 (3.8%) 0/3 (0%) 0/2 (0%) 0/1 (0%)
    Increased tendency to bruise 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/3 (0%) 0/2 (0%) 1/20 (5%) 0/41 (0%) 0/29 (0%) 0/26 (0%) 0/3 (0%) 0/2 (0%) 0/1 (0%)
    Cardiac disorders
    Sinus tachycardia 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/3 (0%) 0/2 (0%) 1/20 (5%) 4/41 (9.8%) 0/29 (0%) 1/26 (3.8%) 0/3 (0%) 0/2 (0%) 0/1 (0%)
    Tachycardia 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/3 (0%) 0/2 (0%) 1/20 (5%) 0/41 (0%) 1/29 (3.4%) 0/26 (0%) 0/3 (0%) 1/2 (50%) 1/1 (100%)
    Atrial flutter 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/3 (0%) 0/2 (0%) 1/20 (5%) 2/41 (4.9%) 0/29 (0%) 0/26 (0%) 0/3 (0%) 0/2 (0%) 0/1 (0%)
    Atrial fibrillation 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/3 (0%) 0/2 (0%) 1/20 (5%) 0/41 (0%) 0/29 (0%) 1/26 (3.8%) 0/3 (0%) 0/2 (0%) 0/1 (0%)
    Angina pectoris 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/3 (0%) 0/2 (0%) 1/20 (5%) 0/41 (0%) 0/29 (0%) 0/26 (0%) 0/3 (0%) 0/2 (0%) 0/1 (0%)
    Ear and labyrinth disorders
    Ear pain 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/3 (0%) 0/2 (0%) 0/20 (0%) 1/41 (2.4%) 3/29 (10.3%) 1/26 (3.8%) 0/3 (0%) 0/2 (0%) 0/1 (0%)
    Endocrine disorders
    Hypothyroidism 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/3 (0%) 0/2 (0%) 0/20 (0%) 3/41 (7.3%) 2/29 (6.9%) 2/26 (7.7%) 0/3 (0%) 0/2 (0%) 0/1 (0%)
    Hyperthyroidism 0/2 (0%) 1/2 (50%) 0/2 (0%) 0/3 (0%) 0/2 (0%) 0/20 (0%) 1/41 (2.4%) 2/29 (6.9%) 0/26 (0%) 0/3 (0%) 0/2 (0%) 0/1 (0%)
    Eye disorders
    Lacrimation increased 0/2 (0%) 1/2 (50%) 0/2 (0%) 0/3 (0%) 0/2 (0%) 1/20 (5%) 2/41 (4.9%) 3/29 (10.3%) 0/26 (0%) 0/3 (0%) 0/2 (0%) 0/1 (0%)
    Vision blurred 0/2 (0%) 1/2 (50%) 0/2 (0%) 0/3 (0%) 0/2 (0%) 1/20 (5%) 2/41 (4.9%) 2/29 (6.9%) 0/26 (0%) 0/3 (0%) 0/2 (0%) 0/1 (0%)
    Dry eye 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/3 (0%) 0/2 (0%) 2/20 (10%) 2/41 (4.9%) 1/29 (3.4%) 0/26 (0%) 0/3 (0%) 0/2 (0%) 0/1 (0%)
    Periorbital oedema 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/3 (0%) 0/2 (0%) 0/20 (0%) 0/41 (0%) 4/29 (13.8%) 0/26 (0%) 0/3 (0%) 0/2 (0%) 0/1 (0%)
    Diplopia 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/3 (0%) 0/2 (0%) 0/20 (0%) 1/41 (2.4%) 0/29 (0%) 0/26 (0%) 1/3 (33.3%) 0/2 (0%) 0/1 (0%)
    Conjunctival haemorrhage 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/3 (0%) 0/2 (0%) 1/20 (5%) 0/41 (0%) 0/29 (0%) 0/26 (0%) 0/3 (0%) 0/2 (0%) 0/1 (0%)
    Photophobia 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/3 (0%) 0/2 (0%) 1/20 (5%) 0/41 (0%) 0/29 (0%) 0/26 (0%) 0/3 (0%) 0/2 (0%) 0/1 (0%)
    Gastrointestinal disorders
    Diarrhoea 0/2 (0%) 1/2 (50%) 1/2 (50%) 0/3 (0%) 0/2 (0%) 8/20 (40%) 8/41 (19.5%) 7/29 (24.1%) 7/26 (26.9%) 1/3 (33.3%) 0/2 (0%) 1/1 (100%)
    Nausea 0/2 (0%) 1/2 (50%) 0/2 (0%) 0/3 (0%) 0/2 (0%) 5/20 (25%) 12/41 (29.3%) 3/29 (10.3%) 4/26 (15.4%) 0/3 (0%) 0/2 (0%) 1/1 (100%)
    Constipation 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/3 (0%) 0/2 (0%) 3/20 (15%) 11/41 (26.8%) 3/29 (10.3%) 0/26 (0%) 1/3 (33.3%) 0/2 (0%) 0/1 (0%)
    Abdominal pain 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/3 (0%) 0/2 (0%) 3/20 (15%) 6/41 (14.6%) 5/29 (17.2%) 0/26 (0%) 0/3 (0%) 0/2 (0%) 1/1 (100%)
    Vomiting 0/2 (0%) 1/2 (50%) 0/2 (0%) 0/3 (0%) 0/2 (0%) 4/20 (20%) 4/41 (9.8%) 1/29 (3.4%) 5/26 (19.2%) 0/3 (0%) 0/2 (0%) 0/1 (0%)
    Stomatitis 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/3 (0%) 0/2 (0%) 2/20 (10%) 2/41 (4.9%) 5/29 (17.2%) 2/26 (7.7%) 0/3 (0%) 0/2 (0%) 0/1 (0%)
    Dyspepsia 1/2 (50%) 0/2 (0%) 0/2 (0%) 0/3 (0%) 0/2 (0%) 3/20 (15%) 1/41 (2.4%) 2/29 (6.9%) 0/26 (0%) 1/3 (33.3%) 0/2 (0%) 0/1 (0%)
