Study of ADCT-301 in Patients With Relapsed or Refractory... | NCT02432235 | Trialant
NCT02432235
Sponsor
ADC Therapeutics S.A.
Status
Completed
Last Update Posted
Jul 13, 2021Actual
Enrollment
133Actual
Phase
Phase 1
Conditions
Hodgkin Lymphoma
Non-Hodgkin Lymphoma
Interventions
Camidanlumab tesirine
Countries
United States
United Kingdom
Protocol Section
Identification Module
NCT ID
NCT02432235
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
ADCT-301-001
Secondary IDs
ID
Type
Description
Link
2015-005272-25
EudraCT Number
199948
Registry Identifier
HRA
Brief Title
Study of ADCT-301 in Patients With Relapsed or Refractory Hodgkin and Non-Hodgkin Lymphoma
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
Acronym
Not provided
Organization
ADC Therapeutics S.A.INDUSTRY
Status Module
Record Verification Date
Jul 2021
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Oct 5, 2015Actual
Primary Completion Date
Oct 24, 2019Actual
Completion Date
Oct 24, 2019Actual
First Submitted Date
Feb 26, 2015
First Submission Date that Met QC Criteria
Apr 28, 2015
First Posted Date
May 4, 2015Estimated
Results Waived
Not provided
Results First Submitted Date
May 12, 2021
Results First Submitted that Met QC Criteria
Jul 12, 2021
Results First Posted Date
Jul 13, 2021Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Jul 12, 2021
Last Update Posted Date
Jul 13, 2021Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
ADC Therapeutics S.A.INDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
No
Is FDA Regulated Drug
Not provided
Is FDA Regulated Device
Not provided
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
This study evaluates camidanlumab tesirine in participants with relapsed/refractory Non-Hodgkin or Hodgkin lymphoma.
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).
Conditions Module
Conditions
Hodgkin Lymphoma
Non-Hodgkin Lymphoma
Keywords
Camidanlumab tesirine
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 1
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
133Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
3 μg/kg
Experimental
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
5 μg/kg
Experimental
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
8 μg/kg
Experimental
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
13 μg/kg
Experimental
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
20 μg/kg
Experimental
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.
Interventions
Name
Type
Description
Arm Group Labels
Other Names
Camidanlumab tesirine
Drug
Intravenous (IV) infusion.
100 μg/kg
13 μg/kg
150 μg/kg
20 μg/kg
3 μg/kg
30 μg/kg
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Number of Participants Who Experienced Dose-Limiting Toxicities (DLTs)
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
Cycle 1 Day 1 to end of Cycle 1 or 2 (21 day cycle length)
Recommended Dose of Camidanlumab Tesirine for Part 2
The recommended dose was established by the dose escalation steering committee and based on safety findings during Part 1 of the study.
Cycle 1 Day 1 to end of Cycle 1 or 2 (21 day cycle length)
Number of Participants Reporting at Least One Treatment Emergent Adverse Event (TEAE)
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.
Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
Number of Participants Reporting at Least One Treatment Emergent Serious Adverse Event (SAE)
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 Outcomes
Measure
Description
Time Frame
Overall Response Rate (ORR)
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).
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).
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Male or female age 18 years or older.
Refractory or relapsed lymphoma (per World Health Organization (WHO) Classification system)
Pathologically confirmed relapsed or refractory lymphoma
Availability of formalin-fixed paraffin-embedded (FFPE) tumor tissue block.
Measurable disease, defined by the 2014 Lugano Classification Criteria and Global Response Score Grading Scales for cutaneous T-cell lymphoma (CTCL)
Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2.
Absolute neutrophil count ≥1500/µL. Criterion not applicable to adult T cell leukemia/lymphoma (ATLL) patients.
Platelet count of ≥75000/µL. Criterion not applicable to ATLL patients.
Hemoglobin ≥9.0 g/dL without transfusion within the 2 weeks prior to Day 1.
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
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.
Total serum/plasma bilirubin ≤1.5 times ULN (participants with known Gilbert's syndrome may have a total bilirubin up to ≤3 times ULN)
Women of childbearing potential must have a negative serum beta-human chorionic gonadotropin pregnancy test within 7 days prior to Day 1.
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:
Participants who have an option for any treatment with proven clinical benefit for their lymphoid malignancy at current state of disease.
Active graft-versus-host disease.
Autologous or allogenic transplant within the 60 days prior to Cycle 1 Day 1 (C1D1)
Evidence of myelodysplasia or myeloid leukemia by morphology, immunostains, flow cytometry, or cytogenetics on a bone marrow aspirate or biopsy.
Known history of positive serum human anti-drug antibody (ADA) or known allergy to any component of ADCT-301.
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).
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.
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.
History of Steven's Johnson's syndrome or toxic epidermal necrolysis syndrome.
Pregnant or breastfeeding women.
Significant medical comorbidities, including uncontrolled hypertension (diastolic blood pressure > 115 mm Hg), unstable angina, congestive heart failure (greater than New York Heart Association class II), severe uncontrolled ventricular arrhythmias, 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.
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.
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.
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.
Congenital long QT syndrome or a corrected QT interval (QTc)≥ 450 ms at screening (unless secondary to pacemaker or bundle branch block).
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.
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.
Accepts Healthy Volunteers
No
Sex
All
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
18 Years
Maximum Age
Not provided
Standard Ages
AdultOlder Adult
Study Population
Not provided
Sampling Method
Not provided
Contacts/Locations Module
Central Contacts
Not provided
Overall Officials
Name
Affiliation
Role
Jens Wuerthner, MD, PhD
ADC Therapeutics
Study Director
Locations
Facility
Status
City
State
ZIP
Country
Contacts
City of Hope (City of Hope National Medical Center, City of Hope Medical Center)
Toukam M, Wuerthner J, Havenith K, Hamadani M, Caimi PF, Kopotsha T, Cruz HG, Boni JP. Population pharmacokinetics analysis of camidanlumab tesirine in patients with relapsed or refractory Hodgkin lymphoma and non-Hodgkin lymphoma. Cancer Chemother Pharmacol. 2023 Jan;91(1):13-24. doi: 10.1007/s00280-022-04486-4. Epub 2022 Nov 4.
Participants were included in a screening period of up to 28 days.
Recruitment Details
There were 12 sites that screened and enrolled participants: USA: 7 sites; UK: 5 sites.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
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.
Camidanlumab tesirine: Intravenous (IV) infusion.
FG001
5 μg/kg
Periods
Title
Milestones
Reasons Not Completed
Overall Study
Type
Comment
Milestone Data
STARTED
Baseline Characteristics Module
Baseline Analysis Population Description
Not provided
Outcome Measures Module
Outcome Measures
Adverse Events Module
Frequency Threshold
5
More Info Module
Limitations and Caveats
Not provided
Annotation Section
No data available
No data is available for this block.
Document Section
Large Document Module
Document Has No Statistical Analysis Plan (SAP)
Not provided
Uploaded Document Information
Type
Includes Protocol
Includes SAP
Includes ICF
Document Label
Document Date
Document Uploaded Date
Document File Name
Prot
Yes
No
No
Study Protocol
Jan 4, 2019
Apr 14, 2021
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Not provided
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
MeSH Terms
Intervention Browse Module
MeSH Terms
Non-Randomized
Intervention Model
Sequential Assignment
Intervention Model Description
Not provided
Primary Purpose
Treatment
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
None (Open Label)
Masking Description
Not provided
Who Masked
Not provided
Drug: Camidanlumab tesirine
30 μg/kg
Experimental
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
45 μg/kg
Experimental
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
60 μg/kg
Experimental
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
80 μg/kg
Experimental
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
100 μg/kg
Experimental
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
150 μg/kg
Experimental
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
300 μg/kg
Experimental
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
300 μg/kg
45 μg/kg
5 μg/kg
60 μg/kg
8 μg/kg
80 μg/kg
ADCT-301
Cami
Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
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])
Duration of Response (DoR)
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.
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)
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
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)
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.
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])
Maximum Observed Serum Concentration (Cmax) for Camidanlumab Tesirine
Cmax for HuMax-TAC, pyrrolobenzodiazepine (PBD) conjugated HuMax-TAC, and free warhead (SG3199).
Pre-dose on Day 1 and 1 to 336 hours post-dose of Cycles 1 and 2 (21 day cycle length)
Time to Reach the Maximum Serum Concentration (Tmax) for Camidanlumab Tesirine
Tmax for HuMax-TAC, PBD-conjugated HuMax-TAC, and free warhead (SG3199).
Pre-dose on Day 1 and 1 to 336 hours post-dose of Cycles 1 and 2 (21 day cycle length)
Area Under the Serum Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration (AUC0-last) for Camidanlumab Tesirine
AUC0-last for HuMax-TAC, PBD-conjugated HuMax-TAC, and free warhead (SG3199).
Pre-dose on Day 1 and 1 to 336 hours post-dose of Cycles 1 and 2 (21 day cycle length)
Area Under the Serum Concentration-time Curve From Time 0 to the End of the Dosing Interval (AUC0-t) for Camidanlumab Tesirine
AUC0-tau for HuMax-TAC, PBD-conjugated HuMax-TAC, and free warhead (SG3199) for Cycle 2 only.
Pre-dose on Day 1 and 1 to 336 hours post-dose of Cycle 2 (21 day cycle length)
Area Under the Serum Concentration-time Curve From Time 0 to Infinity (AUC∞) for Camidanlumab Tesirine
AUC∞ HuMax-TAC and PBD-conjugated HuMax-TAC for Cycle 1 only.
Pre-dose on Day 1 and 1 to 336 hours post-dose of Cycle 1 (21 day cycle length)
Accumulation Index (AI) for Camidanlumab Tesirine
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.
