Study to Evaluate the Efficacy and Safety of Camidanlumab... | NCT04052997

ID	Type	Description	Link
2018-002556-32	EudraCT Number

Label	Type	Description	Intervention Names
Camidanlumab Tesirine	Experimental	Camidanlumab Tesirine is administered as a 30- minute intravenous (IV) infusion on Day 1 of each cycle (every 3 weeks). Camidanlumab Tesirine will be administered at a dose of 45 μg/kg every 3 weeks for 2 cycles, then 30 μg/kg for subsequent cycles.	Drug: Camidanlumab Tesirine

Name	Type	Description	Arm Group Labels	Other Names
Camidanlumab Tesirine	Drug	Intravenous Infusion	Camidanlumab Tesirine

Measure	Description	Time Frame
Overall Response Rate (ORR)	ORR according to the 2014 Lugano classification as determined by central review in all-treated participants.ORR will be defined as the proportion of participants with a best overall response (BOR) of complete response (CR) or partial response (PR). Data from the All-treated Population.	Up to 3 years

Measure	Description	Time Frame
Duration of Response (DOR)	DOR defined as the time from the first documentation of tumor response to disease progression or death.	Up to 3 years
CR Rate	CR rate defined as the number of treated participants with a best overall response (BOR) of CR.

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Written informed consent must be obtained prior to any procedures.
Male or female participant aged 18 years or older. (16 years or older at US based sites)
Pathologic diagnosis of classical Hodgkin lymphoma (cHL).
Patients with relapsed or refractory cHL, who have received at least 3 prior lines of systemic therapy (or at least 2 prior lines in HSCT ineligible patients) including brentuximab vedotin and a checkpoint inhibitor approved for cHL (e.g., nivolumab or pembrolizumab). Note 1: Receipt of HSCT to be included in the number of prior therapies needed to meet eligibility.
Measurable disease as defined by the 2014 Lugano Classification.
Availability of formalin-fixed paraffin-embedded (FFPE) tumor tissue block (or minimum 10 freshly cut unstained slides if block is not available).

Note 1: Any biopsy since initial diagnosis is acceptable, but if several samples are available, the most recent sample is preferred.

Note 2: If a sufficient amount of tissue is not available, a fresh biopsy may be taken, provided the procedure is not deemed high-risk and is clinically feasible, and provided it is approved locally.
Eastern Cooperative Oncology Group (ECOG) performance status 0-2.
Adequate organ function as defined by Screening laboratory values within the following parameters:
1. Absolute neutrophil count (ANC) ≥ 1.0 × 103/μL (off growth factors at least 72 h).
2. Platelet count ≥ 75 × 103/μL without transfusion in the past 2 weeks.
3. ALT, AST, or GGT ≤ 2.5 × the upper limit of normal (ULN) if there is no liver involvement; ALT or AST ≤ 5 × ULN if there is liver involvement.
4. Total bilirubin ≤ 1.5 × ULN (participants with known Gilbert's syndrome may have a total bilirubin up to ≤ 3 × ULN with direct bilirubin ≤ 1.5 × ULN).
5. Blood creatinine ≤ 3.0 × ULN or calculated creatinine clearance ≥ 30 mL/min by the Cockcroft-Gault equation.
Note: A laboratory assessment may be repeated a maximum of two times during the Screening Period to confirm eligibility.
Negative beta-human chorionic gonadotropin (β-HCG) pregnancy test within 7 days prior to start of study drug for women of childbearing potential.
Women of childbearing potential (WOCBP) must agree to use a highly effective method of contraception from the time of giving informed consent until at least 9.5 months after the last dose of Camidanlumab Tesirine. Men with female partners who are of childbearing potential must agree to use a highly effective method of contraception from the time of giving informed consent until at least 6.5 months after the participants receives his last dose of Camidanlumab Tesirine.

Exclusion Criteria:

Previous treatment with Camidanlumab Tesirine.
Participation in another investigational interventional study. Being in follow-up of another investigational study is allowed.
Known history of hypersensitivity to or positive serum human anti-drug antibody (ADA) to a CD25 antibody.
Allogenic or autologous transplant within 60 days prior to start of study drug.
Active graft-versus-host disease (GVHD), except for non-neurologic symptoms as a manifestation of mild (≤ Grade 1) chronic GVHD.
Post-transplantation lymphoproliferative disorders.
Active second primary malignancy other than non-melanoma skin cancers, non-metastatic prostate cancer, in situ cervical cancer, ductal or lobular carcinoma in situ of the breast, or other malignancy that the Sponsor's medical monitor and Investigator agree and document should not be exclusionary.
History of symptomatic autoimmune disease (e.g., rheumatoid arthritis, systemic progressive sclerosis [scleroderma], systemic lupus erythematosus, Sjögren's syndrome, autoimmune vasculitis [e.g., Wegener's granulomatosis]) (subjects with vitiligo, type 1 diabetes mellitus, residual hypothyroidism, hypophysitis due to autoimmune condition only requiring hormone replacement may be enrolled).
History of neuropathy considered of autoimmune origin (e.g., polyradiculopathy including Guillain-Barré syndrome and myasthenia gravis) or other central nervous system autoimmune disease (e.g., poliomyelitis, multiple sclerosis).
History of recent infection (within 4 weeks of Cycle 1, Day 1 [C1D1]) considered to be caused by one of the following pathogens: HSV1, HSV2, VZV, EBV, CMV, measles, Influenza A, Zika virus, Chikungunya virus, mycoplasma pneumonia, Campylobacter jejuni, or enterovirus D68, or severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2).

Note: An influenza test and a pathogendirected SARS CoV-2 test (such as polymerase chain reaction) are mandatory and must be negative before initiating study treatment (tests to be performed 3 days or less prior to dosing on C1D1; an additional 2 days are allowed in the event of logistical issues for receiving the results on time).
Participants known to be or having been infected with human immunodeficiency (HIV) virus, hepatitis B virus (HBV), or hepatitis C virus (HCV), and require anti-viral therapy or prophylaxis. Note: Serology testing is mandatory for patients with unknown status.
History of Stevens-Johnson syndrome or toxic epidermal necrolysis.
Failure to recover ≤ Grade 1 (Common Terminology Criteria for Adverse Events version 4.0 [CTCAE v4.0]) from acute non-hematologic toxicity (except ≤ Grade 2 neuropathy or alopecia), due to previous therapy, prior to screening.
Hodgkin lymphoma (HL) with central nervous system involvement, including leptomeningeal disease.
Clinically significant third space fluid accumulation (i.e., ascites requiring drainage or pleural effusion that is either requiring drainage or associated with shortness of breath).
Breastfeeding or pregnant.
Significant medical comorbidities, including uncontrolled hypertension (blood pressure [BP] ≥ 160/100 mmHg repeatedly), unstable angina, congestive heart failure (greater than New York Heart Association class II), electrocardiographic evidence of acute ischemia, coronary angioplasty or myocardial infarction within 3 months prior to screening, severe uncontrolled atrial or ventricular cardiac arrhythmia, poorly controlled diabetes, or severe chronic pulmonary disease.
Major surgery, radiotherapy, chemotherapy, or other anti-neoplastic therapy, within 14 days prior to start of study drug, except shorter if approved by the Sponsor.
Use of any other experimental medication within 30 days prior to start of study drug.
Any live vaccine within 4 weeks prior to start of study drug and planned live vaccine administration after starting study drug.
Congenital long QT (measure between Q wave and T wave in the electrocardiogram) syndrome, or a corrected QTc interval of ≥ 480 ms, at screening (unless secondary to pacemaker or bundle branch block).
Any other significant medical illness, abnormality, or condition that would, in the Investigator's judgment, make the participants inappropriate for study participation or put the participant at risk.