    Abdominal distension 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/3 (0%) 0/2 (0%) 3/20 (15%) 1/41 (2.4%) 2/29 (6.9%) 1/26 (3.8%) 0/3 (0%) 0/2 (0%) 0/1 (0%)
    Dysphagia 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/3 (0%) 0/2 (0%) 1/20 (5%) 3/41 (7.3%) 1/29 (3.4%) 2/26 (7.7%) 0/3 (0%) 0/2 (0%) 0/1 (0%)
    Dry mouth 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/3 (0%) 0/2 (0%) 1/20 (5%) 3/41 (7.3%) 0/29 (0%) 0/26 (0%) 0/3 (0%) 0/2 (0%) 0/1 (0%)
    Mouth ulceration 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/3 (0%) 0/2 (0%) 0/20 (0%) 2/41 (4.9%) 0/29 (0%) 2/26 (7.7%) 0/3 (0%) 0/2 (0%) 0/1 (0%)
    Oral pain 0/2 (0%) 1/2 (50%) 0/2 (0%) 0/3 (0%) 0/2 (0%) 1/20 (5%) 1/41 (2.4%) 0/29 (0%) 0/26 (0%) 0/3 (0%) 0/2 (0%) 0/1 (0%)
    Colitis 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/3 (0%) 1/2 (50%) 0/20 (0%) 1/41 (2.4%) 0/29 (0%) 0/26 (0%) 0/3 (0%) 0/2 (0%) 0/1 (0%)
    Flatulence 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/3 (0%) 0/2 (0%) 2/20 (10%) 0/41 (0%) 0/29 (0%) 0/26 (0%) 0/3 (0%) 0/2 (0%) 0/1 (0%)
    Haemorrhoids 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/3 (0%) 0/2 (0%) 2/20 (10%) 0/41 (0%) 0/29 (0%) 0/26 (0%) 0/3 (0%) 0/2 (0%) 0/1 (0%)
    Lip blister 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/3 (0%) 0/2 (0%) 0/20 (0%) 0/41 (0%) 0/29 (0%) 1/26 (3.8%) 1/3 (33.3%) 0/2 (0%) 0/1 (0%)
    Oesophagitis 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/3 (0%) 0/2 (0%) 1/20 (5%) 0/41 (0%) 0/29 (0%) 1/26 (3.8%) 0/3 (0%) 0/2 (0%) 0/1 (0%)
    Cheilitis 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/3 (0%) 0/2 (0%) 1/20 (5%) 0/41 (0%) 0/29 (0%) 0/26 (0%) 0/3 (0%) 0/2 (0%) 0/1 (0%)
    Oral mucosal blistering 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/3 (0%) 0/2 (0%) 0/20 (0%) 0/41 (0%) 0/29 (0%) 0/26 (0%) 1/3 (33.3%) 0/2 (0%) 0/1 (0%)
    General disorders
    Fatigue 0/2 (0%) 1/2 (50%) 0/2 (0%) 1/3 (33.3%) 0/2 (0%) 10/20 (50%) 16/41 (39%) 13/29 (44.8%) 7/26 (26.9%) 1/3 (33.3%) 0/2 (0%) 1/1 (100%)
    Pyrexia 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/3 (0%) 0/2 (0%) 5/20 (25%) 11/41 (26.8%) 8/29 (27.6%) 8/26 (30.8%) 0/3 (0%) 1/2 (50%) 0/1 (0%)
    Oedema peripheral 0/2 (0%) 1/2 (50%) 0/2 (0%) 0/3 (0%) 0/2 (0%) 4/20 (20%) 5/41 (12.2%) 4/29 (13.8%) 5/26 (19.2%) 1/3 (33.3%) 0/2 (0%) 1/1 (100%)
    Face oedema 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/3 (0%) 0/2 (0%) 3/20 (15%) 2/41 (4.9%) 2/29 (6.9%) 2/26 (7.7%) 0/3 (0%) 0/2 (0%) 0/1 (0%)
    Mucosal inflammation 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/3 (0%) 0/2 (0%) 1/20 (5%) 4/41 (9.8%) 1/29 (3.4%) 1/26 (3.8%) 0/3 (0%) 0/2 (0%) 1/1 (100%)
    Chills 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/3 (0%) 0/2 (0%) 1/20 (5%) 2/41 (4.9%) 1/29 (3.4%) 1/26 (3.8%) 0/3 (0%) 0/2 (0%) 1/1 (100%)
    Localised oedema 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/3 (0%) 0/2 (0%) 0/20 (0%) 1/41 (2.4%) 3/29 (10.3%) 1/26 (3.8%) 0/3 (0%) 0/2 (0%) 0/1 (0%)
    Pain 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/3 (0%) 0/2 (0%) 3/20 (15%) 0/41 (0%) 1/29 (3.4%) 0/26 (0%) 0/3 (0%) 0/2 (0%) 0/1 (0%)
    Asthenia 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/3 (0%) 0/2 (0%) 1/20 (5%) 0/41 (0%) 1/29 (3.4%) 0/26 (0%) 0/3 (0%) 0/2 (0%) 1/1 (100%)
    Influenza like illness 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/3 (0%) 0/2 (0%) 2/20 (10%) 1/41 (2.4%) 0/29 (0%) 0/26 (0%) 0/3 (0%) 0/2 (0%) 0/1 (0%)
    Non-cardiac chest pain 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/3 (0%) 0/2 (0%) 1/20 (5%) 1/41 (2.4%) 0/29 (0%) 0/26 (0%) 1/3 (33.3%) 0/2 (0%) 0/1 (0%)
