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Immunotherapy (Nivolumab or Brentuximab Vedotin) Plus Combination Chemotherapy in Treating Patients With Newly Diagnosed Stage III-IV Classic Hodgkin Lymphoma

A Phase III, Randomized Study of Nivolumab (Opdivo) Plus AVD or Brentuximab Vedotin (Adcetris) Plus AVD in Patients (Age >/= 12 Years) With Newly Diagnosed Advanced Stage Classical Hodgkin Lymphoma

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03907488
Enrollment
994
Registered
2019-04-09
Start date
2019-08-29
Completion date
2027-03-28
Last updated
2026-08-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ann Arbor Stage III Hodgkin Lymphoma, Ann Arbor Stage III Lymphocyte-Depleted Classic Hodgkin Lymphoma, Ann Arbor Stage III Mixed Cellularity Classic Hodgkin Lymphoma, Ann Arbor Stage III Nodular Sclerosis Classic Hodgkin Lymphoma, Ann Arbor Stage IV Hodgkin Lymphoma, Ann Arbor Stage IV Lymphocyte-Depleted Classic Hodgkin Lymphoma, Ann Arbor Stage IV Mixed Cellularity Classic Hodgkin Lymphoma, Ann Arbor Stage IV Nodular Sclerosis Classic Hodgkin Lymphoma, Classic Hodgkin Lymphoma, Lymphocyte-Rich Classic Hodgkin Lymphoma

Brief summary

This phase III trial compares immunotherapy drugs (nivolumab or brentuximab vedotin) when given with combination chemotherapy in treating patients with newly diagnosed stage III or IV classic Hodgkin lymphoma. Immunotherapy with monoclonal antibodies, such as nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Brentuximab vedotin is a monoclonal antibody, brentuximab, linked to a toxic agent called vedotin. Brentuximab attaches to cancer cells in a targeted way and delivers vedotin to kill them. Chemotherapy drugs, such as doxorubicin, vinblastine, and dacarbazine, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. The addition of nivolumab or brentuximab vedotin to combination chemotherapy may shrink the cancer or extend the time without disease symptoms coming back.

Detailed description

PRIMARY OBJECTIVE: I. To compare the progression-free survival (PFS) in patients with newly diagnosed advanced stage classical Hodgkin lymphoma randomized to N-AVD (nivolumab, doxorubicin hydrochloride \[doxorubicin\], vinblastine sulfate \[vinblastine\], dacarbazine) versus that obtained with BV-AVD (brentuximab vedotin, doxorubicin, vinblastine, dacarbazine). SECONDARY OBJECTIVES: I. To compare overall survival (OS) in patients randomized to N-AVD versus BV-AVD. II. To compare event-free survival (EFS) in patients randomized to N-AVD versus BV-AVD. III. To compare the metabolic complete response (CR) rate at the end of treatment in patients randomized to N-AVD versus BV-AVD. IV. To compare the physician-reported treatment-related adverse event rates between arms stratified by age groups. V. To compare patient-reported symptoms using selected Patient Reported Outcome Common Toxicity Criteria for Adverse Events (PRO-CTCAE) items between arms stratified by age groups. VI. To compare the safety and tolerability of N-AVD versus that of BV-AVD. QUALITY OF LIFE OBJECTIVE: I. To compare between arms patient-reported fatigue, neuropathy and health-related quality of life over time (baseline, beginning of cycle 3, 4-8 weeks after the last dose of protocol therapy \[following last dose of study drug or radiation therapy, whichever is later\], and 1 and 3 years after randomization) using the Patient Reported Outcomes Measurement Information System (PROMIS)-Fatigue, the Functional Assessment of Cancer Therapy/Gynecologic Oncology Group-Neurotoxicity (FACT/GOG-Ntx), and the PROMIS Global, respectively. BANKING OBJECTIVES: I. To bank specimens for future correlative studies. II. To bank positron emission tomography (PET)-computed tomography (CT) images for future correlative studies. OUTLINE: Patients are randomized to 1 of 2 arms. ARM I: Patients receive doxorubicin hydrochloride intravenously (IV), vinblastine sulfate IV, dacarbazine IV, and nivolumab IV over 30 minutes on days 1 and 15. Patients may receive pegfilgrastim subcutaneously (SC) on days 2 and 16, or filgrastim SC or IV on days 6-10 and 21-25. Treatment repeats every 28 days for 6 cycles in the absence of disease progression or unacceptable toxicity. After completion of cycle 6, patients may receive radiation therapy 5 days per week for approximately 4 weeks at the discretion of the treating physician. Patients also undergo peripheral blood specimen collection and CT, PET/CT and/or magnetic resonance imaging (MRI) on study. ARM II: Patients receive doxorubicin hydrochloride IV, vinblastine sulfate IV, dacarbazine IV, and brentuximab vedotin IV over 30 minutes on days 1 and 15. Patients may receive pegfilgrastim SC on days 2 and 16, or filgrastim SC or IV on days 6-10 and 21-25. Treatment repeats every 28 days for 6 cycles in the absence of disease progression or unacceptable toxicity. After completion of cycle 6, patients may receive radiation therapy 5 days per week for approximately 4 weeks at the discretion of the treating physician. Patients also undergo peripheral blood specimen collection and CT, PET/CT and MRI on study. After completion of study treatment and prior to disease progression, patients are followed up every 3 months for the first year, every 6 months for years 2 and 3, then annually until 10 years after registration. Patients are followed up at the time of progression and then annually until 10 years after registration. Patients who receive radiation therapy are followed up at 8-12 weeks after completion of radiation therapy.

Interventions

PROCEDUREBiospecimen Collection

Undergo peripheral blood collection

DRUGBrentuximab Vedotin

Given IV

PROCEDUREComputed Tomography

Undergo PET/CT or CT scan

DRUGDacarbazine

Given IV

DRUGDoxorubicin Hydrochloride

Given IV

BIOLOGICALFilgrastim

Given SC or IV

PROCEDUREMagnetic Resonance Imaging

Undergo MRI

BIOLOGICALNivolumab

Given IV

BIOLOGICALPegfilgrastim

Given SC

PROCEDUREPositron Emission Tomography

Undergo PET/CT scan

OTHERQuality-of-Life Assessment

Ancillary studies

OTHERQuestionnaire Administration

Ancillary studies

RADIATIONRadiation Therapy

Receive radiation therapy

DRUGVinblastine Sulfate

Given IV

Sponsors

National Cancer Institute (NCI)
Lead SponsorNIH

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
12 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* All patients must have histologically confirmed newly diagnosed, previously untreated stage III or IV classical Hodgkin lymphoma (nodular sclerosing, mixed cellularity, lymphocyte-rich, or lymphocyte-depleted, or not otherwise specified \[NOS\]). Nodular lymphocyte predominant Hodgkin lymphoma is not eligible. * Patients must have bidimensionally measurable disease (at least one lesion with longest diameter \>= 1.5 cm) documented on the Lymphoma Baseline Tumor Assessment Form in Rave. * Patients must have a whole body or limited whole body PET-CT scan performed within 42 days prior to registration. (A contrast-enhanced \[diagnostic\] CT, MRI or MR-PET is acceptable in event that PET-CT is contra-indicated, however if it is later possible to administer a PET-CT, then PET-CT is strongly preferred for the interim scan (after cycle 2) (if performed) and the EOT assessment. Otherwise, if PET-CT is not subsequently possible, then the same modality as baseline must be used throughout the trial.) NOTE: All images from PET-CT, CT, MRI or MR-PET scans performed as standard of care to assess disease (within 42 days prior to registration) must be submitted and associated radiology reports must be submitted. * Patients must be \>= 12 years of age. * Patients must not have received any prior chemotherapy, radiation, or antibody-based treatment for classical Hodgkin lymphoma. Steroid pre-treatment is permitted. * Patients must not have had prior solid organ transplant. * Patients must not have had prior allogeneic stem cell transplantation. * Patients must not have received a live vaccine within 30 days prior to planned day 1 of protocol therapy (e.g. measles, mumps, rubella, varicella, yellow fever, rabies, Bacillus Calmette-Guerin \[BCG\], oral polio vaccine, and oral typhoid). * At registration, investigator must declare intent-to-treat with residual PET radiation therapy (residual PET RT- RPRT) to be administered after patient completes 6 cycles of therapy if, after end of treatment, the patient meets criteria specified for receiving RT). Patients will be stratified by investigator's intent-to-treat with residual PET RT. * All pediatric patients (\< 18 years of age) will be considered intent-to-treat with Residual PET RT at time of registration. * Patients must have a performance status corresponding to Zubrod scores of 0, 1 or 2. Use Lansky for patients =\< 17 years of age. \*The conversion of the Lansky to Eastern Cooperative Oncology Group (ECOG) scales is intended for National Cancer Institute (NCI) reporting purposes only. * Adults (age 18 or older): Creatinine clearance \>= 30 mL/min, as estimated by the Cockcroft and Gault formula. The creatinine value used in the calculation must have been obtained within 28 days prior to registration. Estimated creatinine clearance is based on actual body weight. Pediatric Patients (age 12-17), the following must have been obtained within 14 days prior to registration: * Measured or calculated creatinine clearance or radioisotope glomerular filtration rate (GFR) \>= 70 ml/min/1.73 m\^2, or * Serum creatinine =\< 1.5 x institutional upper limit of normal (IULN), or a serum creatinine (SCr) based on age/gender as follows: * Age \< 13 maximum serum creatinine: Male 1.2 mg/dL; Female 1.2 mg/dL * Age 13 to \< 16 maximum serum creatinine: Male 1.5 mg/dL; Female 1.4 mg/dL * Age 16-17 maximum serum creatinine: Male 1.7 mg/dL; Female 1.4 mg/dL * Total bilirubin =\< 2 x IULN (must be documented within 28 days prior to registration for adults \[age 18 or older\]; must be documented within 14 days prior to registration for pediatric patients \[age 12-17\]). * Unless due to Gilbert's disease, lymphomatous involvement of liver or vanishing bile duct syndrome * Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =\< 3 x IULN (must be documented within 28 days prior to registration for adults \[age 18 or older\]; must be documented within 14 days prior to registration for pediatric patients \[age 12-17\]). * Unless due to Gilbert's disease, lymphomatous involvement of liver or vanishing bile duct syndrome * Patients must have an echocardiogram (ECHO), multigated acquisition (MUGA), or functional cardiac imaging scan with a left ventricular ejection (LVEF) fraction \>= 50% or a shortening fraction of \>= 27%. For all patients, the ECHO, MUGA, or functional cardiac imaging scan must be performed within 42 days prior to registration. * Patients with known human immunodeficiency virus (HIV) infection must be receiving anti-retroviral therapy and have an undetectable or unquantifiable viral load at their most recent viral load test within 6 months prior to registration. * Patients must not have known active hepatitis B (HBV) or hepatitis C virus (HCV) at date of registration. Patients with previously treated HBV or HCV that have an undetectable viral load within 6 months prior to registration and no residual hepatic impairment are eligible. * Patients must not have any known central nervous system lymphoma. * Patients must not have a history of or active interstitial pneumonitis or interstitial lung disease. * Patients must not have had a diagnosis of inherited or acquired immunodeficiency. * Patients must not have any known uncontrolled intercurrent illness including, but not limited to symptomatic congestive heart failure, unstable angina pectoris, hemodynamically unstable cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements. * Patients must not have a condition requiring systemic treatment with either corticosteroids (\> 10 mg daily prednisone equivalents) or other immunosuppressive medications within 14 days prior to registration. Inhaled or topical steroids, and adrenal replacement doses \> 10 mg daily prednisone equivalents are permitted in the absence of active autoimmune disease. Steroid use for the control of Hodgkin lymphoma symptoms is allowable, but must be discontinued prior to cycle 1, day 1. * Patients with peripheral neuropathy must have \< grade 2 at date of registration. * Patients must not have active autoimmune disease that has required systemic treatment in past 2 years (i.e., with use of disease modifying agents, immunosuppressive drugs, or corticosteroids with doses higher than prednisone 10 mg or equivalent). Autoimmune diseases include but are not limited to autoimmune hepatitis, inflammatory bowel disease (including ulcerative colitis and Crohn's disease), as well as symptomatic disease (e.g.: rheumatoid arthritis, systemic progressive sclerosis \[scleroderma\], systemic lupus erythematosus, autoimmune vasculitis \[e.g., Wegener's granulomatosis\]); central nervous system (CNS) or motor neuropathy considered of autoimmune origin (e.g., Guillain-Barre syndrome and myasthenia gravis, multiple sclerosis or glomerulonephritis). Vitiligo, alopecia, hypothyroidism on stable doses of thyroid replacement therapy, psoriasis not requiring systemic therapy within the past 2 years are permitted. * No second prior malignancy is allowed except for adequately treated basal (or squamous cell) skin cancer, any in situ cancer or other cancer for which the patient has been disease free for two years. * Females of childbearing potential must not be pregnant or nursing, and have a negative pregnancy test within 28 days prior to registration. Women/men of reproductive potential must have agreed to use an effective contraceptive method while receiving study drug and for women until 6 months after receiving the last dose of study drug or, for men, until 7 months after receiving the last dose of study drug. A woman is considered to be of "reproductive potential" if she has had menses at any time in the preceding 12 consecutive months. In addition to routine contraceptive methods, "effective contraception" also includes heterosexual celibacy and surgery intended to prevent pregnancy (or with a side-effect of pregnancy prevention) defined as a hysterectomy, bilateral oophorectomy or bilateral tubal ligation. However, if at any point a previously celibate patient chooses to become heterosexually active during the time period for use of contraceptive measures outlined in the protocol, he/she is responsible for beginning contraceptive measures. * Patients must have one formalin-fixed paraffin embedded (FFPE) diagnostic tumor block or at least 1 diagnostic, 4-5 micron, hematoxylin and eosin (H\&E) slide collected prior to registration and available for submission. * Patients must be offered participation in banking for planned translational medicine and future research. With patient consent, any residuals from the mandatory tissue submission will also be banked for future research. * Patients who can complete Patient-Reported Outcome instruments in English, Spanish, or French must complete the PROMIS Fatigue, the FACT/GOG-Ntx, and the PROMIS Global prior to registration. Patients who do not complete PRO instruments prior to registration but are otherwise eligible will remain eligible for the primary analysis and other secondary analyses. * Patients who can complete Patient-Reported Outcome instruments in English, Spanish, or French must also agree to complete the PROMIS Fatigue, the FACT/GOG-Ntx, the PROMIS Global, and the PRO-CTCAE (or Pediatric \[Ped\] PRO-CTCAE) at the scheduled on-study assessment timepoints. * Patients must be informed of the investigational nature of this study and all patients and/or their parents or legal guardians (for patients \< 18 years of age) must sign and give informed consent and assent (where appropriate) in accordance with institutional and federal guidelines. For participants with impaired decision-making capabilities, legally authorized representatives may sign and give informed consent on behalf of study participants in accordance with applicable federal, local, and Central Institutional Review Board Initiative (CIRB) regulations. * Note: As a part of the Oncology Patient Enrollment Network (OPEN) registration process the treating institution's identity is provided in order to ensure that the current (within 365 days) date of institutional review board approval for this study has been entered in the system.