Facility	Status	City	State	ZIP	Country	Contacts
Mayo Clinic - Arizona		Scottsdale	Arizona	85259	United States
City of Hope Comprehensive Cancer Center

PubMed Identifier	Type	Citation	Retractions
40811783	Derived	Herrera AF, Ansell SM, Zinzani PL, Radford J, Maddocks K, Pinto A, Collins GP, Bachanova V, Bartlett NL, Bence-Bruckler I, Hamadani M, Kline J, Mayer J, Savage KJ, Advani RH, Caimi PF, Casasnovas RO, Feldman T, Hess B, Bastos-Oreiro M, Iyengar S, Szomor A, Townsend W, Andre M, Dyczkowski J, Havenith K, Toukam M, Pantano S, Cruz HG, Wang L, Negievich Y, Lucero M, Wuerthner J, Carlo-Stella C. Camidanlumab tesirine for relapsed or refractory classic Hodgkin lymphoma: a phase 2 study. Blood Adv. 2025 Dec 9;9(23):6205-6217. doi: 10.1182/bloodadvances.2024015600.

ID	Title	Description
FG000	Camidanlumab Tesirine	Participants received IV infusions of camidanlumab tesirine every 3 weeks (Q3W) at a dose of 45 µg/kg on Day 1 of each cycle (one cycle = 21 days) for 2 cycles, followed by 30 µg/kg for subsequent cycles.

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Feb 16, 2022	Jan 15, 2024

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

Overall Response Rate (ORR)

ORR according to the 2014 Lugano classification as determined by central review in all-treated participants.ORR will be defined as the proportion of participants with a best overall response (BOR) of complete response (CR) or partial response (PR). Data from the All-treated Population.

All-Treated Population: All participants who received at least 1 dose of camidanlumab tesirine. This population was used in the primary analyses of efficacy and safety.

Posted

Count of Participants

Participants

Up to 3 years

ID	Title	Description
OG000	Camidanlumab Tesirine	Participants received IV infusions of camidanlumab tesirine Q3W at a dose of 45 µg/kg on Day 1 of each cycle (one cycle = 21 days) for 2 cycles, followed by 30 µg/kg for subsequent cycles.

Units	Counts
Participants	OG000117

Title

Denominators

Categories

Title	Measurements
	OG00082

Secondary

Duration of Response (DOR)

DOR defined as the time from the first documentation of tumor response to disease progression or death.

Data from participants in the All-Treated Population who achieved ether CR or PR by independent reviewer.

Posted

Median

95% Confidence Interval

Months

Up to 3 years

ID	Title	Description
OG000	Camidanlumab Tesirine	Participants received IV infusions of camidanlumab tesirine Q3W at a dose of 45 µg/kg on Day 1 of each cycle (one cycle = 21 days) for 2 cycles, followed by 30 µg/kg for subsequent cycles.

Units	Counts
Participants	OG000

Secondary

CR Rate

CR rate defined as the number of treated participants with a best overall response (BOR) of CR.

All-Treated Population: All participants who received at least 1 dose of camidanlumab tesirine. This population was used in the primary analyses of efficacy and safety.

Posted

Count of Participants

Participants

Up to 3 years

ID	Title	Description
OG000	Camidanlumab Tesirine	Participants received IV infusions of camidanlumab tesirine Q3W at a dose of 45 µg/kg on Day 1 of each cycle (one cycle = 21 days) for 2 cycles, followed by 30 µg/kg for subsequent cycles.

Units	Counts
Participants	OG000

Secondary

Relapse-Free Survival (RFS)

RFS defined as the time from the documentation of CR to disease progression or death.

Data from participants in the All-Treated Population who achieved CR.

Posted

Median

95% Confidence Interval

Months

Up to 3 years

ID	Title	Description
OG000	Camidanlumab Tesirine	Participants received IV infusions of camidanlumab tesirine Q3W at a dose of 45 µg/kg on Day 1 of each cycle (one cycle = 21 days) for 2 cycles, followed by 30 µg/kg for subsequent cycles.

Units	Counts
Participants	OG00039

Secondary

Progression-Free Survival (PFS)

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

All-Treated Population: All participants who received at least 1 dose of camidanlumab tesirine. This population was used in the primary analyses of efficacy and safety.

Posted

Median

95% Confidence Interval

Months

Up to 3 years

ID	Title	Description
OG000	Camidanlumab Tesirine	Participants received IV infusions of camidanlumab tesirine Q3W at a dose of 45 µg/kg on Day 1 of each cycle (one cycle = 21 days) for 2 cycles, followed by 30 µg/kg for subsequent cycles.

Units	Counts
Participants	OG000

Secondary

Overall Survival (OS)

OS defined as the time from first dose of study drug until death due to any cause.

All-Treated Population: All participants who received at least 1 dose of camidanlumab tesirine. This population was used in the primary analyses of efficacy and safety.

Posted

Median

95% Confidence Interval

Months

Up to 3 years

ID	Title	Description
OG000	Camidanlumab Tesirine	Participants received IV infusions of camidanlumab tesirine Q3W at a dose of 45 µg/kg on Day 1 of each cycle (one cycle = 21 days) for 2 cycles, followed by 30 µg/kg for subsequent cycles.

Units	Counts
Participants	OG000

Secondary

Number of Participants Who Received Hematopoietic Stem Cell Transplant (HSCT)

Participants receiving HSCT following camidanlumab tesirine, and without any other anticancer therapy in between, other than the therapies preparing for HSCT, were included in this analysis.

All-Treated Population: All participants who received at least 1 dose of camidanlumab tesirine. This population was used in the primary analyses of efficacy and safety.

Posted

Count of Participants

Participants

Up to 3 years

ID	Title	Description
OG000	Camidanlumab Tesirine	Participants received IV infusions of camidanlumab tesirine Q3W at a dose of 45 µg/kg on Day 1 of each cycle (one cycle = 21 days) for 2 cycles, followed by 30 µg/kg for subsequent cycles.