    Chest pain 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/3 (0%) 0/2 (0%) 1/20 (5%) 0/41 (0%) 0/29 (0%) 1/26 (3.8%) 0/3 (0%) 0/2 (0%) 0/1 (0%)
    Gait disturbance 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/3 (0%) 0/2 (0%) 1/20 (5%) 0/41 (0%) 0/29 (0%) 0/26 (0%) 0/3 (0%) 0/2 (0%) 0/1 (0%)
    Inflammation 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/3 (0%) 0/2 (0%) 1/20 (5%) 0/41 (0%) 0/29 (0%) 0/26 (0%) 0/3 (0%) 0/2 (0%) 0/1 (0%)
    Malaise 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/3 (0%) 0/2 (0%) 1/20 (5%) 0/41 (0%) 0/29 (0%) 0/26 (0%) 0/3 (0%) 0/2 (0%) 0/1 (0%)
    Peripheral swelling 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/3 (0%) 0/2 (0%) 1/20 (5%) 0/41 (0%) 0/29 (0%) 0/26 (0%) 0/3 (0%) 0/2 (0%) 0/1 (0%)
    Immune system disorders
    Seasonal allergy 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/3 (0%) 0/2 (0%) 1/20 (5%) 0/41 (0%) 0/29 (0%) 0/26 (0%) 0/3 (0%) 0/2 (0%) 0/1 (0%)
    Infections and infestations
    Upper respiratory tract infection 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/3 (0%) 0/2 (0%) 2/20 (10%) 4/41 (9.8%) 3/29 (10.3%) 1/26 (3.8%) 0/3 (0%) 0/2 (0%) 0/1 (0%)
    Oral candidiasis 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/3 (0%) 0/2 (0%) 0/20 (0%) 1/41 (2.4%) 2/29 (6.9%) 3/26 (11.5%) 0/3 (0%) 0/2 (0%) 0/1 (0%)
    Candida infection 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/3 (0%) 0/2 (0%) 0/20 (0%) 2/41 (4.9%) 0/29 (0%) 1/26 (3.8%) 1/3 (33.3%) 0/2 (0%) 1/1 (100%)
    Sinusitis 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/3 (0%) 0/2 (0%) 1/20 (5%) 2/41 (4.9%) 1/29 (3.4%) 0/26 (0%) 0/3 (0%) 0/2 (0%) 0/1 (0%)
    Urinary tract infection 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/3 (0%) 0/2 (0%) 1/20 (5%) 1/41 (2.4%) 0/29 (0%) 1/26 (3.8%) 0/3 (0%) 0/2 (0%) 1/1 (100%)
    Cellulitis 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/3 (0%) 0/2 (0%) 0/20 (0%) 0/41 (0%) 1/29 (3.4%) 1/26 (3.8%) 1/3 (33.3%) 0/2 (0%) 0/1 (0%)
    Influenza 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/3 (0%) 0/2 (0%) 0/20 (0%) 3/41 (7.3%) 0/29 (0%) 0/26 (0%) 0/3 (0%) 0/2 (0%) 0/1 (0%)
    Oral herpes 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/3 (0%) 0/2 (0%) 0/20 (0%) 2/41 (4.9%) 0/29 (0%) 0/26 (0%) 0/3 (0%) 0/2 (0%) 1/1 (100%)
    Pharyngitis 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/3 (0%) 0/2 (0%) 0/20 (0%) 3/41 (7.3%) 0/29 (0%) 0/26 (0%) 0/3 (0%) 0/2 (0%) 0/1 (0%)
    Pneumonia 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/3 (0%) 0/2 (0%) 1/20 (5%) 1/41 (2.4%) 1/29 (3.4%) 0/26 (0%) 0/3 (0%) 0/2 (0%) 0/1 (0%)
    Skin infection 0/2 (0%) 0/2 (0%) 1/2 (50%) 0/3 (0%) 0/2 (0%) 0/20 (0%) 0/41 (0%) 2/29 (6.9%) 0/26 (0%) 0/3 (0%) 0/2 (0%) 0/1 (0%)
    Clostridium difficile infection 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/3 (0%) 0/2 (0%) 1/20 (5%) 0/41 (0%) 1/29 (3.4%) 0/26 (0%) 0/3 (0%) 0/2 (0%) 0/1 (0%)
    Arthritis infective 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/3 (0%) 0/2 (0%) 1/20 (5%) 0/41 (0%) 0/29 (0%) 0/26 (0%) 0/3 (0%) 0/2 (0%) 0/1 (0%)
    Aspergillus infection 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/3 (0%) 0/2 (0%) 0/20 (0%) 0/41 (0%) 0/29 (0%) 0/26 (0%) 1/3 (33.3%) 0/2 (0%) 0/1 (0%)
    Herpes simplex 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/3 (0%) 0/2 (0%) 1/20 (5%) 0/41 (0%) 0/29 (0%) 0/26 (0%) 0/3 (0%) 0/2 (0%) 0/1 (0%)
    Vaginal infection 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/3 (0%) 0/2 (0%) 1/20 (5%) 0/41 (0%) 0/29 (0%) 0/26 (0%) 0/3 (0%) 0/2 (0%) 0/1 (0%)
    Injury, poisoning and procedural complications
    Fall 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/3 (0%) 0/2 (0%) 2/20 (10%) 0/41 (0%) 2/29 (6.9%) 0/26 (0%) 0/3 (0%) 0/2 (0%) 0/1 (0%)
