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
Conditions
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
Undergo peripheral blood collection
Given IV
Undergo PET/CT or CT scan
Given IV
Given IV
Given SC or IV
Undergo MRI
Given IV
Given SC
Undergo PET/CT scan
Ancillary studies
Ancillary studies
Receive radiation therapy
Given IV
Sponsors
Study design
Eligibility
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
| Measure | Time frame | Description |
|---|---|---|
| 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 years | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall Survival | From 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 years | 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. |
| Number of Participants With of Adverse Events | Up to 2 years | Only adverse events that are possibly, probably or definitely related to study drug are reported. |
| Metabolic Complete Response Rate | 4-8 weeks after last dose of study drug | This outcome measure will be reported by 11/5/2025. |
Countries
Canada, Puerto Rico, United States
Contacts
SWOG Cancer Research Network
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 |
| Total | 970 |
Baseline characteristics
| Characteristic | Arm I (Chemotherapy, Nivolumab, Radiation) | Arm II (Chemotherapy, Brentuximab Vedotin, Radiation) | Total |
|---|---|---|---|
| Age, Continuous | 27.6 years | 26.8 years | 27 years |
| Age, Customized Age, Stratified 12-17 | 118 Participants | 118 Participants | 236 Participants |
| Age, Customized Age, Stratified 18-60 | 321 Participants | 318 Participants | 639 Participants |
| Age, Customized Age, Stratified >60 | 48 Participants | 47 Participants | 95 Participants |
| Race/Ethnicity, Customized Asian | 11 Participants | 17 Participants | 28 Participants |
| Race/Ethnicity, Customized Black | 58 Participants | 56 Participants | 114 Participants |
| Race/Ethnicity, Customized Hispanic | 66 Participants | 58 Participants | 124 Participants |
| Race/Ethnicity, Customized Other or unknown | 46 Participants | 49 Participants | 95 Participants |
| Race/Ethnicity, Customized White | 372 Participants | 361 Participants | 733 Participants |
| Sex: Female, Male Female | 216 Participants | 210 Participants | 426 Participants |
| Sex: Female, Male Male | 271 Participants | 273 Participants | 544 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 7 / 487 | 14 / 483 |
| other Total, other adverse events | 468 / 481 | 465 / 476 |
| serious Total, serious adverse events | 140 / 481 | 18 / 476 |
Outcome results
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.
| Arm | Measure | Value (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 |
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.
| Arm | Measure | Value (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 |
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
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
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Arm I (Chemotherapy, Nivolumab, Radiation) | Number of Participants With of Adverse Events | Hypomagnesemia | 5 Participants |
| Arm I (Chemotherapy, Nivolumab, Radiation) | Number of Participants With of Adverse Events | Anorectal infection | 1 Participants |
| Arm I (Chemotherapy, Nivolumab, Radiation) | Number of Participants With of Adverse Events | Hyponatremia | 30 Participants |
| Arm I (Chemotherapy, Nivolumab, Radiation) | Number of Participants With of Adverse Events | Dysesthesia | 0 Participants |
| Arm I (Chemotherapy, Nivolumab, Radiation) | Number of Participants With of Adverse Events | Hypoparathyroidism | 1 Participants |
| Arm I (Chemotherapy, Nivolumab, Radiation) | Number of Participants With of Adverse Events | Breast pain | 0 Participants |
| Arm I (Chemotherapy, Nivolumab, Radiation) | Number of Participants With of Adverse Events | Hypophosphatemia | 11 Participants |
| Arm I (Chemotherapy, Nivolumab, Radiation) | Number of Participants With of Adverse Events | Dysgeusia | 37 Participants |
| Arm I (Chemotherapy, Nivolumab, Radiation) | Number of Participants With of Adverse Events | Hypotension | 18 Participants |
| Arm I (Chemotherapy, Nivolumab, Radiation) | Number of Participants With of Adverse Events | Activated partial thromboplastin time prolonged | 2 Participants |
| Arm I (Chemotherapy, Nivolumab, Radiation) | Number of Participants With of Adverse Events | Hypothyroidism | 36 Participants |
| Arm I (Chemotherapy, Nivolumab, Radiation) | Number of Participants With of Adverse Events | Dysmenorrhea | 1 Participants |
| Arm I (Chemotherapy, Nivolumab, Radiation) | Number of Participants With of Adverse Events | Hypoxia | 3 Participants |
| Arm I (Chemotherapy, Nivolumab, Radiation) | Number of Participants With of Adverse Events | Bronchial infection | 2 Participants |
| Arm I (Chemotherapy, Nivolumab, Radiation) | Number of Participants With of Adverse Events | INR increased | 3 Participants |
| Arm I (Chemotherapy, Nivolumab, Radiation) | Number of Participants With of Adverse Events | Dyspepsia | 34 Participants |
| Arm I (Chemotherapy, Nivolumab, Radiation) | Number of Participants With of Adverse Events | Ileus | 0 Participants |
| Arm I (Chemotherapy, Nivolumab, Radiation) | Number of Participants With of Adverse Events | Anorexia | 61 Participants |
| Arm I (Chemotherapy, Nivolumab, Radiation) | Number of Participants With of Adverse Events | Immune system disorders - Other, specify | 1 Participants |
| Arm I (Chemotherapy, Nivolumab, Radiation) | Number of Participants With of Adverse Events | Dysphagia | 8 Participants |
| Arm I (Chemotherapy, Nivolumab, Radiation) | Number of Participants With of Adverse Events | Infections and infestations - Other, specify | 18 Participants |
| Arm I (Chemotherapy, Nivolumab, Radiation) | Number of Participants With of Adverse Events | Bronchospasm | 1 Participants |
| Arm I (Chemotherapy, Nivolumab, Radiation) | Number of Participants With of Adverse Events | Infusion related reaction | 36 Participants |
| Arm I (Chemotherapy, Nivolumab, Radiation) | Number of Participants With of Adverse Events | Dysphasia | 0 Participants |
| Arm I (Chemotherapy, Nivolumab, Radiation) | Number of Participants With of Adverse Events | Infusion site extravasation | 2 Participants |
| Arm I (Chemotherapy, Nivolumab, Radiation) | Number of Participants With of Adverse Events | Alkaline phosphatase increased | 58 Participants |
| Arm I (Chemotherapy, Nivolumab, Radiation) | Number of Participants With of Adverse Events | Injection site reaction | 1 Participants |
| Arm I (Chemotherapy, Nivolumab, Radiation) | Number of Participants With of Adverse Events | Dyspnea | 43 Participants |
| Arm I (Chemotherapy, Nivolumab, Radiation) | Number of Participants With of Adverse Events | Injury, poisoning and procedural complications - O | 1 Participants |
| Arm I (Chemotherapy, Nivolumab, Radiation) | Number of Participants With of Adverse Events | Bruising | 2 Participants |
| Arm I (Chemotherapy, Nivolumab, Radiation) | Number of Participants With of Adverse Events | Insomnia | 30 Participants |
| Arm I (Chemotherapy, Nivolumab, Radiation) | Number of Participants With of Adverse Events | Dysuria | 3 Participants |
| Arm I (Chemotherapy, Nivolumab, Radiation) | Number of Participants With of Adverse Events | Investigations - Other, specify | 13 Participants |
| Arm I (Chemotherapy, Nivolumab, Radiation) | Number of Participants With of Adverse Events | Anosmia | 3 Participants |
| Arm I (Chemotherapy, Nivolumab, Radiation) | Number of Participants With of Adverse Events | Irregular menstruation | 4 Participants |
| Arm I (Chemotherapy, Nivolumab, Radiation) | Number of Participants With of Adverse Events | Ear and labyrinth disorders - Other, specify | 1 Participants |
| Arm I (Chemotherapy, Nivolumab, Radiation) | Number of Participants With of Adverse Events | Irritability | 1 Participants |
| Arm I (Chemotherapy, Nivolumab, Radiation) | Number of Participants With of Adverse Events | Bullous dermatitis | 0 Participants |
| Arm I (Chemotherapy, Nivolumab, Radiation) | Number of Participants With of Adverse Events | Joint range of motion decreased | 0 Participants |
| Arm I (Chemotherapy, Nivolumab, Radiation) | Number of Participants With of Adverse Events | Ear pain | 0 Participants |
| Arm I (Chemotherapy, Nivolumab, Radiation) | Number of Participants With of Adverse Events | Laryngopharyngeal dysesthesia | 1 Participants |
| Arm I (Chemotherapy, Nivolumab, Radiation) | Number of Participants With of Adverse Events | Back pain | 27 Participants |
| Arm I (Chemotherapy, Nivolumab, Radiation) | Number of Participants With of Adverse Events | Lethargy | 3 Participants |
| Arm I (Chemotherapy, Nivolumab, Radiation) | Number of Participants With of Adverse Events | Eczema | 3 Participants |
| Arm I (Chemotherapy, Nivolumab, Radiation) | Number of Participants With of Adverse Events | Leukocytosis | 2 Participants |
| Arm I (Chemotherapy, Nivolumab, Radiation) | Number of Participants With of Adverse Events | Burn | 0 Participants |
| Arm I (Chemotherapy, Nivolumab, Radiation) | Number of Participants With of Adverse Events | Libido decreased | 6 Participants |
| Arm I (Chemotherapy, Nivolumab, Radiation) | Number of Participants With of Adverse Events | Edema face | 1 Participants |
| Arm I (Chemotherapy, Nivolumab, Radiation) | Number of Participants With of Adverse Events | Lip infection | 3 Participants |
| Arm I (Chemotherapy, Nivolumab, Radiation) | Number of Participants With of Adverse Events | Anxiety | 20 Participants |
| Arm I (Chemotherapy, Nivolumab, Radiation) | Number of Participants With of Adverse Events | Lipase increased | 2 Participants |
| Arm I (Chemotherapy, Nivolumab, Radiation) | Number of Participants With of Adverse Events | Edema limbs | 17 Participants |
| Arm I (Chemotherapy, Nivolumab, Radiation) | Number of Participants With of Adverse Events | Localized edema | 3 Participants |
| Arm I (Chemotherapy, Nivolumab, Radiation) | Number of Participants With of Adverse Events | Buttock pain | 1 Participants |
| Arm I (Chemotherapy, Nivolumab, Radiation) | Number of Participants With of Adverse Events | Lung infection | 10 Participants |
| Arm I (Chemotherapy, Nivolumab, Radiation) | Number of Participants With of Adverse Events | Ejection fraction decreased | 3 Participants |
| Arm I (Chemotherapy, Nivolumab, Radiation) | Number of Participants With of Adverse Events | Lymph gland infection | 1 Participants |
| Arm I (Chemotherapy, Nivolumab, Radiation) | Number of Participants With of Adverse Events | Allergic reaction | 4 Participants |
| Arm I (Chemotherapy, Nivolumab, Radiation) | Number of Participants With of Adverse Events | Lymph node pain | 1 Participants |
| Arm I (Chemotherapy, Nivolumab, Radiation) | Number of Participants With of Adverse Events | Electrocardiogram QT corrected interval prolonged | 1 Participants |
| Arm I (Chemotherapy, Nivolumab, Radiation) | Number of Participants With of Adverse Events | Lymphocyte count decreased | 109 Participants |
| Arm I (Chemotherapy, Nivolumab, Radiation) | Number of Participants With of Adverse Events | CD4 lymphocytes decreased | 0 Participants |
| Arm I (Chemotherapy, Nivolumab, Radiation) | Number of Participants With of Adverse Events | Lymphocyte count increased | 4 Participants |
| Arm I (Chemotherapy, Nivolumab, Radiation) | Number of Participants With of Adverse Events | Electrocardiogram T wave abnormal | 1 Participants |
| Arm I (Chemotherapy, Nivolumab, Radiation) | Number of Participants With of Adverse Events | Malaise | 8 Participants |
| Arm I (Chemotherapy, Nivolumab, Radiation) | Number of Participants With of Adverse Events | Appendicitis | 1 Participants |
| Arm I (Chemotherapy, Nivolumab, Radiation) | Number of Participants With of Adverse Events | Memory impairment | 8 Participants |
| Arm I (Chemotherapy, Nivolumab, Radiation) | Number of Participants With of Adverse Events | Endocrine disorders - Other, specify | 9 Participants |
| Arm I (Chemotherapy, Nivolumab, Radiation) | Number of Participants With of Adverse Events | Menorrhagia | 1 Participants |
| Arm I (Chemotherapy, Nivolumab, Radiation) | Number of Participants With of Adverse Events | CPK increased | 1 Participants |