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 Camidanlumab Tesirine
Volume of distribution for HuMax-TAC, PBD-conjugated HuMax-TAC, and free warhead (SG3199).
Pre-dose on Day 1 and 1 to 336 hours post-dose of Cycles 1 and 2 (21 day cycle length)
Apparent Terminal Half-life (T1/2) of Camidanlumab Tesirine
T1/2 of HuMax-TAC, PBD-conjugated HuMax-TAC, and free warhead (SG3199).
Pre-dose on Day 1 and 1 to 336 hours post-dose of Cycles 1 and 2 (21 day cycle length)
Clearance of Camidanlumab Tesirine
Clearance of HuMax-TAC, PBD-conjugated HuMax-TAC, and free warhead (SG3199).
Pre-dose on Day 1 and 1 to 336 hours post-dose of Cycles 1 and 2 (21 day cycle length)
Number of Participants With Anti-drug Antibody Response (ADA) Against Camidanlumab Tesirine
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.
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])
Memorial Sloan-Kettering Cancer Center
New York
New York
10065
United States
University Hospitals Cleveland Medical Center
Cleveland
Ohio
44106
United States
The University of Texas/MD Anderson Cancer Center
Houston
Texas
77030-4009
United States
Cancer Therapy and Research Center at The University of Texas Health Science Center at San Antonio
San Antonio
Texas
78229
United States
Virginia Cancer Specialists, PC
Fairfax
Virginia
22031
United States
Froedtert Hospital/Medical College of Wisconsin
Milwaukee
Wisconsin
53226
United States
Guy's and St. Thomas' Hospital NHS Trust
London
England
SE1 9RT
United Kingdom
The Newcastle Upon Tyne Hospitals NHS Foundation Trust
Newcastle upon Tyne
England
United Kingdom
Churchill Hospital, Oxford University Hospitals NHS Foundation Trust
Oxford
England
OX3 7LE
United Kingdom
The Christie NHS Foundation Trust
Manchester
Greater Manchester
M20 4BX
United Kingdom
Southampton General Hospital, University Hospital Southampton NHS Foundation Trust
Southampton
Hampshire
United Kingdom
Derived
Toukam M, Boni JP, Hamadani M, Caimi PF, Cruz HG, Wuerthner J. Exposure-response analysis of Camidanlumab tesirine in patients with relapsed or refractory classical Hodgkin lymphoma and non-Hodgkin lymphoma. Cancer Chemother Pharmacol. 2023 Jan;91(1):1-12. doi: 10.1007/s00280-022-04487-3. Epub 2022 Nov 4.
Hamadani M, Collins GP, Caimi PF, Samaniego F, Spira A, Davies A, Radford J, Menne T, Karnad A, Zain JM, Fields P, Havenith K, Cruz HG, He S, Boni J, Feingold J, Wuerthner J, Horwitz S. Camidanlumab tesirine in patients with relapsed or refractory lymphoma: a phase 1, open-label, multicentre, dose-escalation, dose-expansion study. Lancet Haematol. 2021 Jun;8(6):e433-e445. doi: 10.1016/S2352-3026(21)00103-4.
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.
FG002
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.
Camidanlumab tesirine: Intravenous (IV) infusion.
FG003
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.
Camidanlumab tesirine: Intravenous (IV) infusion.
FG004
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.
Camidanlumab tesirine: Intravenous (IV) infusion.
FG005
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.
Camidanlumab tesirine: Intravenous (IV) infusion.
FG006
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.
Camidanlumab tesirine: Intravenous (IV) infusion.
FG007
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.
Camidanlumab tesirine: Intravenous (IV) infusion.
FG008
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.
Camidanlumab tesirine: Intravenous (IV) infusion.
FG009
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.
Camidanlumab tesirine: Intravenous (IV) infusion.
FG010
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.
Camidanlumab tesirine: Intravenous (IV) infusion.
FG011
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).
Camidanlumab tesirine: Intravenous (IV) infusion.
FG0002 subjects
FG0012 subjects
FG0022 subjects
FG0033 subjects
FG0042 subjects
FG00520 subjects
FG00641 subjects
FG00729 subjects
FG00826 subjects
FG0093 subjects
FG0102 subjects
FG0111 subjects
COMPLETED
FG0001 subjects
FG0010 subjects
FG0020 subjects
FG0031 subjects
FG0040 subjects
FG0058 subjects
FG00623 subjects
FG0079 subjects
FG0085 subjects
FG0090 subjects
FG0101 subjects
FG0110 subjects
NOT COMPLETED
FG0001 subjects
FG0012 subjects
FG0022 subjects
FG0032 subjects
FG0042 subjects
FG00512 subjects
FG00618 subjects
FG00720 subjects
FG00821 subjects
FG0093 subjects
FG0101 subjects
FG0111 subjects
Type
Comment
Reasons
Death
FG0001 subjects
FG0011 subjects
FG0022 subjects
FG0032 subjects
FG0041 subjects
FG0053 subjects
FG00611 subjects
FG00715 subjects
FG00815 subjects
FG0093 subjects
FG0101 subjects
FG0110 subjects
Withdrawal by Subject
FG0000 subjects
FG0011 subjects
FG0020 subjects
FG0030 subjects
FG004
Lost to Follow-up
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Miscellaneous
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
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.
Camidanlumab tesirine: Intravenous (IV) infusion.
BG001
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.
Camidanlumab tesirine: Intravenous (IV) infusion.
BG002
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.
Camidanlumab tesirine: Intravenous (IV) infusion.
BG003
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.
Camidanlumab tesirine: Intravenous (IV) infusion.
BG004
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.
Camidanlumab tesirine: Intravenous (IV) infusion.
BG005
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.
Camidanlumab tesirine: Intravenous (IV) infusion.
BG006
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.
Camidanlumab tesirine: Intravenous (IV) infusion.
BG007
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.
Camidanlumab tesirine: Intravenous (IV) infusion.
BG008
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.
Camidanlumab tesirine: Intravenous (IV) infusion.
BG009
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.
Camidanlumab tesirine: Intravenous (IV) infusion.
BG010
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.
Camidanlumab tesirine: Intravenous (IV) infusion.
BG011
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).
Camidanlumab tesirine: Intravenous (IV) infusion.
BG012
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG0002
BG0012
BG0022
BG0033
BG0042
BG00520
BG00641
BG00729
BG00826
BG0093
BG0102
BG0111
BG012133
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
Mean
Standard Deviation
years
Title
Denominators
Categories
ParticipantsBG0002
ParticipantsBG0012
ParticipantsBG0022
ParticipantsBG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
ParticipantsBG0002
ParticipantsBG0012
ParticipantsBG002
Ethnicity (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
ParticipantsBG0002
ParticipantsBG0012
ParticipantsBG002
Race (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
ParticipantsBG0002
ParticipantsBG0012
ParticipantsBG002
Region of Enrollment
Number
participants
Title
Denominators
Categories
United States
ParticipantsBG0002
ParticipantsBG0012
ParticipantsBG002
Eastern Cooperative Oncology Group (ECOG) Performance Status
ECOG performance status was graded on a scale of 0-5, where a higher score indicated a worse outcome:
0. = fully active
= capable of light work of a sedentary nature
= capable of self-care; unable to carry out work activities
= capable of only limited self-care
= completely disabled; cannot carry out any self-care
= dead
Count of Participants
Participants
Title
Denominators
Categories
Grade 0
ParticipantsBG0002
ParticipantsBG0012
ParticipantsBG002
Weight
Mean
Standard Deviation
kilograms (kg)
Title
Denominators
Categories
ParticipantsBG0002
ParticipantsBG0012
ParticipantsBG002
Height
One participant in the 20 μg/kg group, one participant in the 30 μg/kg group and two participants in the 45 μg/kg group did not have their height measurement taken.
Mean
Standard Deviation
centimeters (cm)
Title
Denominators
Categories
ParticipantsBG0002
ParticipantsBG0012
ParticipantsBG002
Body Mass Index
One participant in the 20 μg/kg group, one participant in the 30 μg/kg group and two participants in the 45 μg/kg group did not have their height measurement taken, and so their Body Mass Index could not be calculated.
Mean
Standard Deviation
kg/m^2
Title
Denominators
Categories
ParticipantsBG0002
ParticipantsBG0012
ParticipantsBG002
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
Number of Participants Who Experienced Dose-Limiting Toxicities (DLTs)
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
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.
Posted
Count of Participants
Participants
Cycle 1 Day 1 to end of Cycle 1 or 2 (21 day cycle length)
ID
Title
Description
OG000
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.
Camidanlumab tesirine: Intravenous (IV) infusion.
OG001
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.
Camidanlumab tesirine: Intravenous (IV) infusion.
OG002
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.
Camidanlumab tesirine: Intravenous (IV) infusion.
OG003
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.
Camidanlumab tesirine: Intravenous (IV) infusion.
OG004
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.
Camidanlumab tesirine: Intravenous (IV) infusion.
OG005
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.
Camidanlumab tesirine: Intravenous (IV) infusion.
Units
Counts
Participants
OG0002
OG0012
OG0022
OG003
Title
Denominators
Categories
Title
Measurements
OG0000
OG0010
OG0020
OG003
Primary
Recommended Dose of Camidanlumab Tesirine for Part 2
The recommended dose was established by the dose escalation steering committee and based on safety findings during Part 1 of the study.
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.
Posted
Number
μg/kg
Cycle 1 Day 1 to end of Cycle 1 or 2 (21 day cycle length)
ID
Title
Description
OG000
Dose-Limiting Toxicity (DLT) Evaluable Set Analysis Set
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.
Units
Counts
Participants
OG000
Primary
Number of Participants Reporting at Least One Treatment Emergent Adverse Event (TEAE)
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.