    Contusion 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/3 (0%) 0/2 (0%) 0/20 (0%) 0/41 (0%) 2/29 (6.9%) 1/26 (3.8%) 0/3 (0%) 0/2 (0%) 0/1 (0%)
    Skin abrasion 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/3 (0%) 0/2 (0%) 2/20 (10%) 0/41 (0%) 1/29 (3.4%) 0/26 (0%) 0/3 (0%) 0/2 (0%) 0/1 (0%)
    Infusion related reaction 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/3 (0%) 0/2 (0%) 1/20 (5%) 1/41 (2.4%) 0/29 (0%) 0/26 (0%) 0/3 (0%) 0/2 (0%) 0/1 (0%)
    Excoriation 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/3 (0%) 0/2 (0%) 1/20 (5%) 0/41 (0%) 0/29 (0%) 0/26 (0%) 0/3 (0%) 0/2 (0%) 0/1 (0%)
    Scratch 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/3 (0%) 0/2 (0%) 1/20 (5%) 0/41 (0%) 0/29 (0%) 0/26 (0%) 0/3 (0%) 0/2 (0%) 0/1 (0%)
    Investigations
    Gamma-glutamyltransferase increased 0/2 (0%) 1/2 (50%) 0/2 (0%) 1/3 (33.3%) 0/2 (0%) 3/20 (15%) 8/41 (19.5%) 8/29 (27.6%) 6/26 (23.1%) 1/3 (33.3%) 1/2 (50%) 1/1 (100%)
    Alanine aminotransferase increased 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/3 (0%) 1/2 (50%) 0/20 (0%) 9/41 (22%) 6/29 (20.7%) 4/26 (15.4%) 1/3 (33.3%) 1/2 (50%) 1/1 (100%)
    Aspartate aminotransferase increased 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/3 (0%) 0/2 (0%) 1/20 (5%) 7/41 (17.1%) 6/29 (20.7%) 6/26 (23.1%) 1/3 (33.3%) 1/2 (50%) 1/1 (100%)
    Blood alkaline phosphatase increased 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/3 (0%) 0/2 (0%) 2/20 (10%) 5/41 (12.2%) 6/29 (20.7%) 5/26 (19.2%) 0/3 (0%) 0/2 (0%) 1/1 (100%)
    Platelet count decreased 0/2 (0%) 0/2 (0%) 0/2 (0%) 2/3 (66.7%) 0/2 (0%) 1/20 (5%) 2/41 (4.9%) 4/29 (13.8%) 8/26 (30.8%) 1/3 (33.3%) 0/2 (0%) 0/1 (0%)
    Lipase increased 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/3 (0%) 1/2 (50%) 3/20 (15%) 6/41 (14.6%) 1/29 (3.4%) 0/26 (0%) 0/3 (0%) 0/2 (0%) 0/1 (0%)
    Weight decreased 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/3 (0%) 0/2 (0%) 0/20 (0%) 5/41 (12.2%) 5/29 (17.2%) 1/26 (3.8%) 0/3 (0%) 0/2 (0%) 0/1 (0%)
    Neutrophil count decreased 0/2 (0%) 0/2 (0%) 0/2 (0%) 1/3 (33.3%) 0/2 (0%) 2/20 (10%) 1/41 (2.4%) 1/29 (3.4%) 5/26 (19.2%) 0/3 (0%) 0/2 (0%) 0/1 (0%)
    Blood creatinine increased 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/3 (0%) 0/2 (0%) 2/20 (10%) 2/41 (4.9%) 3/29 (10.3%) 2/26 (7.7%) 0/3 (0%) 0/2 (0%) 0/1 (0%)
    Haemoglobin decreased 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/3 (0%) 0/2 (0%) 0/20 (0%) 2/41 (4.9%) 2/29 (6.9%) 3/26 (11.5%) 1/3 (33.3%) 0/2 (0%) 0/1 (0%)
    Blood creatine phosphokinase increased 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/3 (0%) 0/2 (0%) 2/20 (10%) 3/41 (7.3%) 0/29 (0%) 0/26 (0%) 1/3 (33.3%) 0/2 (0%) 0/1 (0%)
    White blood cell count decreased 0/2 (0%) 0/2 (0%) 0/2 (0%) 1/3 (33.3%) 0/2 (0%) 2/20 (10%) 1/41 (2.4%) 1/29 (3.4%) 1/26 (3.8%) 0/3 (0%) 0/2 (0%) 0/1 (0%)
    Amylase increased 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/3 (0%) 0/2 (0%) 2/20 (10%) 3/41 (7.3%) 0/29 (0%) 0/26 (0%) 0/3 (0%) 0/2 (0%) 0/1 (0%)
    Electrocardiogram QT prolonged 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/3 (0%) 0/2 (0%) 0/20 (0%) 1/41 (2.4%) 2/29 (6.9%) 2/26 (7.7%) 0/3 (0%) 0/2 (0%) 0/1 (0%)
    Blood albumin decreased 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/3 (0%) 0/2 (0%) 0/20 (0%) 1/41 (2.4%) 1/29 (3.4%) 1/26 (3.8%) 1/3 (33.3%) 0/2 (0%) 0/1 (0%)
    Weight increased 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/3 (0%) 0/2 (0%) 0/20 (0%) 1/41 (2.4%) 2/29 (6.9%) 1/26 (3.8%) 0/3 (0%) 0/2 (0%) 0/1 (0%)