Units	Counts
Participants	OG000

Secondary

Number of Participants Who Experienced At Least One Treatment-Emergent Adverse Event (TEAE)

An adverse event (AE) is defined as any untoward medical occurrence in a participant or clinical investigation where participants are administered a pharmaceutical product, which does not necessarily have to have a causal relationship with this treatment. A TEAE is defined as an AE that occurs or worsens in the period extending from the first dose of study drug to 30 days after the last dose of study drug in this study or start of a new anticancer therapy/procedure, whichever comes earlier. Clinically significant changes in vital signs, clinical laboratory results, and electrocardiogram were reported as AEs.

All-Treated Population: All participants who received at least 1 dose of camidanlumab tesirine. This population was used in the primary analyses of efficacy and safety.

Posted

Count of Participants

Participants

Up to 3 years

ID	Title	Description
OG000	Camidanlumab Tesirine	Participants received IV infusions of camidanlumab tesirine Q3W at a dose of 45 µg/kg on Day 1 of each cycle (one cycle = 21 days) for 2 cycles, followed by 30 µg/kg for subsequent cycles.

Units	Counts
Participants

Secondary

Number of Participants Who Experienced At Least One Serious Adverse Event (SAE)

An SAE is defined as any adverse event (AE) that:

results in death.
is life threatening.
requires inpatient hospitalization or prolongation of existing hospitalization (hospitalization for elective procedures or for protocol compliance is not considered an SAE).
results in persistent or significant disability/incapacity.
is a congenital anomaly/birth defect.
important medical events that do not meet the preceding criteria but based on appropriate medical judgement may jeopardize the participant or may require medical or surgical intervention to prevent any of the outcomes listed above. Clinically significant changes in vital signs, clinical laboratory results, and electrocardiogram were reported as AEs.

All-Treated Population: All participants who received at least 1 dose of camidanlumab tesirine. This population was used in the primary analyses of efficacy and safety.

Posted

Count of Participants

Participants

Up to 3 years

ID	Title	Description
OG000	Camidanlumab Tesirine	Participants received IV infusions of camidanlumab tesirine Q3W at a dose of 45 µg/kg on Day 1 of each cycle (one cycle = 21 days) for 2 cycles, followed by 30 µg/kg for subsequent cycles.

Units	Counts
Participants

Secondary

Number of Participants With ECOG Performance Status Score of 0-3 at the End of Trial (EOT)

The ECOG Performance Status is a scale used to asses a person's level of functioning in terms of their ability to care for themselves, daily activity, and physical ability. The scale consists of 6 grades, ranging from 0 to 5. A grade of 0 indicates the person is fully active and able to carry on as normal, and a grade of 5 indicates death.

All-Treated Population: All participants who received at least 1 dose of camidanlumab tesirine and reported ECOG data at EOT. This population was used in the primary analyses of efficacy and safety.

Posted

Count of Participants

Participants

EOT (up to 3 years)

ID	Title	Description
OG000	Camidanlumab Tesirine	Participants received IV infusions of camidanlumab tesirine Q3W at a dose of 45 µg/kg on Day 1 of each cycle (one cycle = 21 days) for 2 cycles, followed by 30 µg/kg for subsequent cycles.

Units	Counts
Participants	OG000

Secondary

Maximum Observed Plasma Concentration (Cmax) of Camidanlumab Tesirine Total Antibody

PK Population: The analysis only included participants who received study drug and had at least 1 pre-Cycle 1 Day 1 and 1 post-dose valid (measurable) assessment. Due to the nature of the studied drug (antibody-drug conjugate), some PK parameters frequently could not be measured, or could be measured only briefly.

Posted

Geometric Mean

Geometric Coefficient of Variation

µg/L

Cycle 1 (one cycle = 21 days): day 1 (predose, EOI, 4h postdose), day 8 (168h), day 15 (336h). Cycle 2: day 1 (predose, EOI, 4h postdose), day 8 (168h), day 15 (336h)

ID	Title	Description
OG000	Camidanlumab Tesirine	Participants received IV infusions of camidanlumab tesirine Q3W at a dose of 45 µg/kg on Day 1 of each cycle (one cycle = 21 days) for 2 cycles, followed by 30 µg/kg for subsequent cycles.

Units	Counts
Participants	OG000

Secondary

Cmax of Camidanlumab Tesirine Unconjugated Warhead SG3199

Posted

Geometric Mean

Geometric Coefficient of Variation

µg/L

Cycle 1 (one cycle = 21 days): day 1 (predose, EOI, 4h postdose), day 8 (168h), day 15 (336h). Cycle 2: day 1 (predose, EOI, 4h postdose), day 8 (168h), day 15 (336h)

ID	Title	Description
OG000	Camidanlumab Tesirine	Participants received IV infusions of camidanlumab tesirine Q3W at a dose of 45 µg/kg on Day 1 of each cycle (one cycle = 21 days) for 2 cycles, followed by 30 µg/kg for subsequent cycles.

Units	Counts
Participants	OG000

Secondary

Cmax of Camidanlumab Tesirine PBD-Conjugated Antibody

Posted

Geometric Mean

Geometric Coefficient of Variation

µg/L

Cycle 1 (one cycle = 21 days): day 1 (predose, EOI, 4h postdose), day 8 (168h), day 15 (336h). Cycle 2: day 1 (predose, EOI, 4h postdose), day 8 (168h), day 15 (336h)

ID	Title	Description
OG000	Camidanlumab Tesirine	Participants received IV infusions of camidanlumab tesirine Q3W at a dose of 45 µg/kg on Day 1 of each cycle (one cycle = 21 days) for 2 cycles, followed by 30 µg/kg for subsequent cycles.

Units	Counts
Participants	OG000

Secondary

Area Under the Plasma Concentration-Time Curve From Time 0 to the End of the Dosing Interval (AUCtau) For Camidanlumab Tesirine Total Antibody

Posted

Geometric Mean

Geometric Coefficient of Variation

day*ug/L

Cycle 2 (one cycle = 21 days): day 1 (predose, EOI, 4h postdose), day 8 (168h), day 15 (336h)

ID	Title	Description
OG000	Camidanlumab Tesirine	Participants received IV infusions of camidanlumab tesirine Q3W at a dose of 45 µg/kg on Day 1 of each cycle (one cycle = 21 days) for 2 cycles, followed by 30 µg/kg for subsequent cycles.