Design outcomes

Primary

MeasureTime frameDescription
Progression Free Survival (PFS)From date of registration to date of first observation of progressive disease, or death due to any cause, assessed at 2 yearsWill be reported as the number of participants who have experienced death or progression, measured at two years. Progression will be measured according to the 2014 Lugano classification. Will test the null hypothesis (HR=1) for PFS using stratified log-rank test with a one-sided alpha of 0.021. The analysis will be based on modified intent-to-treat and will include all eligible patients as randomized regardless of treatment received. The one-sided alpha of .021 will control of the overall type-one error of the study (including the 2 interim superiority analyses) to be less than .025.

Secondary

MeasureTime frameDescription
Overall SurvivalFrom date of registration to two years or death.Will be reported as the count of participants who have died, measured at two years. Stratified log-rank test at two-sided alpha level of .05.
Event-free Survival (EFS)From date of registration to date of first occurrence of EFS event, assessed at 2 yearsWill be reported as count of participants who have experienced an EFS event or death at two years. EFS Events are defined as: * Disease progression/relapse * Administration of non-protocol specified systemic anti-lymphoma therapy (i.e. salvage therapy) at any time after initiation of protocol therapy. * Administration of any non-protocol specified radiation therapy at any time afterinitiation of protocol therapy Will be estimated using Kaplan-Meier method and compared between treatment arms using cox regression model.
Number of Participants With of Adverse EventsUp to 2 yearsOnly adverse events that are possibly, probably or definitely related to study drug are reported.
Metabolic Complete Response Rate4-8 weeks after last dose of study drugThis outcome measure will be reported by 11/5/2025.

Countries

Canada, Puerto Rico, United States

Contacts

PRINCIPAL_INVESTIGATORAlex F Herrera

SWOG Cancer Research Network

Participant flow

Participants by arm

ArmCount
Arm I (Chemotherapy, Nivolumab, Radiation)
Patients receive doxorubicin hydrochloride IV, vinblastine sulfate IV, dacarbazine IV, and nivolumab IV over 30 minutes on days 1 and 15. Patients may receive pegfilgrastim SC on days 2 and 16, or filgrastim SC or IV on days 6-10 and 21-25. Treatment repeats every 28 days for 6 cycles in the absence of disease progression or unacceptable toxicity. After completion of cycle 6, patients may receive radiation therapy 5 days per week for approximately 4 weeks at the discretion of the treating physician. Patients also undergo peripheral blood specimen collection and CT, PET/CT and MRI on study. Biospecimen Collection: Undergo peripheral blood collection Computed Tomography: Undergo PET/CT or CT scan Dacarbazine: Given IV Doxorubicin Hydrochloride: Given IV Filgrastim: Given SC or IV Magnetic Resonance Imaging: Undergo MRI Nivolumab: Given IV Pegfilgrastim: Given SC Positron Emission Tomography: Undergo PET/CT scan Quality-of-Life Assessment: Ancillary studies Questionnaire Administration: Ancillary studies Radiation Therapy: Receive radiation therapy Vinblastine Sulfate: Given IV
487
Arm II (Chemotherapy, Brentuximab Vedotin, Radiation)
Patients receive doxorubicin hydrochloride IV, vinblastine sulfate IV, dacarbazine IV, and brentuximab vedotin IV over 30 minutes on days 1 and 15. Patients may receive pegfilgrastim SC on days 2 and 16, or filgrastim SC or IV on days 6-10 and 21-25. Treatment repeats every 28 days for 6 cycles in the absence of disease progression or unacceptable toxicity. After completion of cycle 6, patients may receive radiation therapy 5 days per week for approximately 4 weeks at the discretion of the treating physician. Patients also undergo peripheral blood specimen collection and CT, PET/CT and MRI on study. Biospecimen Collection: Undergo peripheral blood collection Brentuximab Vedotin: Given IV Computed Tomography: Undergo PET/CT or CT scan Dacarbazine: Given IV Doxorubicin Hydrochloride: Given IV Filgrastim: Given SC or IV Magnetic Resonance Imaging: Undergo MRI Pegfilgrastim: Given SC Positron Emission Tomography: Undergo PET/CT scan Quality-of-Life Assessment: Ancillary studies Questionnaire Administration: Ancillary studies Radiation Therapy: Receive radiation therapy Vinblastine Sulfate: Given IV
483
Total970

Baseline characteristics

CharacteristicArm I (Chemotherapy, Nivolumab, Radiation)Arm II (Chemotherapy, Brentuximab Vedotin, Radiation)Total
Age, Continuous27.6 years26.8 years27 years
Age, Customized
Age, Stratified
12-17
118 Participants118 Participants236 Participants
Age, Customized
Age, Stratified
18-60
321 Participants318 Participants639 Participants
Age, Customized
Age, Stratified
>60
48 Participants47 Participants95 Participants
Race/Ethnicity, Customized
Asian
11 Participants17 Participants28 Participants
Race/Ethnicity, Customized
Black
58 Participants56 Participants114 Participants
Race/Ethnicity, Customized
Hispanic
66 Participants58 Participants124 Participants
Race/Ethnicity, Customized
Other or unknown
46 Participants49 Participants95 Participants
Race/Ethnicity, Customized
White
372 Participants361 Participants733 Participants
Sex: Female, Male
Female
216 Participants210 Participants426 Participants
Sex: Female, Male
Male
271 Participants273 Participants544 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
7 / 48714 / 483
other
Total, other adverse events
468 / 481465 / 476
serious
Total, serious adverse events
140 / 48118 / 476

Outcome results

Primary

Progression Free Survival (PFS)

Will be reported as the number of participants who have experienced death or progression, measured at two years. Progression will be measured according to the 2014 Lugano classification. Will test the null hypothesis (HR=1) for PFS using stratified log-rank test with a one-sided alpha of 0.021. The analysis will be based on modified intent-to-treat and will include all eligible patients as randomized regardless of treatment received. The one-sided alpha of .021 will control of the overall type-one error of the study (including the 2 interim superiority analyses) to be less than .025.

Time frame: From date of registration to date of first observation of progressive disease, or death due to any cause, assessed at 2 years

Population: All the patients who underwent randomization except for those who were deemed to be ineligible by pathology review or owing to violation of the eligibility criteria.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Arm I (Chemotherapy, Nivolumab, Radiation)Progression Free Survival (PFS)41 Participants
Arm II (Chemotherapy, Brentuximab Vedotin, Radiation)Progression Free Survival (PFS)81 Participants
Comparison: The primary analysis of PFS used a stratified log rank test statistic and is reported as two-sided test. Stratified Cox regression was used to estimate treatment hazard ratios for treatment effect. 95% two-sided intervals are reported. The Kaplan-Meier method was used to estimate PFS curves.p-value: <0.005Log Rank
Secondary

Event-free Survival (EFS)

Will be reported as count of participants who have experienced an EFS event or death at two years. EFS Events are defined as: * Disease progression/relapse * Administration of non-protocol specified systemic anti-lymphoma therapy (i.e. salvage therapy) at any time after initiation of protocol therapy. * Administration of any non-protocol specified radiation therapy at any time afterinitiation of protocol therapy Will be estimated using Kaplan-Meier method and compared between treatment arms using cox regression model.

Time frame: From date of registration to date of first occurrence of EFS event, assessed at 2 years

Population: All the patients who underwent randomization except for those who were deemed to be ineligible by pathology review or owing to violation of the eligibility criteria.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Arm I (Chemotherapy, Nivolumab, Radiation)Event-free Survival (EFS)52 Participants
Arm II (Chemotherapy, Brentuximab Vedotin, Radiation)Event-free Survival (EFS)91 Participants
Secondary

Metabolic Complete Response Rate

This outcome measure will be reported by 11/5/2025.

Time frame: 4-8 weeks after last dose of study drug

Secondary

Number of Participants With of Adverse Events

Only adverse events that are possibly, probably or definitely related to study drug are reported.