    Lymphocyte count decreased 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/3 (0%) 0/2 (0%) 0/20 (0%) 1/41 (2.4%) 0/29 (0%) 2/26 (7.7%) 0/3 (0%) 0/2 (0%) 0/1 (0%)
    Blood uric acid increased 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/3 (0%) 0/2 (0%) 1/20 (5%) 1/41 (2.4%) 0/29 (0%) 0/26 (0%) 0/3 (0%) 0/2 (0%) 0/1 (0%)
    Metabolism and nutrition disorders
    Decreased appetite 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/3 (0%) 0/2 (0%) 4/20 (20%) 8/41 (19.5%) 6/29 (20.7%) 2/26 (7.7%) 1/3 (33.3%) 1/2 (50%) 1/1 (100%)
    Dehydration 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/3 (0%) 0/2 (0%) 2/20 (10%) 4/41 (9.8%) 0/29 (0%) 2/26 (7.7%) 1/3 (33.3%) 0/2 (0%) 1/1 (100%)
    Hyponatraemia 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/3 (0%) 0/2 (0%) 1/20 (5%) 2/41 (4.9%) 2/29 (6.9%) 3/26 (11.5%) 0/3 (0%) 0/2 (0%) 0/1 (0%)
    Hyperglycaemia 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/3 (0%) 0/2 (0%) 0/20 (0%) 4/41 (9.8%) 1/29 (3.4%) 2/26 (7.7%) 0/3 (0%) 0/2 (0%) 0/1 (0%)
    Hypertriglyceridaemia 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/3 (0%) 0/2 (0%) 1/20 (5%) 4/41 (9.8%) 0/29 (0%) 1/26 (3.8%) 0/3 (0%) 0/2 (0%) 0/1 (0%)
    Hypokalaemia 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/3 (0%) 1/2 (50%) 0/20 (0%) 2/41 (4.9%) 2/29 (6.9%) 1/26 (3.8%) 0/3 (0%) 0/2 (0%) 0/1 (0%)
    Hypophosphataemia 0/2 (0%) 0/2 (0%) 0/2 (0%) 2/3 (66.7%) 0/2 (0%) 1/20 (5%) 1/41 (2.4%) 1/29 (3.4%) 0/26 (0%) 0/3 (0%) 0/2 (0%) 0/1 (0%)
    Hypoalbuminaemia 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/3 (0%) 1/2 (50%) 0/20 (0%) 0/41 (0%) 2/29 (6.9%) 0/26 (0%) 0/3 (0%) 0/2 (0%) 0/1 (0%)
    Hypocalcaemia 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/3 (0%) 1/2 (50%) 0/20 (0%) 0/41 (0%) 2/29 (6.9%) 0/26 (0%) 0/3 (0%) 0/2 (0%) 0/1 (0%)
    Hypomagnesaemia 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/3 (0%) 0/2 (0%) 1/20 (5%) 1/41 (2.4%) 0/29 (0%) 0/26 (0%) 0/3 (0%) 0/2 (0%) 0/1 (0%)
    Vitamin D deficiency 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/3 (0%) 0/2 (0%) 1/20 (5%) 0/41 (0%) 0/29 (0%) 1/26 (3.8%) 0/3 (0%) 0/2 (0%) 0/1 (0%)
    Hyperkalaemia 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/3 (0%) 0/2 (0%) 0/20 (0%) 0/41 (0%) 0/29 (0%) 0/26 (0%) 1/3 (33.3%) 0/2 (0%) 0/1 (0%)
    Hypermagnesaemia 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/3 (0%) 0/2 (0%) 1/20 (5%) 0/41 (0%) 0/29 (0%) 0/26 (0%) 0/3 (0%) 0/2 (0%) 0/1 (0%)
    Lactic acidosis 0/2 (0%) 0/2 (0%) 0/2 (0%) 1/3 (33.3%) 0/2 (0%) 0/20 (0%) 0/41 (0%) 0/29 (0%) 0/26 (0%) 0/3 (0%) 0/2 (0%) 0/1 (0%)
    Musculoskeletal and connective tissue disorders
    Back pain 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/3 (0%) 0/2 (0%) 2/20 (10%) 7/41 (17.1%) 2/29 (6.9%) 5/26 (19.2%) 0/3 (0%) 0/2 (0%) 0/1 (0%)
    Arthralgia 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/3 (0%) 1/2 (50%) 3/20 (15%) 2/41 (4.9%) 1/29 (3.4%) 5/26 (19.2%) 0/3 (0%) 1/2 (50%) 0/1 (0%)
    Myalgia 0/2 (0%) 1/2 (50%) 0/2 (0%) 0/3 (0%) 0/2 (0%) 2/20 (10%) 4/41 (9.8%) 2/29 (6.9%) 0/26 (0%) 1/3 (33.3%) 0/2 (0%) 0/1 (0%)
    Pain in extremity 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/3 (0%) 0/2 (0%) 3/20 (15%) 1/41 (2.4%) 1/29 (3.4%) 5/26 (19.2%) 0/3 (0%) 0/2 (0%) 0/1 (0%)
    Muscle spasms 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/3 (0%) 0/2 (0%) 4/20 (20%) 1/41 (2.4%) 0/29 (0%) 0/26 (0%) 0/3 (0%) 0/2 (0%) 0/1 (0%)
    Muscular weakness 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/3 (0%) 0/2 (0%) 1/20 (5%) 0/41 (0%) 3/29 (10.3%) 1/26 (3.8%) 0/3 (0%) 0/2 (0%) 0/1 (0%)
    Neck pain 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/3 (0%) 0/2 (0%) 1/20 (5%) 3/41 (7.3%) 0/29 (0%) 1/26 (3.8%) 0/3 (0%) 0/2 (0%) 0/1 (0%)