Posted
Count of Participants
Participants
Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
ID
Title
Description
OG000
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.
Camidanlumab tesirine: Intravenous (IV) infusion.
OG001
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.
Camidanlumab tesirine: Intravenous (IV) infusion.
OG002
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.
Camidanlumab tesirine: Intravenous (IV) infusion.
Primary
Number of Participants Reporting at Least One Treatment Emergent Serious Adverse Event (SAE)
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.
Posted
Count of Participants
Participants
Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
ID
Title
Description
OG000
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.
Camidanlumab tesirine: Intravenous (IV) infusion.
OG001
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.
Camidanlumab tesirine: Intravenous (IV) infusion.
OG002
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.
Camidanlumab tesirine: Intravenous (IV) infusion.
Secondary
Overall Response Rate (ORR)
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).
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).
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.
Posted
Count of Participants
Participants
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])
ID
Title
Description
OG000
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.
Camidanlumab tesirine: Intravenous (IV) infusion.
OG001
Secondary
Duration of Response (DoR)
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.
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.
Posted
Median
95% Confidence Interval
Months
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])
ID
Title
Description
OG000
Efficacy Analysis Set
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.
Secondary
Progression-Free Survival (PFS)
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
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.
Posted
Median
95% Confidence Interval
Months
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])
ID
Title
Description
OG000
Efficacy Analysis Set
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.
Secondary
Overall Survival (OS)
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.
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.
Posted
Median
95% Confidence Interval
Months
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])
ID
Title
Description
OG000
Efficacy Analysis Set
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.
Units
Counts
Participants
OG000
Secondary
Maximum Observed Serum Concentration (Cmax) for Camidanlumab Tesirine
Cmax for HuMax-TAC, pyrrolobenzodiazepine (PBD) conjugated HuMax-TAC, and free warhead (SG3199).
Pharmacokinetic (PK) analysis set consisted of all participants who received study drug and have sufficient concentration data for PK analysis.
Posted
Geometric Mean
Geometric Coefficient of Variation
ng/mL
Pre-dose on Day 1 and 1 to 336 hours post-dose of Cycles 1 and 2 (21 day cycle length)
ID
Title
Description
OG000
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.
Camidanlumab tesirine: Intravenous (IV) infusion.
OG001
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.
Camidanlumab tesirine: Intravenous (IV) infusion.
OG002
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.
Camidanlumab tesirine: Intravenous (IV) infusion.
Secondary
Time to Reach the Maximum Serum Concentration (Tmax) for Camidanlumab Tesirine
Tmax for HuMax-TAC, PBD-conjugated HuMax-TAC, and free warhead (SG3199).
Pharmacokinetic (PK) analysis set consisted of all participants who received study drug and have sufficient concentration data for PK analysis.
Posted
Geometric Mean
Geometric Coefficient of Variation
Days
Pre-dose on Day 1 and 1 to 336 hours post-dose of Cycles 1 and 2 (21 day cycle length)
ID
Title
Description
OG000
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.
Camidanlumab tesirine: Intravenous (IV) infusion.
OG001
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.
Camidanlumab tesirine: Intravenous (IV) infusion.
OG002
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.
Camidanlumab tesirine: Intravenous (IV) infusion.
Secondary
Area Under the Serum Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration (AUC0-last) for Camidanlumab Tesirine
AUC0-last for HuMax-TAC, PBD-conjugated HuMax-TAC, and free warhead (SG3199).
Pharmacokinetic (PK) analysis set consisted of all participants who received study drug and have sufficient concentration data for PK analysis.
Posted
Geometric Mean
Geometric Coefficient of Variation
day*ng/mL
Pre-dose on Day 1 and 1 to 336 hours post-dose of Cycles 1 and 2 (21 day cycle length)
ID
Title
Description
OG000
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.
Camidanlumab tesirine: Intravenous (IV) infusion.
OG001
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.
Camidanlumab tesirine: Intravenous (IV) infusion.
OG002
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.
Camidanlumab tesirine: Intravenous (IV) infusion.
Secondary
Area Under the Serum Concentration-time Curve From Time 0 to the End of the Dosing Interval (AUC0-t) for Camidanlumab Tesirine
AUC0-tau for HuMax-TAC, PBD-conjugated HuMax-TAC, and free warhead (SG3199) for Cycle 2 only.
Pharmacokinetic (PK) analysis set consisted of all participants who received study drug and have sufficient concentration data for PK analysis.
Posted
Geometric Least Squares Mean
Geometric Coefficient of Variation
day*ng/mL
Pre-dose on Day 1 and 1 to 336 hours post-dose of Cycle 2 (21 day cycle length)
ID
Title
Description
OG000
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.
Camidanlumab tesirine: Intravenous (IV) infusion.
OG001
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.
Camidanlumab tesirine: Intravenous (IV) infusion.
OG002
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.
Camidanlumab tesirine: Intravenous (IV) infusion.
Secondary
Area Under the Serum Concentration-time Curve From Time 0 to Infinity (AUC∞) for Camidanlumab Tesirine
AUC∞ HuMax-TAC and PBD-conjugated HuMax-TAC for Cycle 1 only.
Pharmacokinetic (PK) analysis set consisted of all participants who received study drug and have sufficient concentration data for PK analysis.
Posted
Geometric Mean
Geometric Coefficient of Variation
day*ng/mL
Pre-dose on Day 1 and 1 to 336 hours post-dose of Cycle 1 (21 day cycle length)
ID
Title
Description
OG000
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.
Camidanlumab tesirine: Intravenous (IV) infusion.
OG001
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.
Camidanlumab tesirine: Intravenous (IV) infusion.
OG002
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.
Camidanlumab tesirine: Intravenous (IV) infusion.
Secondary
Accumulation Index (AI) for Camidanlumab Tesirine
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.
Pharmacokinetic (PK) analysis set consisted of all participants who received study drug and have sufficient concentration data for PK analysis.
Posted
Geometric Mean
Geometric Coefficient of Variation
Ratio
Pre-dose on Day 1 and 1 to 336 hours post-dose of Cycles 1 and 2 (21 day cycle length)
ID
Title
Description
OG000
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.
Camidanlumab tesirine: Intravenous (IV) infusion.
OG001
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.
Camidanlumab tesirine: Intravenous (IV) infusion.
OG002
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.
Camidanlumab tesirine: Intravenous (IV) infusion.
Secondary
Volume of Distribution for Camidanlumab Tesirine
Volume of distribution for HuMax-TAC, PBD-conjugated HuMax-TAC, and free warhead (SG3199).
Pharmacokinetic (PK) analysis set consisted of all participants who received study drug and have sufficient concentration data for PK analysis.
Posted
Geometric Mean
Geometric Coefficient of Variation
Liters
Pre-dose on Day 1 and 1 to 336 hours post-dose of Cycles 1 and 2 (21 day cycle length)
ID
Title
Description
OG000
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.
Camidanlumab tesirine: Intravenous (IV) infusion.
OG001
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.
Camidanlumab tesirine: Intravenous (IV) infusion.
OG002
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.
Camidanlumab tesirine: Intravenous (IV) infusion.
Secondary
Apparent Terminal Half-life (T1/2) of Camidanlumab Tesirine
T1/2 of HuMax-TAC, PBD-conjugated HuMax-TAC, and free warhead (SG3199).
Pharmacokinetic (PK) analysis set consisted of all participants who received study drug and have sufficient concentration data for PK analysis.
Posted
Geometric Mean
Geometric Coefficient of Variation
Days
Pre-dose on Day 1 and 1 to 336 hours post-dose of Cycles 1 and 2 (21 day cycle length)
ID
Title
Description
OG000
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.
Camidanlumab tesirine: Intravenous (IV) infusion.
OG001
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.
Camidanlumab tesirine: Intravenous (IV) infusion.
OG002
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.
Camidanlumab tesirine: Intravenous (IV) infusion.
Secondary
Clearance of Camidanlumab Tesirine
Clearance of HuMax-TAC, PBD-conjugated HuMax-TAC, and free warhead (SG3199).
Pharmacokinetic (PK) analysis set consisted of all participants who received study drug and have sufficient concentration data for PK analysis.
Posted
Geometric Mean
Geometric Coefficient of Variation
Liters/day
Pre-dose on Day 1 and 1 to 336 hours post-dose of Cycles 1 and 2 (21 day cycle length)
ID
Title
Description
OG000
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.
Camidanlumab tesirine: Intravenous (IV) infusion.
OG001
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.
Camidanlumab tesirine: Intravenous (IV) infusion.
OG002
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.
Camidanlumab tesirine: Intravenous (IV) infusion.
Secondary
Number of Participants With Anti-drug Antibody Response (ADA) Against Camidanlumab Tesirine
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.
Safety Analysis Set - The safety analysis set consisted of all participants who received camidanlumab tesirine.
Posted
Count of Participants
Participants
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])
ID
Title
Description
OG000
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.
Camidanlumab tesirine: Intravenous (IV) infusion.
OG001
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.
Camidanlumab tesirine: Intravenous (IV) infusion.
OG002
Time Frame
Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
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]).
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
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.
Camidanlumab tesirine: Intravenous (IV) infusion.
1
2
0
2
1
2
EG001
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.
Camidanlumab tesirine: Intravenous (IV) infusion.
1
2
1
2
2
2
EG002
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.
Camidanlumab tesirine: Intravenous (IV) infusion.
2
2
0
2
2
2
EG003
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.
Camidanlumab tesirine: Intravenous (IV) infusion.
2
3
3
3
3
3
EG004
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.
Camidanlumab tesirine: Intravenous (IV) infusion.
1
2
1
2
2
2
EG005
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.
Camidanlumab tesirine: Intravenous (IV) infusion.