Units	Counts
Participants	OG000

Secondary

AUCtau For Camidanlumab Tesirine PBD-Conjugated Antibody

Posted

Geometric Mean

Geometric Coefficient of Variation

day*ug/L

Cycle 2 (one cycle = 21 days): day 1 (predose, EOI, 4h postdose), day 8 (168h), day 15 (336h)

ID	Title	Description
OG000	Camidanlumab Tesirine	Participants received IV infusions of camidanlumab tesirine Q3W at a dose of 45 µg/kg on Day 1 of each cycle (one cycle = 21 days) for 2 cycles, followed by 30 µg/kg for subsequent cycles.

Units	Counts
Participants	OG000

Secondary

AUCtau For Camidanlumab Tesirine Unconjugated Warhead SG3199

No data collected for this endpoint.

Posted

Cycle 2 (one cycle = 21 days): day 1 (predose, EOI, 4h postdose), day 8 (168h), day 15 (336h)

ID	Title	Description
OG000	Camidanlumab Tesirine	Participants received IV infusions of camidanlumab tesirine Q3W at a dose of 45 µg/kg on Day 1 of each cycle (one cycle = 21 days) for 2 cycles, followed by 30 µg/kg for subsequent cycles.

Units	Counts
Participants	OG0000

Secondary

Area Under the Plasma Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration (AUClast) For Camidanlumab Tesirine Total Antibody

Posted

Geometric Mean

Geometric Coefficient of Variation

day*ug/L

Cycle 1 (one cycle = 21 days): day 1 (predose, EOI, 4h postdose), day 8 (168h), day 15 (336h). Cycle 2: day 1 (predose, EOI, 4h postdose), day 8 (168h), day 15 (336h)

ID	Title	Description
OG000	Camidanlumab Tesirine	Participants received IV infusions of camidanlumab tesirine Q3W at a dose of 45 µg/kg on Day 1 of each cycle (one cycle = 21 days) for 2 cycles, followed by 30 µg/kg for subsequent cycles.

Units	Counts
Participants	OG000

Secondary

AUClast For Camidanlumab Tesirine PBD-Conjugated Antibody

Posted

Geometric Mean

Geometric Coefficient of Variation

day*ug/L

Cycle 1 (one cycle = 21 days): day 1 (predose, EOI, 4h postdose), day 8 (168h), day 15 (336h). Cycle 2: day 1 (predose, EOI, 4h postdose), day 8 (168h), day 15 (336h)

ID	Title	Description
OG000	Camidanlumab Tesirine	Participants received IV infusions of camidanlumab tesirine Q3W at a dose of 45 µg/kg on Day 1 of each cycle (one cycle = 21 days) for 2 cycles, followed by 30 µg/kg for subsequent cycles.

Units	Counts
Participants	OG000

Secondary

AUClast For Camidanlumab Tesirine Unconjugated Warhead SG3199

Posted

Geometric Mean

Geometric Coefficient of Variation

day*ug/L

Cycle 1 (one cycle = 21 days): day 1 (predose, EOI, 4h postdose), day 8 (168h), day 15 (336h). Cycle 2: day 1 (predose, EOI, 4h postdose), day 8 (168h), day 15 (336h)

ID	Title	Description
OG000	Camidanlumab Tesirine	Participants received IV infusions of camidanlumab tesirine Q3W at a dose of 45 µg/kg on Day 1 of each cycle (one cycle = 21 days) for 2 cycles, followed by 30 µg/kg for subsequent cycles.

Units	Counts
Participants	OG000

Secondary

Area Under the Plasma Concentration-Time Curve From Time 0 to Infinity (AUCinf) For Camidanlumab Tesirine Total Antibody

Posted

Geometric Mean

Geometric Coefficient of Variation

day*µg/L

Cycle 1 (one cycle = 21 days): day 1 (predose, EOI, 4h postdose), day 8 (168h), day 15 (336h)

ID	Title	Description
OG000	Camidanlumab Tesirine	Participants received IV infusions of camidanlumab tesirine Q3W at a dose of 45 µg/kg on Day 1 of each cycle (one cycle = 21 days) for 2 cycles, followed by 30 µg/kg for subsequent cycles.

Units	Counts
Participants	OG000

Secondary

AUCinf For Camidanlumab Tesirine PBD-Conjugated Antibody

Posted

Geometric Mean

Geometric Coefficient of Variation

day*µg/L

Cycle 1 (one cycle = 21 days): day 1 (predose, EOI, 4h postdose), day 8 (168h), day 15 (336h)

ID	Title	Description
OG000	Camidanlumab Tesirine	Participants received IV infusions of camidanlumab tesirine Q3W at a dose of 45 µg/kg on Day 1 of each cycle (one cycle = 21 days) for 2 cycles, followed by 30 µg/kg for subsequent cycles.

Units	Counts
Participants	OG000

Secondary

AUCinf For Camidanlumab Tesirine Unconjugated Warhead SG3199

Posted

Geometric Mean

Geometric Coefficient of Variation

day*µg/L

Cycle 1 (one cycle = 21 days): day 1 (predose, EOI, 4h postdose), day 8 (168h), day 15 (336h)

ID	Title	Description
OG000	Camidanlumab Tesirine	Participants received IV infusions of camidanlumab tesirine Q3W at a dose of 45 µg/kg on Day 1 of each cycle (one cycle = 21 days) for 2 cycles, followed by 30 µg/kg for subsequent cycles.

Units	Counts
Participants	OG000

Secondary

Clearance (CL) For Camidanlumab Tesirine Total Antibody

Posted

Geometric Mean

Geometric Coefficient of Variation

L/day

Cycle 1 (one cycle = 21 days): day 1 (predose, EOI, 4h postdose), day 8 (168h), day 15 (336h)

ID	Title	Description
OG000	Camidanlumab Tesirine	Participants received IV infusions of camidanlumab tesirine Q3W at a dose of 45 µg/kg on Day 1 of each cycle (one cycle = 21 days) for 2 cycles, followed by 30 µg/kg for subsequent cycles.

Units	Counts
Participants	OG000

Secondary

CL For Camidanlumab Tesirine PBD-Conjugated Antibody

Posted

Geometric Mean

Geometric Coefficient of Variation

L/day

Cycle 1 (one cycle = 21 days): day 1 (predose, EOI, 4h postdose), day 8 (168h), day 15 (336h)

ID	Title	Description
OG000	Camidanlumab Tesirine	Participants received IV infusions of camidanlumab tesirine Q3W at a dose of 45 µg/kg on Day 1 of each cycle (one cycle = 21 days) for 2 cycles, followed by 30 µg/kg for subsequent cycles.

Units	Counts
Participants	OG000

Secondary

CL For Camidanlumab Tesirine Unconjugated Warhead SG3199

Posted

Geometric Mean

Geometric Coefficient of Variation

L/day

Cycle 1 (one cycle = 21 days): day 1 (predose, EOI, 4h postdose), day 8 (168h), day 15 (336h)

ID	Title	Description
OG000	Camidanlumab Tesirine	Participants received IV infusions of camidanlumab tesirine Q3W at a dose of 45 µg/kg on Day 1 of each cycle (one cycle = 21 days) for 2 cycles, followed by 30 µg/kg for subsequent cycles.