    Flank pain 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/3 (0%) 0/2 (0%) 1/20 (5%) 1/41 (2.4%) 2/29 (6.9%) 0/26 (0%) 0/3 (0%) 0/2 (0%) 0/1 (0%)
    Groin pain 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/3 (0%) 0/2 (0%) 2/20 (10%) 0/41 (0%) 0/29 (0%) 0/26 (0%) 0/3 (0%) 0/2 (0%) 0/1 (0%)
    Myositis 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/3 (0%) 0/2 (0%) 0/20 (0%) 1/41 (2.4%) 0/29 (0%) 0/26 (0%) 1/3 (33.3%) 0/2 (0%) 0/1 (0%)
    Joint swelling 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/3 (0%) 0/2 (0%) 0/20 (0%) 0/41 (0%) 0/29 (0%) 0/26 (0%) 1/3 (33.3%) 0/2 (0%) 0/1 (0%)
    Nervous system disorders
    Headache 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/3 (0%) 0/2 (0%) 5/20 (25%) 4/41 (9.8%) 2/29 (6.9%) 4/26 (15.4%) 0/3 (0%) 0/2 (0%) 0/1 (0%)
    Dizziness 0/2 (0%) 1/2 (50%) 0/2 (0%) 0/3 (0%) 0/2 (0%) 3/20 (15%) 2/41 (4.9%) 3/29 (10.3%) 2/26 (7.7%) 1/3 (33.3%) 0/2 (0%) 1/1 (100%)
    Dysgeusia 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/3 (0%) 0/2 (0%) 4/20 (20%) 1/41 (2.4%) 4/29 (13.8%) 0/26 (0%) 0/3 (0%) 0/2 (0%) 0/1 (0%)
    Peripheral sensory neuropathy 0/2 (0%) 1/2 (50%) 0/2 (0%) 0/3 (0%) 0/2 (0%) 1/20 (5%) 5/41 (12.2%) 0/29 (0%) 1/26 (3.8%) 0/3 (0%) 0/2 (0%) 0/1 (0%)
    Paraesthesia 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/3 (0%) 0/2 (0%) 0/20 (0%) 1/41 (2.4%) 0/29 (0%) 1/26 (3.8%) 1/3 (33.3%) 0/2 (0%) 0/1 (0%)
    Amnesia 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/3 (0%) 0/2 (0%) 1/20 (5%) 0/41 (0%) 0/29 (0%) 0/26 (0%) 0/3 (0%) 0/2 (0%) 0/1 (0%)
    Hypoaesthesia 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/3 (0%) 0/2 (0%) 1/20 (5%) 0/41 (0%) 0/29 (0%) 0/26 (0%) 0/3 (0%) 0/2 (0%) 0/1 (0%)
    Sinus headache 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/3 (0%) 0/2 (0%) 1/20 (5%) 0/41 (0%) 0/29 (0%) 0/26 (0%) 0/3 (0%) 0/2 (0%) 0/1 (0%)
    Psychiatric disorders
    Insomnia 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/3 (0%) 0/2 (0%) 2/20 (10%) 3/41 (7.3%) 3/29 (10.3%) 2/26 (7.7%) 0/3 (0%) 0/2 (0%) 0/1 (0%)
    Anxiety 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/3 (0%) 0/2 (0%) 1/20 (5%) 2/41 (4.9%) 1/29 (3.4%) 0/26 (0%) 0/3 (0%) 0/2 (0%) 0/1 (0%)
    Agitation 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/3 (0%) 0/2 (0%) 1/20 (5%) 0/41 (0%) 1/29 (3.4%) 0/26 (0%) 0/3 (0%) 0/2 (0%) 0/1 (0%)
    Confusional state 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/3 (0%) 0/2 (0%) 0/20 (0%) 0/41 (0%) 0/29 (0%) 0/26 (0%) 0/3 (0%) 0/2 (0%) 1/1 (100%)
    Mood altered 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/3 (0%) 0/2 (0%) 0/20 (0%) 0/41 (0%) 0/29 (0%) 0/26 (0%) 1/3 (33.3%) 0/2 (0%) 0/1 (0%)
    Mood swings 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/3 (0%) 0/2 (0%) 1/20 (5%) 0/41 (0%) 0/29 (0%) 0/26 (0%) 0/3 (0%) 0/2 (0%) 0/1 (0%)
    Renal and urinary disorders
    Acute kidney injury 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/3 (0%) 0/2 (0%) 0/20 (0%) 0/41 (0%) 2/29 (6.9%) 0/26 (0%) 0/3 (0%) 0/2 (0%) 0/1 (0%)
    Reproductive system and breast disorders
    Vulvovaginal pain 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/3 (0%) 0/2 (0%) 1/20 (5%) 1/41 (2.4%) 0/29 (0%) 0/26 (0%) 0/3 (0%) 0/2 (0%) 0/1 (0%)
    Erectile dysfunction 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/3 (0%) 0/2 (0%) 1/20 (5%) 0/41 (0%) 0/29 (0%) 0/26 (0%) 0/3 (0%) 0/2 (0%) 0/1 (0%)
    Pelvic pain 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/3 (0%) 0/2 (0%) 1/20 (5%) 0/41 (0%) 0/29 (0%) 0/26 (0%) 0/3 (0%) 0/2 (0%) 0/1 (0%)
    Vaginal inflammation 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/3 (0%) 0/2 (0%) 1/20 (5%) 0/41 (0%) 0/29 (0%) 0/26 (0%) 0/3 (0%) 0/2 (0%) 0/1 (0%)