3
20
10
20
20
20
EG006
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.
Camidanlumab tesirine: Intravenous (IV) infusion.
11
41
24
41
41
41
EG007
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.
Camidanlumab tesirine: Intravenous (IV) infusion.
15
29
14
29
29
29
EG008
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.
Camidanlumab tesirine: Intravenous (IV) infusion.
15
26
18
26
26
26
EG009
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.
Camidanlumab tesirine: Intravenous (IV) infusion.
3
3
1
3
3
3
EG010
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.
Camidanlumab tesirine: Intravenous (IV) infusion.
1
2
1
2
2
2
EG011
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).
Camidanlumab tesirine: Intravenous (IV) infusion.
0
1
1
1
1
1
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Febrile neutropenia
Blood and lymphatic system disorders
MedDRA (18.0)
Non-systematic Assessment
EG0000 events0 affected2 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected2 at risk
EG0030 events0 affected3 at risk
EG004
Anaemia
Blood and lymphatic system disorders
MedDRA (18.0)
Non-systematic Assessment
EG0000 events0 affected2 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected2 at risk
EG003
Pancytopenia
Blood and lymphatic system disorders
MedDRA (18.0)
Non-systematic Assessment
EG0000 events0 affected2 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected2 at risk
EG003
Neutropenia
Blood and lymphatic system disorders
MedDRA (18.0)
Non-systematic Assessment
EG0000 events0 affected2 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected2 at risk
EG003
Spleen disorder
Blood and lymphatic system disorders
MedDRA (18.0)
Non-systematic Assessment
EG0000 events0 affected2 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected2 at risk
EG003
Atrial fibrillation
Cardiac disorders
MedDRA (18.0)
Non-systematic Assessment
EG0000 events0 affected2 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected2 at risk
EG003
Atrial flutter
Cardiac disorders
MedDRA (18.0)
Non-systematic Assessment
EG0000 events0 affected2 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected2 at risk
EG003
Cardiac arrest
Cardiac disorders
MedDRA (18.0)
Non-systematic Assessment
EG0000 events0 affected2 at risk
EG0011 events1 affected2 at risk
EG0020 events0 affected2 at risk
EG003
Cardiac failure
Cardiac disorders
MedDRA (18.0)
Non-systematic Assessment
EG0000 events0 affected2 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected2 at risk
EG003
Myocardial infarction
Cardiac disorders
MedDRA (18.0)
Non-systematic Assessment
EG0000 events0 affected2 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected2 at risk
EG003
Pericardial effusion
Cardiac disorders
MedDRA (18.0)
Non-systematic Assessment
EG0000 events0 affected2 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected2 at risk
EG003
Sinus tachycardia
Cardiac disorders
MedDRA (18.0)
Non-systematic Assessment
EG0000 events0 affected2 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected2 at risk
EG003
Supraventricular tachycardia
Cardiac disorders
MedDRA (18.0)
Non-systematic Assessment
EG0000 events0 affected2 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected2 at risk
EG003
Ear pain
Ear and labyrinth disorders
MedDRA (18.0)
Non-systematic Assessment
EG0000 events0 affected2 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected2 at risk
EG003
Thyroiditis
Endocrine disorders
MedDRA (18.0)
Non-systematic Assessment
EG0000 events0 affected2 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected2 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA (18.0)
Non-systematic Assessment
EG0000 events0 affected2 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected2 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA (18.0)
Non-systematic Assessment
EG0000 events0 affected2 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected2 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA (18.0)
Non-systematic Assessment
EG0000 events0 affected2 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected2 at risk
EG003
Stomatitis
Gastrointestinal disorders
MedDRA (18.0)
Non-systematic Assessment
EG0000 events0 affected2 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected2 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA (18.0)
Non-systematic Assessment
EG0000 events0 affected2 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected2 at risk
EG003
Abdominal pain lower
Gastrointestinal disorders
MedDRA (18.0)
Non-systematic Assessment
EG0000 events0 affected2 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected2 at risk
EG003
Ascites
Gastrointestinal disorders
MedDRA (18.0)
Non-systematic Assessment
EG0000 events0 affected2 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected2 at risk
EG003
Colitis
Gastrointestinal disorders
MedDRA (18.0)
Non-systematic Assessment
EG0000 events0 affected2 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected2 at risk
EG003
Dysphagia
Gastrointestinal disorders
MedDRA (18.0)
Non-systematic Assessment
EG0000 events0 affected2 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected2 at risk
EG003
Enteritis
Gastrointestinal disorders
MedDRA (18.0)
Non-systematic Assessment
EG0000 events0 affected2 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected2 at risk
EG003
Oesophagitis
Gastrointestinal disorders
MedDRA (18.0)
Non-systematic Assessment
EG0000 events0 affected2 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected2 at risk
EG003
Oral pain
Gastrointestinal disorders
MedDRA (18.0)
Non-systematic Assessment
EG0000 events0 affected2 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected2 at risk
EG003
Proctalgia
Gastrointestinal disorders
MedDRA (18.0)
Non-systematic Assessment
EG0000 events0 affected2 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected2 at risk
EG003
Pyrexia
General disorders
MedDRA (18.0)
Non-systematic Assessment
EG0000 events0 affected2 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected2 at risk
EG003
Disease progression
General disorders
MedDRA (18.0)
Non-systematic Assessment
EG0000 events0 affected2 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected2 at risk
EG003
Fatigue
General disorders
MedDRA (18.0)
Non-systematic Assessment
EG0000 events0 affected2 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected2 at risk
EG003
Non-cardiac chest pain
General disorders
MedDRA (18.0)
Non-systematic Assessment
EG0000 events0 affected2 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected2 at risk
EG003
Oedema peripheral
General disorders
MedDRA (18.0)
Non-systematic Assessment
EG0000 events0 affected2 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected2 at risk
EG003
Chills
General disorders
MedDRA (18.0)
Non-systematic Assessment
EG0000 events0 affected2 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected2 at risk
EG003
Death
General disorders
MedDRA (18.0)
Non-systematic Assessment
EG0000 events0 affected2 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected2 at risk
EG003
Infusion site extravasation
General disorders
MedDRA (18.0)
Non-systematic Assessment
EG0000 events0 affected2 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected2 at risk
EG003
Mucosal inflammation
General disorders
MedDRA (18.0)
Non-systematic Assessment
EG0000 events0 affected2 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected2 at risk
EG003
Hepatic failure
Hepatobiliary disorders
MedDRA (18.0)
Non-systematic Assessment
EG0000 events0 affected2 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected2 at risk
EG003
Lung infection
Infections and infestations
MedDRA (18.0)
Non-systematic Assessment
EG0000 events0 affected2 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected2 at risk
EG003
Pneumocystis jirovecii pneumonia
Infections and infestations
MedDRA (18.0)
Non-systematic Assessment
EG0000 events0 affected2 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected2 at risk
EG003
Neutropenic sepsis
Infections and infestations
MedDRA (18.0)
Non-systematic Assessment
EG0000 events0 affected2 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected2 at risk
EG003
Rhinovirus infection
Infections and infestations
MedDRA (18.0)
Non-systematic Assessment
EG0000 events0 affected2 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected2 at risk
EG003
Sepsis
Infections and infestations
MedDRA (18.0)
Non-systematic Assessment
EG0000 events0 affected2 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected2 at risk
EG003
Clostridium difficile colitis
Infections and infestations
MedDRA (18.0)
Non-systematic Assessment
EG0000 events0 affected2 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected2 at risk
EG003
Rash pustular
Infections and infestations
MedDRA (18.0)
Non-systematic Assessment
EG0000 events0 affected2 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected2 at risk
EG003
Skin infection
Infections and infestations
MedDRA (18.0)
Non-systematic Assessment
EG0000 events0 affected2 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected2 at risk
EG003
Arthritis bacterial
Infections and infestations
MedDRA (18.0)
Non-systematic Assessment
EG0000 events0 affected2 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected2 at risk
EG003
Arthritis infective
Infections and infestations
MedDRA (18.0)
Non-systematic Assessment
EG0000 events0 affected2 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected2 at risk
EG003
Bacteraemia
Infections and infestations
MedDRA (18.0)
Non-systematic Assessment
EG0000 events0 affected2 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected2 at risk
EG003
Cellulitis
Infections and infestations
MedDRA (18.0)
Non-systematic Assessment
EG0000 events0 affected2 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected2 at risk
EG003
Herpes virus infection
Infections and infestations
MedDRA (18.0)
Non-systematic Assessment
EG0000 events0 affected2 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected2 at risk
EG003
Influenza
Infections and infestations
MedDRA (18.0)
Non-systematic Assessment
EG0000 events0 affected2 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected2 at risk
EG003
Pneumonia
Infections and infestations
MedDRA (18.0)
Non-systematic Assessment
EG0000 events0 affected2 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected2 at risk
EG003
Respiratory syncytial virus infection
Infections and infestations
MedDRA (18.0)
Non-systematic Assessment
EG0000 events0 affected2 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected2 at risk
EG003
Soft tissue infection
Infections and infestations
MedDRA (18.0)
Non-systematic Assessment
EG0000 events0 affected2 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected2 at risk
EG003
Wound infection
Infections and infestations
MedDRA (18.0)
Non-systematic Assessment
EG0000 events0 affected2 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected2 at risk
EG003
Fall
Injury, poisoning and procedural complications
MedDRA (18.0)
Non-systematic Assessment
EG0000 events0 affected2 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected2 at risk
EG003
Femur fracture
Injury, poisoning and procedural complications
MedDRA (18.0)
Non-systematic Assessment
EG0000 events0 affected2 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected2 at risk
EG003
Blood creatine phosphokinase increased
Investigations
MedDRA (18.0)
Non-systematic Assessment
EG0000 events0 affected2 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected2 at risk
EG003
Platelet count decreased
Investigations
MedDRA (18.0)
Non-systematic Assessment
EG0000 events0 affected2 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected2 at risk
EG003
Transaminases increased
Investigations
MedDRA (18.0)
Non-systematic Assessment
EG0000 events0 affected2 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected2 at risk
EG003
Alanine aminotransferase increased
Investigations
MedDRA (18.0)
Non-systematic Assessment
EG0000 events0 affected2 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected2 at risk
EG003
Aspartate aminotransferase increased
Investigations
MedDRA (18.0)
Non-systematic Assessment
EG0000 events0 affected2 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected2 at risk
EG003
Blood bilirubin increased
Investigations
MedDRA (18.0)
Non-systematic Assessment
EG0000 events0 affected2 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected2 at risk
EG003
Blood creatinine increased
Investigations
MedDRA (18.0)
Non-systematic Assessment
EG0000 events0 affected2 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected2 at risk
EG003
Hypercalcaemia
Metabolism and nutrition disorders
MedDRA (18.0)
Non-systematic Assessment
EG0000 events0 affected2 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected2 at risk
EG003
Dehydration
Metabolism and nutrition disorders
MedDRA (18.0)
Non-systematic Assessment
EG0000 events0 affected2 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected2 at risk
EG003
Hypokalaemia
Metabolism and nutrition disorders
MedDRA (18.0)
Non-systematic Assessment
EG0000 events0 affected2 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected2 at risk
EG003
Hyponatraemia
Metabolism and nutrition disorders
MedDRA (18.0)
Non-systematic Assessment