Units	Counts
Participants	OG000

Secondary

Clearance at Steady State (CLss) For Camidanlumab Tesirine Total Antibody

Posted

Geometric Mean

Geometric Coefficient of Variation

L/day

Cycle 2 (one cycle = 21 days): day 1 (predose, EOI, 4h postdose), day 8 (168h), day 15 (336h)

ID	Title	Description
OG000	Camidanlumab Tesirine	Participants received IV infusions of camidanlumab tesirine Q3W at a dose of 45 µg/kg on Day 1 of each cycle (one cycle = 21 days) for 2 cycles, followed by 30 µg/kg for subsequent cycles.

Units	Counts
Participants	OG000

Secondary

CLss For Camidanlumab Tesirine PBD-Conjugated Antibody

Posted

Geometric Mean

Geometric Coefficient of Variation

L/day

Cycle 2 (one cycle = 21 days): day 1 (predose, EOI, 4h postdose), day 8 (168h), day 15 (336h)

ID	Title	Description
OG000	Camidanlumab Tesirine	Participants received IV infusions of camidanlumab tesirine Q3W at a dose of 45 µg/kg on Day 1 of each cycle (one cycle = 21 days) for 2 cycles, followed by 30 µg/kg for subsequent cycles.

Units	Counts
Participants	OG000

Secondary

CLss For Camidanlumab Tesirine Unconjugated Warhead SG3199

Posted

Geometric Mean

Geometric Coefficient of Variation

L/day

Cycle 2 (one cycle = 21 days): day 1 (predose, EOI, 4h postdose), day 8 (168h), day 15 (336h)

ID	Title	Description
OG000	Camidanlumab Tesirine	Participants received IV infusions of camidanlumab tesirine Q3W at a dose of 45 µg/kg on Day 1 of each cycle (one cycle = 21 days) for 2 cycles, followed by 30 µg/kg for subsequent cycles.

Units	Counts
Participants	OG000

Secondary

Apparent Terminal Elimination Half-Life (T1/2) For Camidanlumab Tesirine Total Antibody

Posted

Geometric Mean

Geometric Coefficient of Variation

day

Cycle 1 (one cycle = 21 days): day 1 (predose, EOI, 4h postdose), day 8 (168h), day 15 (336h). Cycle 2: day 1 (predose, EOI, 4h postdose), day 8 (168h), day 15 (336h)

ID	Title	Description
OG000	Camidanlumab Tesirine	Participants received IV infusions of camidanlumab tesirine Q3W at a dose of 45 µg/kg on Day 1 of each cycle (one cycle = 21 days) for 2 cycles, followed by 30 µg/kg for subsequent cycles.

Units	Counts
Participants	OG000

Secondary

T1/2 For Camidanlumab Tesirine PBD-Conjugated Antibody

Posted

Geometric Mean

Geometric Coefficient of Variation

day

Cycle 1 (one cycle = 21 days): day 1 (predose, EOI, 4h postdose), day 8 (168h), day 15 (336h). Cycle 2: day 1 (predose, EOI, 4h postdose), day 8 (168h), day 15 (336h)

ID	Title	Description
OG000	Camidanlumab Tesirine	Participants received IV infusions of camidanlumab tesirine Q3W at a dose of 45 µg/kg on Day 1 of each cycle (one cycle = 21 days) for 2 cycles, followed by 30 µg/kg for subsequent cycles.

Units	Counts
Participants	OG000

Secondary

T1/2 For Camidanlumab Tesirine Unconjugated Warhead SG3199

Posted

Geometric Mean

Geometric Coefficient of Variation

day

Cycle 1 (one cycle = 21 days): day 1 (predose, EOI, 4h postdose), day 8 (168h), day 15 (336h). Cycle 2: day 1 (predose, EOI, 4h postdose), day 8 (168h), day 15 (336h)

ID	Title	Description
OG000	Camidanlumab Tesirine	Participants received IV infusions of camidanlumab tesirine Q3W at a dose of 45 µg/kg on Day 1 of each cycle (one cycle = 21 days) for 2 cycles, followed by 30 µg/kg for subsequent cycles.

Units	Counts
Participants	OG000

Secondary

Volume of Distribution at Steady State (Vss) For Camidanlumab Tesirine Total Antibody

Posted

Geometric Mean

Geometric Coefficient of Variation

Cycle 1 (one cycle = 21 days): day 1 (predose, EOI, 4h postdose), day 8 (168h), day 15 (336h). Cycle 2: day 1 (predose, EOI, 4h postdose), day 8 (168h), day 15 (336h)

ID	Title	Description
OG000	Camidanlumab Tesirine	Participants received IV infusions of camidanlumab tesirine Q3W at a dose of 45 µg/kg on Day 1 of each cycle (one cycle = 21 days) for 2 cycles, followed by 30 µg/kg for subsequent cycles.

Units	Counts
Participants	OG000

Secondary

Vss For Camidanlumab Tesirine PBD-Conjugated Antibody

Posted

Geometric Least Squares Mean

Geometric Coefficient of Variation

Cycle 1 (one cycle = 21 days): day 1 (predose, EOI, 4h postdose), day 8 (168h), day 15 (336h). Cycle 2: day 1 (predose, EOI, 4h postdose), day 8 (168h), day 15 (336h)

ID	Title	Description
OG000	Camidanlumab Tesirine	Participants received IV infusions of camidanlumab tesirine Q3W at a dose of 45 µg/kg on Day 1 of each cycle (one cycle = 21 days) for 2 cycles, followed by 30 µg/kg for subsequent cycles.

Units	Counts
Participants	OG000

Secondary

Vss For Camidanlumab Tesirine Unconjugated Warhead SG3199

Posted

Geometric Mean

Geometric Coefficient of Variation

Cycle 1 (one cycle = 21 days): day 1 (predose, EOI, 4h postdose), day 8 (168h), day 15 (336h). Cycle 2: day 1 (predose, EOI, 4h postdose), day 8 (168h), day 15 (336h)

ID	Title	Description
OG000	Camidanlumab Tesirine	Participants received IV infusions of camidanlumab tesirine Q3W at a dose of 45 µg/kg on Day 1 of each cycle (one cycle = 21 days) for 2 cycles, followed by 30 µg/kg for subsequent cycles.

Units	Counts
Participants	OG000

Secondary

Accumulation Index (AI) For Camidanlumab Tesirine Total Antibody

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.

Posted

Geometric Least Squares Mean

Geometric Coefficient of Variation

ratio

Cycle 1 and 2: day 0 to 21

ID	Title	Description
OG000	Camidanlumab Tesirine	Participants received IV infusions of camidanlumab tesirine Q3W at a dose of 45 µg/kg on Day 1 of each cycle (one cycle = 21 days) for 2 cycles, followed by 30 µg/kg for subsequent cycles.