| Arm I (Chemotherapy, Nivolumab, Radiation) | Number of Participants With of Adverse Events | Metabolism and nutrition disorders - Other, specif | 5 Participants |
| Arm I (Chemotherapy, Nivolumab, Radiation) | Number of Participants With of Adverse Events | Enterocolitis | 2 Participants |
| Arm I (Chemotherapy, Nivolumab, Radiation) | Number of Participants With of Adverse Events | Mitral valve disease | 1 Participants |
| Arm I (Chemotherapy, Nivolumab, Radiation) | Number of Participants With of Adverse Events | Acute kidney injury | 3 Participants |
| Arm I (Chemotherapy, Nivolumab, Radiation) | Number of Participants With of Adverse Events | Movements involuntary | 1 Participants |
| Arm I (Chemotherapy, Nivolumab, Radiation) | Number of Participants With of Adverse Events | Enterocolitis infectious | 1 Participants |
| Arm I (Chemotherapy, Nivolumab, Radiation) | Number of Participants With of Adverse Events | Mucosal infection | 1 Participants |
| Arm I (Chemotherapy, Nivolumab, Radiation) | Number of Participants With of Adverse Events | Cardiac arrest | 0 Participants |
| Arm I (Chemotherapy, Nivolumab, Radiation) | Number of Participants With of Adverse Events | Mucositis oral | 109 Participants |
| Arm I (Chemotherapy, Nivolumab, Radiation) | Number of Participants With of Adverse Events | Eosinophilia | 12 Participants |
| Arm I (Chemotherapy, Nivolumab, Radiation) | Number of Participants With of Adverse Events | Muscle cramp | 14 Participants |
| Arm I (Chemotherapy, Nivolumab, Radiation) | Number of Participants With of Adverse Events | Arthralgia | 65 Participants |
| Arm I (Chemotherapy, Nivolumab, Radiation) | Number of Participants With of Adverse Events | Muscle weakness lower limb | 5 Participants |
| Arm I (Chemotherapy, Nivolumab, Radiation) | Number of Participants With of Adverse Events | Epistaxis | 10 Participants |
| Arm I (Chemotherapy, Nivolumab, Radiation) | Number of Participants With of Adverse Events | Muscle weakness trunk | 1 Participants |
| Arm I (Chemotherapy, Nivolumab, Radiation) | Number of Participants With of Adverse Events | Cardiac disorders - Other, specify | 6 Participants |
| Arm I (Chemotherapy, Nivolumab, Radiation) | Number of Participants With of Adverse Events | Muscle weakness upper limb | 1 Participants |
| Arm I (Chemotherapy, Nivolumab, Radiation) | Number of Participants With of Adverse Events | Erectile dysfunction | 2 Participants |
| Arm I (Chemotherapy, Nivolumab, Radiation) | Number of Participants With of Adverse Events | Musculoskeletal and connective tissue disorder - | 5 Participants |
| Arm I (Chemotherapy, Nivolumab, Radiation) | Number of Participants With of Adverse Events | Allergic rhinitis | 0 Participants |
| Arm I (Chemotherapy, Nivolumab, Radiation) | Number of Participants With of Adverse Events | Myalgia | 54 Participants |
| Arm I (Chemotherapy, Nivolumab, Radiation) | Number of Participants With of Adverse Events | Erythema multiforme | 1 Participants |
| Arm I (Chemotherapy, Nivolumab, Radiation) | Number of Participants With of Adverse Events | Myositis | 2 Participants |
| Arm I (Chemotherapy, Nivolumab, Radiation) | Number of Participants With of Adverse Events | Cardiac troponin I increased | 1 Participants |
| Arm I (Chemotherapy, Nivolumab, Radiation) | Number of Participants With of Adverse Events | Nail changes | 2 Participants |
| Arm I (Chemotherapy, Nivolumab, Radiation) | Number of Participants With of Adverse Events | Erythroderma | 1 Participants |
| Arm I (Chemotherapy, Nivolumab, Radiation) | Number of Participants With of Adverse Events | Nail discoloration | 7 Participants |
| Arm I (Chemotherapy, Nivolumab, Radiation) | Number of Participants With of Adverse Events | Arthritis | 3 Participants |
| Arm I (Chemotherapy, Nivolumab, Radiation) | Number of Participants With of Adverse Events | Nail infection | 3 Participants |
| Arm I (Chemotherapy, Nivolumab, Radiation) | Number of Participants With of Adverse Events | Esophageal pain | 1 Participants |
| Arm I (Chemotherapy, Nivolumab, Radiation) | Number of Participants With of Adverse Events | Nail ridging | 1 Participants |
| Arm I (Chemotherapy, Nivolumab, Radiation) | Number of Participants With of Adverse Events | Cardiac troponin T increased | 1 Participants |
| Arm I (Chemotherapy, Nivolumab, Radiation) | Number of Participants With of Adverse Events | Nasal congestion | 6 Participants |
| Arm I (Chemotherapy, Nivolumab, Radiation) | Number of Participants With of Adverse Events | Esophagitis | 2 Participants |
| Arm I (Chemotherapy, Nivolumab, Radiation) | Number of Participants With of Adverse Events | Nausea | 317 Participants |
| Arm I (Chemotherapy, Nivolumab, Radiation) | Number of Participants With of Adverse Events | Eye disorders - Other, specify | 3 Participants |
| Arm I (Chemotherapy, Nivolumab, Radiation) | Number of Participants With of Adverse Events | Neck edema | 3 Participants |
| Arm I (Chemotherapy, Nivolumab, Radiation) | Number of Participants With of Adverse Events | Abdominal distension | 1 Participants |
| Arm I (Chemotherapy, Nivolumab, Radiation) | Number of Participants With of Adverse Events | Neck pain | 4 Participants |
| Arm I (Chemotherapy, Nivolumab, Radiation) | Number of Participants With of Adverse Events | Facial muscle weakness | 1 Participants |
| Arm I (Chemotherapy, Nivolumab, Radiation) | Number of Participants With of Adverse Events | Neoplasms benign, malignant and unspecified (incl | 2 Participants |
| Arm I (Chemotherapy, Nivolumab, Radiation) | Number of Participants With of Adverse Events | Catheter related infection | 1 Participants |
| Arm I (Chemotherapy, Nivolumab, Radiation) | Number of Participants With of Adverse Events | Nervous system disorders - Other, specify | 5 Participants |
| Arm I (Chemotherapy, Nivolumab, Radiation) | Number of Participants With of Adverse Events | Facial pain | 1 Participants |
| Arm I (Chemotherapy, Nivolumab, Radiation) | Number of Participants With of Adverse Events | Neuralgia | 2 Participants |
| Arm I (Chemotherapy, Nivolumab, Radiation) | Number of Participants With of Adverse Events | Ascites | 1 Participants |
| Arm I (Chemotherapy, Nivolumab, Radiation) | Number of Participants With of Adverse Events | Neutrophil count decreased | 275 Participants |
| Arm I (Chemotherapy, Nivolumab, Radiation) | Number of Participants With of Adverse Events | Fall | 5 Participants |
| Arm I (Chemotherapy, Nivolumab, Radiation) | Number of Participants With of Adverse Events | Non-cardiac chest pain | 16 Participants |
| Arm I (Chemotherapy, Nivolumab, Radiation) | Number of Participants With of Adverse Events | Cheilitis | 1 Participants |
| Arm I (Chemotherapy, Nivolumab, Radiation) | Number of Participants With of Adverse Events | Oral dysesthesia | 6 Participants |
| Arm I (Chemotherapy, Nivolumab, Radiation) | Number of Participants With of Adverse Events | Fatigue | 232 Participants |
| Arm I (Chemotherapy, Nivolumab, Radiation) | Number of Participants With of Adverse Events | Oral hemorrhage | 0 Participants |
| Arm I (Chemotherapy, Nivolumab, Radiation) | Number of Participants With of Adverse Events | Alopecia | 103 Participants |
| Arm I (Chemotherapy, Nivolumab, Radiation) | Number of Participants With of Adverse Events | Oral pain | 30 Participants |
| Arm I (Chemotherapy, Nivolumab, Radiation) | Number of Participants With of Adverse Events | Febrile neutropenia | 28 Participants |
| Arm I (Chemotherapy, Nivolumab, Radiation) | Number of Participants With of Adverse Events | Pain | 43 Participants |
| Arm I (Chemotherapy, Nivolumab, Radiation) | Number of Participants With of Adverse Events | Chest pain - cardiac | 4 Participants |
| Arm I (Chemotherapy, Nivolumab, Radiation) | Number of Participants With of Adverse Events | Pain in extremity | 22 Participants |
| Arm I (Chemotherapy, Nivolumab, Radiation) | Number of Participants With of Adverse Events | Fecal incontinence | 0 Participants |
| Arm I (Chemotherapy, Nivolumab, Radiation) | Number of Participants With of Adverse Events | Palmar-plantar erythrodysesthesia syndrome | 1 Participants |
| Arm I (Chemotherapy, Nivolumab, Radiation) | Number of Participants With of Adverse Events | Aspartate aminotransferase increased | 129 Participants |
| Arm I (Chemotherapy, Nivolumab, Radiation) | Number of Participants With of Adverse Events | Palpitations | 7 Participants |
| Arm I (Chemotherapy, Nivolumab, Radiation) | Number of Participants With of Adverse Events | Fever | 64 Participants |
| Arm I (Chemotherapy, Nivolumab, Radiation) | Number of Participants With of Adverse Events | Pancreatic enzymes decreased | 0 Participants |
| Arm I (Chemotherapy, Nivolumab, Radiation) | Number of Participants With of Adverse Events | Chest wall pain | 2 Participants |
| Arm I (Chemotherapy, Nivolumab, Radiation) | Number of Participants With of Adverse Events | Pancreatitis | 4 Participants |
| Arm I (Chemotherapy, Nivolumab, Radiation) | Number of Participants With of Adverse Events | Fibrinogen decreased | 2 Participants |
| Arm I (Chemotherapy, Nivolumab, Radiation) | Number of Participants With of Adverse Events | Papulopustular rash | 4 Participants |
| Arm I (Chemotherapy, Nivolumab, Radiation) | Number of Participants With of Adverse Events | Adrenal insufficiency | 2 Participants |
| Arm I (Chemotherapy, Nivolumab, Radiation) | Number of Participants With of Adverse Events | Paresthesia | 36 Participants |
| Arm I (Chemotherapy, Nivolumab, Radiation) | Number of Participants With of Adverse Events | Flank pain | 1 Participants |
| Arm I (Chemotherapy, Nivolumab, Radiation) | Number of Participants With of Adverse Events | Paronychia | 1 Participants |
| Arm I (Chemotherapy, Nivolumab, Radiation) | Number of Participants With of Adverse Events | Chills | 22 Participants |
| Arm I (Chemotherapy, Nivolumab, Radiation) | Number of Participants With of Adverse Events | Paroxysmal atrial tachycardia | 2 Participants |
| Arm I (Chemotherapy, Nivolumab, Radiation) | Number of Participants With of Adverse Events | Flashing lights | 1 Participants |
| Arm I (Chemotherapy, Nivolumab, Radiation) | Number of Participants With of Adverse Events | Pelvic pain | 1 Participants |
| Arm I (Chemotherapy, Nivolumab, Radiation) | Number of Participants With of Adverse Events | Ataxia | 0 Participants |
| Arm I (Chemotherapy, Nivolumab, Radiation) | Number of Participants With of Adverse Events | Penile infection | 0 Participants |
| Arm I (Chemotherapy, Nivolumab, Radiation) | Number of Participants With of Adverse Events | Flatulence | 4 Participants |
| Arm I (Chemotherapy, Nivolumab, Radiation) | Number of Participants With of Adverse Events | Pericardial effusion | 1 Participants |
| Arm I (Chemotherapy, Nivolumab, Radiation) | Number of Participants With of Adverse Events | Cholesterol high | 0 Participants |
| Arm I (Chemotherapy, Nivolumab, Radiation) | Number of Participants With of Adverse Events | Pericarditis | 3 Participants |
| Arm I (Chemotherapy, Nivolumab, Radiation) | Number of Participants With of Adverse Events | Floaters | 0 Participants |
| Arm I (Chemotherapy, Nivolumab, Radiation) | Number of Participants With of Adverse Events | Peripheral motor neuropathy | 21 Participants |
| Arm I (Chemotherapy, Nivolumab, Radiation) | Number of Participants With of Adverse Events | Amenorrhea | 1 Participants |
| Arm I (Chemotherapy, Nivolumab, Radiation) | Number of Participants With of Adverse Events | Peripheral sensory neuropathy | 141 Participants |
| Arm I (Chemotherapy, Nivolumab, Radiation) | Number of Participants With of Adverse Events | Flu like symptoms | 4 Participants |
| Arm I (Chemotherapy, Nivolumab, Radiation) | Number of Participants With of Adverse Events | Pharyngeal mucositis | 1 Participants |
| Arm I (Chemotherapy, Nivolumab, Radiation) | Number of Participants With of Adverse Events | Chronic kidney disease | 1 Participants |
| Arm I (Chemotherapy, Nivolumab, Radiation) | Number of Participants With of Adverse Events | Pharyngitis | 0 Participants |
| Arm I (Chemotherapy, Nivolumab, Radiation) | Number of Participants With of Adverse Events | Flushing | 10 Participants |
| Arm I (Chemotherapy, Nivolumab, Radiation) | Number of Participants With of Adverse Events | Phlebitis | 3 Participants |
| Arm I (Chemotherapy, Nivolumab, Radiation) | Number of Participants With of Adverse Events | Atelectasis | 1 Participants |
| Arm I (Chemotherapy, Nivolumab, Radiation) | Number of Participants With of Adverse Events | Photophobia | 1 Participants |
| Arm I (Chemotherapy, Nivolumab, Radiation) | Number of Participants With of Adverse Events | Folliculitis | 2 Participants |
| Arm I (Chemotherapy, Nivolumab, Radiation) | Number of Participants With of Adverse Events | Photosensitivity | 1 Participants |
| Arm I (Chemotherapy, Nivolumab, Radiation) | Number of Participants With of Adverse Events | Cognitive disturbance | 3 Participants |
| Arm I (Chemotherapy, Nivolumab, Radiation) | Number of Participants With of Adverse Events | Platelet count decreased | 53 Participants |
| Arm I (Chemotherapy, Nivolumab, Radiation) | Number of Participants With of Adverse Events | Fracture | 0 Participants |
| Arm I (Chemotherapy, Nivolumab, Radiation) | Number of Participants With of Adverse Events | Pleural effusion | 2 Participants |
| Arm I (Chemotherapy, Nivolumab, Radiation) | Number of Participants With of Adverse Events | Bacteremia | 0 Participants |
| Arm I (Chemotherapy, Nivolumab, Radiation) | Number of Participants With of Adverse Events | Pleuritic pain | 1 Participants |
| Arm I (Chemotherapy, Nivolumab, Radiation) | Number of Participants With of Adverse Events | GGT increased | 4 Participants |
| Arm I (Chemotherapy, Nivolumab, Radiation) | Number of Participants With of Adverse Events | Pneumonitis | 11 Participants |
| Arm I (Chemotherapy, Nivolumab, Radiation) | Number of Participants With of Adverse Events | Colitis | 6 Participants |
| Arm I (Chemotherapy, Nivolumab, Radiation) | Number of Participants With of Adverse Events | Postnasal drip | 2 Participants |
| Arm I (Chemotherapy, Nivolumab, Radiation) | Number of Participants With of Adverse Events | Gait disturbance | 0 Participants |
| Arm I (Chemotherapy, Nivolumab, Radiation) | Number of Participants With of Adverse Events | Presyncope | 2 Participants |
| Arm I (Chemotherapy, Nivolumab, Radiation) | Number of Participants With of Adverse Events | Atrial fibrillation | 1 Participants |
| Arm I (Chemotherapy, Nivolumab, Radiation) | Number of Participants With of Adverse Events | Productive cough | 2 Participants |
| Arm I (Chemotherapy, Nivolumab, Radiation) | Number of Participants With of Adverse Events | Gastric hemorrhage | 0 Participants |
| Arm I (Chemotherapy, Nivolumab, Radiation) | Number of Participants With of Adverse Events | Proteinuria | 2 Participants |
| Arm I (Chemotherapy, Nivolumab, Radiation) | Number of Participants With of Adverse Events | Colonic obstruction | 0 Participants |
| Arm I (Chemotherapy, Nivolumab, Radiation) | Number of Participants With of Adverse Events | Pruritus | 48 Participants |
| Arm I (Chemotherapy, Nivolumab, Radiation) | Number of Participants With of Adverse Events | Gastritis | 9 Participants |
| Arm I (Chemotherapy, Nivolumab, Radiation) | Number of Participants With of Adverse Events | Psychiatric disorders - Other, specify | 1 Participants |
| Arm I (Chemotherapy, Nivolumab, Radiation) | Number of Participants With of Adverse Events | Amnesia | 1 Participants |
| Arm I (Chemotherapy, Nivolumab, Radiation) | Number of Participants With of Adverse Events | Psychosis | 0 Participants |
| Arm I (Chemotherapy, Nivolumab, Radiation) | Number of Participants With of Adverse Events | Gastroesophageal reflux disease | 27 Participants |
| Arm I (Chemotherapy, Nivolumab, Radiation) | Number of Participants With of Adverse Events | Pulmonary edema | 1 Participants |
| Arm I (Chemotherapy, Nivolumab, Radiation) | Number of Participants With of Adverse Events | Concentration impairment | 4 Participants |
| Arm I (Chemotherapy, Nivolumab, Radiation) | Number of Participants With of Adverse Events | Rash acneiform | 16 Participants |
| Arm I (Chemotherapy, Nivolumab, Radiation) | Number of Participants With of Adverse Events | Gastrointestinal disorders - Other, specify | 10 Participants |
| Arm I (Chemotherapy, Nivolumab, Radiation) | Number of Participants With of Adverse Events | Rash maculo-papular | 55 Participants |
| Arm I (Chemotherapy, Nivolumab, Radiation) | Number of Participants With of Adverse Events | Belching | 3 Participants |
| Arm I (Chemotherapy, Nivolumab, Radiation) | Number of Participants With of Adverse Events | Rash pustular | 0 Participants |
| Arm I (Chemotherapy, Nivolumab, Radiation) | Number of Participants With of Adverse Events | Gastrointestinal pain | 1 Participants |
| Arm I (Chemotherapy, Nivolumab, Radiation) | Number of Participants With of Adverse Events | Rectal fissure | 0 Participants |
| Arm I (Chemotherapy, Nivolumab, Radiation) | Number of Participants With of Adverse Events | Confusion | 3 Participants |
| Arm I (Chemotherapy, Nivolumab, Radiation) | Number of Participants With of Adverse Events | Rectal hemorrhage | 1 Participants |
| Arm I (Chemotherapy, Nivolumab, Radiation) | Number of Participants With of Adverse Events | Gastroparesis | 0 Participants |
| Arm I (Chemotherapy, Nivolumab, Radiation) | Number of Participants With of Adverse Events | Rectal pain | 1 Participants |
| Arm I (Chemotherapy, Nivolumab, Radiation) | Number of Participants With of Adverse Events | Agitation | 4 Participants |
| Arm I (Chemotherapy, Nivolumab, Radiation) | Number of Participants With of Adverse Events | Renal and urinary disorders - Other, specify | 1 Participants |
| Arm I (Chemotherapy, Nivolumab, Radiation) | Number of Participants With of Adverse Events | General disorders and administration site conditio | 7 Participants |
| Arm I (Chemotherapy, Nivolumab, Radiation) | Number of Participants With of Adverse Events | Respiratory failure | 0 Participants |
| Arm I (Chemotherapy, Nivolumab, Radiation) | Number of Participants With of Adverse Events | Conjunctivitis | 1 Participants |
| Arm I (Chemotherapy, Nivolumab, Radiation) | Number of Participants With of Adverse Events | Respiratory, thoracic and mediastinal disorders - | 3 Participants |
| Arm I (Chemotherapy, Nivolumab, Radiation) | Number of Participants With of Adverse Events | Generalized edema | 1 Participants |
| Arm I (Chemotherapy, Nivolumab, Radiation) | Number of Participants With of Adverse Events | Restrictive cardiomyopathy | 1 Participants |
| Arm I (Chemotherapy, Nivolumab, Radiation) | Number of Participants With of Adverse Events | Bladder infection | 1 Participants |
| Arm I (Chemotherapy, Nivolumab, Radiation) | Number of Participants With of Adverse Events | Rhabdomyolysis | 1 Participants |
| Arm I (Chemotherapy, Nivolumab, Radiation) | Number of Participants With of Adverse Events | Generalized muscle weakness | 16 Participants |
| Arm I (Chemotherapy, Nivolumab, Radiation) | Number of Participants With of Adverse Events | Rhinorrhea | 6 Participants |
| Arm I (Chemotherapy, Nivolumab, Radiation) | Number of Participants With of Adverse Events | Conjunctivitis infective | 0 Participants |
| Arm I (Chemotherapy, Nivolumab, Radiation) | Number of Participants With of Adverse Events | Salivary duct inflammation | 1 Participants |
| Arm I (Chemotherapy, Nivolumab, Radiation) | Number of Participants With of Adverse Events | Glucose intolerance | 1 Participants |
| Arm I (Chemotherapy, Nivolumab, Radiation) | Number of Participants With of Adverse Events | Scalp pain | 1 Participants |
| Arm I (Chemotherapy, Nivolumab, Radiation) | Number of Participants With of Adverse Events | Anal fissure | 0 Participants |
| Arm I (Chemotherapy, Nivolumab, Radiation) | Number of Participants With of Adverse Events | Scrotal pain | 0 Participants |
| Arm I (Chemotherapy, Nivolumab, Radiation) | Number of Participants With of Adverse Events | Glucosuria | 2 Participants |
| Arm I (Chemotherapy, Nivolumab, Radiation) | Number of Participants With of Adverse Events | Seizure | 2 Participants |
| Arm I (Chemotherapy, Nivolumab, Radiation) | Number of Participants With of Adverse Events | Constipation | 196 Participants |
| Arm I (Chemotherapy, Nivolumab, Radiation) | Number of Participants With of Adverse Events | Sepsis | 8 Participants |
| Arm I (Chemotherapy, Nivolumab, Radiation) | Number of Participants With of Adverse Events | Guillain-Barre syndrome | 0 Participants |
| Arm I (Chemotherapy, Nivolumab, Radiation) | Number of Participants With of Adverse Events | Serum amylase increased | 1 Participants |
| Arm I (Chemotherapy, Nivolumab, Radiation) | Number of Participants With of Adverse Events | Bloating | 7 Participants |
| Arm I (Chemotherapy, Nivolumab, Radiation) | Number of Participants With of Adverse Events | Sinus bradycardia | 1 Participants |
| Arm I (Chemotherapy, Nivolumab, Radiation) | Number of Participants With of Adverse Events | Gynecomastia | 0 Participants |
| Arm I (Chemotherapy, Nivolumab, Radiation) | Number of Participants With of Adverse Events | Sinus disorder | 0 Participants |
| Arm I (Chemotherapy, Nivolumab, Radiation) | Number of Participants With of Adverse Events | Cough | 33 Participants |
| Arm I (Chemotherapy, Nivolumab, Radiation) | Number of Participants With of Adverse Events | Sinus tachycardia | 17 Participants |
| Arm I (Chemotherapy, Nivolumab, Radiation) | Number of Participants With of Adverse Events | Headache | 71 Participants |
| Arm I (Chemotherapy, Nivolumab, Radiation) | Number of Participants With of Adverse Events | Skin and subcutaneous tissue disorders - Other, sp | 16 Participants |
| Arm I (Chemotherapy, Nivolumab, Radiation) | Number of Participants With of Adverse Events | Abdominal pain | 61 Participants |
| Arm I (Chemotherapy, Nivolumab, Radiation) | Number of Participants With of Adverse Events | Skin hyperpigmentation | 8 Participants |
| Arm I (Chemotherapy, Nivolumab, Radiation) | Number of Participants With of Adverse Events | Heart failure | 2 Participants |
| Arm I (Chemotherapy, Nivolumab, Radiation) | Number of Participants With of Adverse Events | Skin hypopigmentation | 3 Participants |
| Arm I (Chemotherapy, Nivolumab, Radiation) | Number of Participants With of Adverse Events | Creatinine increased | 27 Participants |
| Arm I (Chemotherapy, Nivolumab, Radiation) | Number of Participants With of Adverse Events | Skin infection | 6 Participants |
| Arm I (Chemotherapy, Nivolumab, Radiation) | Number of Participants With of Adverse Events | Hematuria | 4 Participants |
| Arm I (Chemotherapy, Nivolumab, Radiation) | Number of Participants With of Adverse Events | Skin ulceration | 0 Participants |
| Arm I (Chemotherapy, Nivolumab, Radiation) | Number of Participants With of Adverse Events | Blood and lymphatic system disorders - Other, spec | 3 Participants |
| Arm I (Chemotherapy, Nivolumab, Radiation) | Number of Participants With of Adverse Events | Small intestinal obstruction | 0 Participants |
| Arm I (Chemotherapy, Nivolumab, Radiation) | Number of Participants With of Adverse Events | Hemolysis | 1 Participants |
| Arm I (Chemotherapy, Nivolumab, Radiation) | Number of Participants With of Adverse Events | Sneezing | 0 Participants |
| Arm I (Chemotherapy, Nivolumab, Radiation) | Number of Participants With of Adverse Events | Cyanosis | 1 Participants |
| Arm I (Chemotherapy, Nivolumab, Radiation) | Number of Participants With of Adverse Events | Somnolence | 0 Participants |
| Arm I (Chemotherapy, Nivolumab, Radiation) | Number of Participants With of Adverse Events | Hemorrhoidal hemorrhage | 1 Participants |
| Arm I (Chemotherapy, Nivolumab, Radiation) | Number of Participants With of Adverse Events | Sore throat | 16 Participants |
| Arm I (Chemotherapy, Nivolumab, Radiation) | Number of Participants With of Adverse Events | Tendon reflex decreased | 1 Participants |
| Arm I (Chemotherapy, Nivolumab, Radiation) | Number of Participants With of Adverse Events | Anal fistula | 0 Participants |
| Arm I (Chemotherapy, Nivolumab, Radiation) | Number of Participants With of Adverse Events | Spasticity | 1 Participants |
| Arm I (Chemotherapy, Nivolumab, Radiation) | Number of Participants With of Adverse Events | Hemorrhoids | 4 Participants |
| Arm I (Chemotherapy, Nivolumab, Radiation) | Number of Participants With of Adverse Events | Stomach pain | 10 Participants |
| Arm I (Chemotherapy, Nivolumab, Radiation) | Number of Participants With of Adverse Events | Dehydration | 14 Participants |
| Arm I (Chemotherapy, Nivolumab, Radiation) | Number of Participants With of Adverse Events | Stroke | 1 Participants |
| Arm I (Chemotherapy, Nivolumab, Radiation) | Number of Participants With of Adverse Events | Hepatic failure | 2 Participants |
| Arm I (Chemotherapy, Nivolumab, Radiation) | Number of Participants With of Adverse Events | Superficial thrombophlebitis | 3 Participants |
| Arm I (Chemotherapy, Nivolumab, Radiation) | Number of Participants With of Adverse Events | Blood bicarbonate decreased | 3 Participants |
| Arm I (Chemotherapy, Nivolumab, Radiation) | Number of Participants With of Adverse Events | Supraventricular tachycardia | 0 Participants |
| Arm I (Chemotherapy, Nivolumab, Radiation) | Number of Participants With of Adverse Events | Hepatobiliary disorders - Other, specify | 2 Participants |
| Arm I (Chemotherapy, Nivolumab, Radiation) | Number of Participants With of Adverse Events | Syncope | 1 Participants |
| Arm I (Chemotherapy, Nivolumab, Radiation) | Number of Participants With of Adverse Events | Delirium | 0 Participants |
| Arm I (Chemotherapy, Nivolumab, Radiation) | Number of Participants With of Adverse Events | Herpes simplex reactivation | 1 Participants |
| Arm I (Chemotherapy, Nivolumab, Radiation) | Number of Participants With of Adverse Events | Testicular pain | 0 Participants |
| Arm I (Chemotherapy, Nivolumab, Radiation) | Number of Participants With of Adverse Events | Akathisia | 1 Participants |
| Arm I (Chemotherapy, Nivolumab, Radiation) | Number of Participants With of Adverse Events | Thromboembolic event | 12 Participants |
| Arm I (Chemotherapy, Nivolumab, Radiation) | Number of Participants With of Adverse Events | Hiccups | 6 Participants |
| Arm I (Chemotherapy, Nivolumab, Radiation) | Number of Participants With of Adverse Events | Thrush | 7 Participants |
| Arm I (Chemotherapy, Nivolumab, Radiation) | Number of Participants With of Adverse Events | Depressed level of consciousness | 1 Participants |
| Arm I (Chemotherapy, Nivolumab, Radiation) | Number of Participants With of Adverse Events | Thyroid stimulating hormone increased | 28 Participants |
| Arm I (Chemotherapy, Nivolumab, Radiation) | Number of Participants With of Adverse Events | Hoarseness | 0 Participants |
| Arm I (Chemotherapy, Nivolumab, Radiation) | Number of Participants With of Adverse Events | Tinnitus | 8 Participants |
| Arm I (Chemotherapy, Nivolumab, Radiation) | Number of Participants With of Adverse Events | Blood bilirubin increased | 14 Participants |
| Arm I (Chemotherapy, Nivolumab, Radiation) | Number of Participants With of Adverse Events | Tooth discoloration | 0 Participants |
| Arm I (Chemotherapy, Nivolumab, Radiation) | Number of Participants With of Adverse Events | Hot flashes | 9 Participants |
| Arm I (Chemotherapy, Nivolumab, Radiation) | Number of Participants With of Adverse Events | Tooth infection | 1 Participants |
| Arm I (Chemotherapy, Nivolumab, Radiation) | Number of Participants With of Adverse Events | Depression | 10 Participants |
| Arm I (Chemotherapy, Nivolumab, Radiation) | Number of Participants With of Adverse Events | Toothache | 3 Participants |
| Arm I (Chemotherapy, Nivolumab, Radiation) | Number of Participants With of Adverse Events | Hypercalcemia | 6 Participants |
| Arm I (Chemotherapy, Nivolumab, Radiation) | Number of Participants With of Adverse Events | Tracheal mucositis | 0 Participants |
| Arm I (Chemotherapy, Nivolumab, Radiation) | Number of Participants With of Adverse Events | Anal hemorrhage | 1 Participants |
| Arm I (Chemotherapy, Nivolumab, Radiation) | Number of Participants With of Adverse Events | Tracheitis | 1 Participants |
| Arm I (Chemotherapy, Nivolumab, Radiation) | Number of Participants With of Adverse Events | Hyperglycemia | 57 Participants |
| Arm I (Chemotherapy, Nivolumab, Radiation) | Number of Participants With of Adverse Events | Tremor | 4 Participants |
| Arm I (Chemotherapy, Nivolumab, Radiation) | Number of Participants With of Adverse Events | Dermatitis radiation | 0 Participants |
| Arm I (Chemotherapy, Nivolumab, Radiation) | Number of Participants With of Adverse Events | Tumor lysis syndrome | 1 Participants |
| Arm I (Chemotherapy, Nivolumab, Radiation) | Number of Participants With of Adverse Events | Hyperhidrosis | 14 Participants |
| Arm I (Chemotherapy, Nivolumab, Radiation) | Number of Participants With of Adverse Events | Tumor pain | 0 Participants |
| Arm I (Chemotherapy, Nivolumab, Radiation) | Number of Participants With of Adverse Events | Blood lactate dehydrogenase increased | 18 Participants |
| Arm I (Chemotherapy, Nivolumab, Radiation) | Number of Participants With of Adverse Events | Typhlitis | 0 Participants |
| Arm I (Chemotherapy, Nivolumab, Radiation) | Number of Participants With of Adverse Events | Vaginal discharge | 2 Participants |
| Arm I (Chemotherapy, Nivolumab, Radiation) | Number of Participants With of Adverse Events | Hyperkalemia | 5 Participants |
| Arm I (Chemotherapy, Nivolumab, Radiation) | Number of Participants With of Adverse Events | Upper gastrointestinal hemorrhage | 1 Participants |
| Arm I (Chemotherapy, Nivolumab, Radiation) | Number of Participants With of Adverse Events | Diarrhea | 101 Participants |
| Arm I (Chemotherapy, Nivolumab, Radiation) | Number of Participants With of Adverse Events | Upper respiratory infection | 7 Participants |
| Arm I (Chemotherapy, Nivolumab, Radiation) | Number of Participants With of Adverse Events | Hyperlipidemia | 0 Participants |
| Arm I (Chemotherapy, Nivolumab, Radiation) | Number of Participants With of Adverse Events | Urinary frequency | 2 Participants |
| Arm I (Chemotherapy, Nivolumab, Radiation) | Number of Participants With of Adverse Events | Extrapyramidal disorder | 1 Participants |
| Arm I (Chemotherapy, Nivolumab, Radiation) | Number of Participants With of Adverse Events | Urinary incontinence | 1 Participants |
| Arm I (Chemotherapy, Nivolumab, Radiation) | Number of Participants With of Adverse Events | Hypermagnesemia | 4 Participants |
| Arm I (Chemotherapy, Nivolumab, Radiation) | Number of Participants With of Adverse Events | Urinary retention | 0 Participants |
| Arm I (Chemotherapy, Nivolumab, Radiation) | Number of Participants With of Adverse Events | Disseminated intravascular coagulation | 1 Participants |
| Arm I (Chemotherapy, Nivolumab, Radiation) | Number of Participants With of Adverse Events | Urinary tract infection | 7 Participants |
| Arm I (Chemotherapy, Nivolumab, Radiation) | Number of Participants With of Adverse Events | Hypernatremia | 1 Participants |
| Arm I (Chemotherapy, Nivolumab, Radiation) | Number of Participants With of Adverse Events | Urinary tract pain | 2 Participants |
| Arm I (Chemotherapy, Nivolumab, Radiation) | Number of Participants With of Adverse Events | Blurred vision | 11 Participants |
| Arm I (Chemotherapy, Nivolumab, Radiation) | Number of Participants With of Adverse Events | Urinary urgency | 0 Participants |
| Arm I (Chemotherapy, Nivolumab, Radiation) | Number of Participants With of Adverse Events | Hyperphosphatemia | 17 Participants |
| Arm I (Chemotherapy, Nivolumab, Radiation) | Number of Participants With of Adverse Events | Urticaria | 1 Participants |
| Arm I (Chemotherapy, Nivolumab, Radiation) | Number of Participants With of Adverse Events | Dizziness | 29 Participants |
| Arm I (Chemotherapy, Nivolumab, Radiation) | Number of Participants With of Adverse Events | Hypertension | 41 Participants |
| Arm I (Chemotherapy, Nivolumab, Radiation) | Number of Participants With of Adverse Events | Vaginal infection | 2 Participants |
| Arm I (Chemotherapy, Nivolumab, Radiation) | Number of Participants With of Adverse Events | Anemia | 198 Participants |
| Arm I (Chemotherapy, Nivolumab, Radiation) | Number of Participants With of Adverse Events | Vascular access complication | 1 Participants |
| Arm I (Chemotherapy, Nivolumab, Radiation) | Number of Participants With of Adverse Events | Hyperthyroidism | 13 Participants |
| Arm I (Chemotherapy, Nivolumab, Radiation) | Number of Participants With of Adverse Events | Vascular disorders - Other, specify | 3 Participants |
| Arm I (Chemotherapy, Nivolumab, Radiation) | Number of Participants With of Adverse Events | Dry eye | 2 Participants |
| Arm I (Chemotherapy, Nivolumab, Radiation) | Number of Participants With of Adverse Events | Vasovagal reaction | 0 Participants |
| Arm I (Chemotherapy, Nivolumab, Radiation) | Number of Participants With of Adverse Events | Hypertriglyceridemia | 2 Participants |
| Arm I (Chemotherapy, Nivolumab, Radiation) | Number of Participants With of Adverse Events | Ventricular arrhythmia | 1 Participants |
| Arm I (Chemotherapy, Nivolumab, Radiation) | Number of Participants With of Adverse Events | Bone pain | 41 Participants |
| Arm I (Chemotherapy, Nivolumab, Radiation) | Number of Participants With of Adverse Events | Ventricular tachycardia | 1 Participants |
| Arm I (Chemotherapy, Nivolumab, Radiation) | Number of Participants With of Adverse Events | Hyperuricemia | 6 Participants |
| Arm I (Chemotherapy, Nivolumab, Radiation) | Number of Participants With of Adverse Events | Vertigo | 2 Participants |
| Arm I (Chemotherapy, Nivolumab, Radiation) | Number of Participants With of Adverse Events | Dry mouth | 19 Participants |
| Arm I (Chemotherapy, Nivolumab, Radiation) | Number of Participants With of Adverse Events | Vision decreased | 3 Participants |
| Arm I (Chemotherapy, Nivolumab, Radiation) | Number of Participants With of Adverse Events | Hypoalbuminemia | 43 Participants |
| Arm I (Chemotherapy, Nivolumab, Radiation) | Number of Participants With of Adverse Events | Voice alteration | 1 Participants |
| Arm I (Chemotherapy, Nivolumab, Radiation) | Number of Participants With of Adverse Events | Alanine aminotransferase increased | 163 Participants |
| Arm I (Chemotherapy, Nivolumab, Radiation) | Number of Participants With of Adverse Events | Vomiting | 138 Participants |
| Arm I (Chemotherapy, Nivolumab, Radiation) | Number of Participants With of Adverse Events | Hypocalcemia | 34 Participants |
| Arm I (Chemotherapy, Nivolumab, Radiation) | Number of Participants With of Adverse Events | Watering eyes | 1 Participants |
| Arm I (Chemotherapy, Nivolumab, Radiation) | Number of Participants With of Adverse Events | Dry skin | 15 Participants |
| Arm I (Chemotherapy, Nivolumab, Radiation) | Number of Participants With of Adverse Events | Weight gain | 13 Participants |
| Arm I (Chemotherapy, Nivolumab, Radiation) | Number of Participants With of Adverse Events | Hypoglycemia | 7 Participants |
| Arm I (Chemotherapy, Nivolumab, Radiation) | Number of Participants With of Adverse Events | Weight loss | 25 Participants |
| Arm I (Chemotherapy, Nivolumab, Radiation) | Number of Participants With of Adverse Events | Brachial plexopathy | 0 Participants |
| Arm I (Chemotherapy, Nivolumab, Radiation) | Number of Participants With of Adverse Events | Wheezing | 2 Participants |
| Arm I (Chemotherapy, Nivolumab, Radiation) | Number of Participants With of Adverse Events | Hypokalemia | 31 Participants |
| Arm I (Chemotherapy, Nivolumab, Radiation) | Number of Participants With of Adverse Events | White blood cell decreased | 202 Participants |
| Arm I (Chemotherapy, Nivolumab, Radiation) | Number of Participants With of Adverse Events | Dysarthria | 1 Participants |
| Arm I (Chemotherapy, Nivolumab, Radiation) | Number of Participants With of Adverse Events | Wound infection | 0 Participants |
| Arm I (Chemotherapy, Nivolumab, Radiation) | Number of Participants With of Adverse Events | Autoimmune disorder | 1 Participants |
| Arm II (Chemotherapy, Brentuximab Vedotin, Radiation) | Number of Participants With of Adverse Events | Wound infection | 1 Participants |
| Arm II (Chemotherapy, Brentuximab Vedotin, Radiation) | Number of Participants With of Adverse Events | Autoimmune disorder | 0 Participants |
| Arm II (Chemotherapy, Brentuximab Vedotin, Radiation) | Number of Participants With of Adverse Events | Back pain | 35 Participants |
| Arm II (Chemotherapy, Brentuximab Vedotin, Radiation) | Number of Participants With of Adverse Events | Bacteremia | 2 Participants |
| Arm II (Chemotherapy, Brentuximab Vedotin, Radiation) | Number of Participants With of Adverse Events | Esophagitis | 3 Participants |
| Arm II (Chemotherapy, Brentuximab Vedotin, Radiation) | Number of Participants With of Adverse Events | Extrapyramidal disorder | 2 Participants |
| Arm II (Chemotherapy, Brentuximab Vedotin, Radiation) | Number of Participants With of Adverse Events | Abdominal distension | 3 Participants |
| Arm II (Chemotherapy, Brentuximab Vedotin, Radiation) | Number of Participants With of Adverse Events | Abdominal pain | 110 Participants |
| Arm II (Chemotherapy, Brentuximab Vedotin, Radiation) | Number of Participants With of Adverse Events | Activated partial thromboplastin time prolonged | 3 Participants |
| Arm II (Chemotherapy, Brentuximab Vedotin, Radiation) | Number of Participants With of Adverse Events | Acute kidney injury | 3 Participants |
| Arm II (Chemotherapy, Brentuximab Vedotin, Radiation) | Number of Participants With of Adverse Events | Adrenal insufficiency | 0 Participants |
| Arm II (Chemotherapy, Brentuximab Vedotin, Radiation) | Number of Participants With of Adverse Events | Agitation | 0 Participants |
| Arm II (Chemotherapy, Brentuximab Vedotin, Radiation) | Number of Participants With of Adverse Events | Akathisia | 0 Participants |
| Arm II (Chemotherapy, Brentuximab Vedotin, Radiation) | Number of Participants With of Adverse Events | Alanine aminotransferase increased | 209 Participants |
| Arm II (Chemotherapy, Brentuximab Vedotin, Radiation) | Number of Participants With of Adverse Events | Alkaline phosphatase increased | 84 Participants |
| Arm II (Chemotherapy, Brentuximab Vedotin, Radiation) | Number of Participants With of Adverse Events | Allergic reaction | 6 Participants |
| Arm II (Chemotherapy, Brentuximab Vedotin, Radiation) | Number of Participants With of Adverse Events | Allergic rhinitis | 3 Participants |
| Arm II (Chemotherapy, Brentuximab Vedotin, Radiation) | Number of Participants With of Adverse Events | Alopecia | 127 Participants |
| Arm II (Chemotherapy, Brentuximab Vedotin, Radiation) | Number of Participants With of Adverse Events | Amenorrhea | 5 Participants |
| Arm II (Chemotherapy, Brentuximab Vedotin, Radiation) | Number of Participants With of Adverse Events | Amnesia | 0 Participants |
| Arm II (Chemotherapy, Brentuximab Vedotin, Radiation) | Number of Participants With of Adverse Events | Anal fissure | 1 Participants |
| Arm II (Chemotherapy, Brentuximab Vedotin, Radiation) | Number of Participants With of Adverse Events | Anal fistula | 1 Participants |
| Arm II (Chemotherapy, Brentuximab Vedotin, Radiation) | Number of Participants With of Adverse Events | Anal hemorrhage | 1 Participants |
| Arm II (Chemotherapy, Brentuximab Vedotin, Radiation) | Number of Participants With of Adverse Events | Anemia | 222 Participants |
| Arm II (Chemotherapy, Brentuximab Vedotin, Radiation) | Number of Participants With of Adverse Events | Anorectal infection | 0 Participants |
| Arm II (Chemotherapy, Brentuximab Vedotin, Radiation) | Number of Participants With of Adverse Events | Anorexia | 107 Participants |
| Arm II (Chemotherapy, Brentuximab Vedotin, Radiation) | Number of Participants With of Adverse Events | Anosmia | 1 Participants |
| Arm II (Chemotherapy, Brentuximab Vedotin, Radiation) | Number of Participants With of Adverse Events | Anxiety | 30 Participants |
| Arm II (Chemotherapy, Brentuximab Vedotin, Radiation) | Number of Participants With of Adverse Events | Appendicitis | 0 Participants |
| Arm II (Chemotherapy, Brentuximab Vedotin, Radiation) | Number of Participants With of Adverse Events | Arthralgia | 60 Participants |
| Arm II (Chemotherapy, Brentuximab Vedotin, Radiation) | Number of Participants With of Adverse Events | Arthritis | 0 Participants |
| Arm II (Chemotherapy, Brentuximab Vedotin, Radiation) | Number of Participants With of Adverse Events | Ascites | 0 Participants |
| Arm II (Chemotherapy, Brentuximab Vedotin, Radiation) | Number of Participants With of Adverse Events | Aspartate aminotransferase increased | 168 Participants |
| Arm II (Chemotherapy, Brentuximab Vedotin, Radiation) | Number of Participants With of Adverse Events | Ataxia | 3 Participants |
| Arm II (Chemotherapy, Brentuximab Vedotin, Radiation) | Number of Participants With of Adverse Events | Atelectasis | 1 Participants |
| Arm II (Chemotherapy, Brentuximab Vedotin, Radiation) | Number of Participants With of Adverse Events | Atrial fibrillation | 1 Participants |
| Arm II (Chemotherapy, Brentuximab Vedotin, Radiation) | Number of Participants With of Adverse Events | Belching | 1 Participants |
| Arm II (Chemotherapy, Brentuximab Vedotin, Radiation) | Number of Participants With of Adverse Events | Bladder infection | 1 Participants |
| Arm II (Chemotherapy, Brentuximab Vedotin, Radiation) | Number of Participants With of Adverse Events | Bloating | 18 Participants |
| Arm II (Chemotherapy, Brentuximab Vedotin, Radiation) | Number of Participants With of Adverse Events | Blood and lymphatic system disorders - Other, spec | 5 Participants |
| Arm II (Chemotherapy, Brentuximab Vedotin, Radiation) | Number of Participants With of Adverse Events | Blood bicarbonate decreased | 5 Participants |
| Arm II (Chemotherapy, Brentuximab Vedotin, Radiation) | Number of Participants With of Adverse Events | Blood bilirubin increased | 14 Participants |
| Arm II (Chemotherapy, Brentuximab Vedotin, Radiation) | Number of Participants With of Adverse Events | Blood lactate dehydrogenase increased | 25 Participants |
| Arm II (Chemotherapy, Brentuximab Vedotin, Radiation) | Number of Participants With of Adverse Events | Blurred vision | 15 Participants |
| Arm II (Chemotherapy, Brentuximab Vedotin, Radiation) | Number of Participants With of Adverse Events | Bone pain | 99 Participants |
| Arm II (Chemotherapy, Brentuximab Vedotin, Radiation) | Number of Participants With of Adverse Events | Brachial plexopathy | 1 Participants |
| Arm II (Chemotherapy, Brentuximab Vedotin, Radiation) | Number of Participants With of Adverse Events | Breast pain | 1 Participants |
| Arm II (Chemotherapy, Brentuximab Vedotin, Radiation) | Number of Participants With of Adverse Events | Bronchial infection | 0 Participants |
| Arm II (Chemotherapy, Brentuximab Vedotin, Radiation) | Number of Participants With of Adverse Events | Bronchospasm | 0 Participants |
| Arm II (Chemotherapy, Brentuximab Vedotin, Radiation) | Number of Participants With of Adverse Events | Bruising | 8 Participants |
| Arm II (Chemotherapy, Brentuximab Vedotin, Radiation) | Number of Participants With of Adverse Events | Bullous dermatitis | 1 Participants |
| Arm II (Chemotherapy, Brentuximab Vedotin, Radiation) | Number of Participants With of Adverse Events | Burn | 1 Participants |
| Arm II (Chemotherapy, Brentuximab Vedotin, Radiation) | Number of Participants With of Adverse Events | Buttock pain | 0 Participants |
| Arm II (Chemotherapy, Brentuximab Vedotin, Radiation) | Number of Participants With of Adverse Events | CD4 lymphocytes decreased | 1 Participants |
| Arm II (Chemotherapy, Brentuximab Vedotin, Radiation) | Number of Participants With of Adverse Events | CPK increased | 1 Participants |
| Arm II (Chemotherapy, Brentuximab Vedotin, Radiation) | Number of Participants With of Adverse Events | Cardiac arrest | 2 Participants |
| Arm II (Chemotherapy, Brentuximab Vedotin, Radiation) | Number of Participants With of Adverse Events | Cardiac disorders - Other, specify | 0 Participants |
| Arm II (Chemotherapy, Brentuximab Vedotin, Radiation) | Number of Participants With of Adverse Events | Cardiac troponin I increased | 0 Participants |
| Arm II (Chemotherapy, Brentuximab Vedotin, Radiation) | Number of Participants With of Adverse Events | Cardiac troponin T increased | 0 Participants |
| Arm II (Chemotherapy, Brentuximab Vedotin, Radiation) | Number of Participants With of Adverse Events | Catheter related infection | 3 Participants |
| Arm II (Chemotherapy, Brentuximab Vedotin, Radiation) | Number of Participants With of Adverse Events | Cheilitis | 0 Participants |
| Arm II (Chemotherapy, Brentuximab Vedotin, Radiation) | Number of Participants With of Adverse Events | Chest pain - cardiac | 0 Participants |
| Arm II (Chemotherapy, Brentuximab Vedotin, Radiation) | Number of Participants With of Adverse Events | Chest wall pain | 1 Participants |
| Arm II (Chemotherapy, Brentuximab Vedotin, Radiation) | Number of Participants With of Adverse Events | Chills | 20 Participants |
| Arm II (Chemotherapy, Brentuximab Vedotin, Radiation) | Number of Participants With of Adverse Events | Cholesterol high | 1 Participants |
| Arm II (Chemotherapy, Brentuximab Vedotin, Radiation) | Number of Participants With of Adverse Events | Chronic kidney disease | 0 Participants |
| Arm II (Chemotherapy, Brentuximab Vedotin, Radiation) | Number of Participants With of Adverse Events | Cognitive disturbance | 0 Participants |
| Arm II (Chemotherapy, Brentuximab Vedotin, Radiation) | Number of Participants With of Adverse Events | Colitis | 6 Participants |
| Arm II (Chemotherapy, Brentuximab Vedotin, Radiation) | Number of Participants With of Adverse Events | Colonic obstruction | 1 Participants |
| Arm II (Chemotherapy, Brentuximab Vedotin, Radiation) | Number of Participants With of Adverse Events | Concentration impairment | 7 Participants |
| Arm II (Chemotherapy, Brentuximab Vedotin, Radiation) | Number of Participants With of Adverse Events | Confusion | 2 Participants |
| Arm II (Chemotherapy, Brentuximab Vedotin, Radiation) | Number of Participants With of Adverse Events | Conjunctivitis | 4 Participants |
| Arm II (Chemotherapy, Brentuximab Vedotin, Radiation) | Number of Participants With of Adverse Events | Conjunctivitis infective | 2 Participants |
| Arm II (Chemotherapy, Brentuximab Vedotin, Radiation) | Number of Participants With of Adverse Events | Constipation | 209 Participants |
| Arm II (Chemotherapy, Brentuximab Vedotin, Radiation) | Number of Participants With of Adverse Events | Cough | 32 Participants |
| Arm II (Chemotherapy, Brentuximab Vedotin, Radiation) | Number of Participants With of Adverse Events | Creatinine increased | 13 Participants |
| Arm II (Chemotherapy, Brentuximab Vedotin, Radiation) | Number of Participants With of Adverse Events | Cyanosis | 0 Participants |
| Arm II (Chemotherapy, Brentuximab Vedotin, Radiation) | Number of Participants With of Adverse Events | Dehydration | 32 Participants |
| Arm II (Chemotherapy, Brentuximab Vedotin, Radiation) | Number of Participants With of Adverse Events | Delirium | 1 Participants |
| Arm II (Chemotherapy, Brentuximab Vedotin, Radiation) | Number of Participants With of Adverse Events | Depressed level of consciousness | 2 Participants |
| Arm II (Chemotherapy, Brentuximab Vedotin, Radiation) | Number of Participants With of Adverse Events | Depression | 10 Participants |
| Arm II (Chemotherapy, Brentuximab Vedotin, Radiation) | Number of Participants With of Adverse Events | Dermatitis radiation | 2 Participants |
| Arm II (Chemotherapy, Brentuximab Vedotin, Radiation) | Number of Participants With of Adverse Events | Diarrhea | 130 Participants |
| Arm II (Chemotherapy, Brentuximab Vedotin, Radiation) | Number of Participants With of Adverse Events | Disseminated intravascular coagulation | 0 Participants |
| Arm II (Chemotherapy, Brentuximab Vedotin, Radiation) | Number of Participants With of Adverse Events | Dizziness | 40 Participants |
| Arm II (Chemotherapy, Brentuximab Vedotin, Radiation) | Number of Participants With of Adverse Events | Dry eye | 3 Participants |
| Arm II (Chemotherapy, Brentuximab Vedotin, Radiation) | Number of Participants With of Adverse Events | Dry mouth | 32 Participants |
| Arm II (Chemotherapy, Brentuximab Vedotin, Radiation) | Number of Participants With of Adverse Events | Dry skin | 17 Participants |
| Arm II (Chemotherapy, Brentuximab Vedotin, Radiation) | Number of Participants With of Adverse Events | Dysarthria | 0 Participants |
| Arm II (Chemotherapy, Brentuximab Vedotin, Radiation) | Number of Participants With of Adverse Events | Dysesthesia | 3 Participants |
| Arm II (Chemotherapy, Brentuximab Vedotin, Radiation) | Number of Participants With of Adverse Events | Dysgeusia | 60 Participants |
| Arm II (Chemotherapy, Brentuximab Vedotin, Radiation) | Number of Participants With of Adverse Events | Dysmenorrhea | 0 Participants |
| Arm II (Chemotherapy, Brentuximab Vedotin, Radiation) | Number of Participants With of Adverse Events | Dyspepsia | 21 Participants |
| Arm II (Chemotherapy, Brentuximab Vedotin, Radiation) | Number of Participants With of Adverse Events | Dysphagia | 7 Participants |
| Arm II (Chemotherapy, Brentuximab Vedotin, Radiation) | Number of Participants With of Adverse Events | Dysphasia | 1 Participants |
| Arm II (Chemotherapy, Brentuximab Vedotin, Radiation) | Number of Participants With of Adverse Events | Dyspnea | 58 Participants |
| Arm II (Chemotherapy, Brentuximab Vedotin, Radiation) | Number of Participants With of Adverse Events | Dysuria | 1 Participants |
| Arm II (Chemotherapy, Brentuximab Vedotin, Radiation) | Number of Participants With of Adverse Events | Ear and labyrinth disorders - Other, specify | 0 Participants |
| Arm II (Chemotherapy, Brentuximab Vedotin, Radiation) | Number of Participants With of Adverse Events | Ear pain | 1 Participants |
| Arm II (Chemotherapy, Brentuximab Vedotin, Radiation) | Number of Participants With of Adverse Events | Eczema | 7 Participants |
| Arm II (Chemotherapy, Brentuximab Vedotin, Radiation) | Number of Participants With of Adverse Events | Edema face | 5 Participants |
| Arm II (Chemotherapy, Brentuximab Vedotin, Radiation) | Number of Participants With of Adverse Events | Edema limbs | 17 Participants |
| Arm II (Chemotherapy, Brentuximab Vedotin, Radiation) | Number of Participants With of Adverse Events | Ejection fraction decreased | 3 Participants |
| Arm II (Chemotherapy, Brentuximab Vedotin, Radiation) | Number of Participants With of Adverse Events | Electrocardiogram QT corrected interval prolonged | 0 Participants |
| Arm II (Chemotherapy, Brentuximab Vedotin, Radiation) | Number of Participants With of Adverse Events | Electrocardiogram T wave abnormal | 0 Participants |
| Arm II (Chemotherapy, Brentuximab Vedotin, Radiation) | Number of Participants With of Adverse Events | Endocrine disorders - Other, specify | 0 Participants |
| Arm II (Chemotherapy, Brentuximab Vedotin, Radiation) | Number of Participants With of Adverse Events | Enterocolitis | 1 Participants |
| Arm II (Chemotherapy, Brentuximab Vedotin, Radiation) | Number of Participants With of Adverse Events | Enterocolitis infectious | 4 Participants |
| Arm II (Chemotherapy, Brentuximab Vedotin, Radiation) | Number of Participants With of Adverse Events | Eosinophilia | 16 Participants |
| Arm II (Chemotherapy, Brentuximab Vedotin, Radiation) | Number of Participants With of Adverse Events | Epistaxis | 16 Participants |
| Arm II (Chemotherapy, Brentuximab Vedotin, Radiation) | Number of Participants With of Adverse Events | Erectile dysfunction | 0 Participants |
| Arm II (Chemotherapy, Brentuximab Vedotin, Radiation) | Number of Participants With of Adverse Events | Erythema multiforme | 1 Participants |
| Arm II (Chemotherapy, Brentuximab Vedotin, Radiation) | Number of Participants With of Adverse Events | Erythroderma | 0 Participants |
| Arm II (Chemotherapy, Brentuximab Vedotin, Radiation) | Number of Participants With of Adverse Events | Esophageal pain | 0 Participants |
| Arm II (Chemotherapy, Brentuximab Vedotin, Radiation) | Number of Participants With of Adverse Events | Eye disorders - Other, specify | 3 Participants |
| Arm II (Chemotherapy, Brentuximab Vedotin, Radiation) | Number of Participants With of Adverse Events | Facial muscle weakness | 0 Participants |
| Arm II (Chemotherapy, Brentuximab Vedotin, Radiation) | Number of Participants With of Adverse Events | Facial pain | 4 Participants |
| Arm II (Chemotherapy, Brentuximab Vedotin, Radiation) | Number of Participants With of Adverse Events | Fall | 9 Participants |
| Arm II (Chemotherapy, Brentuximab Vedotin, Radiation) | Number of Participants With of Adverse Events | Fatigue | 246 Participants |
| Arm II (Chemotherapy, Brentuximab Vedotin, Radiation) | Number of Participants With of Adverse Events | Febrile neutropenia | 33 Participants |
| Arm II (Chemotherapy, Brentuximab Vedotin, Radiation) | Number of Participants With of Adverse Events | Fecal incontinence | 1 Participants |
| Arm II (Chemotherapy, Brentuximab Vedotin, Radiation) | Number of Participants With of Adverse Events | Fever | 63 Participants |
| Arm II (Chemotherapy, Brentuximab Vedotin, Radiation) | Number of Participants With of Adverse Events | Fibrinogen decreased | 0 Participants |
| Arm II (Chemotherapy, Brentuximab Vedotin, Radiation) | Number of Participants With of Adverse Events | Flank pain | 3 Participants |
| Arm II (Chemotherapy, Brentuximab Vedotin, Radiation) | Number of Participants With of Adverse Events | Flashing lights | 1 Participants |
| Arm II (Chemotherapy, Brentuximab Vedotin, Radiation) | Number of Participants With of Adverse Events | Flatulence | 6 Participants |
| Arm II (Chemotherapy, Brentuximab Vedotin, Radiation) | Number of Participants With of Adverse Events | Floaters | 1 Participants |
| Arm II (Chemotherapy, Brentuximab Vedotin, Radiation) | Number of Participants With of Adverse Events | Flu like symptoms | 3 Participants |
| Arm II (Chemotherapy, Brentuximab Vedotin, Radiation) | Number of Participants With of Adverse Events | Flushing | 3 Participants |
| Arm II (Chemotherapy, Brentuximab Vedotin, Radiation) | Number of Participants With of Adverse Events | Folliculitis | 2 Participants |
| Arm II (Chemotherapy, Brentuximab Vedotin, Radiation) | Number of Participants With of Adverse Events | Fracture | 1 Participants |
| Arm II (Chemotherapy, Brentuximab Vedotin, Radiation) | Number of Participants With of Adverse Events | GGT increased | 4 Participants |
| Arm II (Chemotherapy, Brentuximab Vedotin, Radiation) | Number of Participants With of Adverse Events | Gait disturbance | 2 Participants |
| Arm II (Chemotherapy, Brentuximab Vedotin, Radiation) | Number of Participants With of Adverse Events | Gastric hemorrhage | 1 Participants |
| Arm II (Chemotherapy, Brentuximab Vedotin, Radiation) | Number of Participants With of Adverse Events | Gastritis | 8 Participants |
| Arm II (Chemotherapy, Brentuximab Vedotin, Radiation) | Number of Participants With of Adverse Events | Gastroesophageal reflux disease | 40 Participants |
| Arm II (Chemotherapy, Brentuximab Vedotin, Radiation) | Number of Participants With of Adverse Events | Gastrointestinal disorders - Other, specify | 14 Participants |
| Arm II (Chemotherapy, Brentuximab Vedotin, Radiation) | Number of Participants With of Adverse Events | Gastrointestinal pain | 0 Participants |
| Arm II (Chemotherapy, Brentuximab Vedotin, Radiation) | Number of Participants With of Adverse Events | Gastroparesis | 1 Participants |
| Arm II (Chemotherapy, Brentuximab Vedotin, Radiation) | Number of Participants With of Adverse Events | General disorders and administration site conditio | 6 Participants |
| Arm II (Chemotherapy, Brentuximab Vedotin, Radiation) | Number of Participants With of Adverse Events | Generalized edema | 0 Participants |
| Arm II (Chemotherapy, Brentuximab Vedotin, Radiation) | Number of Participants With of Adverse Events | Generalized muscle weakness | 25 Participants |
| Arm II (Chemotherapy, Brentuximab Vedotin, Radiation) | Number of Participants With of Adverse Events | Glucose intolerance | 0 Participants |
| Arm II (Chemotherapy, Brentuximab Vedotin, Radiation) | Number of Participants With of Adverse Events | Glucosuria | 2 Participants |
| Arm II (Chemotherapy, Brentuximab Vedotin, Radiation) | Number of Participants With of Adverse Events | Guillain-Barre syndrome | 1 Participants |
| Arm II (Chemotherapy, Brentuximab Vedotin, Radiation) | Number of Participants With of Adverse Events | Gynecomastia | 1 Participants |
| Arm II (Chemotherapy, Brentuximab Vedotin, Radiation) | Number of Participants With of Adverse Events | Headache | 77 Participants |
| Arm II (Chemotherapy, Brentuximab Vedotin, Radiation) | Number of Participants With of Adverse Events | Heart failure | 1 Participants |
| Arm II (Chemotherapy, Brentuximab Vedotin, Radiation) | Number of Participants With of Adverse Events | Hematuria | 0 Participants |
| Arm II (Chemotherapy, Brentuximab Vedotin, Radiation) | Number of Participants With of Adverse Events | Hemolysis | 0 Participants |
| Arm II (Chemotherapy, Brentuximab Vedotin, Radiation) | Number of Participants With of Adverse Events | Hemorrhoidal hemorrhage | 0 Participants |
| Arm II (Chemotherapy, Brentuximab Vedotin, Radiation) | Number of Participants With of Adverse Events | Hemorrhoids | 1 Participants |
| Arm II (Chemotherapy, Brentuximab Vedotin, Radiation) | Number of Participants With of Adverse Events | Hepatic failure | 0 Participants |
| Arm II (Chemotherapy, Brentuximab Vedotin, Radiation) | Number of Participants With of Adverse Events | Hepatobiliary disorders - Other, specify | 1 Participants |
| Arm II (Chemotherapy, Brentuximab Vedotin, Radiation) | Number of Participants With of Adverse Events | Herpes simplex reactivation | 3 Participants |
| Arm II (Chemotherapy, Brentuximab Vedotin, Radiation) | Number of Participants With of Adverse Events | Hiccups | 11 Participants |
| Arm II (Chemotherapy, Brentuximab Vedotin, Radiation) | Number of Participants With of Adverse Events | Hoarseness | 4 Participants |
| Arm II (Chemotherapy, Brentuximab Vedotin, Radiation) | Number of Participants With of Adverse Events | Hot flashes | 20 Participants |
| Arm II (Chemotherapy, Brentuximab Vedotin, Radiation) | Number of Participants With of Adverse Events | Hypercalcemia | 10 Participants |
| Arm II (Chemotherapy, Brentuximab Vedotin, Radiation) | Number of Participants With of Adverse Events | Hyperglycemia | 67 Participants |
| Arm II (Chemotherapy, Brentuximab Vedotin, Radiation) | Number of Participants With of Adverse Events | Hyperhidrosis | 16 Participants |
| Arm II (Chemotherapy, Brentuximab Vedotin, Radiation) | Number of Participants With of Adverse Events | Hyperkalemia | 4 Participants |
| Arm II (Chemotherapy, Brentuximab Vedotin, Radiation) | Number of Participants With of Adverse Events | Hyperlipidemia | 1 Participants |
| Arm II (Chemotherapy, Brentuximab Vedotin, Radiation) | Number of Participants With of Adverse Events | Hypermagnesemia | 3 Participants |
| Arm II (Chemotherapy, Brentuximab Vedotin, Radiation) | Number of Participants With of Adverse Events | Hypernatremia | 5 Participants |
| Arm II (Chemotherapy, Brentuximab Vedotin, Radiation) | Number of Participants With of Adverse Events | Hyperphosphatemia | 16 Participants |
| Arm II (Chemotherapy, Brentuximab Vedotin, Radiation) | Number of Participants With of Adverse Events | Hypertension | 43 Participants |
| Arm II (Chemotherapy, Brentuximab Vedotin, Radiation) | Number of Participants With of Adverse Events | Hyperthyroidism | 0 Participants |
| Arm II (Chemotherapy, Brentuximab Vedotin, Radiation) | Number of Participants With of Adverse Events | Hypertriglyceridemia | 2 Participants |
| Arm II (Chemotherapy, Brentuximab Vedotin, Radiation) | Number of Participants With of Adverse Events | Hyperuricemia | 9 Participants |
| Arm II (Chemotherapy, Brentuximab Vedotin, Radiation) | Number of Participants With of Adverse Events | Hypoalbuminemia | 41 Participants |
| Arm II (Chemotherapy, Brentuximab Vedotin, Radiation) | Number of Participants With of Adverse Events | Hypocalcemia | 35 Participants |
| Arm II (Chemotherapy, Brentuximab Vedotin, Radiation) | Number of Participants With of Adverse Events | Hypoglycemia | 6 Participants |
| Arm II (Chemotherapy, Brentuximab Vedotin, Radiation) | Number of Participants With of Adverse Events | Hypokalemia | 64 Participants |
| Arm II (Chemotherapy, Brentuximab Vedotin, Radiation) | Number of Participants With of Adverse Events | Hypomagnesemia | 22 Participants |
| Arm II (Chemotherapy, Brentuximab Vedotin, Radiation) | Number of Participants With of Adverse Events | Hyponatremia | 57 Participants |
| Arm II (Chemotherapy, Brentuximab Vedotin, Radiation) | Number of Participants With of Adverse Events | Hypoparathyroidism | 0 Participants |
| Arm II (Chemotherapy, Brentuximab Vedotin, Radiation) | Number of Participants With of Adverse Events | Hypophosphatemia | 19 Participants |
| Arm II (Chemotherapy, Brentuximab Vedotin, Radiation) | Number of Participants With of Adverse Events | Hypotension | 18 Participants |
| Arm II (Chemotherapy, Brentuximab Vedotin, Radiation) | Number of Participants With of Adverse Events | Hypothyroidism | 3 Participants |
| Arm II (Chemotherapy, Brentuximab Vedotin, Radiation) | Number of Participants With of Adverse Events | Hypoxia | 3 Participants |
| Arm II (Chemotherapy, Brentuximab Vedotin, Radiation) | Number of Participants With of Adverse Events | INR increased | 1 Participants |
| Arm II (Chemotherapy, Brentuximab Vedotin, Radiation) | Number of Participants With of Adverse Events | Ileus | 4 Participants |
| Arm II (Chemotherapy, Brentuximab Vedotin, Radiation) | Number of Participants With of Adverse Events | Immune system disorders - Other, specify | 1 Participants |
| Arm II (Chemotherapy, Brentuximab Vedotin, Radiation) | Number of Participants With of Adverse Events | Infections and infestations - Other, specify | 12 Participants |
| Arm II (Chemotherapy, Brentuximab Vedotin, Radiation) | Number of Participants With of Adverse Events | Infusion related reaction | 10 Participants |
| Arm II (Chemotherapy, Brentuximab Vedotin, Radiation) | Number of Participants With of Adverse Events | Infusion site extravasation | 2 Participants |
| Arm II (Chemotherapy, Brentuximab Vedotin, Radiation) | Number of Participants With of Adverse Events | Injection site reaction | 2 Participants |
| Arm II (Chemotherapy, Brentuximab Vedotin, Radiation) | Number of Participants With of Adverse Events | Injury, poisoning and procedural complications - O | 0 Participants |
| Arm II (Chemotherapy, Brentuximab Vedotin, Radiation) | Number of Participants With of Adverse Events | Insomnia | 54 Participants |
| Arm II (Chemotherapy, Brentuximab Vedotin, Radiation) | Number of Participants With of Adverse Events | Investigations - Other, specify | 10 Participants |
| Arm II (Chemotherapy, Brentuximab Vedotin, Radiation) | Number of Participants With of Adverse Events | Irregular menstruation | 5 Participants |
| Arm II (Chemotherapy, Brentuximab Vedotin, Radiation) | Number of Participants With of Adverse Events | Irritability | 1 Participants |
| Arm II (Chemotherapy, Brentuximab Vedotin, Radiation) | Number of Participants With of Adverse Events | Joint range of motion decreased | 2 Participants |
| Arm II (Chemotherapy, Brentuximab Vedotin, Radiation) | Number of Participants With of Adverse Events | Laryngopharyngeal dysesthesia | 0 Participants |
| Arm II (Chemotherapy, Brentuximab Vedotin, Radiation) | Number of Participants With of Adverse Events | Lethargy | 2 Participants |
| Arm II (Chemotherapy, Brentuximab Vedotin, Radiation) | Number of Participants With of Adverse Events | Leukocytosis | 6 Participants |
| Arm II (Chemotherapy, Brentuximab Vedotin, Radiation) | Number of Participants With of Adverse Events | Libido decreased | 3 Participants |
| Arm II (Chemotherapy, Brentuximab Vedotin, Radiation) | Number of Participants With of Adverse Events | Lip infection | 0 Participants |
| Arm II (Chemotherapy, Brentuximab Vedotin, Radiation) | Number of Participants With of Adverse Events | Lipase increased | 1 Participants |
| Arm II (Chemotherapy, Brentuximab Vedotin, Radiation) | Number of Participants With of Adverse Events | Localized edema | 3 Participants |
| Arm II (Chemotherapy, Brentuximab Vedotin, Radiation) | Number of Participants With of Adverse Events | Lung infection | 14 Participants |
| Arm II (Chemotherapy, Brentuximab Vedotin, Radiation) | Number of Participants With of Adverse Events | Lymph gland infection | 0 Participants |
| Arm II (Chemotherapy, Brentuximab Vedotin, Radiation) | Number of Participants With of Adverse Events | Lymph node pain | 3 Participants |
| Arm II (Chemotherapy, Brentuximab Vedotin, Radiation) | Number of Participants With of Adverse Events | Lymphocyte count decreased | 114 Participants |
| Arm II (Chemotherapy, Brentuximab Vedotin, Radiation) | Number of Participants With of Adverse Events | Lymphocyte count increased | 10 Participants |
| Arm II (Chemotherapy, Brentuximab Vedotin, Radiation) | Number of Participants With of Adverse Events | Malaise | 3 Participants |
| Arm II (Chemotherapy, Brentuximab Vedotin, Radiation) | Number of Participants With of Adverse Events | Memory impairment | 4 Participants |
| Arm II (Chemotherapy, Brentuximab Vedotin, Radiation) | Number of Participants With of Adverse Events | Menorrhagia | 1 Participants |
| Arm II (Chemotherapy, Brentuximab Vedotin, Radiation) | Number of Participants With of Adverse Events | Metabolism and nutrition disorders - Other, specif | 2 Participants |
| Arm II (Chemotherapy, Brentuximab Vedotin, Radiation) | Number of Participants With of Adverse Events | Mitral valve disease | 0 Participants |
| Arm II (Chemotherapy, Brentuximab Vedotin, Radiation) | Number of Participants With of Adverse Events | Movements involuntary | 2 Participants |
| Arm II (Chemotherapy, Brentuximab Vedotin, Radiation) | Number of Participants With of Adverse Events | Mucosal infection | 1 Participants |
| Arm II (Chemotherapy, Brentuximab Vedotin, Radiation) | Number of Participants With of Adverse Events | Mucositis oral | 100 Participants |
| Arm II (Chemotherapy, Brentuximab Vedotin, Radiation) | Number of Participants With of Adverse Events | Muscle cramp | 19 Participants |
| Arm II (Chemotherapy, Brentuximab Vedotin, Radiation) | Number of Participants With of Adverse Events | Muscle weakness lower limb | 7 Participants |
| Arm II (Chemotherapy, Brentuximab Vedotin, Radiation) | Number of Participants With of Adverse Events | Muscle weakness trunk | 0 Participants |
| Arm II (Chemotherapy, Brentuximab Vedotin, Radiation) | Number of Participants With of Adverse Events | Muscle weakness upper limb | 2 Participants |
| Arm II (Chemotherapy, Brentuximab Vedotin, Radiation) | Number of Participants With of Adverse Events | Musculoskeletal and connective tissue disorder - | 6 Participants |
| Arm II (Chemotherapy, Brentuximab Vedotin, Radiation) | Number of Participants With of Adverse Events | Myalgia | 58 Participants |
| Arm II (Chemotherapy, Brentuximab Vedotin, Radiation) | Number of Participants With of Adverse Events | Myositis | 0 Participants |
| Arm II (Chemotherapy, Brentuximab Vedotin, Radiation) | Number of Participants With of Adverse Events | Nail changes | 9 Participants |
| Arm II (Chemotherapy, Brentuximab Vedotin, Radiation) | Number of Participants With of Adverse Events | Nail discoloration | 16 Participants |
| Arm II (Chemotherapy, Brentuximab Vedotin, Radiation) | Number of Participants With of Adverse Events | Nail infection | 2 Participants |
| Arm II (Chemotherapy, Brentuximab Vedotin, Radiation) | Number of Participants With of Adverse Events | Nail ridging | 1 Participants |
| Arm II (Chemotherapy, Brentuximab Vedotin, Radiation) | Number of Participants With of Adverse Events | Nasal congestion | 12 Participants |
| Arm II (Chemotherapy, Brentuximab Vedotin, Radiation) | Number of Participants With of Adverse Events | Nausea | 331 Participants |
| Arm II (Chemotherapy, Brentuximab Vedotin, Radiation) | Number of Participants With of Adverse Events | Neck edema | 2 Participants |
| Arm II (Chemotherapy, Brentuximab Vedotin, Radiation) | Number of Participants With of Adverse Events | Neck pain | 3 Participants |
| Arm II (Chemotherapy, Brentuximab Vedotin, Radiation) | Number of Participants With of Adverse Events | Neoplasms benign, malignant and unspecified (incl | 0 Participants |
| Arm II (Chemotherapy, Brentuximab Vedotin, Radiation) | Number of Participants With of Adverse Events | Nervous system disorders - Other, specify | 8 Participants |
| Arm II (Chemotherapy, Brentuximab Vedotin, Radiation) | Number of Participants With of Adverse Events | Neuralgia | 3 Participants |
| Arm II (Chemotherapy, Brentuximab Vedotin, Radiation) | Number of Participants With of Adverse Events | Neutrophil count decreased | 166 Participants |
| Arm II (Chemotherapy, Brentuximab Vedotin, Radiation) | Number of Participants With of Adverse Events | Non-cardiac chest pain | 16 Participants |
| Arm II (Chemotherapy, Brentuximab Vedotin, Radiation) | Number of Participants With of Adverse Events | Oral dysesthesia | 6 Participants |
| Arm II (Chemotherapy, Brentuximab Vedotin, Radiation) | Number of Participants With of Adverse Events | Oral hemorrhage | 1 Participants |
| Arm II (Chemotherapy, Brentuximab Vedotin, Radiation) | Number of Participants With of Adverse Events | Oral pain | 24 Participants |
| Arm II (Chemotherapy, Brentuximab Vedotin, Radiation) | Number of Participants With of Adverse Events | Pain | 31 Participants |
| Arm II (Chemotherapy, Brentuximab Vedotin, Radiation) | Number of Participants With of Adverse Events | Pain in extremity | 36 Participants |
| Arm II (Chemotherapy, Brentuximab Vedotin, Radiation) | Number of Participants With of Adverse Events | Palmar-plantar erythrodysesthesia syndrome | 2 Participants |
| Arm II (Chemotherapy, Brentuximab Vedotin, Radiation) | Number of Participants With of Adverse Events | Palpitations | 2 Participants |
| Arm II (Chemotherapy, Brentuximab Vedotin, Radiation) | Number of Participants With of Adverse Events | Pancreatic enzymes decreased | 1 Participants |
| Arm II (Chemotherapy, Brentuximab Vedotin, Radiation) | Number of Participants With of Adverse Events | Pancreatitis | 1 Participants |
| Arm II (Chemotherapy, Brentuximab Vedotin, Radiation) | Number of Participants With of Adverse Events | Papulopustular rash | 3 Participants |
| Arm II (Chemotherapy, Brentuximab Vedotin, Radiation) | Number of Participants With of Adverse Events | Paresthesia | 43 Participants |
| Arm II (Chemotherapy, Brentuximab Vedotin, Radiation) | Number of Participants With of Adverse Events | Paronychia | 2 Participants |
| Arm II (Chemotherapy, Brentuximab Vedotin, Radiation) | Number of Participants With of Adverse Events | Paroxysmal atrial tachycardia | 0 Participants |
| Arm II (Chemotherapy, Brentuximab Vedotin, Radiation) | Number of Participants With of Adverse Events | Pelvic pain | 2 Participants |
| Arm II (Chemotherapy, Brentuximab Vedotin, Radiation) | Number of Participants With of Adverse Events | Penile infection | 1 Participants |
| Arm II (Chemotherapy, Brentuximab Vedotin, Radiation) | Number of Participants With of Adverse Events | Pericardial effusion | 0 Participants |
| Arm II (Chemotherapy, Brentuximab Vedotin, Radiation) | Number of Participants With of Adverse Events | Pericarditis | 0 Participants |
| Arm II (Chemotherapy, Brentuximab Vedotin, Radiation) | Number of Participants With of Adverse Events | Peripheral motor neuropathy | 36 Participants |
| Arm II (Chemotherapy, Brentuximab Vedotin, Radiation) | Number of Participants With of Adverse Events | Peripheral sensory neuropathy | 268 Participants |
| Arm II (Chemotherapy, Brentuximab Vedotin, Radiation) | Number of Participants With of Adverse Events | Pharyngeal mucositis | 0 Participants |
| Arm II (Chemotherapy, Brentuximab Vedotin, Radiation) | Number of Participants With of Adverse Events | Pharyngitis | 1 Participants |
| Arm II (Chemotherapy, Brentuximab Vedotin, Radiation) | Number of Participants With of Adverse Events | Phlebitis | 4 Participants |
| Arm II (Chemotherapy, Brentuximab Vedotin, Radiation) | Number of Participants With of Adverse Events | Photophobia | 2 Participants |
| Arm II (Chemotherapy, Brentuximab Vedotin, Radiation) | Number of Participants With of Adverse Events | Photosensitivity | 2 Participants |
| Arm II (Chemotherapy, Brentuximab Vedotin, Radiation) | Number of Participants With of Adverse Events | Platelet count decreased | 89 Participants |
| Arm II (Chemotherapy, Brentuximab Vedotin, Radiation) | Number of Participants With of Adverse Events | Pleural effusion | 1 Participants |
| Arm II (Chemotherapy, Brentuximab Vedotin, Radiation) | Number of Participants With of Adverse Events | Pleuritic pain | 0 Participants |
| Arm II (Chemotherapy, Brentuximab Vedotin, Radiation) | Number of Participants With of Adverse Events | Pneumonitis | 15 Participants |
| Arm II (Chemotherapy, Brentuximab Vedotin, Radiation) | Number of Participants With of Adverse Events | Postnasal drip | 1 Participants |
| Arm II (Chemotherapy, Brentuximab Vedotin, Radiation) | Number of Participants With of Adverse Events | Presyncope | 3 Participants |
| Arm II (Chemotherapy, Brentuximab Vedotin, Radiation) | Number of Participants With of Adverse Events | Productive cough | 2 Participants |
| Arm II (Chemotherapy, Brentuximab Vedotin, Radiation) | Number of Participants With of Adverse Events | Proteinuria | 2 Participants |
| Arm II (Chemotherapy, Brentuximab Vedotin, Radiation) | Number of Participants With of Adverse Events | Pruritus | 25 Participants |
| Arm II (Chemotherapy, Brentuximab Vedotin, Radiation) | Number of Participants With of Adverse Events | Psychiatric disorders - Other, specify | 3 Participants |
| Arm II (Chemotherapy, Brentuximab Vedotin, Radiation) | Number of Participants With of Adverse Events | Psychosis | 1 Participants |
| Arm II (Chemotherapy, Brentuximab Vedotin, Radiation) | Number of Participants With of Adverse Events | Pulmonary edema | 1 Participants |
| Arm II (Chemotherapy, Brentuximab Vedotin, Radiation) | Number of Participants With of Adverse Events | Rash acneiform | 12 Participants |
| Arm II (Chemotherapy, Brentuximab Vedotin, Radiation) | Number of Participants With of Adverse Events | Rash maculo-papular | 59 Participants |
| Arm II (Chemotherapy, Brentuximab Vedotin, Radiation) | Number of Participants With of Adverse Events | Rash pustular | 1 Participants |
| Arm II (Chemotherapy, Brentuximab Vedotin, Radiation) | Number of Participants With of Adverse Events | Rectal fissure | 1 Participants |
| Arm II (Chemotherapy, Brentuximab Vedotin, Radiation) | Number of Participants With of Adverse Events | Rectal hemorrhage | 2 Participants |
| Arm II (Chemotherapy, Brentuximab Vedotin, Radiation) | Number of Participants With of Adverse Events | Rectal pain | 4 Participants |
| Arm II (Chemotherapy, Brentuximab Vedotin, Radiation) | Number of Participants With of Adverse Events | Renal and urinary disorders - Other, specify | 1 Participants |
| Arm II (Chemotherapy, Brentuximab Vedotin, Radiation) | Number of Participants With of Adverse Events | Respiratory failure | 3 Participants |
| Arm II (Chemotherapy, Brentuximab Vedotin, Radiation) | Number of Participants With of Adverse Events | Respiratory, thoracic and mediastinal disorders - | 6 Participants |
| Arm II (Chemotherapy, Brentuximab Vedotin, Radiation) | Number of Participants With of Adverse Events | Restrictive cardiomyopathy | 0 Participants |
| Arm II (Chemotherapy, Brentuximab Vedotin, Radiation) | Number of Participants With of Adverse Events | Rhabdomyolysis | 0 Participants |
| Arm II (Chemotherapy, Brentuximab Vedotin, Radiation) | Number of Participants With of Adverse Events | Rhinorrhea | 8 Participants |
| Arm II (Chemotherapy, Brentuximab Vedotin, Radiation) | Number of Participants With of Adverse Events | Salivary duct inflammation | 2 Participants |
| Arm II (Chemotherapy, Brentuximab Vedotin, Radiation) | Number of Participants With of Adverse Events | Scalp pain | 0 Participants |
| Arm II (Chemotherapy, Brentuximab Vedotin, Radiation) | Number of Participants With of Adverse Events | Scrotal pain | 1 Participants |
| Arm II (Chemotherapy, Brentuximab Vedotin, Radiation) | Number of Participants With of Adverse Events | Seizure | 1 Participants |
| Arm II (Chemotherapy, Brentuximab Vedotin, Radiation) | Number of Participants With of Adverse Events | Sepsis | 15 Participants |
| Arm II (Chemotherapy, Brentuximab Vedotin, Radiation) | Number of Participants With of Adverse Events | Serum amylase increased | 0 Participants |
| Arm II (Chemotherapy, Brentuximab Vedotin, Radiation) | Number of Participants With of Adverse Events | Sinus bradycardia | 3 Participants |
| Arm II (Chemotherapy, Brentuximab Vedotin, Radiation) | Number of Participants With of Adverse Events | Sinus disorder | 1 Participants |
| Arm II (Chemotherapy, Brentuximab Vedotin, Radiation) | Number of Participants With of Adverse Events | Sinus tachycardia | 25 Participants |
| Arm II (Chemotherapy, Brentuximab Vedotin, Radiation) | Number of Participants With of Adverse Events | Skin and subcutaneous tissue disorders - Other, sp | 18 Participants |
| Arm II (Chemotherapy, Brentuximab Vedotin, Radiation) | Number of Participants With of Adverse Events | Skin hyperpigmentation | 8 Participants |
| Arm II (Chemotherapy, Brentuximab Vedotin, Radiation) | Number of Participants With of Adverse Events | Skin hypopigmentation | 0 Participants |
| Arm II (Chemotherapy, Brentuximab Vedotin, Radiation) | Number of Participants With of Adverse Events | Skin infection | 10 Participants |
| Arm II (Chemotherapy, Brentuximab Vedotin, Radiation) | Number of Participants With of Adverse Events | Skin ulceration | 1 Participants |
| Arm II (Chemotherapy, Brentuximab Vedotin, Radiation) | Number of Participants With of Adverse Events | Small intestinal obstruction | 1 Participants |
| Arm II (Chemotherapy, Brentuximab Vedotin, Radiation) | Number of Participants With of Adverse Events | Sneezing | 1 Participants |
| Arm II (Chemotherapy, Brentuximab Vedotin, Radiation) | Number of Participants With of Adverse Events | Somnolence | 1 Participants |
| Arm II (Chemotherapy, Brentuximab Vedotin, Radiation) | Number of Participants With of Adverse Events | Sore throat | 27 Participants |
| Arm II (Chemotherapy, Brentuximab Vedotin, Radiation) | Number of Participants With of Adverse Events | Spasticity | 1 Participants |
| Arm II (Chemotherapy, Brentuximab Vedotin, Radiation) | Number of Participants With of Adverse Events | Stomach pain | 10 Participants |
| Arm II (Chemotherapy, Brentuximab Vedotin, Radiation) | Number of Participants With of Adverse Events | Stroke | 0 Participants |
| Arm II (Chemotherapy, Brentuximab Vedotin, Radiation) | Number of Participants With of Adverse Events | Superficial thrombophlebitis | 3 Participants |
| Arm II (Chemotherapy, Brentuximab Vedotin, Radiation) | Number of Participants With of Adverse Events | Supraventricular tachycardia | 1 Participants |
| Arm II (Chemotherapy, Brentuximab Vedotin, Radiation) | Number of Participants With of Adverse Events | Syncope | 2 Participants |
| Arm II (Chemotherapy, Brentuximab Vedotin, Radiation) | Number of Participants With of Adverse Events | Tendon reflex decreased | 1 Participants |
| Arm II (Chemotherapy, Brentuximab Vedotin, Radiation) | Number of Participants With of Adverse Events | Testicular pain | 2 Participants |
| Arm II (Chemotherapy, Brentuximab Vedotin, Radiation) | Number of Participants With of Adverse Events | Thromboembolic event | 10 Participants |
| Arm II (Chemotherapy, Brentuximab Vedotin, Radiation) | Number of Participants With of Adverse Events | Thrush | 14 Participants |
| Arm II (Chemotherapy, Brentuximab Vedotin, Radiation) | Number of Participants With of Adverse Events | Thyroid stimulating hormone increased | 1 Participants |
| Arm II (Chemotherapy, Brentuximab Vedotin, Radiation) | Number of Participants With of Adverse Events | Tinnitus | 6 Participants |
| Arm II (Chemotherapy, Brentuximab Vedotin, Radiation) | Number of Participants With of Adverse Events | Tooth discoloration | 1 Participants |
| Arm II (Chemotherapy, Brentuximab Vedotin, Radiation) | Number of Participants With of Adverse Events | Tooth infection | 0 Participants |
| Arm II (Chemotherapy, Brentuximab Vedotin, Radiation) | Number of Participants With of Adverse Events | Toothache | 2 Participants |
| Arm II (Chemotherapy, Brentuximab Vedotin, Radiation) | Number of Participants With of Adverse Events | Tracheal mucositis | 1 Participants |
| Arm II (Chemotherapy, Brentuximab Vedotin, Radiation) | Number of Participants With of Adverse Events | Tracheitis | 0 Participants |
| Arm II (Chemotherapy, Brentuximab Vedotin, Radiation) | Number of Participants With of Adverse Events | Tremor | 3 Participants |
| Arm II (Chemotherapy, Brentuximab Vedotin, Radiation) | Number of Participants With of Adverse Events | Tumor lysis syndrome | 1 Participants |
| Arm II (Chemotherapy, Brentuximab Vedotin, Radiation) | Number of Participants With of Adverse Events | Tumor pain | 1 Participants |
| Arm II (Chemotherapy, Brentuximab Vedotin, Radiation) | Number of Participants With of Adverse Events | Typhlitis | 3 Participants |
| Arm II (Chemotherapy, Brentuximab Vedotin, Radiation) | Number of Participants With of Adverse Events | Upper gastrointestinal hemorrhage | 0 Participants |
| Arm II (Chemotherapy, Brentuximab Vedotin, Radiation) | Number of Participants With of Adverse Events | Upper respiratory infection | 8 Participants |
| Arm II (Chemotherapy, Brentuximab Vedotin, Radiation) | Number of Participants With of Adverse Events | Urinary frequency | 2 Participants |
| Arm II (Chemotherapy, Brentuximab Vedotin, Radiation) | Number of Participants With of Adverse Events | Urinary incontinence | 1 Participants |
| Arm II (Chemotherapy, Brentuximab Vedotin, Radiation) | Number of Participants With of Adverse Events | Urinary retention | 1 Participants |
| Arm II (Chemotherapy, Brentuximab Vedotin, Radiation) | Number of Participants With of Adverse Events | Urinary tract infection | 12 Participants |
| Arm II (Chemotherapy, Brentuximab Vedotin, Radiation) | Number of Participants With of Adverse Events | Urinary tract pain | 0 Participants |
| Arm II (Chemotherapy, Brentuximab Vedotin, Radiation) | Number of Participants With of Adverse Events | Urinary urgency | 1 Participants |
| Arm II (Chemotherapy, Brentuximab Vedotin, Radiation) | Number of Participants With of Adverse Events | Urticaria | 2 Participants |
| Arm II (Chemotherapy, Brentuximab Vedotin, Radiation) | Number of Participants With of Adverse Events | Vaginal discharge | 0 Participants |
| Arm II (Chemotherapy, Brentuximab Vedotin, Radiation) | Number of Participants With of Adverse Events | Vaginal infection | 4 Participants |
| Arm II (Chemotherapy, Brentuximab Vedotin, Radiation) | Number of Participants With of Adverse Events | Vascular access complication | 2 Participants |
| Arm II (Chemotherapy, Brentuximab Vedotin, Radiation) | Number of Participants With of Adverse Events | Vascular disorders - Other, specify | 1 Participants |
| Arm II (Chemotherapy, Brentuximab Vedotin, Radiation) | Number of Participants With of Adverse Events | Vasovagal reaction | 1 Participants |
| Arm II (Chemotherapy, Brentuximab Vedotin, Radiation) | Number of Participants With of Adverse Events | Ventricular arrhythmia | 1 Participants |
| Arm II (Chemotherapy, Brentuximab Vedotin, Radiation) | Number of Participants With of Adverse Events | Ventricular tachycardia | 1 Participants |
| Arm II (Chemotherapy, Brentuximab Vedotin, Radiation) | Number of Participants With of Adverse Events | Vertigo | 1 Participants |
| Arm II (Chemotherapy, Brentuximab Vedotin, Radiation) | Number of Participants With of Adverse Events | Vision decreased | 0 Participants |
| Arm II (Chemotherapy, Brentuximab Vedotin, Radiation) | Number of Participants With of Adverse Events | Voice alteration | 2 Participants |
| Arm II (Chemotherapy, Brentuximab Vedotin, Radiation) | Number of Participants With of Adverse Events | Vomiting | 160 Participants |
| Arm II (Chemotherapy, Brentuximab Vedotin, Radiation) | Number of Participants With of Adverse Events | Watering eyes | 5 Participants |
| Arm II (Chemotherapy, Brentuximab Vedotin, Radiation) | Number of Participants With of Adverse Events | Weight gain | 8 Participants |
| Arm II (Chemotherapy, Brentuximab Vedotin, Radiation) | Number of Participants With of Adverse Events | Weight loss | 71 Participants |
| Arm II (Chemotherapy, Brentuximab Vedotin, Radiation) | Number of Participants With of Adverse Events | Wheezing | 1 Participants |
| Arm II (Chemotherapy, Brentuximab Vedotin, Radiation) | Number of Participants With of Adverse Events | White blood cell decreased | 136 Participants |
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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Arm I (Chemotherapy, Nivolumab, Radiation) | Overall Survival | 7 Participants |
| Arm II (Chemotherapy, Brentuximab Vedotin, Radiation) | Overall Survival | 14 Participants |