EG0000 events0 affected2 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected2 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA (18.0)
Non-systematic Assessment
EG0000 events0 affected2 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected2 at risk
EG003
Muscular weakness
Musculoskeletal and connective tissue disorders
MedDRA (18.0)
Non-systematic Assessment
EG0000 events0 affected2 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected2 at risk
EG003
Flank pain
Musculoskeletal and connective tissue disorders
MedDRA (18.0)
Non-systematic Assessment
EG0000 events0 affected2 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected2 at risk
EG003
Musculoskeletal chest pain
Musculoskeletal and connective tissue disorders
MedDRA (18.0)
Non-systematic Assessment
EG0000 events0 affected2 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected2 at risk
EG003
Lymphoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (18.0)
Non-systematic Assessment
EG0000 events0 affected2 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected2 at risk
EG003
Hodgkins disease
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (18.0)
Non-systematic Assessment
EG0000 events0 affected2 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected2 at risk
EG003
Metastases to meninges
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (18.0)
Non-systematic Assessment
EG0000 events0 affected2 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected2 at risk
EG003
Guillain-Barre syndrome
Nervous system disorders
MedDRA (18.0)
Non-systematic Assessment
EG0000 events0 affected2 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected2 at risk
EG003
Aphasia
Nervous system disorders
MedDRA (18.0)
Non-systematic Assessment
EG0000 events0 affected2 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected2 at risk
EG003
Autonomic nervous system imbalance
Nervous system disorders
MedDRA (18.0)
Non-systematic Assessment
EG0000 events0 affected2 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected2 at risk
EG003
Dysaesthesia
Nervous system disorders
MedDRA (18.0)
Non-systematic Assessment
EG0000 events0 affected2 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected2 at risk
EG003
Facial nerve disorder
Nervous system disorders
MedDRA (18.0)
Non-systematic Assessment
EG0000 events0 affected2 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected2 at risk
EG003
Haemorrhage intracranial
Nervous system disorders
MedDRA (18.0)
Non-systematic Assessment
EG0000 events0 affected2 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected2 at risk
EG003
Paraesthesia
Nervous system disorders
MedDRA (18.0)
Non-systematic Assessment
EG0000 events0 affected2 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected2 at risk
EG003
Peripheral sensory neuropathy
Nervous system disorders
MedDRA (18.0)
Non-systematic Assessment
EG0000 events0 affected2 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected2 at risk
EG003
Posterior reversible encephalopathy syndrome
Nervous system disorders
MedDRA (18.0)
Non-systematic Assessment
EG0000 events0 affected2 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected2 at risk
EG003
Radiculopathy
Nervous system disorders
MedDRA (18.0)
Non-systematic Assessment
EG0000 events0 affected2 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected2 at risk
EG003
Seizure
Nervous system disorders
MedDRA (18.0)
Non-systematic Assessment
EG0000 events0 affected2 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected2 at risk
EG003
Syncope
Nervous system disorders
MedDRA (18.0)
Non-systematic Assessment
EG0000 events0 affected2 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected2 at risk
EG003
Transient ischaemic attack
Nervous system disorders
MedDRA (18.0)
Non-systematic Assessment
EG0000 events0 affected2 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected2 at risk
EG003
VIIth nerve paralysis
Nervous system disorders
MedDRA (18.0)
Non-systematic Assessment
EG0000 events0 affected2 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected2 at risk
EG003
Acute kidney injury
Renal and urinary disorders
MedDRA (18.0)
Non-systematic Assessment
EG0000 events0 affected2 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected2 at risk
EG003
Dysuria
Renal and urinary disorders
MedDRA (18.0)
Non-systematic Assessment
EG0000 events0 affected2 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected2 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA (18.0)
Non-systematic Assessment
EG0000 events0 affected2 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected2 at risk
EG003
Pleural effusion
Respiratory, thoracic and mediastinal disorders
MedDRA (18.0)
Non-systematic Assessment
EG0000 events0 affected2 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected2 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA (18.0)
Non-systematic Assessment
EG0000 events0 affected2 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected2 at risk
EG003
Hypoxia
Respiratory, thoracic and mediastinal disorders
MedDRA (18.0)
Non-systematic Assessment
EG0000 events0 affected2 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected2 at risk
EG003
Pulmonary embolism
Respiratory, thoracic and mediastinal disorders
MedDRA (18.0)
Non-systematic Assessment
EG0000 events0 affected2 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected2 at risk
EG003
Acute respiratory distress syndrome
Respiratory, thoracic and mediastinal disorders
MedDRA (18.0)
Non-systematic Assessment
EG0000 events0 affected2 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected2 at risk
EG003
Pulmonary oedema
Respiratory, thoracic and mediastinal disorders
MedDRA (18.0)
Non-systematic Assessment
EG0000 events0 affected2 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected2 at risk
EG003
Respiratory failure
Respiratory, thoracic and mediastinal disorders
MedDRA (18.0)
Non-systematic Assessment
EG0000 events0 affected2 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected2 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
MedDRA (18.0)
Non-systematic Assessment
EG0000 events0 affected2 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected2 at risk
EG003
Rash maculo-papular
Skin and subcutaneous tissue disorders
MedDRA (18.0)
Non-systematic Assessment
EG0000 events0 affected2 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected2 at risk
EG003
Rash generalised
Skin and subcutaneous tissue disorders
MedDRA (18.0)
Non-systematic Assessment
EG0000 events0 affected2 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected2 at risk
EG003
Embolism
Vascular disorders
MedDRA (18.0)
Non-systematic Assessment
EG0000 events0 affected2 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected2 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected2 at risk
EG0011 affected2 at risk
EG0020 affected2 at risk
EG0031 affected3 at risk
EG0041 affected2 at risk
EG0056 affected20 at risk
EG0068 affected41 at risk
EG0072 affected29 at risk
EG0085 affected26 at risk
EG0090 affected3 at risk
EG0101 affected2 at risk
EG0111 affected1 at risk
Thrombocytopenia
Blood and lymphatic system disorders
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Neutropenia
Blood and lymphatic system disorders
MedDRA (18.0)
Non-systematic Assessment
EG0001 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Lymph node pain
Blood and lymphatic system disorders
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Increased tendency to bruise
Blood and lymphatic system disorders
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Sinus tachycardia
Cardiac disorders
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Tachycardia
Cardiac disorders
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Atrial flutter
Cardiac disorders
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Atrial fibrillation
Cardiac disorders
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Angina pectoris
Cardiac disorders
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Ear pain
Ear and labyrinth disorders
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Hypothyroidism
Endocrine disorders
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Hyperthyroidism
Endocrine disorders
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected2 at risk
EG0011 affected2 at risk
EG0020 affected2 at risk
EG003
Lacrimation increased
Eye disorders
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected2 at risk
EG0011 affected2 at risk
EG0020 affected2 at risk
EG003
Vision blurred
Eye disorders
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected2 at risk
EG0011 affected2 at risk
EG0020 affected2 at risk
EG003
Dry eye
Eye disorders
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Periorbital oedema
Eye disorders
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Diplopia
Eye disorders
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Conjunctival haemorrhage
Eye disorders
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Photophobia
Eye disorders
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected2 at risk
EG0011 affected2 at risk
EG0021 affected2 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected2 at risk
EG0011 affected2 at risk
EG0020 affected2 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected2 at risk
EG0011 affected2 at risk
EG0020 affected2 at risk
EG003
Stomatitis
Gastrointestinal disorders
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Dyspepsia
Gastrointestinal disorders
MedDRA (18.0)
Non-systematic Assessment
EG0001 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Abdominal distension
Gastrointestinal disorders
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Dysphagia
Gastrointestinal disorders
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Dry mouth
Gastrointestinal disorders
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Mouth ulceration
Gastrointestinal disorders
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Oral pain
Gastrointestinal disorders
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected2 at risk
EG0011 affected2 at risk
EG0020 affected2 at risk
EG003
Colitis
Gastrointestinal disorders
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Flatulence
Gastrointestinal disorders
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Haemorrhoids
Gastrointestinal disorders
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Lip blister
Gastrointestinal disorders
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Oesophagitis
Gastrointestinal disorders
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Cheilitis
Gastrointestinal disorders
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Oral mucosal blistering
Gastrointestinal disorders
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Fatigue
General disorders
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected2 at risk
EG0011 affected2 at risk
EG0020 affected2 at risk
EG003
Pyrexia
General disorders
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Oedema peripheral
General disorders
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected2 at risk
EG0011 affected2 at risk
EG0020 affected2 at risk
EG003
Face oedema
General disorders
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Mucosal inflammation
General disorders
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Chills
General disorders
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Localised oedema
General disorders
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Pain
General disorders
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Asthenia
General disorders
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Influenza like illness
General disorders
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Non-cardiac chest pain
General disorders
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Chest pain
General disorders
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Gait disturbance
General disorders
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Inflammation
General disorders
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Malaise
General disorders
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Peripheral swelling
General disorders
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Seasonal allergy
Immune system disorders
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Oral candidiasis
Infections and infestations
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Candida infection
Infections and infestations
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Sinusitis
Infections and infestations
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Cellulitis
Infections and infestations
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Influenza
Infections and infestations
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Oral herpes
Infections and infestations
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Pharyngitis
Infections and infestations
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Pneumonia
Infections and infestations
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Skin infection
Infections and infestations
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0021 affected2 at risk
EG003
Clostridium difficile infection
Infections and infestations
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Arthritis infective
Infections and infestations