Units	Counts
Participants	OG000

Secondary

AI For Camidanlumab Tesirine PBD-Conjugated Antibody

AI is the ratio of AUC from 0 to 21 days for Cycle 2 divided by AUC from 0 to 21 days for Cycle 1.

Posted

Geometric Mean

Geometric Coefficient of Variation

ratio

Cycle 1 and 2: day 0 to 21

ID	Title	Description
OG000	Camidanlumab Tesirine	Participants received IV infusions of camidanlumab tesirine Q3W at a dose of 45 µg/kg on Day 1 of each cycle (one cycle = 21 days) for 2 cycles, followed by 30 µg/kg for subsequent cycles.

Units	Counts
Participants	OG000

Secondary

AI For Camidanlumab Tesirine Unconjugated Warhead SG3199

AI is the ratio of AUC from 0 to 21 days for Cycle 2 divided by AUC from 0 to 21 days for Cycle 1.

Posted

Geometric Mean

Geometric Coefficient of Variation

ratio

Cycle 1 and 2: day 0 to 21

ID	Title	Description
OG000	Camidanlumab Tesirine	Participants received IV infusions of camidanlumab tesirine Q3W at a dose of 45 µg/kg on Day 1 of each cycle (one cycle = 21 days) for 2 cycles, followed by 30 µg/kg for subsequent cycles.

Units	Counts
Participants	OG000

Secondary

Number of Participants With Confirmed Positive Anti-Drug Antibody (ADA) Responses Post Dose

Detection of ADAs was performed by using a screening assay for identification of antibody positive samples/participants, a confirmation assay, and titer assessment.

All-Treated Population: All participants who received at least 1 dose of camidanlumab tesirine. This population was used in the primary analyses of efficacy and safety.

Posted

Count of Participants

Participants

Up to 3 years

ID	Title	Description
OG000	Camidanlumab Tesirine	Participants received IV infusions of camidanlumab tesirine Q3W at a dose of 45 µg/kg on Day 1 of each cycle (one cycle = 21 days) for 2 cycles, followed by 30 µg/kg for subsequent cycles.

Units	Counts
Participants	OG000

Secondary

Change From Baseline in Health-Related Quality of Life (HRQoL) as Measured by EuroQoL-5 Dimensions-5 Levels (EQ-5D-5L) Visual Analog Scale (VAS)

Participants were asked to indicate their health state on a VAS with scores ranging from 'the worst health you can imagine' (score 0) to 'the best health you can imagine' (score 100). Participants are asked to mark an "X" on the VAS to indicate their own health and then to report the score in a text box. Positive changes from Baseline represent an an improvement in heath.

Patient Reported Outcome (PRO) Population: All participants in the all-treated population with baseline score (at least one instrument) and at least 1 post-baseline score (in at least one instrument).

Posted

Mean

Standard Deviation

score on a scale

Baseline, Day 1 of Cycles 2 to 15 (one cycle = 21 days) and EOT (up to 3 years)

ID	Title	Description
OG000	Camidanlumab Tesirine	Participants received IV infusions of camidanlumab tesirine Q3W at a dose of 45 µg/kg on Day 1 of each cycle (one cycle = 21 days) for 2 cycles, followed by 30 µg/kg for subsequent cycles.

Units	Counts
Participants	OG000

Secondary

Change From Baseline in HRQoL as Measured by Functional Assessment of Cancer Therapy - Lymphoma (FACT-Lym)

The FACT-Lym consists of a 27-item general core questionnaire (i.e., Functional Assessment of Cancer Therapy - General [FACT-G]) and a 15-item disease-specific questionnaire (Lymphoma Subscale). The FACT-G includes 4 domains: physical well-being, social/family well-being, emotional well-being, and functional well-being. The total FACT-Lym score (0-168) was obtained by summing individual subscale scores. Higher scores for the scales indicate better quality of life. Change was calculated as the value at the last observation minus the value at baseline.

PRO Population: All participants in the all-treated population with baseline score (at least one instrument) and at least 1 post-baseline score (in at least one instrument).

Posted

Mean

Standard Deviation

score on a scale

Baseline, Day 1 of Cycles 2 to 15 (one cycle = 21 days) and EOT (up to 3 years)

ID	Title	Description
OG000	Camidanlumab Tesirine	Participants received IV infusions of camidanlumab tesirine Q3W at a dose of 45 µg/kg on Day 1 of each cycle (one cycle = 21 days) for 2 cycles, followed by 30 µg/kg for subsequent cycles.