Time frame: Up to 2 years

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
Arm I (Chemotherapy, Nivolumab, Radiation)Number of Participants With of Adverse EventsHypomagnesemia5 Participants
Arm I (Chemotherapy, Nivolumab, Radiation)Number of Participants With of Adverse EventsAnorectal infection1 Participants
Arm I (Chemotherapy, Nivolumab, Radiation)Number of Participants With of Adverse EventsHyponatremia30 Participants
Arm I (Chemotherapy, Nivolumab, Radiation)Number of Participants With of Adverse EventsDysesthesia0 Participants
Arm I (Chemotherapy, Nivolumab, Radiation)Number of Participants With of Adverse EventsHypoparathyroidism1 Participants
Arm I (Chemotherapy, Nivolumab, Radiation)Number of Participants With of Adverse EventsBreast pain0 Participants
Arm I (Chemotherapy, Nivolumab, Radiation)Number of Participants With of Adverse EventsHypophosphatemia11 Participants
Arm I (Chemotherapy, Nivolumab, Radiation)Number of Participants With of Adverse EventsDysgeusia37 Participants
Arm I (Chemotherapy, Nivolumab, Radiation)Number of Participants With of Adverse EventsHypotension18 Participants
Arm I (Chemotherapy, Nivolumab, Radiation)Number of Participants With of Adverse EventsActivated partial thromboplastin time prolonged2 Participants
Arm I (Chemotherapy, Nivolumab, Radiation)Number of Participants With of Adverse EventsHypothyroidism36 Participants
Arm I (Chemotherapy, Nivolumab, Radiation)Number of Participants With of Adverse EventsDysmenorrhea1 Participants
Arm I (Chemotherapy, Nivolumab, Radiation)Number of Participants With of Adverse EventsHypoxia3 Participants
Arm I (Chemotherapy, Nivolumab, Radiation)Number of Participants With of Adverse EventsBronchial infection2 Participants
Arm I (Chemotherapy, Nivolumab, Radiation)Number of Participants With of Adverse EventsINR increased3 Participants
Arm I (Chemotherapy, Nivolumab, Radiation)Number of Participants With of Adverse EventsDyspepsia34 Participants
Arm I (Chemotherapy, Nivolumab, Radiation)Number of Participants With of Adverse EventsIleus0 Participants
Arm I (Chemotherapy, Nivolumab, Radiation)Number of Participants With of Adverse EventsAnorexia61 Participants
Arm I (Chemotherapy, Nivolumab, Radiation)Number of Participants With of Adverse EventsImmune system disorders - Other, specify1 Participants
Arm I (Chemotherapy, Nivolumab, Radiation)Number of Participants With of Adverse EventsDysphagia8 Participants
Arm I (Chemotherapy, Nivolumab, Radiation)Number of Participants With of Adverse EventsInfections and infestations - Other, specify18 Participants
Arm I (Chemotherapy, Nivolumab, Radiation)Number of Participants With of Adverse EventsBronchospasm1 Participants
Arm I (Chemotherapy, Nivolumab, Radiation)Number of Participants With of Adverse EventsInfusion related reaction36 Participants
Arm I (Chemotherapy, Nivolumab, Radiation)Number of Participants With of Adverse EventsDysphasia0 Participants
Arm I (Chemotherapy, Nivolumab, Radiation)Number of Participants With of Adverse EventsInfusion site extravasation2 Participants
Arm I (Chemotherapy, Nivolumab, Radiation)Number of Participants With of Adverse EventsAlkaline phosphatase increased58 Participants
Arm I (Chemotherapy, Nivolumab, Radiation)Number of Participants With of Adverse EventsInjection site reaction1 Participants
Arm I (Chemotherapy, Nivolumab, Radiation)Number of Participants With of Adverse EventsDyspnea43 Participants
Arm I (Chemotherapy, Nivolumab, Radiation)Number of Participants With of Adverse EventsInjury, poisoning and procedural complications - O1 Participants
Arm I (Chemotherapy, Nivolumab, Radiation)Number of Participants With of Adverse EventsBruising2 Participants
Arm I (Chemotherapy, Nivolumab, Radiation)Number of Participants With of Adverse EventsInsomnia30 Participants
Arm I (Chemotherapy, Nivolumab, Radiation)Number of Participants With of Adverse EventsDysuria3 Participants
Arm I (Chemotherapy, Nivolumab, Radiation)Number of Participants With of Adverse EventsInvestigations - Other, specify13 Participants
Arm I (Chemotherapy, Nivolumab, Radiation)Number of Participants With of Adverse EventsAnosmia3 Participants
Arm I (Chemotherapy, Nivolumab, Radiation)Number of Participants With of Adverse EventsIrregular menstruation4 Participants
Arm I (Chemotherapy, Nivolumab, Radiation)Number of Participants With of Adverse EventsEar and labyrinth disorders - Other, specify1 Participants
Arm I (Chemotherapy, Nivolumab, Radiation)Number of Participants With of Adverse EventsIrritability1 Participants
Arm I (Chemotherapy, Nivolumab, Radiation)Number of Participants With of Adverse EventsBullous dermatitis0 Participants
Arm I (Chemotherapy, Nivolumab, Radiation)Number of Participants With of Adverse EventsJoint range of motion decreased0 Participants
Arm I (Chemotherapy, Nivolumab, Radiation)Number of Participants With of Adverse EventsEar pain0 Participants
Arm I (Chemotherapy, Nivolumab, Radiation)Number of Participants With of Adverse EventsLaryngopharyngeal dysesthesia1 Participants
Arm I (Chemotherapy, Nivolumab, Radiation)Number of Participants With of Adverse EventsBack pain27 Participants
Arm I (Chemotherapy, Nivolumab, Radiation)Number of Participants With of Adverse EventsLethargy3 Participants
Arm I (Chemotherapy, Nivolumab, Radiation)Number of Participants With of Adverse EventsEczema3 Participants
Arm I (Chemotherapy, Nivolumab, Radiation)Number of Participants With of Adverse EventsLeukocytosis2 Participants
Arm I (Chemotherapy, Nivolumab, Radiation)Number of Participants With of Adverse EventsBurn0 Participants
Arm I (Chemotherapy, Nivolumab, Radiation)Number of Participants With of Adverse EventsLibido decreased6 Participants
Arm I (Chemotherapy, Nivolumab, Radiation)Number of Participants With of Adverse EventsEdema face1 Participants
Arm I (Chemotherapy, Nivolumab, Radiation)Number of Participants With of Adverse EventsLip infection3 Participants
Arm I (Chemotherapy, Nivolumab, Radiation)Number of Participants With of Adverse EventsAnxiety20 Participants
Arm I (Chemotherapy, Nivolumab, Radiation)Number of Participants With of Adverse EventsLipase increased2 Participants
Arm I (Chemotherapy, Nivolumab, Radiation)Number of Participants With of Adverse EventsEdema limbs17 Participants
Arm I (Chemotherapy, Nivolumab, Radiation)Number of Participants With of Adverse EventsLocalized edema3 Participants
Arm I (Chemotherapy, Nivolumab, Radiation)Number of Participants With of Adverse EventsButtock pain1 Participants
Arm I (Chemotherapy, Nivolumab, Radiation)Number of Participants With of Adverse EventsLung infection10 Participants
Arm I (Chemotherapy, Nivolumab, Radiation)Number of Participants With of Adverse EventsEjection fraction decreased3 Participants
Arm I (Chemotherapy, Nivolumab, Radiation)Number of Participants With of Adverse EventsLymph gland infection1 Participants
Arm I (Chemotherapy, Nivolumab, Radiation)Number of Participants With of Adverse EventsAllergic reaction4 Participants
Arm I (Chemotherapy, Nivolumab, Radiation)Number of Participants With of Adverse EventsLymph node pain1 Participants
Arm I (Chemotherapy, Nivolumab, Radiation)Number of Participants With of Adverse EventsElectrocardiogram QT corrected interval prolonged1 Participants
Arm I (Chemotherapy, Nivolumab, Radiation)Number of Participants With of Adverse EventsLymphocyte count decreased109 Participants
Arm I (Chemotherapy, Nivolumab, Radiation)Number of Participants With of Adverse EventsCD4 lymphocytes decreased0 Participants
Arm I (Chemotherapy, Nivolumab, Radiation)Number of Participants With of Adverse EventsLymphocyte count increased4 Participants
Arm I (Chemotherapy, Nivolumab, Radiation)Number of Participants With of Adverse EventsElectrocardiogram T wave abnormal1 Participants
Arm I (Chemotherapy, Nivolumab, Radiation)Number of Participants With of Adverse EventsMalaise8 Participants
Arm I (Chemotherapy, Nivolumab, Radiation)Number of Participants With of Adverse EventsAppendicitis1 Participants
Arm I (Chemotherapy, Nivolumab, Radiation)Number of Participants With of Adverse EventsMemory impairment8 Participants
Arm I (Chemotherapy, Nivolumab, Radiation)Number of Participants With of Adverse EventsEndocrine disorders - Other, specify9 Participants
Arm I (Chemotherapy, Nivolumab, Radiation)Number of Participants With of Adverse EventsMenorrhagia1 Participants
Arm I (Chemotherapy, Nivolumab, Radiation)Number of Participants With of Adverse EventsCPK increased1 Participants
Arm I (Chemotherapy, Nivolumab, Radiation)Number of Participants With of Adverse EventsMetabolism and nutrition disorders - Other, specif5 Participants
Arm I (Chemotherapy, Nivolumab, Radiation)Number of Participants With of Adverse EventsEnterocolitis2 Participants
Arm I (Chemotherapy, Nivolumab, Radiation)Number of Participants With of Adverse EventsMitral valve disease1 Participants
Arm I (Chemotherapy, Nivolumab, Radiation)Number of Participants With of Adverse EventsAcute kidney injury3 Participants
Arm I (Chemotherapy, Nivolumab, Radiation)Number of Participants With of Adverse EventsMovements involuntary1 Participants
Arm I (Chemotherapy, Nivolumab, Radiation)Number of Participants With of Adverse EventsEnterocolitis infectious1 Participants
Arm I (Chemotherapy, Nivolumab, Radiation)Number of Participants With of Adverse EventsMucosal infection1 Participants
Arm I (Chemotherapy, Nivolumab, Radiation)Number of Participants With of Adverse EventsCardiac arrest0 Participants
Arm I (Chemotherapy, Nivolumab, Radiation)Number of Participants With of Adverse EventsMucositis oral109 Participants
Arm I (Chemotherapy, Nivolumab, Radiation)Number of Participants With of Adverse EventsEosinophilia12 Participants
Arm I (Chemotherapy, Nivolumab, Radiation)Number of Participants With of Adverse EventsMuscle cramp14 Participants
Arm I (Chemotherapy, Nivolumab, Radiation)Number of Participants With of Adverse EventsArthralgia65 Participants
Arm I (Chemotherapy, Nivolumab, Radiation)Number of Participants With of Adverse EventsMuscle weakness lower limb5 Participants
Arm I (Chemotherapy, Nivolumab, Radiation)Number of Participants With of Adverse EventsEpistaxis10 Participants
Arm I (Chemotherapy, Nivolumab, Radiation)Number of Participants With of Adverse EventsMuscle weakness trunk1 Participants
Arm I (Chemotherapy, Nivolumab, Radiation)Number of Participants With of Adverse EventsCardiac disorders - Other, specify6 Participants
Arm I (Chemotherapy, Nivolumab, Radiation)Number of Participants With of Adverse EventsMuscle weakness upper limb1 Participants
Arm I (Chemotherapy, Nivolumab, Radiation)Number of Participants With of Adverse EventsErectile dysfunction2 Participants
Arm I (Chemotherapy, Nivolumab, Radiation)Number of Participants With of Adverse EventsMusculoskeletal and connective tissue disorder -5 Participants
Arm I (Chemotherapy, Nivolumab, Radiation)Number of Participants With of Adverse EventsAllergic rhinitis0 Participants
Arm I (Chemotherapy, Nivolumab, Radiation)Number of Participants With of Adverse EventsMyalgia54 Participants
Arm I (Chemotherapy, Nivolumab, Radiation)Number of Participants With of Adverse EventsErythema multiforme1 Participants
Arm I (Chemotherapy, Nivolumab, Radiation)Number of Participants With of Adverse EventsMyositis2 Participants
Arm I (Chemotherapy, Nivolumab, Radiation)Number of Participants With of Adverse EventsCardiac troponin I increased1 Participants
Arm I (Chemotherapy, Nivolumab, Radiation)Number of Participants With of Adverse EventsNail changes2 Participants
Arm I (Chemotherapy, Nivolumab, Radiation)Number of Participants With of Adverse EventsErythroderma1 Participants
Arm I (Chemotherapy, Nivolumab, Radiation)Number of Participants With of Adverse EventsNail discoloration7 Participants
Arm I (Chemotherapy, Nivolumab, Radiation)Number of Participants With of Adverse EventsArthritis3 Participants
Arm I (Chemotherapy, Nivolumab, Radiation)Number of Participants With of Adverse EventsNail infection3 Participants
Arm I (Chemotherapy, Nivolumab, Radiation)Number of Participants With of Adverse EventsEsophageal pain1 Participants
Arm I (Chemotherapy, Nivolumab, Radiation)Number of Participants With of Adverse EventsNail ridging1 Participants
Arm I (Chemotherapy, Nivolumab, Radiation)Number of Participants With of Adverse EventsCardiac troponin T increased1 Participants
Arm I (Chemotherapy, Nivolumab, Radiation)Number of Participants With of Adverse EventsNasal congestion6 Participants
Arm I (Chemotherapy, Nivolumab, Radiation)Number of Participants With of Adverse EventsEsophagitis2 Participants
Arm I (Chemotherapy, Nivolumab, Radiation)Number of Participants With of Adverse EventsNausea317 Participants
Arm I (Chemotherapy, Nivolumab, Radiation)Number of Participants With of Adverse EventsEye disorders - Other, specify3 Participants
Arm I (Chemotherapy, Nivolumab, Radiation)Number of Participants With of Adverse EventsNeck edema3 Participants
Arm I (Chemotherapy, Nivolumab, Radiation)Number of Participants With of Adverse EventsAbdominal distension1 Participants
Arm I (Chemotherapy, Nivolumab, Radiation)Number of Participants With of Adverse EventsNeck pain4 Participants
Arm I (Chemotherapy, Nivolumab, Radiation)Number of Participants With of Adverse EventsFacial muscle weakness1 Participants
Arm I (Chemotherapy, Nivolumab, Radiation)Number of Participants With of Adverse EventsNeoplasms benign, malignant and unspecified (incl2 Participants
Arm I (Chemotherapy, Nivolumab, Radiation)Number of Participants With of Adverse EventsCatheter related infection1 Participants
Arm I (Chemotherapy, Nivolumab, Radiation)Number of Participants With of Adverse EventsNervous system disorders - Other, specify5 Participants
Arm I (Chemotherapy, Nivolumab, Radiation)Number of Participants With of Adverse EventsFacial pain1 Participants
Arm I (Chemotherapy, Nivolumab, Radiation)Number of Participants With of Adverse EventsNeuralgia2 Participants
Arm I (Chemotherapy, Nivolumab, Radiation)Number of Participants With of Adverse EventsAscites1 Participants
Arm I (Chemotherapy, Nivolumab, Radiation)Number of Participants With of Adverse EventsNeutrophil count decreased275 Participants
Arm I (Chemotherapy, Nivolumab, Radiation)Number of Participants With of Adverse EventsFall5 Participants
Arm I (Chemotherapy, Nivolumab, Radiation)Number of Participants With of Adverse EventsNon-cardiac chest pain16 Participants
Arm I (Chemotherapy, Nivolumab, Radiation)Number of Participants With of Adverse EventsCheilitis1 Participants
Arm I (Chemotherapy, Nivolumab, Radiation)Number of Participants With of Adverse EventsOral dysesthesia6 Participants
Arm I (Chemotherapy, Nivolumab, Radiation)Number of Participants With of Adverse EventsFatigue232 Participants
Arm I (Chemotherapy, Nivolumab, Radiation)Number of Participants With of Adverse EventsOral hemorrhage0 Participants
Arm I (Chemotherapy, Nivolumab, Radiation)Number of Participants With of Adverse EventsAlopecia103 Participants
Arm I (Chemotherapy, Nivolumab, Radiation)Number of Participants With of Adverse EventsOral pain30 Participants
Arm I (Chemotherapy, Nivolumab, Radiation)Number of Participants With of Adverse EventsFebrile neutropenia28 Participants
Arm I (Chemotherapy, Nivolumab, Radiation)Number of Participants With of Adverse EventsPain43 Participants
Arm I (Chemotherapy, Nivolumab, Radiation)Number of Participants With of Adverse EventsChest pain - cardiac4 Participants
Arm I (Chemotherapy, Nivolumab, Radiation)Number of Participants With of Adverse EventsPain in extremity22 Participants
Arm I (Chemotherapy, Nivolumab, Radiation)Number of Participants With of Adverse EventsFecal incontinence0 Participants
Arm I (Chemotherapy, Nivolumab, Radiation)Number of Participants With of Adverse EventsPalmar-plantar erythrodysesthesia syndrome1 Participants
Arm I (Chemotherapy, Nivolumab, Radiation)Number of Participants With of Adverse EventsAspartate aminotransferase increased129 Participants
Arm I (Chemotherapy, Nivolumab, Radiation)Number of Participants With of Adverse EventsPalpitations7 Participants
Arm I (Chemotherapy, Nivolumab, Radiation)Number of Participants With of Adverse EventsFever64 Participants
Arm I (Chemotherapy, Nivolumab, Radiation)Number of Participants With of Adverse EventsPancreatic enzymes decreased0 Participants
Arm I (Chemotherapy, Nivolumab, Radiation)Number of Participants With of Adverse EventsChest wall pain2 Participants
Arm I (Chemotherapy, Nivolumab, Radiation)Number of Participants With of Adverse EventsPancreatitis4 Participants
Arm I (Chemotherapy, Nivolumab, Radiation)Number of Participants With of Adverse EventsFibrinogen decreased2 Participants
Arm I (Chemotherapy, Nivolumab, Radiation)Number of Participants With of Adverse EventsPapulopustular rash4 Participants
Arm I (Chemotherapy, Nivolumab, Radiation)Number of Participants With of Adverse EventsAdrenal insufficiency2 Participants
Arm I (Chemotherapy, Nivolumab, Radiation)Number of Participants With of Adverse EventsParesthesia36 Participants
Arm I (Chemotherapy, Nivolumab, Radiation)Number of Participants With of Adverse EventsFlank pain1 Participants
Arm I (Chemotherapy, Nivolumab, Radiation)Number of Participants With of Adverse EventsParonychia1 Participants
Arm I (Chemotherapy, Nivolumab, Radiation)Number of Participants With of Adverse EventsChills22 Participants
Arm I (Chemotherapy, Nivolumab, Radiation)Number of Participants With of Adverse EventsParoxysmal atrial tachycardia2 Participants
Arm I (Chemotherapy, Nivolumab, Radiation)Number of Participants With of Adverse EventsFlashing lights1 Participants
Arm I (Chemotherapy, Nivolumab, Radiation)Number of Participants With of Adverse EventsPelvic pain1 Participants
Arm I (Chemotherapy, Nivolumab, Radiation)Number of Participants With of Adverse EventsAtaxia0 Participants
Arm I (Chemotherapy, Nivolumab, Radiation)Number of Participants With of Adverse EventsPenile infection0 Participants
Arm I (Chemotherapy, Nivolumab, Radiation)Number of Participants With of Adverse EventsFlatulence4 Participants
Arm I (Chemotherapy, Nivolumab, Radiation)Number of Participants With of Adverse EventsPericardial effusion1 Participants
Arm I (Chemotherapy, Nivolumab, Radiation)Number of Participants With of Adverse EventsCholesterol high0 Participants
Arm I (Chemotherapy, Nivolumab, Radiation)Number of Participants With of Adverse EventsPericarditis3 Participants
Arm I (Chemotherapy, Nivolumab, Radiation)Number of Participants With of Adverse EventsFloaters0 Participants
Arm I (Chemotherapy, Nivolumab, Radiation)Number of Participants With of Adverse EventsPeripheral motor neuropathy21 Participants
Arm I (Chemotherapy, Nivolumab, Radiation)Number of Participants With of Adverse EventsAmenorrhea1 Participants
Arm I (Chemotherapy, Nivolumab, Radiation)Number of Participants With of Adverse EventsPeripheral sensory neuropathy141 Participants
Arm I (Chemotherapy, Nivolumab, Radiation)Number of Participants With of Adverse EventsFlu like symptoms4 Participants
Arm I (Chemotherapy, Nivolumab, Radiation)Number of Participants With of Adverse EventsPharyngeal mucositis1 Participants
Arm I (Chemotherapy, Nivolumab, Radiation)Number of Participants With of Adverse EventsChronic kidney disease1 Participants
Arm I (Chemotherapy, Nivolumab, Radiation)Number of Participants With of Adverse EventsPharyngitis0 Participants
Arm I (Chemotherapy, Nivolumab, Radiation)Number of Participants With of Adverse EventsFlushing10 Participants
Arm I (Chemotherapy, Nivolumab, Radiation)Number of Participants With of Adverse EventsPhlebitis3 Participants
Arm I (Chemotherapy, Nivolumab, Radiation)Number of Participants With of Adverse EventsAtelectasis1 Participants
Arm I (Chemotherapy, Nivolumab, Radiation)Number of Participants With of Adverse EventsPhotophobia1 Participants
Arm I (Chemotherapy, Nivolumab, Radiation)Number of Participants With of Adverse EventsFolliculitis2 Participants
Arm I (Chemotherapy, Nivolumab, Radiation)Number of Participants With of Adverse EventsPhotosensitivity1 Participants
Arm I (Chemotherapy, Nivolumab, Radiation)Number of Participants With of Adverse EventsCognitive disturbance3 Participants
Arm I (Chemotherapy, Nivolumab, Radiation)Number of Participants With of Adverse EventsPlatelet count decreased53 Participants
Arm I (Chemotherapy, Nivolumab, Radiation)Number of Participants With of Adverse EventsFracture0 Participants
Arm I (Chemotherapy, Nivolumab, Radiation)Number of Participants With of Adverse EventsPleural effusion2 Participants
Arm I (Chemotherapy, Nivolumab, Radiation)Number of Participants With of Adverse EventsBacteremia0 Participants
Arm I (Chemotherapy, Nivolumab, Radiation)Number of Participants With of Adverse EventsPleuritic pain1 Participants
Arm I (Chemotherapy, Nivolumab, Radiation)Number of Participants With of Adverse EventsGGT increased4 Participants
Arm I (Chemotherapy, Nivolumab, Radiation)Number of Participants With of Adverse EventsPneumonitis11 Participants
Arm I (Chemotherapy, Nivolumab, Radiation)Number of Participants With of Adverse EventsColitis6 Participants
Arm I (Chemotherapy, Nivolumab, Radiation)Number of Participants With of Adverse EventsPostnasal drip2 Participants
Arm I (Chemotherapy, Nivolumab, Radiation)Number of Participants With of Adverse EventsGait disturbance0 Participants
Arm I (Chemotherapy, Nivolumab, Radiation)Number of Participants With of Adverse EventsPresyncope2 Participants
Arm I (Chemotherapy, Nivolumab, Radiation)Number of Participants With of Adverse EventsAtrial fibrillation1 Participants
Arm I (Chemotherapy, Nivolumab, Radiation)Number of Participants With of Adverse EventsProductive cough2 Participants
Arm I (Chemotherapy, Nivolumab, Radiation)Number of Participants With of Adverse EventsGastric hemorrhage0 Participants
Arm I (Chemotherapy, Nivolumab, Radiation)Number of Participants With of Adverse EventsProteinuria2 Participants
Arm I (Chemotherapy, Nivolumab, Radiation)Number of Participants With of Adverse EventsColonic obstruction0 Participants
Arm I (Chemotherapy, Nivolumab, Radiation)Number of Participants With of Adverse EventsPruritus48 Participants
Arm I (Chemotherapy, Nivolumab, Radiation)Number of Participants With of Adverse EventsGastritis9 Participants
Arm I (Chemotherapy, Nivolumab, Radiation)Number of Participants With of Adverse EventsPsychiatric disorders - Other, specify1 Participants
Arm I (Chemotherapy, Nivolumab, Radiation)Number of Participants With of Adverse EventsAmnesia1 Participants
Arm I (Chemotherapy, Nivolumab, Radiation)Number of Participants With of Adverse EventsPsychosis0 Participants
Arm I (Chemotherapy, Nivolumab, Radiation)Number of Participants With of Adverse EventsGastroesophageal reflux disease27 Participants
Arm I (Chemotherapy, Nivolumab, Radiation)Number of Participants With of Adverse EventsPulmonary edema1 Participants
Arm I (Chemotherapy, Nivolumab, Radiation)Number of Participants With of Adverse EventsConcentration impairment4 Participants
Arm I (Chemotherapy, Nivolumab, Radiation)Number of Participants With of Adverse EventsRash acneiform16 Participants
Arm I (Chemotherapy, Nivolumab, Radiation)Number of Participants With of Adverse EventsGastrointestinal disorders - Other, specify10 Participants
Arm I (Chemotherapy, Nivolumab, Radiation)Number of Participants With of Adverse EventsRash maculo-papular55 Participants
Arm I (Chemotherapy, Nivolumab, Radiation)Number of Participants With of Adverse EventsBelching3 Participants
Arm I (Chemotherapy, Nivolumab, Radiation)Number of Participants With of Adverse EventsRash pustular0 Participants
Arm I (Chemotherapy, Nivolumab, Radiation)Number of Participants With of Adverse EventsGastrointestinal pain1 Participants
Arm I (Chemotherapy, Nivolumab, Radiation)Number of Participants With of Adverse EventsRectal fissure0 Participants
Arm I (Chemotherapy, Nivolumab, Radiation)Number of Participants With of Adverse EventsConfusion3 Participants
Arm I (Chemotherapy, Nivolumab, Radiation)Number of Participants With of Adverse EventsRectal hemorrhage1 Participants
Arm I (Chemotherapy, Nivolumab, Radiation)Number of Participants With of Adverse EventsGastroparesis0 Participants
Arm I (Chemotherapy, Nivolumab, Radiation)Number of Participants With of Adverse EventsRectal pain1 Participants
Arm I (Chemotherapy, Nivolumab, Radiation)Number of Participants With of Adverse EventsAgitation4 Participants
Arm I (Chemotherapy, Nivolumab, Radiation)Number of Participants With of Adverse EventsRenal and urinary disorders - Other, specify1 Participants
Arm I (Chemotherapy, Nivolumab, Radiation)Number of Participants With of Adverse EventsGeneral disorders and administration site conditio7 Participants
Arm I (Chemotherapy, Nivolumab, Radiation)Number of Participants With of Adverse EventsRespiratory failure0 Participants
Arm I (Chemotherapy, Nivolumab, Radiation)Number of Participants With of Adverse EventsConjunctivitis1 Participants
Arm I (Chemotherapy, Nivolumab, Radiation)Number of Participants With of Adverse EventsRespiratory, thoracic and mediastinal disorders -3 Participants
Arm I (Chemotherapy, Nivolumab, Radiation)Number of Participants With of Adverse EventsGeneralized edema1 Participants
Arm I (Chemotherapy, Nivolumab, Radiation)Number of Participants With of Adverse EventsRestrictive cardiomyopathy1 Participants
Arm I (Chemotherapy, Nivolumab, Radiation)Number of Participants With of Adverse EventsBladder infection1 Participants
Arm I (Chemotherapy, Nivolumab, Radiation)Number of Participants With of Adverse EventsRhabdomyolysis1 Participants
Arm I (Chemotherapy, Nivolumab, Radiation)Number of Participants With of Adverse EventsGeneralized muscle weakness16 Participants
Arm I (Chemotherapy, Nivolumab, Radiation)Number of Participants With of Adverse EventsRhinorrhea6 Participants
Arm I (Chemotherapy, Nivolumab, Radiation)Number of Participants With of Adverse EventsConjunctivitis infective0 Participants
Arm I (Chemotherapy, Nivolumab, Radiation)Number of Participants With of Adverse EventsSalivary duct inflammation1 Participants
Arm I (Chemotherapy, Nivolumab, Radiation)Number of Participants With of Adverse EventsGlucose intolerance1 Participants
Arm I (Chemotherapy, Nivolumab, Radiation)Number of Participants With of Adverse EventsScalp pain1 Participants
Arm I (Chemotherapy, Nivolumab, Radiation)Number of Participants With of Adverse EventsAnal fissure0 Participants
Arm I (Chemotherapy, Nivolumab, Radiation)Number of Participants With of Adverse EventsScrotal pain0 Participants
Arm I (Chemotherapy, Nivolumab, Radiation)Number of Participants With of Adverse EventsGlucosuria2 Participants
Arm I (Chemotherapy, Nivolumab, Radiation)Number of Participants With of Adverse EventsSeizure2 Participants
Arm I (Chemotherapy, Nivolumab, Radiation)Number of Participants With of Adverse EventsConstipation196 Participants
Arm I (Chemotherapy, Nivolumab, Radiation)Number of Participants With of Adverse EventsSepsis8 Participants
Arm I (Chemotherapy, Nivolumab, Radiation)Number of Participants With of Adverse EventsGuillain-Barre syndrome0 Participants
Arm I (Chemotherapy, Nivolumab, Radiation)Number of Participants With of Adverse EventsSerum amylase increased1 Participants
Arm I (Chemotherapy, Nivolumab, Radiation)Number of Participants With of Adverse EventsBloating7 Participants
Arm I (Chemotherapy, Nivolumab, Radiation)Number of Participants With of Adverse EventsSinus bradycardia1 Participants
Arm I (Chemotherapy, Nivolumab, Radiation)Number of Participants With of Adverse EventsGynecomastia0 Participants
Arm I (Chemotherapy, Nivolumab, Radiation)Number of Participants With of Adverse EventsSinus disorder0 Participants
Arm I (Chemotherapy, Nivolumab, Radiation)Number of Participants With of Adverse EventsCough33 Participants
Arm I (Chemotherapy, Nivolumab, Radiation)Number of Participants With of Adverse EventsSinus tachycardia17 Participants
Arm I (Chemotherapy, Nivolumab, Radiation)Number of Participants With of Adverse EventsHeadache71 Participants
Arm I (Chemotherapy, Nivolumab, Radiation)Number of Participants With of Adverse EventsSkin and subcutaneous tissue disorders - Other, sp16 Participants
Arm I (Chemotherapy, Nivolumab, Radiation)Number of Participants With of Adverse EventsAbdominal pain61 Participants
Arm I (Chemotherapy, Nivolumab, Radiation)Number of Participants With of Adverse EventsSkin hyperpigmentation8 Participants
Arm I (Chemotherapy, Nivolumab, Radiation)Number of Participants With of Adverse EventsHeart failure2 Participants
Arm I (Chemotherapy, Nivolumab, Radiation)Number of Participants With of Adverse EventsSkin hypopigmentation3 Participants
Arm I (Chemotherapy, Nivolumab, Radiation)Number of Participants With of Adverse EventsCreatinine increased27 Participants
Arm I (Chemotherapy, Nivolumab, Radiation)Number of Participants With of Adverse EventsSkin infection6 Participants
Arm I (Chemotherapy, Nivolumab, Radiation)Number of Participants With of Adverse EventsHematuria4 Participants
Arm I (Chemotherapy, Nivolumab, Radiation)Number of Participants With of Adverse EventsSkin ulceration0 Participants
Arm I (Chemotherapy, Nivolumab, Radiation)Number of Participants With of Adverse EventsBlood and lymphatic system disorders - Other, spec3 Participants
Arm I (Chemotherapy, Nivolumab, Radiation)Number of Participants With of Adverse EventsSmall intestinal obstruction0 Participants
Arm I (Chemotherapy, Nivolumab, Radiation)Number of Participants With of Adverse EventsHemolysis1 Participants
Arm I (Chemotherapy, Nivolumab, Radiation)Number of Participants With of Adverse EventsSneezing0 Participants
Arm I (Chemotherapy, Nivolumab, Radiation)Number of Participants With of Adverse EventsCyanosis1 Participants
Arm I (Chemotherapy, Nivolumab, Radiation)Number of Participants With of Adverse EventsSomnolence0 Participants
Arm I (Chemotherapy, Nivolumab, Radiation)Number of Participants With of Adverse EventsHemorrhoidal hemorrhage1 Participants
Arm I (Chemotherapy, Nivolumab, Radiation)Number of Participants With of Adverse EventsSore throat16 Participants
Arm I (Chemotherapy, Nivolumab, Radiation)Number of Participants With of Adverse EventsTendon reflex decreased1 Participants
Arm I (Chemotherapy, Nivolumab, Radiation)Number of Participants With of Adverse EventsAnal fistula0 Participants
Arm I (Chemotherapy, Nivolumab, Radiation)Number of Participants With of Adverse EventsSpasticity1 Participants
Arm I (Chemotherapy, Nivolumab, Radiation)Number of Participants With of Adverse EventsHemorrhoids4 Participants
Arm I (Chemotherapy, Nivolumab, Radiation)Number of Participants With of Adverse EventsStomach pain10 Participants
Arm I (Chemotherapy, Nivolumab, Radiation)Number of Participants With of Adverse EventsDehydration14 Participants
Arm I (Chemotherapy, Nivolumab, Radiation)Number of Participants With of Adverse EventsStroke1 Participants
Arm I (Chemotherapy, Nivolumab, Radiation)Number of Participants With of Adverse EventsHepatic failure2 Participants
Arm I (Chemotherapy, Nivolumab, Radiation)Number of Participants With of Adverse EventsSuperficial thrombophlebitis3 Participants
Arm I (Chemotherapy, Nivolumab, Radiation)Number of Participants With of Adverse EventsBlood bicarbonate decreased3 Participants
Arm I (Chemotherapy, Nivolumab, Radiation)Number of Participants With of Adverse EventsSupraventricular tachycardia0 Participants
Arm I (Chemotherapy, Nivolumab, Radiation)Number of Participants With of Adverse EventsHepatobiliary disorders - Other, specify2 Participants
Arm I (Chemotherapy, Nivolumab, Radiation)Number of Participants With of Adverse EventsSyncope1 Participants
Arm I (Chemotherapy, Nivolumab, Radiation)Number of Participants With of Adverse EventsDelirium0 Participants
Arm I (Chemotherapy, Nivolumab, Radiation)Number of Participants With of Adverse EventsHerpes simplex reactivation1 Participants
Arm I (Chemotherapy, Nivolumab, Radiation)Number of Participants With of Adverse EventsTesticular pain0 Participants
Arm I (Chemotherapy, Nivolumab, Radiation)Number of Participants With of Adverse EventsAkathisia1 Participants
Arm I (Chemotherapy, Nivolumab, Radiation)Number of Participants With of Adverse EventsThromboembolic event12 Participants
Arm I (Chemotherapy, Nivolumab, Radiation)Number of Participants With of Adverse EventsHiccups6 Participants
Arm I (Chemotherapy, Nivolumab, Radiation)Number of Participants With of Adverse EventsThrush7 Participants
Arm I (Chemotherapy, Nivolumab, Radiation)Number of Participants With of Adverse EventsDepressed level of consciousness1 Participants
Arm I (Chemotherapy, Nivolumab, Radiation)Number of Participants With of Adverse EventsThyroid stimulating hormone increased28 Participants
Arm I (Chemotherapy, Nivolumab, Radiation)Number of Participants With of Adverse EventsHoarseness0 Participants
Arm I (Chemotherapy, Nivolumab, Radiation)Number of Participants With of Adverse EventsTinnitus8 Participants
Arm I (Chemotherapy, Nivolumab, Radiation)Number of Participants With of Adverse EventsBlood bilirubin increased14 Participants
Arm I (Chemotherapy, Nivolumab, Radiation)Number of Participants With of Adverse EventsTooth discoloration0 Participants
Arm I (Chemotherapy, Nivolumab, Radiation)Number of Participants With of Adverse EventsHot flashes9 Participants
Arm I (Chemotherapy, Nivolumab, Radiation)Number of Participants With of Adverse EventsTooth infection1 Participants
Arm I (Chemotherapy, Nivolumab, Radiation)Number of Participants With of Adverse EventsDepression10 Participants
Arm I (Chemotherapy, Nivolumab, Radiation)Number of Participants With of Adverse EventsToothache3 Participants
Arm I (Chemotherapy, Nivolumab, Radiation)Number of Participants With of Adverse EventsHypercalcemia6 Participants
Arm I (Chemotherapy, Nivolumab, Radiation)Number of Participants With of Adverse EventsTracheal mucositis0 Participants
Arm I (Chemotherapy, Nivolumab, Radiation)Number of Participants With of Adverse EventsAnal hemorrhage1 Participants
Arm I (Chemotherapy, Nivolumab, Radiation)Number of Participants With of Adverse EventsTracheitis1 Participants
Arm I (Chemotherapy, Nivolumab, Radiation)Number of Participants With of Adverse EventsHyperglycemia57 Participants
Arm I (Chemotherapy, Nivolumab, Radiation)Number of Participants With of Adverse EventsTremor4 Participants
Arm I (Chemotherapy, Nivolumab, Radiation)Number of Participants With of Adverse EventsDermatitis radiation0 Participants
Arm I (Chemotherapy, Nivolumab, Radiation)Number of Participants With of Adverse EventsTumor lysis syndrome1 Participants
Arm I (Chemotherapy, Nivolumab, Radiation)Number of Participants With of Adverse EventsHyperhidrosis14 Participants
Arm I (Chemotherapy, Nivolumab, Radiation)Number of Participants With of Adverse EventsTumor pain0 Participants
Arm I (Chemotherapy, Nivolumab, Radiation)Number of Participants With of Adverse EventsBlood lactate dehydrogenase increased18 Participants
Arm I (Chemotherapy, Nivolumab, Radiation)Number of Participants With of Adverse EventsTyphlitis0 Participants
Arm I (Chemotherapy, Nivolumab, Radiation)Number of Participants With of Adverse EventsVaginal discharge2 Participants
Arm I (Chemotherapy, Nivolumab, Radiation)Number of Participants With of Adverse EventsHyperkalemia5 Participants
Arm I (Chemotherapy, Nivolumab, Radiation)Number of Participants With of Adverse EventsUpper gastrointestinal hemorrhage1 Participants
Arm I (Chemotherapy, Nivolumab, Radiation)Number of Participants With of Adverse EventsDiarrhea101 Participants
Arm I (Chemotherapy, Nivolumab, Radiation)Number of Participants With of Adverse EventsUpper respiratory infection7 Participants
Arm I (Chemotherapy, Nivolumab, Radiation)Number of Participants With of Adverse EventsHyperlipidemia0 Participants
Arm I (Chemotherapy, Nivolumab, Radiation)Number of Participants With of Adverse EventsUrinary frequency2 Participants
Arm I (Chemotherapy, Nivolumab, Radiation)Number of Participants With of Adverse EventsExtrapyramidal disorder1 Participants
Arm I (Chemotherapy, Nivolumab, Radiation)Number of Participants With of Adverse EventsUrinary incontinence1 Participants
Arm I (Chemotherapy, Nivolumab, Radiation)Number of Participants With of Adverse EventsHypermagnesemia4 Participants
Arm I (Chemotherapy, Nivolumab, Radiation)Number of Participants With of Adverse EventsUrinary retention0 Participants
Arm I (Chemotherapy, Nivolumab, Radiation)Number of Participants With of Adverse EventsDisseminated intravascular coagulation1 Participants
Arm I (Chemotherapy, Nivolumab, Radiation)Number of Participants With of Adverse EventsUrinary tract infection7 Participants
Arm I (Chemotherapy, Nivolumab, Radiation)Number of Participants With of Adverse EventsHypernatremia1 Participants
Arm I (Chemotherapy, Nivolumab, Radiation)Number of Participants With of Adverse EventsUrinary tract pain2 Participants
Arm I (Chemotherapy, Nivolumab, Radiation)Number of Participants With of Adverse EventsBlurred vision11 Participants
Arm I (Chemotherapy, Nivolumab, Radiation)Number of Participants With of Adverse EventsUrinary urgency0 Participants
Arm I (Chemotherapy, Nivolumab, Radiation)Number of Participants With of Adverse EventsHyperphosphatemia17 Participants
Arm I (Chemotherapy, Nivolumab, Radiation)Number of Participants With of Adverse EventsUrticaria1 Participants
Arm I (Chemotherapy, Nivolumab, Radiation)Number of Participants With of Adverse EventsDizziness29 Participants
Arm I (Chemotherapy, Nivolumab, Radiation)Number of Participants With of Adverse EventsHypertension41 Participants
Arm I (Chemotherapy, Nivolumab, Radiation)Number of Participants With of Adverse EventsVaginal infection2 Participants
Arm I (Chemotherapy, Nivolumab, Radiation)Number of Participants With of Adverse EventsAnemia198 Participants
Arm I (Chemotherapy, Nivolumab, Radiation)Number of Participants With of Adverse EventsVascular access complication1 Participants
Arm I (Chemotherapy, Nivolumab, Radiation)Number of Participants With of Adverse EventsHyperthyroidism13 Participants
Arm I (Chemotherapy, Nivolumab, Radiation)Number of Participants With of Adverse EventsVascular disorders - Other, specify3 Participants
Arm I (Chemotherapy, Nivolumab, Radiation)Number of Participants With of Adverse EventsDry eye2 Participants
Arm I (Chemotherapy, Nivolumab, Radiation)Number of Participants With of Adverse EventsVasovagal reaction0 Participants
Arm I (Chemotherapy, Nivolumab, Radiation)Number of Participants With of Adverse EventsHypertriglyceridemia2 Participants
Arm I (Chemotherapy, Nivolumab, Radiation)Number of Participants With of Adverse EventsVentricular arrhythmia1 Participants
Arm I (Chemotherapy, Nivolumab, Radiation)Number of Participants With of Adverse EventsBone pain41 Participants
Arm I (Chemotherapy, Nivolumab, Radiation)Number of Participants With of Adverse EventsVentricular tachycardia1 Participants
Arm I (Chemotherapy, Nivolumab, Radiation)Number of Participants With of Adverse EventsHyperuricemia6 Participants
Arm I (Chemotherapy, Nivolumab, Radiation)Number of Participants With of Adverse EventsVertigo2 Participants
Arm I (Chemotherapy, Nivolumab, Radiation)Number of Participants With of Adverse EventsDry mouth19 Participants
Arm I (Chemotherapy, Nivolumab, Radiation)Number of Participants With of Adverse EventsVision decreased3 Participants
Arm I (Chemotherapy, Nivolumab, Radiation)Number of Participants With of Adverse EventsHypoalbuminemia43 Participants
Arm I (Chemotherapy, Nivolumab, Radiation)Number of Participants With of Adverse EventsVoice alteration1 Participants
Arm I (Chemotherapy, Nivolumab, Radiation)Number of Participants With of Adverse EventsAlanine aminotransferase increased163 Participants
Arm I (Chemotherapy, Nivolumab, Radiation)Number of Participants With of Adverse EventsVomiting138 Participants
Arm I (Chemotherapy, Nivolumab, Radiation)Number of Participants With of Adverse EventsHypocalcemia34 Participants
Arm I (Chemotherapy, Nivolumab, Radiation)Number of Participants With of Adverse EventsWatering eyes1 Participants
Arm I (Chemotherapy, Nivolumab, Radiation)Number of Participants With of Adverse EventsDry skin15 Participants
Arm I (Chemotherapy, Nivolumab, Radiation)Number of Participants With of Adverse EventsWeight gain13 Participants
Arm I (Chemotherapy, Nivolumab, Radiation)Number of Participants With of Adverse EventsHypoglycemia7 Participants
Arm I (Chemotherapy, Nivolumab, Radiation)Number of Participants With of Adverse EventsWeight loss25 Participants
Arm I (Chemotherapy, Nivolumab, Radiation)Number of Participants With of Adverse EventsBrachial plexopathy0 Participants
Arm I (Chemotherapy, Nivolumab, Radiation)Number of Participants With of Adverse EventsWheezing2 Participants
Arm I (Chemotherapy, Nivolumab, Radiation)Number of Participants With of Adverse EventsHypokalemia31 Participants
Arm I (Chemotherapy, Nivolumab, Radiation)Number of Participants With of Adverse EventsWhite blood cell decreased202 Participants
Arm I (Chemotherapy, Nivolumab, Radiation)Number of Participants With of Adverse EventsDysarthria1 Participants
Arm I (Chemotherapy, Nivolumab, Radiation)Number of Participants With of Adverse EventsWound infection0 Participants
Arm I (Chemotherapy, Nivolumab, Radiation)Number of Participants With of Adverse EventsAutoimmune disorder1 Participants
Arm II (Chemotherapy, Brentuximab Vedotin, Radiation)Number of Participants With of Adverse EventsWound infection1 Participants
Arm II (Chemotherapy, Brentuximab Vedotin, Radiation)Number of Participants With of Adverse EventsAutoimmune disorder0 Participants
Arm II (Chemotherapy, Brentuximab Vedotin, Radiation)Number of Participants With of Adverse EventsBack pain35 Participants
Arm II (Chemotherapy, Brentuximab Vedotin, Radiation)Number of Participants With of Adverse EventsBacteremia2 Participants
Arm II (Chemotherapy, Brentuximab Vedotin, Radiation)Number of Participants With of Adverse EventsEsophagitis3 Participants
Arm II (Chemotherapy, Brentuximab Vedotin, Radiation)Number of Participants With of Adverse EventsExtrapyramidal disorder2 Participants
Arm II (Chemotherapy, Brentuximab Vedotin, Radiation)Number of Participants With of Adverse EventsAbdominal distension3 Participants
Arm II (Chemotherapy, Brentuximab Vedotin, Radiation)Number of Participants With of Adverse EventsAbdominal pain110 Participants
Arm II (Chemotherapy, Brentuximab Vedotin, Radiation)Number of Participants With of Adverse EventsActivated partial thromboplastin time prolonged3 Participants
Arm II (Chemotherapy, Brentuximab Vedotin, Radiation)Number of Participants With of Adverse EventsAcute kidney injury3 Participants
Arm II (Chemotherapy, Brentuximab Vedotin, Radiation)Number of Participants With of Adverse EventsAdrenal insufficiency0 Participants
Arm II (Chemotherapy, Brentuximab Vedotin, Radiation)Number of Participants With of Adverse EventsAgitation0 Participants
Arm II (Chemotherapy, Brentuximab Vedotin, Radiation)Number of Participants With of Adverse EventsAkathisia0 Participants
Arm II (Chemotherapy, Brentuximab Vedotin, Radiation)Number of Participants With of Adverse EventsAlanine aminotransferase increased209 Participants
Arm II (Chemotherapy, Brentuximab Vedotin, Radiation)Number of Participants With of Adverse EventsAlkaline phosphatase increased84 Participants
Arm II (Chemotherapy, Brentuximab Vedotin, Radiation)Number of Participants With of Adverse EventsAllergic reaction6 Participants
Arm II (Chemotherapy, Brentuximab Vedotin, Radiation)Number of Participants With of Adverse EventsAllergic rhinitis3 Participants
Arm II (Chemotherapy, Brentuximab Vedotin, Radiation)Number of Participants With of Adverse EventsAlopecia127 Participants
Arm II (Chemotherapy, Brentuximab Vedotin, Radiation)Number of Participants With of Adverse EventsAmenorrhea5 Participants
Arm II (Chemotherapy, Brentuximab Vedotin, Radiation)Number of Participants With of Adverse EventsAmnesia0 Participants
Arm II (Chemotherapy, Brentuximab Vedotin, Radiation)Number of Participants With of Adverse EventsAnal fissure1 Participants
Arm II (Chemotherapy, Brentuximab Vedotin, Radiation)Number of Participants With of Adverse EventsAnal fistula1 Participants
Arm II (Chemotherapy, Brentuximab Vedotin, Radiation)Number of Participants With of Adverse EventsAnal hemorrhage1 Participants
Arm II (Chemotherapy, Brentuximab Vedotin, Radiation)Number of Participants With of Adverse EventsAnemia222 Participants
Arm II (Chemotherapy, Brentuximab Vedotin, Radiation)Number of Participants With of Adverse EventsAnorectal infection0 Participants
Arm II (Chemotherapy, Brentuximab Vedotin, Radiation)Number of Participants With of Adverse EventsAnorexia107 Participants
Arm II (Chemotherapy, Brentuximab Vedotin, Radiation)Number of Participants With of Adverse EventsAnosmia1 Participants
Arm II (Chemotherapy, Brentuximab Vedotin, Radiation)Number of Participants With of Adverse EventsAnxiety30 Participants
Arm II (Chemotherapy, Brentuximab Vedotin, Radiation)Number of Participants With of Adverse EventsAppendicitis0 Participants
Arm II (Chemotherapy, Brentuximab Vedotin, Radiation)Number of Participants With of Adverse EventsArthralgia60 Participants
Arm II (Chemotherapy, Brentuximab Vedotin, Radiation)Number of Participants With of Adverse EventsArthritis0 Participants
Arm II (Chemotherapy, Brentuximab Vedotin, Radiation)Number of Participants With of Adverse EventsAscites0 Participants
Arm II (Chemotherapy, Brentuximab Vedotin, Radiation)Number of Participants With of Adverse EventsAspartate aminotransferase increased168 Participants
Arm II (Chemotherapy, Brentuximab Vedotin, Radiation)Number of Participants With of Adverse EventsAtaxia3 Participants
Arm II (Chemotherapy, Brentuximab Vedotin, Radiation)Number of Participants With of Adverse EventsAtelectasis1 Participants
Arm II (Chemotherapy, Brentuximab Vedotin, Radiation)Number of Participants With of Adverse EventsAtrial fibrillation1 Participants
Arm II (Chemotherapy, Brentuximab Vedotin, Radiation)Number of Participants With of Adverse EventsBelching1 Participants
Arm II (Chemotherapy, Brentuximab Vedotin, Radiation)Number of Participants With of Adverse EventsBladder infection1 Participants
Arm II (Chemotherapy, Brentuximab Vedotin, Radiation)Number of Participants With of Adverse EventsBloating18 Participants
Arm II (Chemotherapy, Brentuximab Vedotin, Radiation)Number of Participants With of Adverse EventsBlood and lymphatic system disorders - Other, spec5 Participants
Arm II (Chemotherapy, Brentuximab Vedotin, Radiation)Number of Participants With of Adverse EventsBlood bicarbonate decreased5 Participants
Arm II (Chemotherapy, Brentuximab Vedotin, Radiation)Number of Participants With of Adverse EventsBlood bilirubin increased14 Participants
Arm II (Chemotherapy, Brentuximab Vedotin, Radiation)Number of Participants With of Adverse EventsBlood lactate dehydrogenase increased25 Participants
Arm II (Chemotherapy, Brentuximab Vedotin, Radiation)Number of Participants With of Adverse EventsBlurred vision15 Participants
Arm II (Chemotherapy, Brentuximab Vedotin, Radiation)Number of Participants With of Adverse EventsBone pain99 Participants
Arm II (Chemotherapy, Brentuximab Vedotin, Radiation)Number of Participants With of Adverse EventsBrachial plexopathy1 Participants
Arm II (Chemotherapy, Brentuximab Vedotin, Radiation)Number of Participants With of Adverse EventsBreast pain1 Participants
Arm II (Chemotherapy, Brentuximab Vedotin, Radiation)Number of Participants With of Adverse EventsBronchial infection0 Participants
Arm II (Chemotherapy, Brentuximab Vedotin, Radiation)Number of Participants With of Adverse EventsBronchospasm0 Participants
Arm II (Chemotherapy, Brentuximab Vedotin, Radiation)Number of Participants With of Adverse EventsBruising8 Participants
Arm II (Chemotherapy, Brentuximab Vedotin, Radiation)Number of Participants With of Adverse EventsBullous dermatitis1 Participants
Arm II (Chemotherapy, Brentuximab Vedotin, Radiation)Number of Participants With of Adverse EventsBurn1 Participants
Arm II (Chemotherapy, Brentuximab Vedotin, Radiation)Number of Participants With of Adverse EventsButtock pain0 Participants
Arm II (Chemotherapy, Brentuximab Vedotin, Radiation)Number of Participants With of Adverse EventsCD4 lymphocytes decreased1 Participants
Arm II (Chemotherapy, Brentuximab Vedotin, Radiation)Number of Participants With of Adverse EventsCPK increased1 Participants
Arm II (Chemotherapy, Brentuximab Vedotin, Radiation)Number of Participants With of Adverse EventsCardiac arrest2 Participants
Arm II (Chemotherapy, Brentuximab Vedotin, Radiation)Number of Participants With of Adverse EventsCardiac disorders - Other, specify0 Participants
Arm II (Chemotherapy, Brentuximab Vedotin, Radiation)Number of Participants With of Adverse EventsCardiac troponin I increased0 Participants
Arm II (Chemotherapy, Brentuximab Vedotin, Radiation)Number of Participants With of Adverse EventsCardiac troponin T increased0 Participants
Arm II (Chemotherapy, Brentuximab Vedotin, Radiation)Number of Participants With of Adverse EventsCatheter related infection3 Participants
Arm II (Chemotherapy, Brentuximab Vedotin, Radiation)Number of Participants With of Adverse EventsCheilitis0 Participants
Arm II (Chemotherapy, Brentuximab Vedotin, Radiation)Number of Participants With of Adverse EventsChest pain - cardiac0 Participants
Arm II (Chemotherapy, Brentuximab Vedotin, Radiation)Number of Participants With of Adverse EventsChest wall pain1 Participants
Arm II (Chemotherapy, Brentuximab Vedotin, Radiation)Number of Participants With of Adverse EventsChills20 Participants
Arm II (Chemotherapy, Brentuximab Vedotin, Radiation)Number of Participants With of Adverse EventsCholesterol high1 Participants
Arm II (Chemotherapy, Brentuximab Vedotin, Radiation)Number of Participants With of Adverse EventsChronic kidney disease0 Participants
Arm II (Chemotherapy, Brentuximab Vedotin, Radiation)Number of Participants With of Adverse EventsCognitive disturbance0 Participants
Arm II (Chemotherapy, Brentuximab Vedotin, Radiation)Number of Participants With of Adverse EventsColitis6 Participants
Arm II (Chemotherapy, Brentuximab Vedotin, Radiation)Number of Participants With of Adverse EventsColonic obstruction1 Participants
Arm II (Chemotherapy, Brentuximab Vedotin, Radiation)Number of Participants With of Adverse EventsConcentration impairment7 Participants
Arm II (Chemotherapy, Brentuximab Vedotin, Radiation)Number of Participants With of Adverse EventsConfusion2 Participants
Arm II (Chemotherapy, Brentuximab Vedotin, Radiation)Number of Participants With of Adverse EventsConjunctivitis4 Participants
Arm II (Chemotherapy, Brentuximab Vedotin, Radiation)Number of Participants With of Adverse EventsConjunctivitis infective2 Participants
Arm II (Chemotherapy, Brentuximab Vedotin, Radiation)Number of Participants With of Adverse EventsConstipation209 Participants
Arm II (Chemotherapy, Brentuximab Vedotin, Radiation)Number of Participants With of Adverse EventsCough32 Participants
Arm II (Chemotherapy, Brentuximab Vedotin, Radiation)Number of Participants With of Adverse EventsCreatinine increased13 Participants
Arm II (Chemotherapy, Brentuximab Vedotin, Radiation)Number of Participants With of Adverse EventsCyanosis0 Participants
Arm II (Chemotherapy, Brentuximab Vedotin, Radiation)Number of Participants With of Adverse EventsDehydration32 Participants
Arm II (Chemotherapy, Brentuximab Vedotin, Radiation)Number of Participants With of Adverse EventsDelirium1 Participants
Arm II (Chemotherapy, Brentuximab Vedotin, Radiation)Number of Participants With of Adverse EventsDepressed level of consciousness2 Participants
Arm II (Chemotherapy, Brentuximab Vedotin, Radiation)Number of Participants With of Adverse EventsDepression10 Participants
Arm II (Chemotherapy, Brentuximab Vedotin, Radiation)Number of Participants With of Adverse EventsDermatitis radiation2 Participants
Arm II (Chemotherapy, Brentuximab Vedotin, Radiation)Number of Participants With of Adverse EventsDiarrhea130 Participants
Arm II (Chemotherapy, Brentuximab Vedotin, Radiation)Number of Participants With of Adverse EventsDisseminated intravascular coagulation0 Participants
Arm II (Chemotherapy, Brentuximab Vedotin, Radiation)Number of Participants With of Adverse EventsDizziness40 Participants
Arm II (Chemotherapy, Brentuximab Vedotin, Radiation)Number of Participants With of Adverse EventsDry eye3 Participants
Arm II (Chemotherapy, Brentuximab Vedotin, Radiation)Number of Participants With of Adverse EventsDry mouth32 Participants
Arm II (Chemotherapy, Brentuximab Vedotin, Radiation)Number of Participants With of Adverse EventsDry skin17 Participants
Arm II (Chemotherapy, Brentuximab Vedotin, Radiation)Number of Participants With of Adverse EventsDysarthria0 Participants
Arm II (Chemotherapy, Brentuximab Vedotin, Radiation)Number of Participants With of Adverse EventsDysesthesia3 Participants
Arm II (Chemotherapy, Brentuximab Vedotin, Radiation)Number of Participants With of Adverse EventsDysgeusia60 Participants
Arm II (Chemotherapy, Brentuximab Vedotin, Radiation)Number of Participants With of Adverse EventsDysmenorrhea0 Participants
Arm II (Chemotherapy, Brentuximab Vedotin, Radiation)Number of Participants With of Adverse EventsDyspepsia21 Participants
Arm II (Chemotherapy, Brentuximab Vedotin, Radiation)Number of Participants With of Adverse EventsDysphagia7 Participants
Arm II (Chemotherapy, Brentuximab Vedotin, Radiation)Number of Participants With of Adverse EventsDysphasia1 Participants
Arm II (Chemotherapy, Brentuximab Vedotin, Radiation)Number of Participants With of Adverse EventsDyspnea58 Participants
Arm II (Chemotherapy, Brentuximab Vedotin, Radiation)Number of Participants With of Adverse EventsDysuria1 Participants
Arm II (Chemotherapy, Brentuximab Vedotin, Radiation)Number of Participants With of Adverse EventsEar and labyrinth disorders - Other, specify0 Participants
Arm II (Chemotherapy, Brentuximab Vedotin, Radiation)Number of Participants With of Adverse EventsEar pain1 Participants
Arm II (Chemotherapy, Brentuximab Vedotin, Radiation)Number of Participants With of Adverse EventsEczema7 Participants
Arm II (Chemotherapy, Brentuximab Vedotin, Radiation)Number of Participants With of Adverse EventsEdema face5 Participants
Arm II (Chemotherapy, Brentuximab Vedotin, Radiation)Number of Participants With of Adverse EventsEdema limbs17 Participants
Arm II (Chemotherapy, Brentuximab Vedotin, Radiation)Number of Participants With of Adverse EventsEjection fraction decreased3 Participants
Arm II (Chemotherapy, Brentuximab Vedotin, Radiation)Number of Participants With of Adverse EventsElectrocardiogram QT corrected interval prolonged0 Participants
Arm II (Chemotherapy, Brentuximab Vedotin, Radiation)Number of Participants With of Adverse EventsElectrocardiogram T wave abnormal0 Participants
Arm II (Chemotherapy, Brentuximab Vedotin, Radiation)Number of Participants With of Adverse EventsEndocrine disorders - Other, specify0 Participants
Arm II (Chemotherapy, Brentuximab Vedotin, Radiation)Number of Participants With of Adverse EventsEnterocolitis1 Participants
Arm II (Chemotherapy, Brentuximab Vedotin, Radiation)Number of Participants With of Adverse EventsEnterocolitis infectious4 Participants
Arm II (Chemotherapy, Brentuximab Vedotin, Radiation)Number of Participants With of Adverse EventsEosinophilia16 Participants
Arm II (Chemotherapy, Brentuximab Vedotin, Radiation)Number of Participants With of Adverse EventsEpistaxis16 Participants
Arm II (Chemotherapy, Brentuximab Vedotin, Radiation)Number of Participants With of Adverse EventsErectile dysfunction0 Participants
Arm II (Chemotherapy, Brentuximab Vedotin, Radiation)Number of Participants With of Adverse EventsErythema multiforme1 Participants
Arm II (Chemotherapy, Brentuximab Vedotin, Radiation)Number of Participants With of Adverse EventsErythroderma0 Participants
Arm II (Chemotherapy, Brentuximab Vedotin, Radiation)Number of Participants With of Adverse EventsEsophageal pain0 Participants
Arm II (Chemotherapy, Brentuximab Vedotin, Radiation)Number of Participants With of Adverse EventsEye disorders - Other, specify3 Participants
Arm II (Chemotherapy, Brentuximab Vedotin, Radiation)Number of Participants With of Adverse EventsFacial muscle weakness0 Participants
Arm II (Chemotherapy, Brentuximab Vedotin, Radiation)Number of Participants With of Adverse EventsFacial pain4 Participants
Arm II (Chemotherapy, Brentuximab Vedotin, Radiation)Number of Participants With of Adverse EventsFall9 Participants
Arm II (Chemotherapy, Brentuximab Vedotin, Radiation)Number of Participants With of Adverse EventsFatigue246 Participants
Arm II (Chemotherapy, Brentuximab Vedotin, Radiation)Number of Participants With of Adverse EventsFebrile neutropenia33 Participants
Arm II (Chemotherapy, Brentuximab Vedotin, Radiation)Number of Participants With of Adverse EventsFecal incontinence1 Participants
Arm II (Chemotherapy, Brentuximab Vedotin, Radiation)Number of Participants With of Adverse EventsFever63 Participants
Arm II (Chemotherapy, Brentuximab Vedotin, Radiation)Number of Participants With of Adverse EventsFibrinogen decreased0 Participants
Arm II (Chemotherapy, Brentuximab Vedotin, Radiation)Number of Participants With of Adverse EventsFlank pain3 Participants
Arm II (Chemotherapy, Brentuximab Vedotin, Radiation)Number of Participants With of Adverse EventsFlashing lights1 Participants
Arm II (Chemotherapy, Brentuximab Vedotin, Radiation)Number of Participants With of Adverse EventsFlatulence6 Participants
Arm II (Chemotherapy, Brentuximab Vedotin, Radiation)Number of Participants With of Adverse EventsFloaters1 Participants
Arm II (Chemotherapy, Brentuximab Vedotin, Radiation)Number of Participants With of Adverse EventsFlu like symptoms3 Participants
Arm II (Chemotherapy, Brentuximab Vedotin, Radiation)Number of Participants With of Adverse EventsFlushing3 Participants
Arm II (Chemotherapy, Brentuximab Vedotin, Radiation)Number of Participants With of Adverse EventsFolliculitis2 Participants
Arm II (Chemotherapy, Brentuximab Vedotin, Radiation)Number of Participants With of Adverse EventsFracture1 Participants
Arm II (Chemotherapy, Brentuximab Vedotin, Radiation)Number of Participants With of Adverse EventsGGT increased4 Participants
Arm II (Chemotherapy, Brentuximab Vedotin, Radiation)Number of Participants With of Adverse EventsGait disturbance2 Participants
Arm II (Chemotherapy, Brentuximab Vedotin, Radiation)Number of Participants With of Adverse EventsGastric hemorrhage1 Participants
Arm II (Chemotherapy, Brentuximab Vedotin, Radiation)Number of Participants With of Adverse EventsGastritis8 Participants
Arm II (Chemotherapy, Brentuximab Vedotin, Radiation)Number of Participants With of Adverse EventsGastroesophageal reflux disease40 Participants
Arm II (Chemotherapy, Brentuximab Vedotin, Radiation)Number of Participants With of Adverse EventsGastrointestinal disorders - Other, specify14 Participants
Arm II (Chemotherapy, Brentuximab Vedotin, Radiation)Number of Participants With of Adverse EventsGastrointestinal pain0 Participants
Arm II (Chemotherapy, Brentuximab Vedotin, Radiation)Number of Participants With of Adverse EventsGastroparesis1 Participants
Arm II (Chemotherapy, Brentuximab Vedotin, Radiation)Number of Participants With of Adverse EventsGeneral disorders and administration site conditio6 Participants
Arm II (Chemotherapy, Brentuximab Vedotin, Radiation)Number of Participants With of Adverse EventsGeneralized edema0 Participants
Arm II (Chemotherapy, Brentuximab Vedotin, Radiation)Number of Participants With of Adverse EventsGeneralized muscle weakness25 Participants
Arm II (Chemotherapy, Brentuximab Vedotin, Radiation)Number of Participants With of Adverse EventsGlucose intolerance0 Participants
Arm II (Chemotherapy, Brentuximab Vedotin, Radiation)Number of Participants With of Adverse EventsGlucosuria2 Participants
Arm II (Chemotherapy, Brentuximab Vedotin, Radiation)Number of Participants With of Adverse EventsGuillain-Barre syndrome1 Participants
Arm II (Chemotherapy, Brentuximab Vedotin, Radiation)Number of Participants With of Adverse EventsGynecomastia1 Participants
Arm II (Chemotherapy, Brentuximab Vedotin, Radiation)Number of Participants With of Adverse EventsHeadache77 Participants
Arm II (Chemotherapy, Brentuximab Vedotin, Radiation)Number of Participants With of Adverse EventsHeart failure1 Participants
Arm II (Chemotherapy, Brentuximab Vedotin, Radiation)Number of Participants With of Adverse EventsHematuria0 Participants
Arm II (Chemotherapy, Brentuximab Vedotin, Radiation)Number of Participants With of Adverse EventsHemolysis0 Participants
Arm II (Chemotherapy, Brentuximab Vedotin, Radiation)Number of Participants With of Adverse EventsHemorrhoidal hemorrhage0 Participants
Arm II (Chemotherapy, Brentuximab Vedotin, Radiation)Number of Participants With of Adverse EventsHemorrhoids1 Participants
Arm II (Chemotherapy, Brentuximab Vedotin, Radiation)Number of Participants With of Adverse EventsHepatic failure0 Participants
Arm II (Chemotherapy, Brentuximab Vedotin, Radiation)Number of Participants With of Adverse EventsHepatobiliary disorders - Other, specify1 Participants
Arm II (Chemotherapy, Brentuximab Vedotin, Radiation)Number of Participants With of Adverse EventsHerpes simplex reactivation3 Participants
Arm II (Chemotherapy, Brentuximab Vedotin, Radiation)Number of Participants With of Adverse EventsHiccups11 Participants
Arm II (Chemotherapy, Brentuximab Vedotin, Radiation)Number of Participants With of Adverse EventsHoarseness4 Participants
Arm II (Chemotherapy, Brentuximab Vedotin, Radiation)Number of Participants With of Adverse EventsHot flashes20 Participants
Arm II (Chemotherapy, Brentuximab Vedotin, Radiation)Number of Participants With of Adverse EventsHypercalcemia10 Participants
Arm II (Chemotherapy, Brentuximab Vedotin, Radiation)Number of Participants With of Adverse EventsHyperglycemia67 Participants
Arm II (Chemotherapy, Brentuximab Vedotin, Radiation)Number of Participants With of Adverse EventsHyperhidrosis16 Participants
Arm II (Chemotherapy, Brentuximab Vedotin, Radiation)Number of Participants With of Adverse EventsHyperkalemia4 Participants
Arm II (Chemotherapy, Brentuximab Vedotin, Radiation)Number of Participants With of Adverse EventsHyperlipidemia1 Participants
Arm II (Chemotherapy, Brentuximab Vedotin, Radiation)Number of Participants With of Adverse EventsHypermagnesemia3 Participants
Arm II (Chemotherapy, Brentuximab Vedotin, Radiation)Number of Participants With of Adverse EventsHypernatremia5 Participants
Arm II (Chemotherapy, Brentuximab Vedotin, Radiation)Number of Participants With of Adverse EventsHyperphosphatemia16 Participants
Arm II (Chemotherapy, Brentuximab Vedotin, Radiation)Number of Participants With of Adverse EventsHypertension43 Participants
Arm II (Chemotherapy, Brentuximab Vedotin, Radiation)Number of Participants With of Adverse EventsHyperthyroidism0 Participants
Arm II (Chemotherapy, Brentuximab Vedotin, Radiation)Number of Participants With of Adverse EventsHypertriglyceridemia2 Participants
Arm II (Chemotherapy, Brentuximab Vedotin, Radiation)Number of Participants With of Adverse EventsHyperuricemia9 Participants
Arm II (Chemotherapy, Brentuximab Vedotin, Radiation)Number of Participants With of Adverse EventsHypoalbuminemia41 Participants
Arm II (Chemotherapy, Brentuximab Vedotin, Radiation)Number of Participants With of Adverse EventsHypocalcemia35 Participants
Arm II (Chemotherapy, Brentuximab Vedotin, Radiation)Number of Participants With of Adverse EventsHypoglycemia6 Participants
Arm II (Chemotherapy, Brentuximab Vedotin, Radiation)Number of Participants With of Adverse EventsHypokalemia64 Participants
Arm II (Chemotherapy, Brentuximab Vedotin, Radiation)Number of Participants With of Adverse EventsHypomagnesemia22 Participants
Arm II (Chemotherapy, Brentuximab Vedotin, Radiation)Number of Participants With of Adverse EventsHyponatremia57 Participants
Arm II (Chemotherapy, Brentuximab Vedotin, Radiation)Number of Participants With of Adverse EventsHypoparathyroidism0 Participants
Arm II (Chemotherapy, Brentuximab Vedotin, Radiation)Number of Participants With of Adverse EventsHypophosphatemia19 Participants
Arm II (Chemotherapy, Brentuximab Vedotin, Radiation)Number of Participants With of Adverse EventsHypotension18 Participants
Arm II (Chemotherapy, Brentuximab Vedotin, Radiation)Number of Participants With of Adverse EventsHypothyroidism3 Participants
Arm II (Chemotherapy, Brentuximab Vedotin, Radiation)Number of Participants With of Adverse EventsHypoxia3 Participants
Arm II (Chemotherapy, Brentuximab Vedotin, Radiation)Number of Participants With of Adverse EventsINR increased1 Participants
Arm II (Chemotherapy, Brentuximab Vedotin, Radiation)Number of Participants With of Adverse EventsIleus4 Participants
Arm II (Chemotherapy, Brentuximab Vedotin, Radiation)Number of Participants With of Adverse EventsImmune system disorders - Other, specify1 Participants
Arm II (Chemotherapy, Brentuximab Vedotin, Radiation)Number of Participants With of Adverse EventsInfections and infestations - Other, specify12 Participants
Arm II (Chemotherapy, Brentuximab Vedotin, Radiation)Number of Participants With of Adverse EventsInfusion related reaction10 Participants
Arm II (Chemotherapy, Brentuximab Vedotin, Radiation)Number of Participants With of Adverse EventsInfusion site extravasation2 Participants
Arm II (Chemotherapy, Brentuximab Vedotin, Radiation)Number of Participants With of Adverse EventsInjection site reaction2 Participants
Arm II (Chemotherapy, Brentuximab Vedotin, Radiation)Number of Participants With of Adverse EventsInjury, poisoning and procedural complications - O0 Participants
Arm II (Chemotherapy, Brentuximab Vedotin, Radiation)Number of Participants With of Adverse EventsInsomnia54 Participants
Arm II (Chemotherapy, Brentuximab Vedotin, Radiation)Number of Participants With of Adverse EventsInvestigations - Other, specify10 Participants
Arm II (Chemotherapy, Brentuximab Vedotin, Radiation)Number of Participants With of Adverse EventsIrregular menstruation5 Participants
Arm II (Chemotherapy, Brentuximab Vedotin, Radiation)Number of Participants With of Adverse EventsIrritability1 Participants
Arm II (Chemotherapy, Brentuximab Vedotin, Radiation)Number of Participants With of Adverse EventsJoint range of motion decreased2 Participants
Arm II (Chemotherapy, Brentuximab Vedotin, Radiation)Number of Participants With of Adverse EventsLaryngopharyngeal dysesthesia0 Participants
Arm II (Chemotherapy, Brentuximab Vedotin, Radiation)Number of Participants With of Adverse EventsLethargy2 Participants
Arm II (Chemotherapy, Brentuximab Vedotin, Radiation)Number of Participants With of Adverse EventsLeukocytosis6 Participants
Arm II (Chemotherapy, Brentuximab Vedotin, Radiation)Number of Participants With of Adverse EventsLibido decreased3 Participants
Arm II (Chemotherapy, Brentuximab Vedotin, Radiation)Number of Participants With of Adverse EventsLip infection0 Participants
Arm II (Chemotherapy, Brentuximab Vedotin, Radiation)Number of Participants With of Adverse EventsLipase increased1 Participants
Arm II (Chemotherapy, Brentuximab Vedotin, Radiation)Number of Participants With of Adverse EventsLocalized edema3 Participants
Arm II (Chemotherapy, Brentuximab Vedotin, Radiation)Number of Participants With of Adverse EventsLung infection14 Participants
Arm II (Chemotherapy, Brentuximab Vedotin, Radiation)Number of Participants With of Adverse EventsLymph gland infection0 Participants
Arm II (Chemotherapy, Brentuximab Vedotin, Radiation)Number of Participants With of Adverse EventsLymph node pain3 Participants
Arm II (Chemotherapy, Brentuximab Vedotin, Radiation)Number of Participants With of Adverse EventsLymphocyte count decreased114 Participants
Arm II (Chemotherapy, Brentuximab Vedotin, Radiation)Number of Participants With of Adverse EventsLymphocyte count increased10 Participants
Arm II (Chemotherapy, Brentuximab Vedotin, Radiation)Number of Participants With of Adverse EventsMalaise3 Participants
Arm II (Chemotherapy, Brentuximab Vedotin, Radiation)Number of Participants With of Adverse EventsMemory impairment4 Participants
Arm II (Chemotherapy, Brentuximab Vedotin, Radiation)Number of Participants With of Adverse EventsMenorrhagia1 Participants
Arm II (Chemotherapy, Brentuximab Vedotin, Radiation)Number of Participants With of Adverse EventsMetabolism and nutrition disorders - Other, specif2 Participants
Arm II (Chemotherapy, Brentuximab Vedotin, Radiation)Number of Participants With of Adverse EventsMitral valve disease0 Participants
Arm II (Chemotherapy, Brentuximab Vedotin, Radiation)Number of Participants With of Adverse EventsMovements involuntary2 Participants
Arm II (Chemotherapy, Brentuximab Vedotin, Radiation)Number of Participants With of Adverse EventsMucosal infection1 Participants
Arm II (Chemotherapy, Brentuximab Vedotin, Radiation)Number of Participants With of Adverse EventsMucositis oral100 Participants
Arm II (Chemotherapy, Brentuximab Vedotin, Radiation)Number of Participants With of Adverse EventsMuscle cramp19 Participants
Arm II (Chemotherapy, Brentuximab Vedotin, Radiation)Number of Participants With of Adverse EventsMuscle weakness lower limb7 Participants
Arm II (Chemotherapy, Brentuximab Vedotin, Radiation)Number of Participants With of Adverse EventsMuscle weakness trunk0 Participants
Arm II (Chemotherapy, Brentuximab Vedotin, Radiation)Number of Participants With of Adverse EventsMuscle weakness upper limb2 Participants
Arm II (Chemotherapy, Brentuximab Vedotin, Radiation)Number of Participants With of Adverse EventsMusculoskeletal and connective tissue disorder -6 Participants
Arm II (Chemotherapy, Brentuximab Vedotin, Radiation)Number of Participants With of Adverse EventsMyalgia58 Participants
Arm II (Chemotherapy, Brentuximab Vedotin, Radiation)Number of Participants With of Adverse EventsMyositis0 Participants
Arm II (Chemotherapy, Brentuximab Vedotin, Radiation)Number of Participants With of Adverse EventsNail changes9 Participants
Arm II (Chemotherapy, Brentuximab Vedotin, Radiation)Number of Participants With of Adverse EventsNail discoloration16 Participants
Arm II (Chemotherapy, Brentuximab Vedotin, Radiation)Number of Participants With of Adverse EventsNail infection2 Participants
Arm II (Chemotherapy, Brentuximab Vedotin, Radiation)Number of Participants With of Adverse EventsNail ridging1 Participants
Arm II (Chemotherapy, Brentuximab Vedotin, Radiation)Number of Participants With of Adverse EventsNasal congestion12 Participants
Arm II (Chemotherapy, Brentuximab Vedotin, Radiation)Number of Participants With of Adverse EventsNausea331 Participants
Arm II (Chemotherapy, Brentuximab Vedotin, Radiation)Number of Participants With of Adverse EventsNeck edema2 Participants
Arm II (Chemotherapy, Brentuximab Vedotin, Radiation)Number of Participants With of Adverse EventsNeck pain3 Participants
Arm II (Chemotherapy, Brentuximab Vedotin, Radiation)Number of Participants With of Adverse EventsNeoplasms benign, malignant and unspecified (incl0 Participants
Arm II (Chemotherapy, Brentuximab Vedotin, Radiation)Number of Participants With of Adverse EventsNervous system disorders - Other, specify8 Participants
Arm II (Chemotherapy, Brentuximab Vedotin, Radiation)Number of Participants With of Adverse EventsNeuralgia3 Participants
Arm II (Chemotherapy, Brentuximab Vedotin, Radiation)Number of Participants With of Adverse EventsNeutrophil count decreased166 Participants
Arm II (Chemotherapy, Brentuximab Vedotin, Radiation)Number of Participants With of Adverse EventsNon-cardiac chest pain16 Participants
Arm II (Chemotherapy, Brentuximab Vedotin, Radiation)Number of Participants With of Adverse EventsOral dysesthesia6 Participants
Arm II (Chemotherapy, Brentuximab Vedotin, Radiation)Number of Participants With of Adverse EventsOral hemorrhage1 Participants
Arm II (Chemotherapy, Brentuximab Vedotin, Radiation)Number of Participants With of Adverse EventsOral pain24 Participants
Arm II (Chemotherapy, Brentuximab Vedotin, Radiation)Number of Participants With of Adverse EventsPain31 Participants
Arm II (Chemotherapy, Brentuximab Vedotin, Radiation)Number of Participants With of Adverse EventsPain in extremity36 Participants
Arm II (Chemotherapy, Brentuximab Vedotin, Radiation)Number of Participants With of Adverse EventsPalmar-plantar erythrodysesthesia syndrome2 Participants
Arm II (Chemotherapy, Brentuximab Vedotin, Radiation)Number of Participants With of Adverse EventsPalpitations2 Participants
Arm II (Chemotherapy, Brentuximab Vedotin, Radiation)Number of Participants With of Adverse EventsPancreatic enzymes decreased1 Participants
Arm II (Chemotherapy, Brentuximab Vedotin, Radiation)Number of Participants With of Adverse EventsPancreatitis1 Participants
Arm II (Chemotherapy, Brentuximab Vedotin, Radiation)Number of Participants With of Adverse EventsPapulopustular rash3 Participants
Arm II (Chemotherapy, Brentuximab Vedotin, Radiation)Number of Participants With of Adverse EventsParesthesia43 Participants
Arm II (Chemotherapy, Brentuximab Vedotin, Radiation)Number of Participants With of Adverse EventsParonychia2 Participants
Arm II (Chemotherapy, Brentuximab Vedotin, Radiation)Number of Participants With of Adverse EventsParoxysmal atrial tachycardia0 Participants
Arm II (Chemotherapy, Brentuximab Vedotin, Radiation)Number of Participants With of Adverse EventsPelvic pain2 Participants
Arm II (Chemotherapy, Brentuximab Vedotin, Radiation)Number of Participants With of Adverse EventsPenile infection1 Participants
Arm II (Chemotherapy, Brentuximab Vedotin, Radiation)Number of Participants With of Adverse EventsPericardial effusion0 Participants
Arm II (Chemotherapy, Brentuximab Vedotin, Radiation)Number of Participants With of Adverse EventsPericarditis0 Participants
Arm II (Chemotherapy, Brentuximab Vedotin, Radiation)Number of Participants With of Adverse EventsPeripheral motor neuropathy36 Participants
Arm II (Chemotherapy, Brentuximab Vedotin, Radiation)Number of Participants With of Adverse EventsPeripheral sensory neuropathy268 Participants
Arm II (Chemotherapy, Brentuximab Vedotin, Radiation)Number of Participants With of Adverse EventsPharyngeal mucositis0 Participants
Arm II (Chemotherapy, Brentuximab Vedotin, Radiation)Number of Participants With of Adverse EventsPharyngitis1 Participants
Arm II (Chemotherapy, Brentuximab Vedotin, Radiation)Number of Participants With of Adverse EventsPhlebitis4 Participants
Arm II (Chemotherapy, Brentuximab Vedotin, Radiation)Number of Participants With of Adverse EventsPhotophobia2 Participants
Arm II (Chemotherapy, Brentuximab Vedotin, Radiation)Number of Participants With of Adverse EventsPhotosensitivity2 Participants
Arm II (Chemotherapy, Brentuximab Vedotin, Radiation)Number of Participants With of Adverse EventsPlatelet count decreased89 Participants
Arm II (Chemotherapy, Brentuximab Vedotin, Radiation)Number of Participants With of Adverse EventsPleural effusion1 Participants
Arm II (Chemotherapy, Brentuximab Vedotin, Radiation)Number of Participants With of Adverse EventsPleuritic pain0 Participants
Arm II (Chemotherapy, Brentuximab Vedotin, Radiation)Number of Participants With of Adverse EventsPneumonitis15 Participants
Arm II (Chemotherapy, Brentuximab Vedotin, Radiation)Number of Participants With of Adverse EventsPostnasal drip1 Participants
Arm II (Chemotherapy, Brentuximab Vedotin, Radiation)Number of Participants With of Adverse EventsPresyncope3 Participants
Arm II (Chemotherapy, Brentuximab Vedotin, Radiation)Number of Participants With of Adverse EventsProductive cough2 Participants
Arm II (Chemotherapy, Brentuximab Vedotin, Radiation)Number of Participants With of Adverse EventsProteinuria2 Participants
Arm II (Chemotherapy, Brentuximab Vedotin, Radiation)Number of Participants With of Adverse EventsPruritus25 Participants
Arm II (Chemotherapy, Brentuximab Vedotin, Radiation)Number of Participants With of Adverse EventsPsychiatric disorders - Other, specify3 Participants
Arm II (Chemotherapy, Brentuximab Vedotin, Radiation)Number of Participants With of Adverse EventsPsychosis1 Participants
Arm II (Chemotherapy, Brentuximab Vedotin, Radiation)Number of Participants With of Adverse EventsPulmonary edema1 Participants
Arm II (Chemotherapy, Brentuximab Vedotin, Radiation)Number of Participants With of Adverse EventsRash acneiform12 Participants
Arm II (Chemotherapy, Brentuximab Vedotin, Radiation)Number of Participants With of Adverse EventsRash maculo-papular59 Participants
Arm II (Chemotherapy, Brentuximab Vedotin, Radiation)Number of Participants With of Adverse EventsRash pustular1 Participants
Arm II (Chemotherapy, Brentuximab Vedotin, Radiation)Number of Participants With of Adverse EventsRectal fissure1 Participants
Arm II (Chemotherapy, Brentuximab Vedotin, Radiation)Number of Participants With of Adverse EventsRectal hemorrhage2 Participants
Arm II (Chemotherapy, Brentuximab Vedotin, Radiation)Number of Participants With of Adverse EventsRectal pain4 Participants
Arm II (Chemotherapy, Brentuximab Vedotin, Radiation)Number of Participants With of Adverse EventsRenal and urinary disorders - Other, specify1 Participants
Arm II (Chemotherapy, Brentuximab Vedotin, Radiation)Number of Participants With of Adverse EventsRespiratory failure3 Participants
Arm II (Chemotherapy, Brentuximab Vedotin, Radiation)Number of Participants With of Adverse EventsRespiratory, thoracic and mediastinal disorders -6 Participants
Arm II (Chemotherapy, Brentuximab Vedotin, Radiation)Number of Participants With of Adverse EventsRestrictive cardiomyopathy0 Participants
Arm II (Chemotherapy, Brentuximab Vedotin, Radiation)Number of Participants With of Adverse EventsRhabdomyolysis0 Participants
Arm II (Chemotherapy, Brentuximab Vedotin, Radiation)Number of Participants With of Adverse EventsRhinorrhea8 Participants
Arm II (Chemotherapy, Brentuximab Vedotin, Radiation)Number of Participants With of Adverse EventsSalivary duct inflammation2 Participants
Arm II (Chemotherapy, Brentuximab Vedotin, Radiation)Number of Participants With of Adverse EventsScalp pain0 Participants
Arm II (Chemotherapy, Brentuximab Vedotin, Radiation)Number of Participants With of Adverse EventsScrotal pain1 Participants
Arm II (Chemotherapy, Brentuximab Vedotin, Radiation)Number of Participants With of Adverse EventsSeizure1 Participants
Arm II (Chemotherapy, Brentuximab Vedotin, Radiation)Number of Participants With of Adverse EventsSepsis15 Participants
Arm II (Chemotherapy, Brentuximab Vedotin, Radiation)Number of Participants With of Adverse EventsSerum amylase increased0 Participants
Arm II (Chemotherapy, Brentuximab Vedotin, Radiation)Number of Participants With of Adverse EventsSinus bradycardia3 Participants
Arm II (Chemotherapy, Brentuximab Vedotin, Radiation)Number of Participants With of Adverse EventsSinus disorder1 Participants
Arm II (Chemotherapy, Brentuximab Vedotin, Radiation)Number of Participants With of Adverse EventsSinus tachycardia25 Participants
Arm II (Chemotherapy, Brentuximab Vedotin, Radiation)Number of Participants With of Adverse EventsSkin and subcutaneous tissue disorders - Other, sp18 Participants
Arm II (Chemotherapy, Brentuximab Vedotin, Radiation)Number of Participants With of Adverse EventsSkin hyperpigmentation8 Participants
Arm II (Chemotherapy, Brentuximab Vedotin, Radiation)Number of Participants With of Adverse EventsSkin hypopigmentation0 Participants
Arm II (Chemotherapy, Brentuximab Vedotin, Radiation)Number of Participants With of Adverse EventsSkin infection10 Participants
Arm II (Chemotherapy, Brentuximab Vedotin, Radiation)Number of Participants With of Adverse EventsSkin ulceration1 Participants
Arm II (Chemotherapy, Brentuximab Vedotin, Radiation)Number of Participants With of Adverse EventsSmall intestinal obstruction1 Participants
Arm II (Chemotherapy, Brentuximab Vedotin, Radiation)Number of Participants With of Adverse EventsSneezing1 Participants
Arm II (Chemotherapy, Brentuximab Vedotin, Radiation)Number of Participants With of Adverse EventsSomnolence1 Participants
Arm II (Chemotherapy, Brentuximab Vedotin, Radiation)Number of Participants With of Adverse EventsSore throat27 Participants
Arm II (Chemotherapy, Brentuximab Vedotin, Radiation)Number of Participants With of Adverse EventsSpasticity1 Participants
Arm II (Chemotherapy, Brentuximab Vedotin, Radiation)Number of Participants With of Adverse EventsStomach pain10 Participants
Arm II (Chemotherapy, Brentuximab Vedotin, Radiation)Number of Participants With of Adverse EventsStroke0 Participants
Arm II (Chemotherapy, Brentuximab Vedotin, Radiation)Number of Participants With of Adverse EventsSuperficial thrombophlebitis3 Participants
Arm II (Chemotherapy, Brentuximab Vedotin, Radiation)Number of Participants With of Adverse EventsSupraventricular tachycardia1 Participants
Arm II (Chemotherapy, Brentuximab Vedotin, Radiation)Number of Participants With of Adverse EventsSyncope2 Participants
Arm II (Chemotherapy, Brentuximab Vedotin, Radiation)Number of Participants With of Adverse EventsTendon reflex decreased1 Participants
Arm II (Chemotherapy, Brentuximab Vedotin, Radiation)Number of Participants With of Adverse EventsTesticular pain2 Participants
Arm II (Chemotherapy, Brentuximab Vedotin, Radiation)Number of Participants With of Adverse EventsThromboembolic event10 Participants
Arm II (Chemotherapy, Brentuximab Vedotin, Radiation)Number of Participants With of Adverse EventsThrush14 Participants
Arm II (Chemotherapy, Brentuximab Vedotin, Radiation)Number of Participants With of Adverse EventsThyroid stimulating hormone increased1 Participants
Arm II (Chemotherapy, Brentuximab Vedotin, Radiation)Number of Participants With of Adverse EventsTinnitus6 Participants
Arm II (Chemotherapy, Brentuximab Vedotin, Radiation)Number of Participants With of Adverse EventsTooth discoloration1 Participants
Arm II (Chemotherapy, Brentuximab Vedotin, Radiation)Number of Participants With of Adverse EventsTooth infection0 Participants
Arm II (Chemotherapy, Brentuximab Vedotin, Radiation)Number of Participants With of Adverse EventsToothache2 Participants
Arm II (Chemotherapy, Brentuximab Vedotin, Radiation)Number of Participants With of Adverse EventsTracheal mucositis1 Participants
Arm II (Chemotherapy, Brentuximab Vedotin, Radiation)Number of Participants With of Adverse EventsTracheitis0 Participants
Arm II (Chemotherapy, Brentuximab Vedotin, Radiation)Number of Participants With of Adverse EventsTremor3 Participants
Arm II (Chemotherapy, Brentuximab Vedotin, Radiation)Number of Participants With of Adverse EventsTumor lysis syndrome1 Participants
Arm II (Chemotherapy, Brentuximab Vedotin, Radiation)Number of Participants With of Adverse EventsTumor pain1 Participants
Arm II (Chemotherapy, Brentuximab Vedotin, Radiation)Number of Participants With of Adverse EventsTyphlitis3 Participants
Arm II (Chemotherapy, Brentuximab Vedotin, Radiation)Number of Participants With of Adverse EventsUpper gastrointestinal hemorrhage0 Participants
Arm II (Chemotherapy, Brentuximab Vedotin, Radiation)Number of Participants With of Adverse EventsUpper respiratory infection8 Participants
Arm II (Chemotherapy, Brentuximab Vedotin, Radiation)Number of Participants With of Adverse EventsUrinary frequency2 Participants
Arm II (Chemotherapy, Brentuximab Vedotin, Radiation)Number of Participants With of Adverse EventsUrinary incontinence1 Participants
Arm II (Chemotherapy, Brentuximab Vedotin, Radiation)Number of Participants With of Adverse EventsUrinary retention1 Participants
Arm II (Chemotherapy, Brentuximab Vedotin, Radiation)Number of Participants With of Adverse EventsUrinary tract infection12 Participants
Arm II (Chemotherapy, Brentuximab Vedotin, Radiation)Number of Participants With of Adverse EventsUrinary tract pain0 Participants
Arm II (Chemotherapy, Brentuximab Vedotin, Radiation)Number of Participants With of Adverse EventsUrinary urgency1 Participants
Arm II (Chemotherapy, Brentuximab Vedotin, Radiation)Number of Participants With of Adverse EventsUrticaria2 Participants
Arm II (Chemotherapy, Brentuximab Vedotin, Radiation)Number of Participants With of Adverse EventsVaginal discharge0 Participants
Arm II (Chemotherapy, Brentuximab Vedotin, Radiation)Number of Participants With of Adverse EventsVaginal infection4 Participants
Arm II (Chemotherapy, Brentuximab Vedotin, Radiation)Number of Participants With of Adverse EventsVascular access complication2 Participants
Arm II (Chemotherapy, Brentuximab Vedotin, Radiation)Number of Participants With of Adverse EventsVascular disorders - Other, specify1 Participants
Arm II (Chemotherapy, Brentuximab Vedotin, Radiation)Number of Participants With of Adverse EventsVasovagal reaction1 Participants
Arm II (Chemotherapy, Brentuximab Vedotin, Radiation)Number of Participants With of Adverse EventsVentricular arrhythmia1 Participants
Arm II (Chemotherapy, Brentuximab Vedotin, Radiation)Number of Participants With of Adverse EventsVentricular tachycardia1 Participants
Arm II (Chemotherapy, Brentuximab Vedotin, Radiation)Number of Participants With of Adverse EventsVertigo1 Participants
Arm II (Chemotherapy, Brentuximab Vedotin, Radiation)Number of Participants With of Adverse EventsVision decreased0 Participants
Arm II (Chemotherapy, Brentuximab Vedotin, Radiation)Number of Participants With of Adverse EventsVoice alteration2 Participants
Arm II (Chemotherapy, Brentuximab Vedotin, Radiation)Number of Participants With of Adverse EventsVomiting160 Participants
Arm II (Chemotherapy, Brentuximab Vedotin, Radiation)Number of Participants With of Adverse EventsWatering eyes5 Participants
Arm II (Chemotherapy, Brentuximab Vedotin, Radiation)Number of Participants With of Adverse EventsWeight gain8 Participants
Arm II (Chemotherapy, Brentuximab Vedotin, Radiation)Number of Participants With of Adverse EventsWeight loss71 Participants
Arm II (Chemotherapy, Brentuximab Vedotin, Radiation)Number of Participants With of Adverse EventsWheezing1 Participants
Arm II (Chemotherapy, Brentuximab Vedotin, Radiation)Number of Participants With of Adverse EventsWhite blood cell decreased136 Participants
Secondary

Overall Survival

Will be reported as the count of participants who have died, measured at two years. Stratified log-rank test at two-sided alpha level of .05.

Time frame: From date of registration to two years or death.

Population: All the patients who underwent randomization except for those who were deemed to be ineligible by pathology review or owing to violation of the eligibility criteria.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Arm I (Chemotherapy, Nivolumab, Radiation)Overall Survival7 Participants
Arm II (Chemotherapy, Brentuximab Vedotin, Radiation)Overall Survival14 Participants

Source: ClinicalTrials.gov · Data processed: Aug 5, 2026