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Aspergillus infection
Infections and infestations
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Herpes simplex
Infections and infestations
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Vaginal infection
Infections and infestations
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Fall
Injury, poisoning and procedural complications
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Contusion
Injury, poisoning and procedural complications
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Skin abrasion
Injury, poisoning and procedural complications
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Infusion related reaction
Injury, poisoning and procedural complications
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Excoriation
Injury, poisoning and procedural complications
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Scratch
Injury, poisoning and procedural complications
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Gamma-glutamyltransferase increased
Investigations
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected2 at risk
EG0011 affected2 at risk
EG0020 affected2 at risk
EG003
Alanine aminotransferase increased
Investigations
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Aspartate aminotransferase increased
Investigations
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Blood alkaline phosphatase increased
Investigations
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Platelet count decreased
Investigations
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Lipase increased
Investigations
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Weight decreased
Investigations
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Neutrophil count decreased
Investigations
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Blood creatinine increased
Investigations
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Haemoglobin decreased
Investigations
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Blood creatine phosphokinase increased
Investigations
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
White blood cell count decreased
Investigations
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Amylase increased
Investigations
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Electrocardiogram QT prolonged
Investigations
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Blood albumin decreased
Investigations
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Weight increased
Investigations
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Lymphocyte count decreased
Investigations
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Blood uric acid increased
Investigations
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Decreased appetite
Metabolism and nutrition disorders
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Dehydration
Metabolism and nutrition disorders
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Hyponatraemia
Metabolism and nutrition disorders
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Hyperglycaemia
Metabolism and nutrition disorders
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Hypertriglyceridaemia
Metabolism and nutrition disorders
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Hypokalaemia
Metabolism and nutrition disorders
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Hypophosphataemia
Metabolism and nutrition disorders
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Hypoalbuminaemia
Metabolism and nutrition disorders
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Hypocalcaemia
Metabolism and nutrition disorders
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Hypomagnesaemia
Metabolism and nutrition disorders
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Vitamin D deficiency
Metabolism and nutrition disorders
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Hyperkalaemia
Metabolism and nutrition disorders
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Hypermagnesaemia
Metabolism and nutrition disorders
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Lactic acidosis
Metabolism and nutrition disorders
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Myalgia
Musculoskeletal and connective tissue disorders
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected2 at risk
EG0011 affected2 at risk
EG0020 affected2 at risk
EG003
Pain in extremity
Musculoskeletal and connective tissue disorders
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Muscle spasms
Musculoskeletal and connective tissue disorders
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Muscular weakness
Musculoskeletal and connective tissue disorders
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Neck pain
Musculoskeletal and connective tissue disorders
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Flank pain
Musculoskeletal and connective tissue disorders
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Groin pain
Musculoskeletal and connective tissue disorders
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Myositis
Musculoskeletal and connective tissue disorders
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Joint swelling
Musculoskeletal and connective tissue disorders
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Headache
Nervous system disorders
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Dizziness
Nervous system disorders
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected2 at risk
EG0011 affected2 at risk
EG0020 affected2 at risk
EG003
Dysgeusia
Nervous system disorders
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Peripheral sensory neuropathy
Nervous system disorders
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected2 at risk
EG0011 affected2 at risk
EG0020 affected2 at risk
EG003
Paraesthesia
Nervous system disorders
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Amnesia
Nervous system disorders
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Hypoaesthesia
Nervous system disorders
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Sinus headache
Nervous system disorders
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Insomnia
Psychiatric disorders
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Anxiety
Psychiatric disorders
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Agitation
Psychiatric disorders
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Confusional state
Psychiatric disorders
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Mood altered
Psychiatric disorders
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Mood swings
Psychiatric disorders
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Acute kidney injury
Renal and urinary disorders
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Vulvovaginal pain
Reproductive system and breast disorders
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Erectile dysfunction
Reproductive system and breast disorders
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Pelvic pain
Reproductive system and breast disorders
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Vaginal inflammation
Reproductive system and breast disorders
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA (18.0)
Non-systematic Assessment
EG0001 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected2 at risk
EG0011 affected2 at risk
EG0020 affected2 at risk
EG003
Pleural effusion
Respiratory, thoracic and mediastinal disorders
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Nasal congestion
Respiratory, thoracic and mediastinal disorders
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Oropharyngeal pain
Respiratory, thoracic and mediastinal disorders
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected2 at risk
EG0011 affected2 at risk
EG0020 affected2 at risk
EG003
Dysphonia
Respiratory, thoracic and mediastinal disorders
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Wheezing
Respiratory, thoracic and mediastinal disorders
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Dyspnoea exertional
Respiratory, thoracic and mediastinal disorders
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected2 at risk
EG0011 affected2 at risk
EG0020 affected2 at risk
EG003
Pneumonitis
Respiratory, thoracic and mediastinal disorders
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Upper-airway cough syndrome
Respiratory, thoracic and mediastinal disorders
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Acute respiratory distress syndrome
Respiratory, thoracic and mediastinal disorders
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Rhinitis allergic
Respiratory, thoracic and mediastinal disorders
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Rash maculo-papular
Skin and subcutaneous tissue disorders
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0021 affected2 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Pruritus
Skin and subcutaneous tissue disorders
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Erythema
Skin and subcutaneous tissue disorders
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Photosensitivity reaction
Skin and subcutaneous tissue disorders
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Dry skin
Skin and subcutaneous tissue disorders
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Rash erythematous
Skin and subcutaneous tissue disorders
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Dermatitis acneiform
Skin and subcutaneous tissue disorders
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Blister
Skin and subcutaneous tissue disorders
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Rash generalised
Skin and subcutaneous tissue disorders
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Rash papular
Skin and subcutaneous tissue disorders
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Hyperhidrosis
Skin and subcutaneous tissue disorders
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Night sweats
Skin and subcutaneous tissue disorders
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Pain of skin
Skin and subcutaneous tissue disorders
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Skin mass
Skin and subcutaneous tissue disorders
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Skin ulcer
Skin and subcutaneous tissue disorders
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Swelling face
Skin and subcutaneous tissue disorders
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Dermatitis bullous
Skin and subcutaneous tissue disorders
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Erythema multiforme
Skin and subcutaneous tissue disorders
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Skin hyperpigmentation
Skin and subcutaneous tissue disorders
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Dermal cyst
Skin and subcutaneous tissue disorders
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Skin discolouration
Skin and subcutaneous tissue disorders
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Hypertension
Vascular disorders
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Hypotension
Vascular disorders
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Flushing
Vascular disorders
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Deep vein thrombosis
Vascular disorders
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Hot flush
Vascular disorders
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Thrombosis
Vascular disorders
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
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
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.
OG007
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.
Camidanlumab tesirine: Intravenous (IV) infusion.
OG008
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.
Camidanlumab tesirine: Intravenous (IV) infusion.
OG009
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.
Camidanlumab tesirine: Intravenous (IV) infusion.
OG010
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.
Camidanlumab tesirine: Intravenous (IV) infusion.
OG011
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).
Camidanlumab tesirine: Intravenous (IV) infusion.
2
OG0042
OG00510
OG00615
OG00729
OG00816
OG0093
OG0102
OG0111
0
OG0041
OG0052
OG0061
OG0070
OG0081
OG0090
OG0100
OG0110
86
Title
Denominators
Categories
Participants with Hodgkin Lymphoma (Dose level 1: 30 µg/kg)
ParticipantsOG00010
Title
Measurements
OG00030
Participants with Hodgkin Lymphoma (Dose level 2: 45 µg/kg)
ParticipantsOG00015
Title
Measurements
OG00045
Participants with T-cell Lymphoma (80 µg/kg)
ParticipantsOG00016
Title
Measurements
OG00080
OG003
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.
Camidanlumab tesirine: Intravenous (IV) infusion.
OG004
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.
Camidanlumab tesirine: Intravenous (IV) infusion.
OG005
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.
Camidanlumab tesirine: Intravenous (IV) infusion.
OG006
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.
Camidanlumab tesirine: Intravenous (IV) infusion.
OG007
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.
Camidanlumab tesirine: Intravenous (IV) infusion.
OG008
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.
Camidanlumab tesirine: Intravenous (IV) infusion.
OG009
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.
Camidanlumab tesirine: Intravenous (IV) infusion.
OG010
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.
Camidanlumab tesirine: Intravenous (IV) infusion.
OG011
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).
Camidanlumab tesirine: Intravenous (IV) infusion.
Units
Counts
Participants
OG0002
OG0012
OG0022
OG0033
OG0042
OG00520
OG00641
OG00729
OG00826
OG0093
OG0102
OG0111
Title
Denominators
Categories
Title
Measurements
OG0001
OG0012
OG0022
OG0033
OG0042
OG00520
OG00641
OG00729
OG00826
OG0093
OG0102
OG0111
OG003
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.
Camidanlumab tesirine: Intravenous (IV) infusion.
OG004
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.
Camidanlumab tesirine: Intravenous (IV) infusion.
OG005
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.
Camidanlumab tesirine: Intravenous (IV) infusion.
OG006
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.
Camidanlumab tesirine: Intravenous (IV) infusion.
OG007
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.
Camidanlumab tesirine: Intravenous (IV) infusion.
OG008
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.
Camidanlumab tesirine: Intravenous (IV) infusion.
OG009
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.
Camidanlumab tesirine: Intravenous (IV) infusion.
OG010
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.
Camidanlumab tesirine: Intravenous (IV) infusion.
OG011
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).
Camidanlumab tesirine: Intravenous (IV) infusion.
Units
Counts
Participants
OG0002
OG0012
OG0022
OG0033
OG0042
OG00520
OG00641
OG00729
OG00826
OG0093
OG0102
OG0111
Title
Denominators
Categories
Title
Measurements
OG0000
OG0011
OG0020
OG0033
OG0041
OG00510
OG00624
OG00714
OG00818
OG0091
OG0101
OG0111
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.
Camidanlumab tesirine: Intravenous (IV) infusion.
OG002
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.
Camidanlumab tesirine: Intravenous (IV) infusion.
OG003
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.
Camidanlumab tesirine: Intravenous (IV) infusion.
OG004
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.
Camidanlumab tesirine: Intravenous (IV) infusion.
OG005
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.
Camidanlumab tesirine: Intravenous (IV) infusion.
OG006
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.
Camidanlumab tesirine: Intravenous (IV) infusion.
OG007
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.
Camidanlumab tesirine: Intravenous (IV) infusion.
OG008
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.
Camidanlumab tesirine: Intravenous (IV) infusion.
OG009
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.
Camidanlumab tesirine: Intravenous (IV) infusion.
OG010
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.
Camidanlumab tesirine: Intravenous (IV) infusion.
OG011
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).
Camidanlumab tesirine: Intravenous (IV) infusion.
Units
Counts
Participants
OG0002
OG0012
OG0022
OG0033
OG0042
OG00520
OG00641
OG00728
OG00824
OG0093
OG0102
OG0111
Title
Denominators
Categories
Title
Measurements
OG0000
OG0010
OG0020
OG0031
OG0040
OG00511
OG00632
OG00715
OG00812
OG0092
OG0101
OG0111
Units
Counts
Participants
OG000130
Title
Denominators
Categories
Title
Measurements
OG0005.19(4.50 to 7.23)
Units
Counts
Participants
OG000130
Title
Denominators
Categories
Title
Measurements
OG0005.22(3.78 to 5.95)
130
Title
Denominators
Categories
Title
Measurements
OG00016.26(10.02 to NA)Insufficient number of participants died during the study, so confidence upper limit could not be calculated.
OG003
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.
Camidanlumab tesirine: Intravenous (IV) infusion.
OG004
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.
Camidanlumab tesirine: Intravenous (IV) infusion.
OG005
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.
Camidanlumab tesirine: Intravenous (IV) infusion.
OG006
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.
Camidanlumab tesirine: Intravenous (IV) infusion.
OG007
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.
Camidanlumab tesirine: Intravenous (IV) infusion.
OG008
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.
Camidanlumab tesirine: Intravenous (IV) infusion.
OG009
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.
Camidanlumab tesirine: Intravenous (IV) infusion.
OG010
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.
Camidanlumab tesirine: Intravenous (IV) infusion.
OG011
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).
Camidanlumab tesirine: Intravenous (IV) infusion.
Units
Counts
Participants
OG0001
OG0011
OG0022
OG0033
OG0042
OG00520
OG00641
OG00729
OG00825
OG0093
OG0102
OG0111
Title
Denominators
Categories
Cycle 1 - HuMax-TAC
ParticipantsOG0001
ParticipantsOG0011
ParticipantsOG0022
ParticipantsOG0033
ParticipantsOG0042
ParticipantsOG00520
ParticipantsOG00641
ParticipantsOG00728
ParticipantsOG00823
ParticipantsOG0093
ParticipantsOG0102
ParticipantsOG0111
Title
Measurements
OG000109
OG00162.5
OG002131± 20.7
OG003
Cycle 2 - HuMax-TAC
ParticipantsOG0001
ParticipantsOG0010
ParticipantsOG0022
ParticipantsOG0032
Cycle 1 - PBD-conjugated HuMax-TAC
ParticipantsOG0001
ParticipantsOG0010
ParticipantsOG0022
ParticipantsOG0033
Cycle 2 - PBD-conjugated HuMax-TAC
ParticipantsOG0001
ParticipantsOG0010
ParticipantsOG0022
ParticipantsOG0032
Cycle 1 - Free warhead (SG3199)
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Cycle 2 - Free warhead (SG3199)
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
OG003
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.
Camidanlumab tesirine: Intravenous (IV) infusion.
OG004
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.
Camidanlumab tesirine: Intravenous (IV) infusion.
OG005
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.
Camidanlumab tesirine: Intravenous (IV) infusion.
OG006
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.
Camidanlumab tesirine: Intravenous (IV) infusion.
OG007
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.
Camidanlumab tesirine: Intravenous (IV) infusion.
OG008
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.
Camidanlumab tesirine: Intravenous (IV) infusion.
OG009
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.
Camidanlumab tesirine: Intravenous (IV) infusion.
OG010
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.
Camidanlumab tesirine: Intravenous (IV) infusion.
OG011
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).
Camidanlumab tesirine: Intravenous (IV) infusion.
Units
Counts
Participants
OG0001
OG0011
OG0022
OG0033
OG0042
OG00520
OG00641
OG00729
OG00825
OG0093
OG0102
OG0111
Title
Denominators
Categories
Cycle 1 - HuMax-TAC
ParticipantsOG0001
ParticipantsOG0011
ParticipantsOG0022
ParticipantsOG0033
ParticipantsOG0042
ParticipantsOG00520
ParticipantsOG00641
ParticipantsOG00728
ParticipantsOG00823
ParticipantsOG0093
ParticipantsOG0102
ParticipantsOG0111
Title
Measurements
OG0000.155
OG0010.0830
OG0020.0970± 22.4
OG003
Cycle 2 - HuMax-TAC
ParticipantsOG0001
ParticipantsOG0010
ParticipantsOG0022
ParticipantsOG0032
Cycle 1 - PBD-conjugated HuMax-TAC
ParticipantsOG0001
ParticipantsOG0010
ParticipantsOG0022
ParticipantsOG0033
Cycle 2 - PBD-conjugated HuMax-TAC
ParticipantsOG0001
ParticipantsOG0010
ParticipantsOG0022
ParticipantsOG0032
Cycle 1 - Free warhead (SG3199)
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Cycle 2 - Free warhead (SG3199)
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
OG003
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.
Camidanlumab tesirine: Intravenous (IV) infusion.
OG004
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.
Camidanlumab tesirine: Intravenous (IV) infusion.
OG005
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.
Camidanlumab tesirine: Intravenous (IV) infusion.
OG006
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.
Camidanlumab tesirine: Intravenous (IV) infusion.
OG007
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.
Camidanlumab tesirine: Intravenous (IV) infusion.
OG008
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.
Camidanlumab tesirine: Intravenous (IV) infusion.
OG009
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.
Camidanlumab tesirine: Intravenous (IV) infusion.
OG010
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.
Camidanlumab tesirine: Intravenous (IV) infusion.
OG011
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).
Camidanlumab tesirine: Intravenous (IV) infusion.
Units
Counts
Participants
OG0001
OG0011
OG0022
OG0033
OG0042
OG00520
OG00641
OG00729
OG00825
OG0093
OG0102
OG0111
Title
Denominators
Categories
Cycle 1 - HuMax-TAC
ParticipantsOG0001
ParticipantsOG0011
ParticipantsOG0022
ParticipantsOG0033
ParticipantsOG0042
ParticipantsOG00520
ParticipantsOG00641
ParticipantsOG00728
ParticipantsOG00823
ParticipantsOG0093
ParticipantsOG0102
ParticipantsOG0111
Title
Measurements
OG00082.7
OG0012.60
OG00248.2± 207
OG003
Cycle 2 - HuMax-TAC
ParticipantsOG0001
ParticipantsOG0010
ParticipantsOG0022
ParticipantsOG0033
Cycle 1 - PBD-conjugated HuMax-TAC
ParticipantsOG0001
ParticipantsOG0010
ParticipantsOG0022
ParticipantsOG0033
Cycle 2 - PBD-conjugated HuMax-TAC
ParticipantsOG0001
ParticipantsOG0010
ParticipantsOG0022
ParticipantsOG0032
Cycle 1 - Free warhead (SG3199)
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Cycle 2 - Free warhead (SG3199)
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
OG003
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.
Camidanlumab tesirine: Intravenous (IV) infusion.
OG004
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.
Camidanlumab tesirine: Intravenous (IV) infusion.
OG005
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.
Camidanlumab tesirine: Intravenous (IV) infusion.
OG006
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.
Camidanlumab tesirine: Intravenous (IV) infusion.
OG007
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.
Camidanlumab tesirine: Intravenous (IV) infusion.
OG008
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.
Camidanlumab tesirine: Intravenous (IV) infusion.
OG009
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.
Camidanlumab tesirine: Intravenous (IV) infusion.
OG010
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.
Camidanlumab tesirine: Intravenous (IV) infusion.
OG011
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).
Camidanlumab tesirine: Intravenous (IV) infusion.
Units
Counts
Participants
OG0000
OG0010
OG0022
OG0032
OG0041
OG00518
OG00633
OG00723
OG00817
OG0092
OG0102
OG0111
Title
Denominators
Categories
Cycle 2 - HuMax-TAC
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0022
ParticipantsOG0032
ParticipantsOG0041
ParticipantsOG00518
ParticipantsOG00633
ParticipantsOG00723
ParticipantsOG00817
ParticipantsOG0091
ParticipantsOG0102
ParticipantsOG0111
Title
Measurements
OG002195± 22.3
OG003596± 25.9
OG004747
OG005
Cycle 2 - PBD-conjugated HuMax-TAC
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0021
ParticipantsOG0032
Cycle 2 - Free warhead (SG3199)
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
OG003
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.
Camidanlumab tesirine: Intravenous (IV) infusion.
OG004
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.
Camidanlumab tesirine: Intravenous (IV) infusion.
OG005
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.
Camidanlumab tesirine: Intravenous (IV) infusion.
OG006
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.
Camidanlumab tesirine: Intravenous (IV) infusion.
OG007
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.
Camidanlumab tesirine: Intravenous (IV) infusion.
OG008
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.
Camidanlumab tesirine: Intravenous (IV) infusion.
OG009
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.
Camidanlumab tesirine: Intravenous (IV) infusion.
OG010
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.
Camidanlumab tesirine: Intravenous (IV) infusion.
OG011
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).
Camidanlumab tesirine: Intravenous (IV) infusion.
Units
Counts
Participants
OG0000
OG0010
OG0020
OG0030
OG0041
OG00514
OG00629
OG00723
OG00818
OG0092
OG0102
OG0111
Title
Denominators
Categories
Cycle 1 - HuMax-TAC
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
ParticipantsOG0040
ParticipantsOG00514
ParticipantsOG00623
ParticipantsOG00723
ParticipantsOG00818
ParticipantsOG0092
ParticipantsOG0102
ParticipantsOG0111
Title
Measurements
OG0051283± 63.1
OG0063001± 75.0
OG0073618± 52.9
OG008
Cycle 1 - PBD-conjugated HuMax-TAC
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
OG003
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.
Camidanlumab tesirine: Intravenous (IV) infusion.
OG004
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.
Camidanlumab tesirine: Intravenous (IV) infusion.
OG005
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.
Camidanlumab tesirine: Intravenous (IV) infusion.
OG006
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.
Camidanlumab tesirine: Intravenous (IV) infusion.
OG007
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.
Camidanlumab tesirine: Intravenous (IV) infusion.
OG008
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.
Camidanlumab tesirine: Intravenous (IV) infusion.
OG009
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.
Camidanlumab tesirine: Intravenous (IV) infusion.
OG010
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.
Camidanlumab tesirine: Intravenous (IV) infusion.
OG011
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).
Camidanlumab tesirine: Intravenous (IV) infusion.
Units
Counts
Participants
OG0000
OG0010
OG0022
OG0032
OG0041
OG00518
OG00633
OG00722
OG00817
OG0092
OG0102
OG0111
Title
Denominators
Categories
HuMax-TAC
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0022
ParticipantsOG0032
ParticipantsOG0041
ParticipantsOG00516
ParticipantsOG00633
ParticipantsOG00721
ParticipantsOG00815
ParticipantsOG0091
ParticipantsOG0102
ParticipantsOG0111
Title
Measurements
OG0021.00± 0.0000132
OG0031.00± 0.000584
OG0041.00
OG005
PBD-conjugated HuMax-TAC
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0021
ParticipantsOG0032
Free warhead (SG3199)
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
OG003
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.
Camidanlumab tesirine: Intravenous (IV) infusion.
OG004
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.
Camidanlumab tesirine: Intravenous (IV) infusion.
OG005
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.
Camidanlumab tesirine: Intravenous (IV) infusion.
OG006
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.
Camidanlumab tesirine: Intravenous (IV) infusion.
OG007
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.
Camidanlumab tesirine: Intravenous (IV) infusion.
OG008
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.
Camidanlumab tesirine: Intravenous (IV) infusion.
OG009
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.
Camidanlumab tesirine: Intravenous (IV) infusion.
OG010
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.
Camidanlumab tesirine: Intravenous (IV) infusion.
OG011
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).
Camidanlumab tesirine: Intravenous (IV) infusion.
Units
Counts
Participants
OG0000
OG0010
OG0022
OG0032
OG0041
OG00518
OG00633
OG00723
OG00818
OG0092
OG0102
OG0111
Title
Denominators
Categories
Cycle 1 - HuMax-TAC
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
ParticipantsOG0040
ParticipantsOG00514
ParticipantsOG00623
ParticipantsOG00723
ParticipantsOG00818
ParticipantsOG0092
ParticipantsOG0102
ParticipantsOG0111
Title
Measurements
OG0053.93± 43.2
OG0064.57± 26.9
OG0074.55± 27.0
OG008
Cycle 2 - HuMax-TAC
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0022
ParticipantsOG0032
Cycle 1 - PBD-conjugated HuMax-TAC
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Cycle 2 - PBD-conjugated HuMax-TAC
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0021
ParticipantsOG0032
Cycle 2 - Free warhead (SG3199)
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
OG003
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.
Camidanlumab tesirine: Intravenous (IV) infusion.
OG004
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.
Camidanlumab tesirine: Intravenous (IV) infusion.
OG005
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.
Camidanlumab tesirine: Intravenous (IV) infusion.
OG006
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.
Camidanlumab tesirine: Intravenous (IV) infusion.
OG007
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.
Camidanlumab tesirine: Intravenous (IV) infusion.
OG008
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.
Camidanlumab tesirine: Intravenous (IV) infusion.
OG009
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.
Camidanlumab tesirine: Intravenous (IV) infusion.
OG010
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.
Camidanlumab tesirine: Intravenous (IV) infusion.
OG011
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).
Camidanlumab tesirine: Intravenous (IV) infusion.
Units
Counts
Participants
OG0000
OG0010
OG0022
OG0032
OG0041
OG00518
OG00633
OG00723
OG00818
OG0092
OG0102
OG0111
Title
Denominators
Categories
Cycle 1 - HuMax-TAC
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
ParticipantsOG0040
ParticipantsOG00514
ParticipantsOG00623
ParticipantsOG00723
ParticipantsOG00818
ParticipantsOG0092
ParticipantsOG0102
ParticipantsOG0111
Title
Measurements
OG0051.58± 58.9
OG0062.62± 44.1
OG0072.76± 51.9
OG008
Cycle 2 - HuMax-TAC
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0022
ParticipantsOG0032
Cycle 1 - PBD-conjugated HuMax-TAC
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Cycle 2 - PBD-conjugated HuMax-TAC
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0021
ParticipantsOG0032
Cycle 2 - Free warhead (SG3199)
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
OG003
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.
Camidanlumab tesirine: Intravenous (IV) infusion.
OG004
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.
Camidanlumab tesirine: Intravenous (IV) infusion.
OG005
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.
Camidanlumab tesirine: Intravenous (IV) infusion.
OG006
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.
Camidanlumab tesirine: Intravenous (IV) infusion.
OG007
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.
Camidanlumab tesirine: Intravenous (IV) infusion.
OG008
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.
Camidanlumab tesirine: Intravenous (IV) infusion.
OG009
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.
Camidanlumab tesirine: Intravenous (IV) infusion.
OG010
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.
Camidanlumab tesirine: Intravenous (IV) infusion.
OG011
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).
Camidanlumab tesirine: Intravenous (IV) infusion.
Units
Counts
Participants
OG0000
OG0010
OG0022
OG0032
OG0041
OG00518
OG00633
OG00723
OG00818
OG0092
OG0102
OG0111
Title
Denominators
Categories
Cycle 1 - HuMax-TAC
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
ParticipantsOG0040
ParticipantsOG00514
ParticipantsOG00623
ParticipantsOG00723
ParticipantsOG00818
ParticipantsOG0092
ParticipantsOG0102
ParticipantsOG0111
Title
Measurements
OG0051.82± 69.0
OG0061.29± 64.0
OG0071.24± 54.5
OG008
Cycle 2 - HuMax-TAC
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0022
ParticipantsOG0032
Cycle 1 - PBD-conjugated HuMax-TAC
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Cycle 2 - PBD-conjugated HuMax-TAC
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0021
ParticipantsOG0032
Cycle 2 - Free warhead (SG3199)
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
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.
Camidanlumab tesirine: Intravenous (IV) infusion.
OG003
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.
Camidanlumab tesirine: Intravenous (IV) infusion.
OG004
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.
Camidanlumab tesirine: Intravenous (IV) infusion.
OG005
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.
Camidanlumab tesirine: Intravenous (IV) infusion.
OG006
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.
Camidanlumab tesirine: Intravenous (IV) infusion.
OG007
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.
Camidanlumab tesirine: Intravenous (IV) infusion.
OG008
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.
Camidanlumab tesirine: Intravenous (IV) infusion.
OG009
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.
Camidanlumab tesirine: Intravenous (IV) infusion.
OG010
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.
Camidanlumab tesirine: Intravenous (IV) infusion.
OG011
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).