Units	Counts
Participants

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Bone marrow failure	Blood and lymphatic system disorders	MedDRA (22.0.)	Systematic Assessment	EG0001 events1 affected117 at risk
Febrile neutropenia	Blood and lymphatic system disorders	MedDRA (22.0.)	Systematic Assessment	EG0001 events1 affected117 at risk
Acute myocardial infarction	Cardiac disorders	MedDRA (22.0.)	Systematic Assessment	EG0001 events1 affected117 at risk
Cardiac arrest	Cardiac disorders	MedDRA (22.0.)	Systematic Assessment	EG0001 events1 affected117 at risk
Left ventricular failure	Cardiac disorders	MedDRA (22.0.)	Systematic Assessment	EG0001 events1 affected117 at risk
Myocardial infarction	Cardiac disorders	MedDRA (22.0.)	Systematic Assessment	EG0001 events1 affected117 at risk
Thyroiditis	Endocrine disorders	MedDRA (22.0.)	Systematic Assessment	EG0001 events1 affected117 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA (22.0.)	Systematic Assessment	EG0002 events2 affected117 at risk
Duodenal ulcer	Gastrointestinal disorders	MedDRA (22.0.)	Systematic Assessment	EG0001 events1 affected117 at risk
Duodenal ulcer perforation	Gastrointestinal disorders	MedDRA (22.0.)	Systematic Assessment	EG0001 events1 affected117 at risk
Inguinal hernia	Gastrointestinal disorders	MedDRA (22.0.)	Systematic Assessment	EG0001 events1 affected117 at risk
Intestinal obstruction	Gastrointestinal disorders	MedDRA (22.0.)	Systematic Assessment	EG0001 events1 affected117 at risk
Small intestinal obstruction	Gastrointestinal disorders	MedDRA (22.0.)	Systematic Assessment	EG0002 events1 affected117 at risk
Pyrexia	General disorders	MedDRA (22.0.)	Systematic Assessment	EG0003 events3 affected117 at risk
Drug-induced liver injury	Hepatobiliary disorders	MedDRA (22.0.)	Systematic Assessment	EG0001 events1 affected117 at risk
Cellulitis	Infections and infestations	MedDRA (22.0.)	Systematic Assessment	EG0002 events2 affected117 at risk
Pneumonia	Infections and infestations	MedDRA (22.0.)	Systematic Assessment	EG0002 events2 affected117 at risk
Adenovirus infection	Infections and infestations	MedDRA (22.0.)	Systematic Assessment	EG0001 events1 affected117 at risk
Bronchopulmonary aspergillosis	Infections and infestations	MedDRA (22.0.)	Systematic Assessment	EG0001 events1 affected117 at risk
JC virus infection	Infections and infestations	MedDRA (22.0.)	Systematic Assessment	EG0001 events1 affected117 at risk
Lung infection	Infections and infestations	MedDRA (22.0.)	Systematic Assessment	EG0001 events1 affected117 at risk
Pneumonia bacterial	Infections and infestations	MedDRA (22.0.)	Systematic Assessment	EG0001 events1 affected117 at risk
Pneumonia pneumococcal	Infections and infestations	MedDRA (22.0.)	Systematic Assessment	EG0001 events1 affected117 at risk
Rash pustular	Infections and infestations	MedDRA (22.0.)	Systematic Assessment	EG0001 events1 affected117 at risk
Sepsis	Infections and infestations	MedDRA (22.0.)	Systematic Assessment	EG0001 events1 affected117 at risk
Septic shock	Infections and infestations	MedDRA (22.0.)	Systematic Assessment	EG0001 events1 affected117 at risk
Tooth infection	Infections and infestations	MedDRA (22.0.)	Systematic Assessment	EG0001 events1 affected117 at risk
Varicella zoster virus infection	Infections and infestations	MedDRA (22.0.)	Systematic Assessment	EG0001 events1 affected117 at risk
Transplant failure	Injury, poisoning and procedural complications	MedDRA (22.0.)	Systematic Assessment	EG0001 events1 affected117 at risk
Diabetic ketoacidosis	Metabolism and nutrition disorders	MedDRA (22.0.)	Systematic Assessment	EG0002 events2 affected117 at risk
Acidosis	Metabolism and nutrition disorders	MedDRA (22.0.)	Systematic Assessment	EG0001 events1 affected117 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA (22.0.)	Systematic Assessment	EG0001 events1 affected117 at risk
Electrolyte imbalance	Metabolism and nutrition disorders	MedDRA (22.0.)	Systematic Assessment	EG0001 events1 affected117 at risk
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA (22.0.)	Systematic Assessment	EG0001 events1 affected117 at risk
Type 1 diabetes mellitus	Metabolism and nutrition disorders	MedDRA (22.0.)	Systematic Assessment	EG0001 events1 affected117 at risk
Muscular weakness	Musculoskeletal and connective tissue disorders	MedDRA (22.0.)	Systematic Assessment	EG0001 events1 affected117 at risk
Myositis	Musculoskeletal and connective tissue disorders	MedDRA (22.0.)	Systematic Assessment	EG0001 events1 affected117 at risk
Cancer pain	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (22.0.)	Systematic Assessment	EG0001 events1 affected117 at risk
Guillain-Barre syndrome	Nervous system disorders	MedDRA (22.0.)	Systematic Assessment	EG0004 events4 affected117 at risk
Epilepsy	Nervous system disorders	MedDRA (22.0.)	Systematic Assessment	EG0001 events1 affected117 at risk
Peripheral motor neuropathy	Nervous system disorders	MedDRA (22.0.)	Systematic Assessment	EG0001 events1 affected117 at risk
Peripheral sensory neuropathy	Nervous system disorders	MedDRA (22.0.)	Systematic Assessment	EG0001 events1 affected117 at risk
Radiculopathy	Nervous system disorders	MedDRA (22.0.)	Systematic Assessment	EG0001 events1 affected117 at risk
Syncope	Nervous system disorders	MedDRA (22.0.)	Systematic Assessment	EG0001 events1 affected117 at risk
Device occlusion	Product Issues	MedDRA (22.0.)	Systematic Assessment	EG0001 events1 affected117 at risk
Acute kidney injury	Renal and urinary disorders	MedDRA (22.0.)	Systematic Assessment	EG0001 events1 affected117 at risk
Tubulointerstitial nephritis	Renal and urinary disorders	MedDRA (22.0.)	Systematic Assessment	EG0001 events1 affected117 at risk
Pneumonitis	Respiratory, thoracic and mediastinal disorders	MedDRA (22.0.)	Systematic Assessment	EG0002 events2 affected117 at risk
Acute respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA (22.0.)	Systematic Assessment	EG0001 events1 affected117 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA (22.0.)	Systematic Assessment	EG0001 events1 affected117 at risk
Respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA (22.0.)	Systematic Assessment	EG0001 events1 affected117 at risk
Rash maculo-papular	Skin and subcutaneous tissue disorders	MedDRA (22.0.)	Systematic Assessment	EG0003 events3 affected117 at risk
Dermatitis exfoliative generalised	Skin and subcutaneous tissue disorders	MedDRA (22.0.)	Systematic Assessment	EG0001 events1 affected117 at risk
Dermatosis	Skin and subcutaneous tissue disorders	MedDRA (22.0.)	Systematic Assessment	EG0001 events1 affected117 at risk
Eczema	Skin and subcutaneous tissue disorders	MedDRA (22.0.)	Systematic Assessment	EG0001 events1 affected117 at risk
Lichenoid keratosis	Skin and subcutaneous tissue disorders	MedDRA (22.0.)	Systematic Assessment	EG0001 events1 affected117 at risk
Parakeratosis	Skin and subcutaneous tissue disorders	MedDRA (22.0.)	Systematic Assessment	EG0001 events1 affected117 at risk
Photosensitivity reaction	Skin and subcutaneous tissue disorders	MedDRA (22.0.)	Systematic Assessment	EG0001 events1 affected117 at risk