    Respiratory, thoracic and mediastinal disorders
    Cough 1/2 (50%) 0/2 (0%) 0/2 (0%) 1/3 (33.3%) 0/2 (0%) 5/20 (25%) 9/41 (22%) 6/29 (20.7%) 7/26 (26.9%) 0/3 (0%) 0/2 (0%) 0/1 (0%)
    Dyspnoea 0/2 (0%) 1/2 (50%) 0/2 (0%) 0/3 (0%) 0/2 (0%) 2/20 (10%) 7/41 (17.1%) 6/29 (20.7%) 4/26 (15.4%) 0/3 (0%) 0/2 (0%) 0/1 (0%)
    Pleural effusion 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/3 (0%) 0/2 (0%) 2/20 (10%) 1/41 (2.4%) 4/29 (13.8%) 3/26 (11.5%) 1/3 (33.3%) 0/2 (0%) 0/1 (0%)
    Nasal congestion 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/3 (0%) 0/2 (0%) 3/20 (15%) 0/41 (0%) 1/29 (3.4%) 3/26 (11.5%) 0/3 (0%) 0/2 (0%) 0/1 (0%)
    Oropharyngeal pain 0/2 (0%) 1/2 (50%) 0/2 (0%) 0/3 (0%) 0/2 (0%) 0/20 (0%) 4/41 (9.8%) 1/29 (3.4%) 1/26 (3.8%) 0/3 (0%) 0/2 (0%) 0/1 (0%)
    Dysphonia 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/3 (0%) 0/2 (0%) 0/20 (0%) 1/41 (2.4%) 2/29 (6.9%) 1/26 (3.8%) 0/3 (0%) 0/2 (0%) 0/1 (0%)
    Wheezing 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/3 (0%) 0/2 (0%) 1/20 (5%) 1/41 (2.4%) 2/29 (6.9%) 0/26 (0%) 0/3 (0%) 0/2 (0%) 0/1 (0%)
    Dyspnoea exertional 0/2 (0%) 1/2 (50%) 0/2 (0%) 0/3 (0%) 0/2 (0%) 1/20 (5%) 0/41 (0%) 0/29 (0%) 1/26 (3.8%) 0/3 (0%) 0/2 (0%) 0/1 (0%)
    Pneumonitis 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/3 (0%) 0/2 (0%) 1/20 (5%) 0/41 (0%) 2/29 (6.9%) 0/26 (0%) 0/3 (0%) 0/2 (0%) 0/1 (0%)
    Upper-airway cough syndrome 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/3 (0%) 0/2 (0%) 2/20 (10%) 0/41 (0%) 0/29 (0%) 1/26 (3.8%) 0/3 (0%) 0/2 (0%) 0/1 (0%)
    Acute respiratory distress syndrome 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/3 (0%) 0/2 (0%) 0/20 (0%) 0/41 (0%) 1/29 (3.4%) 0/26 (0%) 1/3 (33.3%) 0/2 (0%) 0/1 (0%)
    Rhinitis allergic 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/3 (0%) 0/2 (0%) 0/20 (0%) 0/41 (0%) 0/29 (0%) 0/26 (0%) 0/3 (0%) 1/2 (50%) 0/1 (0%)
    Skin and subcutaneous tissue disorders
    Rash maculo-papular 0/2 (0%) 0/2 (0%) 1/2 (50%) 1/3 (33.3%) 0/2 (0%) 7/20 (35%) 16/41 (39%) 9/29 (31%) 4/26 (15.4%) 0/3 (0%) 0/2 (0%) 0/1 (0%)
    Rash 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/3 (0%) 1/2 (50%) 4/20 (20%) 9/41 (22%) 4/29 (13.8%) 4/26 (15.4%) 0/3 (0%) 0/2 (0%) 1/1 (100%)
    Pruritus 0/2 (0%) 0/2 (0%) 0/2 (0%) 1/3 (33.3%) 1/2 (50%) 7/20 (35%) 5/41 (12.2%) 5/29 (17.2%) 1/26 (3.8%) 0/3 (0%) 0/2 (0%) 0/1 (0%)
    Erythema 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/3 (0%) 0/2 (0%) 1/20 (5%) 2/41 (4.9%) 5/29 (17.2%) 5/26 (19.2%) 2/3 (66.7%) 0/2 (0%) 1/1 (100%)
    Photosensitivity reaction 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/3 (0%) 0/2 (0%) 1/20 (5%) 2/41 (4.9%) 4/29 (13.8%) 4/26 (15.4%) 1/3 (33.3%) 1/2 (50%) 0/1 (0%)
    Dry skin 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/3 (0%) 0/2 (0%) 2/20 (10%) 1/41 (2.4%) 2/29 (6.9%) 2/26 (7.7%) 1/3 (33.3%) 0/2 (0%) 0/1 (0%)
    Rash erythematous 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/3 (0%) 0/2 (0%) 1/20 (5%) 2/41 (4.9%) 1/29 (3.4%) 0/26 (0%) 1/3 (33.3%) 0/2 (0%) 1/1 (100%)
    Dermatitis acneiform 0/2 (0%) 0/2 (0%) 0/2 (0%) 1/3 (33.3%) 1/2 (50%) 0/20 (0%) 1/41 (2.4%) 0/29 (0%) 1/26 (3.8%) 0/3 (0%) 0/2 (0%) 1/1 (100%)
    Blister 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/3 (0%) 0/2 (0%) 0/20 (0%) 0/41 (0%) 0/29 (0%) 2/26 (7.7%) 1/3 (33.3%) 0/2 (0%) 1/1 (100%)
    Rash generalised 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/3 (0%) 0/2 (0%) 0/20 (0%) 3/41 (7.3%) 0/29 (0%) 1/26 (3.8%) 0/3 (0%) 0/2 (0%) 0/1 (0%)
    Rash papular 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/3 (0%) 0/2 (0%) 0/20 (0%) 1/41 (2.4%) 1/29 (3.4%) 2/26 (7.7%) 0/3 (0%) 0/2 (0%) 0/1 (0%)
    Hyperhidrosis 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/3 (0%) 0/2 (0%) 0/20 (0%) 1/41 (2.4%) 2/29 (6.9%) 0/26 (0%) 0/3 (0%) 0/2 (0%) 0/1 (0%)
    Night sweats 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/3 (0%) 1/2 (50%) 1/20 (5%) 1/41 (2.4%) 0/29 (0%) 0/26 (0%) 0/3 (0%) 0/2 (0%) 0/1 (0%)
    Pain of skin 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/3 (0%) 0/2 (0%) 1/20 (5%) 0/41 (0%) 1/29 (3.4%) 1/26 (3.8%) 0/3 (0%) 0/2 (0%) 0/1 (0%)
    Skin mass 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/3 (0%) 0/2 (0%) 1/20 (5%) 0/41 (0%) 1/29 (3.4%) 1/26 (3.8%) 0/3 (0%) 0/2 (0%) 0/1 (0%)
    Skin ulcer 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/3 (0%) 0/2 (0%) 0/20 (0%) 0/41 (0%) 0/29 (0%) 2/26 (7.7%) 1/3 (33.3%) 0/2 (0%) 0/1 (0%)
    Swelling face 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/3 (0%) 0/2 (0%) 1/20 (5%) 0/41 (0%) 2/29 (6.9%) 0/26 (0%) 0/3 (0%) 0/2 (0%) 0/1 (0%)
    Dermatitis bullous 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/3 (0%) 0/2 (0%) 1/20 (5%) 0/41 (0%) 0/29 (0%) 1/26 (3.8%) 0/3 (0%) 0/2 (0%) 0/1 (0%)
    Erythema multiforme 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/3 (0%) 0/2 (0%) 1/20 (5%) 0/41 (0%) 0/29 (0%) 1/26 (3.8%) 0/3 (0%) 0/2 (0%) 0/1 (0%)
    Skin hyperpigmentation 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/3 (0%) 0/2 (0%) 0/20 (0%) 0/41 (0%) 0/29 (0%) 2/26 (7.7%) 0/3 (0%) 0/2 (0%) 0/1 (0%)
    Dermal cyst 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/3 (0%) 0/2 (0%) 1/20 (5%) 0/41 (0%) 0/29 (0%) 0/26 (0%) 0/3 (0%) 0/2 (0%) 0/1 (0%)
    Skin discolouration 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/3 (0%) 0/2 (0%) 1/20 (5%) 0/41 (0%) 0/29 (0%) 0/26 (0%) 0/3 (0%) 0/2 (0%) 0/1 (0%)
    Vascular disorders
    Hypertension 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/3 (0%) 0/2 (0%) 2/20 (10%) 1/41 (2.4%) 1/29 (3.4%) 0/26 (0%) 0/3 (0%) 0/2 (0%) 1/1 (100%)
    Hypotension 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/3 (0%) 0/2 (0%) 0/20 (0%) 1/41 (2.4%) 2/29 (6.9%) 2/26 (7.7%) 0/3 (0%) 0/2 (0%) 0/1 (0%)
    Flushing 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/3 (0%) 0/2 (0%) 2/20 (10%) 1/41 (2.4%) 0/29 (0%) 0/26 (0%) 0/3 (0%) 0/2 (0%) 0/1 (0%)
    Deep vein thrombosis 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/3 (0%) 0/2 (0%) 1/20 (5%) 0/41 (0%) 0/29 (0%) 1/26 (3.8%) 0/3 (0%) 0/2 (0%) 0/1 (0%)
    Hot flush 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/3 (0%) 0/2 (0%) 1/20 (5%) 1/41 (2.4%) 0/29 (0%) 0/26 (0%) 0/3 (0%) 0/2 (0%) 0/1 (0%)
    Thrombosis 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/3 (0%) 0/2 (0%) 1/20 (5%) 0/41 (0%) 0/29 (0%) 0/26 (0%) 0/3 (0%) 0/2 (0%) 0/1 (0%)

    Limitations/Caveats

    [Not Specified]

    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 PI is sponsor can review results comms. prior to public release and can embargo comms. regarding trial results for a period >60 but ≤180 days from time submitted to sponsor review. Sponsor can't require changes to the comms, extend embargo or require changes to comms, except removing confidential info that are not results

    Results Point of Contact

    Name/Title Clinical Trials Information
    Organization ADC Therapeutics SA
    Phone 954-903-7994 ext 954
    Email clinical.trials@adctherapeutics.com
    Responsible Party:
    ADC Therapeutics S.A.
    ClinicalTrials.gov Identifier:
    NCT02432235
    Other Study ID Numbers:
    • ADCT-301-001
    • 2015-005272-25
    • 199948
    First Posted:
    May 4, 2015
    Last Update Posted:
    Jul 13, 2021
    Last Verified:
    Jul 1, 2021