Shock haemorrhagic	Vascular disorders	MedDRA (22.0.)	Systematic Assessment	EG0001 events1 affected117 at risk
Superior vena cava occlusion	Vascular disorders	MedDRA (22.0.)	Systematic Assessment	EG0001 events1 affected117 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA (22.0.)	Systematic Assessment	EG00039 events29 affected117 at risk
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA (22.0.)	Systematic Assessment	EG00034 events24 affected117 at risk
Neutropenia	Blood and lymphatic system disorders	MedDRA (22.0.)	Systematic Assessment	EG00029 events19 affected117 at risk
Lymphopenia	Blood and lymphatic system disorders	MedDRA (22.0.)	Systematic Assessment	EG00026 events18 affected117 at risk
Sinus tachycardia	Cardiac disorders	MedDRA (22.0.)	Systematic Assessment	EG0008 events8 affected117 at risk
Hypothyroidism	Endocrine disorders	MedDRA (22.0.)	Systematic Assessment	EG00012 events12 affected117 at risk
Hyperthyroidism	Endocrine disorders	MedDRA (22.0.)	Systematic Assessment	EG0008 events8 affected117 at risk
Thyroiditis	Endocrine disorders	MedDRA (22.0.)	Systematic Assessment	EG0007 events7 affected117 at risk
Nausea	Gastrointestinal disorders	MedDRA (22.0.)	Systematic Assessment	EG00040 events32 affected117 at risk
Constipation	Gastrointestinal disorders	MedDRA (22.0.)	Systematic Assessment	EG00023 events20 affected117 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA (22.0.)	Systematic Assessment	EG00026 events19 affected117 at risk
Vomiting	Gastrointestinal disorders	MedDRA (22.0.)	Systematic Assessment	EG00017 events13 affected117 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA (22.0.)	Systematic Assessment	EG00014 events12 affected117 at risk
Dry mouth	Gastrointestinal disorders	MedDRA (22.0.)	Systematic Assessment	EG0007 events7 affected117 at risk
Dyspepsia	Gastrointestinal disorders	MedDRA (22.0.)	Systematic Assessment	EG0006 events6 affected117 at risk
Stomatitis	Gastrointestinal disorders	MedDRA (22.0.)	Systematic Assessment	EG0006 events6 affected117 at risk
Fatigue	General disorders	MedDRA (22.0.)	Systematic Assessment	EG00053 events45 affected117 at risk
Pyrexia	General disorders	MedDRA (22.0.)	Systematic Assessment	EG00047 events35 affected117 at risk
Oedema peripheral	General disorders	MedDRA (22.0.)	Systematic Assessment	EG00015 events14 affected117 at risk
Chills	General disorders	MedDRA (22.0.)	Systematic Assessment	EG00014 events12 affected117 at risk
Asthenia	General disorders	MedDRA (22.0.)	Systematic Assessment	EG0008 events8 affected117 at risk
Face oedema	General disorders	MedDRA (22.0.)	Systematic Assessment	EG0007 events7 affected117 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA (22.0.)	Systematic Assessment	EG0008 events7 affected117 at risk
Gamma-glutamyltransferase increased	Investigations	MedDRA (22.0.)	Systematic Assessment	EG00026 events20 affected117 at risk
Alanine aminotransferase increased	Investigations	MedDRA (22.0.)	Systematic Assessment	EG00016 events15 affected117 at risk
Aspartate aminotransferase increased	Investigations	MedDRA (22.0.)	Systematic Assessment	EG00017 events14 affected117 at risk
Blood alkaline phosphatase increased	Investigations	MedDRA (22.0.)	Systematic Assessment	EG00015 events11 affected117 at risk
Amylase increased	Investigations	MedDRA (22.0.)	Systematic Assessment	EG00012 events9 affected117 at risk
Lipase increased	Investigations	MedDRA (22.0.)	Systematic Assessment	EG00011 events9 affected117 at risk
Weight decreased	Investigations	MedDRA (22.0.)	Systematic Assessment	EG0009 events9 affected117 at risk
Hypophosphataemia	Metabolism and nutrition disorders	MedDRA (22.0.)	Systematic Assessment	EG00029 events21 affected117 at risk
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA (22.0.)	Systematic Assessment	EG00021 events14 affected117 at risk
Hypokalaemia	Metabolism and nutrition disorders	MedDRA (22.0.)	Systematic Assessment	EG00018 events14 affected117 at risk
Decreased appetite	Metabolism and nutrition disorders	MedDRA (22.0.)	Systematic Assessment	EG00012 events12 affected117 at risk
Hypomagnesaemia	Metabolism and nutrition disorders	MedDRA (22.0.)	Systematic Assessment	EG00010 events9 affected117 at risk
Hyponatraemia	Metabolism and nutrition disorders	MedDRA (22.0.)	Systematic Assessment	EG0009 events7 affected117 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA (22.0.)	Systematic Assessment	EG0007 events6 affected117 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA (22.0.)	Systematic Assessment	EG00022 events19 affected117 at risk
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA (22.0.)	Systematic Assessment	EG00015 events11 affected117 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA (22.0.)	Systematic Assessment	EG0009 events6 affected117 at risk
Headache	Nervous system disorders	MedDRA (22.0.)	Systematic Assessment	EG00022 events19 affected117 at risk
Dizziness	Nervous system disorders	MedDRA (22.0.)	Systematic Assessment	EG00013 events12 affected117 at risk
Peripheral sensory neuropathy	Nervous system disorders	MedDRA (22.0.)	Systematic Assessment	EG0007 events7 affected117 at risk
Dysgeusia	Nervous system disorders	MedDRA (22.0.)	Systematic Assessment	EG0006 events6 affected117 at risk
Neuropathy peripheral	Nervous system disorders	MedDRA (22.0.)	Systematic Assessment	EG0006 events6 affected117 at risk
Insomnia	Psychiatric disorders	MedDRA (22.0.)	Systematic Assessment	EG00017 events16 affected117 at risk
Anxiety	Psychiatric disorders	MedDRA (22.0.)	Systematic Assessment	EG0008 events6 affected117 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA (22.0.)	Systematic Assessment	EG00018 events16 affected117 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA (22.0.)	Systematic Assessment	EG00012 events12 affected117 at risk
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	MedDRA (22.0.)	Systematic Assessment	EG00011 events10 affected117 at risk
Rash maculo-papular	Skin and subcutaneous tissue disorders	MedDRA (22.0.)	Systematic Assessment	EG00038 affected117 at risk
Rash	Skin and subcutaneous tissue disorders	MedDRA (22.0.)	Systematic Assessment	EG00036 events31 affected117 at risk
Pruritus	Skin and subcutaneous tissue disorders	MedDRA (22.0.)	Systematic Assessment	EG00030 events28 affected117 at risk
Erythema	Skin and subcutaneous tissue disorders	MedDRA (22.0.)	Systematic Assessment	EG00019 events14 affected117 at risk
Dry skin	Skin and subcutaneous tissue disorders	MedDRA (22.0.)	Systematic Assessment	EG0008 events7 affected117 at risk
Hypertension	Vascular disorders	MedDRA (22.0.)	Systematic Assessment	EG0009 events6 affected117 at risk
Muscular weakness	Musculoskeletal and connective tissue disorders	MedDRA (22.0.)	Systematic Assessment	EG0006 affected117 at risk

ID	Term
D006689	Hodgkin Disease
D012008	Recurrence
D008223	Lymphoma

ID	Term
D009370	Neoplasms by Histologic Type
D009369	Neoplasms
D008232	Lymphoproliferative Disorders
D008206	Lymphatic Diseases
D006425	Hemic and Lymphatic Diseases
D007160	Immunoproliferative Disorders
D007154	Immune System Diseases
D020969	Disease Attributes
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms