Lymphoma, Nonneoplastic Condition
Conditions
Keywords
stage III adult Hodgkin lymphoma, stage IV adult Hodgkin lymphoma, adult lymphocyte depletion Hodgkin lymphoma, adult lymphocyte predominant Hodgkin lymphoma, adult mixed cellularity Hodgkin lymphoma, adult nodular sclerosis Hodgkin lymphoma, HIV infection
Brief summary
RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more cancer cells. G-CSF may help lessen the side effects in patients receiving chemotherapy. Imaging procedures, such as fludeoxyglucose F 18-PET/CT imaging, may help doctors predict how patients will respond to treatment. PURPOSE: This phase II trial is studying fludeoxyglucose F 18-PET/CT imaging to see how well it works in assessing response to combination chemotherapy and allow doctors to plan better additional further treatment in treating patients with stage III or stage IV Hodgkin lymphoma.
Detailed description
OBJECTIVES: Primary * To estimate the 2-year progression-free survival (PFS) of HIV-negative patients with stage III-IV Hodgkin lymphoma treated with response-adapted therapy based on fludeoxyglucose F 18 (FDG)-PET imaging after 2 courses of doxorubicin hydrochloride, bleomycin, vinblastine, and dacarbazine (ABVD). * To estimate the 2-year PFS of patients who are PET-positive after treatment with 2 courses of ABVD and an escalated dose regimen comprising cyclophosphamide, doxorubicin hydrochloride, etoposide, vincristine sulfate, bleomycin, procarbazine hydrochloride, and prednisone (BEACOPP). Secondary * To estimate the 2-year overall survival (OS) of patients treated with these regimens. * To estimate the response rate (i.e., complete and partial responses) in patients treated with these regimens. * To evaluate the toxicity of these response-adapted regimens. * To document the feasibility of centralized, real-time review of FDG-PET imaging for U.S. cooperative group studies. * To prospectively evaluate the overall response rate, complete response rate, PFS, and OS of HIV-positive patients treated with these response-adapted regimens. OUTLINE: This is a multicenter study. All patients undergo baseline whole-body fludeoxyglucose F 18 (FDG)-PET/CT imaging before beginning chemotherapy. Patients then receive doxorubicin hydrochloride IV, bleomycin IV, vinblastine IV, and dacarbazine IV (ABVD) on days 1 and 15. Treatment repeats every 28 days for up to 2 courses in the absence of disease progression or unacceptable toxicity. Between days 22 and 25 of course 2, patients undergo a second FDG-PET/CT scan to assess response. Subsequent therapy is based on FDG-PET/CT scan results. Patients are stratified according to FDG-PET positivity (yes vs no). Patients who are FDG-PET-negative continue treatment with ABVD for up to 4 additional courses in the absence of disease progression or unacceptable toxicity. Patients who are FDG-PET-positive are then further stratified according to HIV positivity (yes or no) and receive 1 of the following treatment regimens: * Escalated-dose BEACOPP chemotherapy: HIV-negative patients receive escalated-dose BEACOPP chemotherapy comprising doxorubicin hydrochloride IV and cyclophosphamide IV on day 1, etoposide IV on days 1-3, oral procarbazine hydrochloride on days 1-7, oral prednisone on days 1-14, and bleomycin IV and vincristine IV on day 8. Patients receive filgrastim (G-CSF) subcutaneously on days 8-14. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. * Standard-dose BEACOPP chemotherapy: HIV-positive patients receive standard dose BEACOPP chemotherapy comprising doxorubicin hydrochloride IV and cyclophosphamide IV on day 1, etoposide IV on days 1-3, oral procarbazine hydrochloride on days 1-7, oral prednisone on days 1-14, and bleomycin IV and vincristine IV on day 8. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Six to eight weeks after completion of chemotherapy, patients undergo a post-treatment FDG-PET/CT scan. Some patients may undergo bone marrow biopsy at 1 month after the last course of chemotherapy. After completion of study treatment, patients are followed up periodically for 7 years.
Interventions
BIOLOGICALbleomycin sulfate
BIOLOGICALfilgrastim
DRUGABVD regimen
DRUGBEACOPP regimen
DRUGcyclophosphamide
DRUGdacarbazine
DRUGdoxorubicin hydrochloride
DRUGetoposide
DRUGprednisone
DRUGprocarbazine hydrochloride
DRUGvinblastine sulfate
DRUGvincristine sulfate
Sponsors
National Cancer Institute (NCI)
SWOG Cancer Research Network
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
DISEASE CHARACTERISTICS: * Histologically confirmed classical Hodgkin lymphoma (HL) (i.e., nodular sclerosis, mixed cellularity, lymphocyte-rich, or lymphocyte-depleted) * Previously untreated stage III or IV disease * No nodular lymphocyte predominant disease * Bidimensionally measurable disease * Adequate biopsy samples from original diagnostic specimen must be available for pathologic review * Tissue obtained from core biopsies allowed * No tissue obtained from needle aspirations or cytologies * Must have known HIV status * No multi-drug resistant HIV infection, CD4 counts \< 150/μL, or other concurrent AIDS-defining conditions in HIV-positive patients * HIV-positive patients with CD4 counts ≥ 150/μL at the time of enrollment OR documented CD4 count \> 250/μL at any time within 8 months prior to HL diagnosis allowed * Must have undergone unilateral or bilateral bone marrow biopsy within the past 42 days * Must have a diagnostic quality CT scan of the chest/abdomen and pelvis AND baseline FDG-PET scan within the past 28 days * Combined PET/CT scans required * No older stand-alone FDG-PET scans * No low-resolution localization CT scans as part of a combined PET/CT scans PATIENT CHARACTERISTICS: * Zubrod performance status 0-2 * Serum erythrocyte sedimentation rate, lactate dehydrogenase (LDH), hemoglobin, albumin, white blood cell count (WBC), and lymphocytes measured within the past 28 days * Serum estradiol (women only), testosterone (men only), follicle stimulating hormone (FSH) and luteinizing hormone (LH) (both men and women) levels must be drawn within 60 days prior to registration * Not pregnant or nursing * Fertile patients must use effective contraception during and for ≥ 6 months after completion of study therapy * No significant cardiac abnormalities as assessed by multiple gated acquisition scan (MUGA) or ECHO AND cardiac ejection fraction ≥ 45% in patients with a history of hypertension or cardiac symptoms * Hepatitis B-negative (i.e., hepatitis B surface antigen-negative or anti-hepatitis B core antigen-negative) * Patients immune to or immunized against hepatitis B (i.e., anti-hepatitis B surface antibody-positive) are eligible * Hepatitis C-negative (i.e., anti-hepatitis C antibody-negative) * No significant lung disease with abnormal lung function tests (i.e., diffusing capacity of lung for carbon monoxide (DLCO) \> 25% below predicted after correction for hemoglobin) unless attributable to lymphoma * No requirement for continuous supplemental oxygen therapy * No other prior malignancy except adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated stage I or II cancer from which the patient is currently in complete remission, or any other cancer from which the patient has been disease-free for 5 years PRIOR CONCURRENT THERAPY: * See Disease Characteristics * No prior chemotherapy, radiotherapy, or antibody therapy for lymphoma * No prior solid organ transplantation
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of HIV-negative Patients With 2-year Progression-free Survival (PFS) Treated With 2 Initial Cycles of Adriamycin, Bleomycin, Vnblastine, and Dacarbazine (ABVD) Followed by Response-adapted Therapy Based on Interim FDG-PET Imaging. | 2 years | Disease progression is defined using the 2007 revised Cheson et al. criteria that is at least 50% increase in sum of the product of the diameters (SPD) of target measurable nodal lesions over the smallest sum observed, or \>= 50% increase in greatest transverse diameter (GTD) of any nodal \> 1 cm in shortest axis, or \>= 50% increase in the SPD of other target measurable lesions over the smallest sum observed, any new bone marrow involvement, any new lesion, lymph node with long axis is \> 1.5 cm or if both long and short axes are \> 1 cm, PET positive if patients with no pretreatment PET scan or when PET scan was positive before therapy. Progression-free survival is measured from date of registration to date of first observation of progressive disease, or death due to any cause. Patients last known to be alive and progression-free are censored at date of last contact. |
| Percentage of HIV-negative Patients Who Are PET-positive After 2 Cycles of ABVD With 2-year PFS | 2 years | Disease progression is defined using the 2007 revised Cheson et al. criteria that is at least 50% increase in sum of the product of the diameters (SPD) of target measurable nodal lesions over the smallest sum observed, or \>= 50% increase in greatest transverse diameter (GTD) of any nodal \> 1 cm in shortest axis, or \>= 50% increase in the SPD of other target measurable lesions over the smallest sum observed, any new bone marrow involvement, any new lesion, lymph node with long axis is \> 1.5 cm or if both long and short axes are \> 1 cm, PET positive if patients with no pretreatment PET scan or when PET scan was positive before therapy. Progression-free survival is measured from date of registration to date of first observation of progressive disease, or death due to any cause. Patients last known to be alive and progression-free are censored at date of last contact. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of HIV-negative Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Up to 1 year | Adverse Events (AEs) are reported by the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. For each patient, worst grade of each event type is reported. Grade 3 = Severe, Grade 4 = Life-threatening, Grade 5 = Fatal. |
| Percentage of HIV-positive Patients With 2-year Progression-free Survival (PFS) Treated With Initial 2 Cycles of Adriamycin, Bleomycin, Vnblastine, and Dacarbazine (ABVD) Followed by Response-adapted Therapy Based on Interim FDG-PET Imaging. | 2 years | Disease progression is defined using the 2007 revised Cheson et al. criteria that is at least 50% increase in sum of the product of the diameters (SPD) of target measurable nodal lesions over the smallest sum observed, or \>= 50% increase in greatest transverse diameter (GTD) of any nodal \> 1 cm in shortest axis, or \>= 50% increase in the SPD of other target measurable lesions over the smallest sum observed, any new bone marrow involvement, any new lesion, lymph node with long axis is \>1.5 cm or if both long and short axes are \> 1 cm, PET positive if patients with no pretreatment PET scan or when PET scan was positive before therapy. progression-free survival is measured from date of registration to date of first observation of progressive disease, or death due to any cause. Patients last known to be alive and progression-free are censored at date of last contact. |
| Percentage of HIV-negative Patients With 2-year Overall Survival (OS) Treated With 2 Initial Cycles of ABVD Followed by Response-Adapted Therapy Based on Interim FDG-PET Imaging | 2 years | Measured from date of registration to date of death due to any cause. Patients last known to be alive and are censored at date of last contact. |
| Complete and Partial Response Rates for HIV-positive Patients Treated With Response-Adapted Therapy Based on FDG-PET Imaging After 2 Cycles of ABVD | 7 months after registration | Complete Response (CR) is a complete disappearance of all disease with the exception of the following. If no PET scan or when the PET scan was positive before therapy, a post-treatment residual mass of any size is permitted if it is PET negative. If the PET scan was negative before therapy, all nodal masses at baseline must have regressed. No new lesions. Previously enlarged organs must have regressed and not be palpable. Bone marrow (BM) must be negative if positive at baseline. Normalization of markers. Partial Response (PR) is a 50% decrease in the sum of products of greatest diameters (SPD) for up to 6 identified dominant lesions, including spleenic and hepatic nodules from baseline. No new lesions and no increase in the size of liver, spleen or other nodes. If PET scan or when the PET scan was positive before therapy, PET should be positive in at least one previously involved site. |
| Number of HIV-positive Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Up to 1 year | Adverse Events (AEs) are reported by the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. For each patient, worst grade of each event type is reported. Grade 3 = Severe, Grade 4 = Life-threatening, Grade 5 = Fatal. |
| Percentage of HIV-positive Patients With 5-year Overall Survival (OS) Treated With 2 Initial Cycles of ABVD Followed by Response-Adapted Therapy Based on Interim FDG-PET Imaging. | 5 years | Measured from date of registration to date of death due to any cause. Patients last known to be alive and are censored at date of last contact. |
| Complete and Partial Response Rates for HIV-negative Patients Treated With Response- Adapted Therapy Based on FDG-PET Imaging After 2 Cycles of ABVD | 7 months after registration | Complete Response (CR) is a complete disappearance of all disease with the exception of the following. If no PET scan or when the PET scan was positive before therapy, a post-treatment residual mass of any size is permitted if it is PET negative. If the PET scan was negative before therapy, all nodal masses at baseline must have regressed. No new lesions. Previously enlarged organs must have regressed and not be palpable. Bone marrow (BM) must be negative if positive at baseline. Normalization of markers. Partial Response (PR) is a 50% decrease in the sum of products of greatest diameters (SPD) for up to 6 identified dominant lesions, including spleenic and hepatic nodules from baseline. No new lesions and no increase in the size of liver, spleen or other nodes. If PET scan or when the PET scan was positive before therapy, PET should be positive in at least one previously involved site. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| HIV-negative: Initial ABVD Doxorubicin 25 mg/m\^2 IV, Bleomycin 10u/m\^2 IV, Vinblastine 6mg/m\^2 IV, Dacarbazine 375 mg/m\^2 IV Days 1,15 Q 28 Days x 2 cycles | 336 |
| HIV-positive: Initial ABVD Doxorubicin 25 mg/m\^2 IV, Bleomycin 10u/m\^2 IV, Vinblastine 6mg/m\^2 IV, Dacarbazine 375 mg/m\^2 IV Days 1,15 Q 28 Days x 2 cycles | 12 |
| Total | 348 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 |
|---|---|---|---|---|---|---|---|
| Initial Registration | Adverse Event | 1 | 0 | 0 | 0 | 0 | 0 |
| Initial Registration | Ineligible | 22 | 1 | 0 | 0 | 0 | 0 |
| Initial Registration | Reasons not Protocol Specified | 2 | 0 | 0 | 0 | 0 | 0 |
| Initial Registration | Refusal Unrelated to Adverse Event | 1 | 0 | 0 | 0 | 0 | 0 |
| PET-directed Therapy | Adverse Event | 0 | 0 | 0 | 1 | 0 | 0 |
| PET-directed Therapy | Death | 0 | 0 | 0 | 2 | 0 | 0 |
| PET-directed Therapy | Protocol Violation | 0 | 0 | 0 | 6 | 0 | 0 |
| PET-directed Therapy | Refusal Unrelated to Adverse Event | 0 | 0 | 0 | 1 | 0 | 0 |
Baseline characteristics
| Characteristic | HIV-positive: Initial ABVD | Total | HIV-negative: Initial ABVD |
|---|---|---|---|
| Age, Continuous | 44.6 years | 32.4 years | 32.1 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 3 Participants | 31 Participants | 28 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 8 Participants | 281 Participants | 273 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants | 36 Participants | 35 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 7 Participants | 7 Participants |
| Race (NIH/OMB) Black or African American | 4 Participants | 36 Participants | 32 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 3 Participants | 3 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 3 Participants | 3 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 3 Participants | 20 Participants | 17 Participants |
| Race (NIH/OMB) White | 5 Participants | 279 Participants | 274 Participants |
| Sex: Female, Male Female | 2 Participants | 149 Participants | 147 Participants |
| Sex: Female, Male Male | 10 Participants | 199 Participants | 189 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk |
|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 335 / 336 | 268 / 270 | 49 / 49 | 12 / 12 | 9 / 10 | 1 / 1 |
| serious Total, serious adverse events | 1 / 336 | 6 / 270 | 2 / 49 | 1 / 12 | 0 / 10 | 0 / 1 |
Outcome results
Primary
Percentage of HIV-negative Patients Who Are PET-positive After 2 Cycles of ABVD With 2-year PFS
Disease progression is defined using the 2007 revised Cheson et al. criteria that is at least 50% increase in sum of the product of the diameters (SPD) of target measurable nodal lesions over the smallest sum observed, or \>= 50% increase in greatest transverse diameter (GTD) of any nodal \> 1 cm in shortest axis, or \>= 50% increase in the SPD of other target measurable lesions over the smallest sum observed, any new bone marrow involvement, any new lesion, lymph node with long axis is \> 1.5 cm or if both long and short axes are \> 1 cm, PET positive if patients with no pretreatment PET scan or when PET scan was positive before therapy. Progression-free survival is measured from date of registration to date of first observation of progressive disease, or death due to any cause. Patients last known to be alive and progression-free are censored at date of last contact.
Time frame: 2 years
Population: Eligible and evaluable HIV-negative patients who were PET-positive after 2 cycles of ABVD were included in the analysis.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| HIV-negative: 2 Cycles of ABVD Followed by PET-directed Therap | Percentage of HIV-negative Patients Who Are PET-positive After 2 Cycles of ABVD With 2-year PFS | 64 percentage of participants |
Primary
Percentage of HIV-negative Patients With 2-year Progression-free Survival (PFS) Treated With 2 Initial Cycles of Adriamycin, Bleomycin, Vnblastine, and Dacarbazine (ABVD) Followed by Response-adapted Therapy Based on Interim FDG-PET Imaging.
Disease progression is defined using the 2007 revised Cheson et al. criteria that is at least 50% increase in sum of the product of the diameters (SPD) of target measurable nodal lesions over the smallest sum observed, or \>= 50% increase in greatest transverse diameter (GTD) of any nodal \> 1 cm in shortest axis, or \>= 50% increase in the SPD of other target measurable lesions over the smallest sum observed, any new bone marrow involvement, any new lesion, lymph node with long axis is \> 1.5 cm or if both long and short axes are \> 1 cm, PET positive if patients with no pretreatment PET scan or when PET scan was positive before therapy. Progression-free survival is measured from date of registration to date of first observation of progressive disease, or death due to any cause. Patients last known to be alive and progression-free are censored at date of last contact.
Time frame: 2 years
Population: Eligible and evaluable HIV-negative patients who started initial ABVD were included in the analysis regardless the response-adapted therapy after 2 initial cycles of ABVD was administered.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| HIV-negative: 2 Cycles of ABVD Followed by PET-directed Therap | Percentage of HIV-negative Patients With 2-year Progression-free Survival (PFS) Treated With 2 Initial Cycles of Adriamycin, Bleomycin, Vnblastine, and Dacarbazine (ABVD) Followed by Response-adapted Therapy Based on Interim FDG-PET Imaging. | 79 percentage of participants |
Secondary
Complete and Partial Response Rates for HIV-negative Patients Treated With Response- Adapted Therapy Based on FDG-PET Imaging After 2 Cycles of ABVD
Complete Response (CR) is a complete disappearance of all disease with the exception of the following. If no PET scan or when the PET scan was positive before therapy, a post-treatment residual mass of any size is permitted if it is PET negative. If the PET scan was negative before therapy, all nodal masses at baseline must have regressed. No new lesions. Previously enlarged organs must have regressed and not be palpable. Bone marrow (BM) must be negative if positive at baseline. Normalization of markers. Partial Response (PR) is a 50% decrease in the sum of products of greatest diameters (SPD) for up to 6 identified dominant lesions, including spleenic and hepatic nodules from baseline. No new lesions and no increase in the size of liver, spleen or other nodes. If PET scan or when the PET scan was positive before therapy, PET should be positive in at least one previously involved site.
Time frame: 7 months after registration
Population: Only eligible and evaluable HIV-negative patients who treated with response-adapted therapy based on FDG-PET imaging after 2 cycles of ABVD were included in the analysis
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| HIV-negative: 2 Cycles of ABVD Followed by PET-directed Therap | Complete and Partial Response Rates for HIV-negative Patients Treated With Response- Adapted Therapy Based on FDG-PET Imaging After 2 Cycles of ABVD | 100 percentage of patients |
| PET-positive: BEACOPP Escalated After 2 Cycles of ABVD | Complete and Partial Response Rates for HIV-negative Patients Treated With Response- Adapted Therapy Based on FDG-PET Imaging After 2 Cycles of ABVD | 93 percentage of patients |
Secondary
Complete and Partial Response Rates for HIV-positive Patients Treated With Response-Adapted Therapy Based on FDG-PET Imaging After 2 Cycles of ABVD
Complete Response (CR) is a complete disappearance of all disease with the exception of the following. If no PET scan or when the PET scan was positive before therapy, a post-treatment residual mass of any size is permitted if it is PET negative. If the PET scan was negative before therapy, all nodal masses at baseline must have regressed. No new lesions. Previously enlarged organs must have regressed and not be palpable. Bone marrow (BM) must be negative if positive at baseline. Normalization of markers. Partial Response (PR) is a 50% decrease in the sum of products of greatest diameters (SPD) for up to 6 identified dominant lesions, including spleenic and hepatic nodules from baseline. No new lesions and no increase in the size of liver, spleen or other nodes. If PET scan or when the PET scan was positive before therapy, PET should be positive in at least one previously involved site.
Time frame: 7 months after registration
Population: Eligible and evaluable HIV-positive patients who treated with 2 initial cycles of ABVD followed by response-adapted therapy based on interim FDG-PET imaging were included he analysis.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| HIV-negative: 2 Cycles of ABVD Followed by PET-directed Therap | Complete and Partial Response Rates for HIV-positive Patients Treated With Response-Adapted Therapy Based on FDG-PET Imaging After 2 Cycles of ABVD | Complete Response | 9 Participants |
| HIV-negative: 2 Cycles of ABVD Followed by PET-directed Therap | Complete and Partial Response Rates for HIV-positive Patients Treated With Response-Adapted Therapy Based on FDG-PET Imaging After 2 Cycles of ABVD | Partial Response | 1 Participants |
| PET-positive: BEACOPP Escalated After 2 Cycles of ABVD | Complete and Partial Response Rates for HIV-positive Patients Treated With Response-Adapted Therapy Based on FDG-PET Imaging After 2 Cycles of ABVD | Complete Response | 0 Participants |
| PET-positive: BEACOPP Escalated After 2 Cycles of ABVD | Complete and Partial Response Rates for HIV-positive Patients Treated With Response-Adapted Therapy Based on FDG-PET Imaging After 2 Cycles of ABVD | Partial Response | 1 Participants |
Secondary
Number of HIV-negative Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Adverse Events (AEs) are reported by the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. For each patient, worst grade of each event type is reported. Grade 3 = Severe, Grade 4 = Life-threatening, Grade 5 = Fatal.
Time frame: Up to 1 year
Population: Eligible HIV-negative patients who had received any treatment were included in the adverse event summaries. Six interim PET-positive patients who did not receive BEACOPP were excluded. patients Any CTCAE 4.0 event of Grade 3 (severe), Grade 4 (life threatening), or Grade 5 (fatal) which deemed to be related to protocol treatment are included.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| HIV-negative: 2 Cycles of ABVD Followed by PET-directed Therap | Number of HIV-negative Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Mood alteration - agitation | 1 Participants |
| HIV-negative: 2 Cycles of ABVD Followed by PET-directed Therap | Number of HIV-negative Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Glucose, serum-high (hyperglycemia) | 0 Participants |
| HIV-negative: 2 Cycles of ABVD Followed by PET-directed Therap | Number of HIV-negative Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Rash/desquamation | 1 Participants |
| HIV-negative: 2 Cycles of ABVD Followed by PET-directed Therap | Number of HIV-negative Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Inf w/normal ANC or Gr 1-2 neutrophils - Skin | 1 Participants |
| HIV-negative: 2 Cycles of ABVD Followed by PET-directed Therap | Number of HIV-negative Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Fever in absence of neutropenia, ANC lt1.0x10e9/L | 0 Participants |
| HIV-negative: 2 Cycles of ABVD Followed by PET-directed Therap | Number of HIV-negative Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Rigors/chills | 1 Participants |
| HIV-negative: 2 Cycles of ABVD Followed by PET-directed Therap | Number of HIV-negative Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Pain - Back | 1 Participants |
| HIV-negative: 2 Cycles of ABVD Followed by PET-directed Therap | Number of HIV-negative Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Febrile neutropenia | 8 Participants |
| HIV-negative: 2 Cycles of ABVD Followed by PET-directed Therap | Number of HIV-negative Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Sodium, serum-low (hyponatremia) | 1 Participants |
| HIV-negative: 2 Cycles of ABVD Followed by PET-directed Therap | Number of HIV-negative Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Musculoskeletal/Soft Tissue-Other (Specify) | 0 Participants |
| HIV-negative: 2 Cycles of ABVD Followed by PET-directed Therap | Number of HIV-negative Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Fatigue (asthenia, lethargy, malaise) | 10 Participants |
| HIV-negative: 2 Cycles of ABVD Followed by PET-directed Therap | Number of HIV-negative Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Syncope (fainting) | 1 Participants |
| HIV-negative: 2 Cycles of ABVD Followed by PET-directed Therap | Number of HIV-negative Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Inf w/normal ANC or Gr 1-2 neutrophils - Oral cav | 0 Participants |
| HIV-negative: 2 Cycles of ABVD Followed by PET-directed Therap | Number of HIV-negative Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | FEV(1) | 0 Participants |
| HIV-negative: 2 Cycles of ABVD Followed by PET-directed Therap | Number of HIV-negative Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Thrombosis/thrombus/embolism | 2 Participants |
| HIV-negative: 2 Cycles of ABVD Followed by PET-directed Therap | Number of HIV-negative Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Pain - Bone | 0 Participants |
| HIV-negative: 2 Cycles of ABVD Followed by PET-directed Therap | Number of HIV-negative Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Dyspnea (shortness of breath) | 4 Participants |
| HIV-negative: 2 Cycles of ABVD Followed by PET-directed Therap | Number of HIV-negative Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Vomiting | 5 Participants |
| HIV-negative: 2 Cycles of ABVD Followed by PET-directed Therap | Number of HIV-negative Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Weight gain | 0 Participants |
| HIV-negative: 2 Cycles of ABVD Followed by PET-directed Therap | Number of HIV-negative Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Dizziness | 1 Participants |
| HIV-negative: 2 Cycles of ABVD Followed by PET-directed Therap | Number of HIV-negative Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | ALT, SGPT (serum glutamic pyruvic transaminase) | 3 Participants |
| HIV-negative: 2 Cycles of ABVD Followed by PET-directed Therap | Number of HIV-negative Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Inf w/normal ANC or Gr 1-2 neutrophils - Lung | 1 Participants |
| HIV-negative: 2 Cycles of ABVD Followed by PET-directed Therap | Number of HIV-negative Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Diarrhea | 0 Participants |
| HIV-negative: 2 Cycles of ABVD Followed by PET-directed Therap | Number of HIV-negative Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | AST, SGOT | 1 Participants |
| HIV-negative: 2 Cycles of ABVD Followed by PET-directed Therap | Number of HIV-negative Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Pain - Cardiac/heart | 0 Participants |
| HIV-negative: 2 Cycles of ABVD Followed by PET-directed Therap | Number of HIV-negative Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Dehydration | 1 Participants |
| HIV-negative: 2 Cycles of ABVD Followed by PET-directed Therap | Number of HIV-negative Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Adult respiratory distress syndrome (ARDS) | 0 Participants |
| HIV-negative: 2 Cycles of ABVD Followed by PET-directed Therap | Number of HIV-negative Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Metabolic/Laboratory-Other (Specify) | 1 Participants |
| HIV-negative: 2 Cycles of ABVD Followed by PET-directed Therap | Number of HIV-negative Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Cytokine release syndrome/acute infusion reaction | 1 Participants |
| HIV-negative: 2 Cycles of ABVD Followed by PET-directed Therap | Number of HIV-negative Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Albumin, serum-low (hypoalbuminemia) | 1 Participants |
| HIV-negative: 2 Cycles of ABVD Followed by PET-directed Therap | Number of HIV-negative Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Inf w/normal ANC or Gr 1-2 neutrophils - Catheter | 1 Participants |
| HIV-negative: 2 Cycles of ABVD Followed by PET-directed Therap | Number of HIV-negative Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Creatinine | 0 Participants |
| HIV-negative: 2 Cycles of ABVD Followed by PET-directed Therap | Number of HIV-negative Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Alkaline phosphatase | 1 Participants |
| HIV-negative: 2 Cycles of ABVD Followed by PET-directed Therap | Number of HIV-negative Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Pain - Chest wall | 1 Participants |
| HIV-negative: 2 Cycles of ABVD Followed by PET-directed Therap | Number of HIV-negative Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Cough | 0 Participants |
| HIV-negative: 2 Cycles of ABVD Followed by PET-directed Therap | Number of HIV-negative Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Allergic reaction/hypersensitivity | 2 Participants |
| HIV-negative: 2 Cycles of ABVD Followed by PET-directed Therap | Number of HIV-negative Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Nausea | 7 Participants |
| HIV-negative: 2 Cycles of ABVD Followed by PET-directed Therap | Number of HIV-negative Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Constipation | 1 Participants |
| HIV-negative: 2 Cycles of ABVD Followed by PET-directed Therap | Number of HIV-negative Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Anorexia | 1 Participants |
| HIV-negative: 2 Cycles of ABVD Followed by PET-directed Therap | Number of HIV-negative Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Inf (clin/microbio) w/Gr 3-4 neuts - Vagina | 1 Participants |
| HIV-negative: 2 Cycles of ABVD Followed by PET-directed Therap | Number of HIV-negative Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Colitis, infectious (e.g., Clostridium difficile) | 1 Participants |
| HIV-negative: 2 Cycles of ABVD Followed by PET-directed Therap | Number of HIV-negative Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Arthritis (non-septic) | 1 Participants |
| HIV-negative: 2 Cycles of ABVD Followed by PET-directed Therap | Number of HIV-negative Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Pain - Chest/thorax NOS | 0 Participants |
| HIV-negative: 2 Cycles of ABVD Followed by PET-directed Therap | Number of HIV-negative Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Colitis | 0 Participants |
| HIV-negative: 2 Cycles of ABVD Followed by PET-directed Therap | Number of HIV-negative Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Carbon monoxide diffusion capacity (DL(co)) | 0 Participants |
| HIV-negative: 2 Cycles of ABVD Followed by PET-directed Therap | Number of HIV-negative Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Mucositis/stomatitis (functional/symp) - Oral cav | 1 Participants |
| HIV-negative: 2 Cycles of ABVD Followed by PET-directed Therap | Number of HIV-negative Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Inf (clin/microbio) w/Gr 3-4 neuts - Upper airway | 0 Participants |
| HIV-negative: 2 Cycles of ABVD Followed by PET-directed Therap | Number of HIV-negative Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Inf (clin/microbio) w/Gr 3-4 neuts - UTI | 0 Participants |
| HIV-negative: 2 Cycles of ABVD Followed by PET-directed Therap | Number of HIV-negative Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Pain - Extremity-limb | 1 Participants |
| HIV-negative: 2 Cycles of ABVD Followed by PET-directed Therap | Number of HIV-negative Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Lymphopenia | 15 Participants |
| HIV-negative: 2 Cycles of ABVD Followed by PET-directed Therap | Number of HIV-negative Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Inf (clin/microbio) w/Gr 3-4 neuts - Soft tissue | 0 Participants |
| HIV-negative: 2 Cycles of ABVD Followed by PET-directed Therap | Number of HIV-negative Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Pain - Head/headache | 2 Participants |
| HIV-negative: 2 Cycles of ABVD Followed by PET-directed Therap | Number of HIV-negative Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Neuropathy: motor | 2 Participants |
| HIV-negative: 2 Cycles of ABVD Followed by PET-directed Therap | Number of HIV-negative Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Inf (clin/microbio) w/Gr 3-4 neuts - Skin | 0 Participants |
| HIV-negative: 2 Cycles of ABVD Followed by PET-directed Therap | Number of HIV-negative Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Pain - Joint | 1 Participants |
| HIV-negative: 2 Cycles of ABVD Followed by PET-directed Therap | Number of HIV-negative Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Mucositis/stomatitis (clinical exam) - Oral cavity | 1 Participants |
| HIV-negative: 2 Cycles of ABVD Followed by PET-directed Therap | Number of HIV-negative Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Inf (clin/microbio) w/Gr 3-4 neuts - Mucosa | 1 Participants |
| HIV-negative: 2 Cycles of ABVD Followed by PET-directed Therap | Number of HIV-negative Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Pain - Muscle | 1 Participants |
| HIV-negative: 2 Cycles of ABVD Followed by PET-directed Therap | Number of HIV-negative Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Leukocytes (total WBC) | 73 Participants |
| HIV-negative: 2 Cycles of ABVD Followed by PET-directed Therap | Number of HIV-negative Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Pain - Oral cavity | 1 Participants |
| HIV-negative: 2 Cycles of ABVD Followed by PET-directed Therap | Number of HIV-negative Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Neuropathy: sensory | 4 Participants |
| HIV-negative: 2 Cycles of ABVD Followed by PET-directed Therap | Number of HIV-negative Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Inf (clin/microbio) w/Gr 3-4 neuts - Meninges | 1 Participants |
| HIV-negative: 2 Cycles of ABVD Followed by PET-directed Therap | Number of HIV-negative Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Pain - Skin | 0 Participants |
| HIV-negative: 2 Cycles of ABVD Followed by PET-directed Therap | Number of HIV-negative Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Mood alteration - anxiety | 1 Participants |
| HIV-negative: 2 Cycles of ABVD Followed by PET-directed Therap | Number of HIV-negative Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Inf (clin/microbio) w/Gr 3-4 neuts - Lung | 0 Participants |
| HIV-negative: 2 Cycles of ABVD Followed by PET-directed Therap | Number of HIV-negative Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Pain - Stomach | 0 Participants |
| HIV-negative: 2 Cycles of ABVD Followed by PET-directed Therap | Number of HIV-negative Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Left ventricular systolic dysfunction | 0 Participants |
| HIV-negative: 2 Cycles of ABVD Followed by PET-directed Therap | Number of HIV-negative Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Inf (clin/microbio) w/Gr 3-4 neuts - Colon | 0 Participants |
| HIV-negative: 2 Cycles of ABVD Followed by PET-directed Therap | Number of HIV-negative Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Pain - Throat/pharynx/larynx | 0 Participants |
| HIV-negative: 2 Cycles of ABVD Followed by PET-directed Therap | Number of HIV-negative Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Neutrophils/granulocytes (ANC/AGC) | 206 Participants |
| HIV-negative: 2 Cycles of ABVD Followed by PET-directed Therap | Number of HIV-negative Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Inf (clin/microbio) w/Gr 3-4 neuts - Blood | 2 Participants |
| HIV-negative: 2 Cycles of ABVD Followed by PET-directed Therap | Number of HIV-negative Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Pain - Tumor pain | 1 Participants |
| HIV-negative: 2 Cycles of ABVD Followed by PET-directed Therap | Number of HIV-negative Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Muscle weakness, not d/t neuropathy - body/general | 0 Participants |
| HIV-negative: 2 Cycles of ABVD Followed by PET-directed Therap | Number of HIV-negative Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Hypoxia | 0 Participants |
| HIV-negative: 2 Cycles of ABVD Followed by PET-directed Therap | Number of HIV-negative Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Pain-Other (Specify) | 1 Participants |
| HIV-negative: 2 Cycles of ABVD Followed by PET-directed Therap | Number of HIV-negative Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Infection with unknown ANC - Lung (pneumonia) | 0 Participants |
| HIV-negative: 2 Cycles of ABVD Followed by PET-directed Therap | Number of HIV-negative Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Hypotension | 0 Participants |
| HIV-negative: 2 Cycles of ABVD Followed by PET-directed Therap | Number of HIV-negative Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Pancreatic endocrine: glucose intolerance | 1 Participants |
| HIV-negative: 2 Cycles of ABVD Followed by PET-directed Therap | Number of HIV-negative Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Osteonecrosis (avascular necrosis) | 0 Participants |
| HIV-negative: 2 Cycles of ABVD Followed by PET-directed Therap | Number of HIV-negative Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Hemorrhage, pulmonary/upper respiratory - Nose | 0 Participants |
| HIV-negative: 2 Cycles of ABVD Followed by PET-directed Therap | Number of HIV-negative Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Phosphate, serum-low (hypophosphatemia) | 1 Participants |
| HIV-negative: 2 Cycles of ABVD Followed by PET-directed Therap | Number of HIV-negative Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Mood alteration - depression | 1 Participants |
| HIV-negative: 2 Cycles of ABVD Followed by PET-directed Therap | Number of HIV-negative Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Hemolysis | 0 Participants |
| HIV-negative: 2 Cycles of ABVD Followed by PET-directed Therap | Number of HIV-negative Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Platelets | 1 Participants |
| HIV-negative: 2 Cycles of ABVD Followed by PET-directed Therap | Number of HIV-negative Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Pneumonitis/pulmonary infiltrates | 1 Participants |
| HIV-negative: 2 Cycles of ABVD Followed by PET-directed Therap | Number of HIV-negative Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Infection with normal ANC or Grade 1 or 2 neutroph | 1 Participants |
| HIV-negative: 2 Cycles of ABVD Followed by PET-directed Therap | Number of HIV-negative Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Hemoglobin | 10 Participants |
| HIV-negative: 2 Cycles of ABVD Followed by PET-directed Therap | Number of HIV-negative Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Potassium, serum-high (hyperkalemia) | 0 Participants |
| HIV-negative: 2 Cycles of ABVD Followed by PET-directed Therap | Number of HIV-negative Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Pain - Abdomen NOS | 2 Participants |
| HIV-negative: 2 Cycles of ABVD Followed by PET-directed Therap | Number of HIV-negative Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Heartburn/dyspepsia | 1 Participants |
| HIV-negative: 2 Cycles of ABVD Followed by PET-directed Therap | Number of HIV-negative Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Potassium, serum-low (hypokalemia) | 0 Participants |
| PET-positive: BEACOPP Escalated After 2 Cycles of ABVD | Number of HIV-negative Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Inf w/normal ANC or Gr 1-2 neutrophils - Oral cav | 0 Participants |
| PET-positive: BEACOPP Escalated After 2 Cycles of ABVD | Number of HIV-negative Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Vomiting | 4 Participants |
| PET-positive: BEACOPP Escalated After 2 Cycles of ABVD | Number of HIV-negative Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Mucositis/stomatitis (functional/symp) - Oral cav | 0 Participants |
| PET-positive: BEACOPP Escalated After 2 Cycles of ABVD | Number of HIV-negative Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Muscle weakness, not d/t neuropathy - body/general | 0 Participants |
| PET-positive: BEACOPP Escalated After 2 Cycles of ABVD | Number of HIV-negative Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Musculoskeletal/Soft Tissue-Other (Specify) | 1 Participants |
| PET-positive: BEACOPP Escalated After 2 Cycles of ABVD | Number of HIV-negative Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Nausea | 5 Participants |
| PET-positive: BEACOPP Escalated After 2 Cycles of ABVD | Number of HIV-negative Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Neuropathy: motor | 3 Participants |
| PET-positive: BEACOPP Escalated After 2 Cycles of ABVD | Number of HIV-negative Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Neuropathy: sensory | 12 Participants |
| PET-positive: BEACOPP Escalated After 2 Cycles of ABVD | Number of HIV-negative Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Neutrophils/granulocytes (ANC/AGC) | 165 Participants |
| PET-positive: BEACOPP Escalated After 2 Cycles of ABVD | Number of HIV-negative Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Osteonecrosis (avascular necrosis) | 0 Participants |
| PET-positive: BEACOPP Escalated After 2 Cycles of ABVD | Number of HIV-negative Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Pain - Abdomen NOS | 5 Participants |
| PET-positive: BEACOPP Escalated After 2 Cycles of ABVD | Number of HIV-negative Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Pain - Back | 0 Participants |
| PET-positive: BEACOPP Escalated After 2 Cycles of ABVD | Number of HIV-negative Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Pain - Bone | 0 Participants |
| PET-positive: BEACOPP Escalated After 2 Cycles of ABVD | Number of HIV-negative Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Pain - Cardiac/heart | 1 Participants |
| PET-positive: BEACOPP Escalated After 2 Cycles of ABVD | Number of HIV-negative Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Pain - Chest wall | 1 Participants |
| PET-positive: BEACOPP Escalated After 2 Cycles of ABVD | Number of HIV-negative Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Pain - Chest/thorax NOS | 1 Participants |
| PET-positive: BEACOPP Escalated After 2 Cycles of ABVD | Number of HIV-negative Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Pain - Extremity-limb | 0 Participants |
| PET-positive: BEACOPP Escalated After 2 Cycles of ABVD | Number of HIV-negative Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Pain - Head/headache | 2 Participants |
| PET-positive: BEACOPP Escalated After 2 Cycles of ABVD | Number of HIV-negative Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Pain - Joint | 0 Participants |
| PET-positive: BEACOPP Escalated After 2 Cycles of ABVD | Number of HIV-negative Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Pain - Muscle | 1 Participants |
| PET-positive: BEACOPP Escalated After 2 Cycles of ABVD | Number of HIV-negative Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Pain - Oral cavity | 0 Participants |
| PET-positive: BEACOPP Escalated After 2 Cycles of ABVD | Number of HIV-negative Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Pain - Skin | 1 Participants |
| PET-positive: BEACOPP Escalated After 2 Cycles of ABVD | Number of HIV-negative Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Pain - Stomach | 1 Participants |
| PET-positive: BEACOPP Escalated After 2 Cycles of ABVD | Number of HIV-negative Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Pain - Throat/pharynx/larynx | 0 Participants |
| PET-positive: BEACOPP Escalated After 2 Cycles of ABVD | Number of HIV-negative Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Pain - Tumor pain | 0 Participants |
| PET-positive: BEACOPP Escalated After 2 Cycles of ABVD | Number of HIV-negative Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Pain-Other (Specify) | 2 Participants |
| PET-positive: BEACOPP Escalated After 2 Cycles of ABVD | Number of HIV-negative Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Pancreatic endocrine: glucose intolerance | 1 Participants |
| PET-positive: BEACOPP Escalated After 2 Cycles of ABVD | Number of HIV-negative Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Phosphate, serum-low (hypophosphatemia) | 0 Participants |
| PET-positive: BEACOPP Escalated After 2 Cycles of ABVD | Number of HIV-negative Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Pneumonitis/pulmonary infiltrates | 4 Participants |
| PET-positive: BEACOPP Escalated After 2 Cycles of ABVD | Number of HIV-negative Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Potassium, serum-high (hyperkalemia) | 0 Participants |
| PET-positive: BEACOPP Escalated After 2 Cycles of ABVD | Number of HIV-negative Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Potassium, serum-low (hypokalemia) | 0 Participants |
| PET-positive: BEACOPP Escalated After 2 Cycles of ABVD | Number of HIV-negative Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Rash/desquamation | 0 Participants |
| PET-positive: BEACOPP Escalated After 2 Cycles of ABVD | Number of HIV-negative Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Rigors/chills | 0 Participants |
| PET-positive: BEACOPP Escalated After 2 Cycles of ABVD | Number of HIV-negative Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Sodium, serum-low (hyponatremia) | 0 Participants |
| PET-positive: BEACOPP Escalated After 2 Cycles of ABVD | Number of HIV-negative Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Syncope (fainting) | 0 Participants |
| PET-positive: BEACOPP Escalated After 2 Cycles of ABVD | Number of HIV-negative Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Thrombosis/thrombus/embolism | 5 Participants |
| PET-positive: BEACOPP Escalated After 2 Cycles of ABVD | Number of HIV-negative Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Weight gain | 2 Participants |
| PET-positive: BEACOPP Escalated After 2 Cycles of ABVD | Number of HIV-negative Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | ALT, SGPT (serum glutamic pyruvic transaminase) | 0 Participants |
| PET-positive: BEACOPP Escalated After 2 Cycles of ABVD | Number of HIV-negative Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | AST, SGOT | 0 Participants |
| PET-positive: BEACOPP Escalated After 2 Cycles of ABVD | Number of HIV-negative Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Adult respiratory distress syndrome (ARDS) | 2 Participants |
| PET-positive: BEACOPP Escalated After 2 Cycles of ABVD | Number of HIV-negative Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Albumin, serum-low (hypoalbuminemia) | 0 Participants |
| PET-positive: BEACOPP Escalated After 2 Cycles of ABVD | Number of HIV-negative Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Alkaline phosphatase | 0 Participants |
| PET-positive: BEACOPP Escalated After 2 Cycles of ABVD | Number of HIV-negative Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Allergic reaction/hypersensitivity | 2 Participants |
| PET-positive: BEACOPP Escalated After 2 Cycles of ABVD | Number of HIV-negative Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Anorexia | 1 Participants |
| PET-positive: BEACOPP Escalated After 2 Cycles of ABVD | Number of HIV-negative Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Arthritis (non-septic) | 0 Participants |
| PET-positive: BEACOPP Escalated After 2 Cycles of ABVD | Number of HIV-negative Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Carbon monoxide diffusion capacity (DL(co)) | 2 Participants |
| PET-positive: BEACOPP Escalated After 2 Cycles of ABVD | Number of HIV-negative Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Colitis | 1 Participants |
| PET-positive: BEACOPP Escalated After 2 Cycles of ABVD | Number of HIV-negative Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Colitis, infectious (e.g., Clostridium difficile) | 0 Participants |
| PET-positive: BEACOPP Escalated After 2 Cycles of ABVD | Number of HIV-negative Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Constipation | 0 Participants |
| PET-positive: BEACOPP Escalated After 2 Cycles of ABVD | Number of HIV-negative Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Cough | 1 Participants |
| PET-positive: BEACOPP Escalated After 2 Cycles of ABVD | Number of HIV-negative Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Creatinine | 0 Participants |
| PET-positive: BEACOPP Escalated After 2 Cycles of ABVD | Number of HIV-negative Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Cytokine release syndrome/acute infusion reaction | 0 Participants |
| PET-positive: BEACOPP Escalated After 2 Cycles of ABVD | Number of HIV-negative Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Dehydration | 2 Participants |
| PET-positive: BEACOPP Escalated After 2 Cycles of ABVD | Number of HIV-negative Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Diarrhea | 1 Participants |
| PET-positive: BEACOPP Escalated After 2 Cycles of ABVD | Number of HIV-negative Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Dizziness | 0 Participants |
| PET-positive: BEACOPP Escalated After 2 Cycles of ABVD | Number of HIV-negative Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Dyspnea (shortness of breath) | 9 Participants |
| PET-positive: BEACOPP Escalated After 2 Cycles of ABVD | Number of HIV-negative Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | FEV(1) | 1 Participants |
| PET-positive: BEACOPP Escalated After 2 Cycles of ABVD | Number of HIV-negative Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Fatigue (asthenia, lethargy, malaise) | 15 Participants |
| PET-positive: BEACOPP Escalated After 2 Cycles of ABVD | Number of HIV-negative Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Febrile neutropenia | 17 Participants |
| PET-positive: BEACOPP Escalated After 2 Cycles of ABVD | Number of HIV-negative Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Fever in absence of neutropenia, ANC lt1.0x10e9/L | 3 Participants |
| PET-positive: BEACOPP Escalated After 2 Cycles of ABVD | Number of HIV-negative Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Glucose, serum-high (hyperglycemia) | 1 Participants |
| PET-positive: BEACOPP Escalated After 2 Cycles of ABVD | Number of HIV-negative Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Heartburn/dyspepsia | 0 Participants |
| PET-positive: BEACOPP Escalated After 2 Cycles of ABVD | Number of HIV-negative Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Hemoglobin | 4 Participants |
| PET-positive: BEACOPP Escalated After 2 Cycles of ABVD | Number of HIV-negative Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Hemolysis | 0 Participants |
| PET-positive: BEACOPP Escalated After 2 Cycles of ABVD | Number of HIV-negative Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Hemorrhage, pulmonary/upper respiratory - Nose | 0 Participants |
| PET-positive: BEACOPP Escalated After 2 Cycles of ABVD | Number of HIV-negative Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Hypotension | 0 Participants |
| PET-positive: BEACOPP Escalated After 2 Cycles of ABVD | Number of HIV-negative Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Hypoxia | 3 Participants |
| PET-positive: BEACOPP Escalated After 2 Cycles of ABVD | Number of HIV-negative Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Inf (clin/microbio) w/Gr 3-4 neuts - Blood | 1 Participants |
| PET-positive: BEACOPP Escalated After 2 Cycles of ABVD | Number of HIV-negative Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Inf (clin/microbio) w/Gr 3-4 neuts - Colon | 0 Participants |
| PET-positive: BEACOPP Escalated After 2 Cycles of ABVD | Number of HIV-negative Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Inf (clin/microbio) w/Gr 3-4 neuts - Lung | 4 Participants |
| PET-positive: BEACOPP Escalated After 2 Cycles of ABVD | Number of HIV-negative Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Inf (clin/microbio) w/Gr 3-4 neuts - Meninges | 0 Participants |
| PET-positive: BEACOPP Escalated After 2 Cycles of ABVD | Number of HIV-negative Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Inf (clin/microbio) w/Gr 3-4 neuts - Mucosa | 0 Participants |
| PET-positive: BEACOPP Escalated After 2 Cycles of ABVD | Number of HIV-negative Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Inf (clin/microbio) w/Gr 3-4 neuts - Skin | 1 Participants |
| PET-positive: BEACOPP Escalated After 2 Cycles of ABVD | Number of HIV-negative Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Inf (clin/microbio) w/Gr 3-4 neuts - Soft tissue | 1 Participants |
| PET-positive: BEACOPP Escalated After 2 Cycles of ABVD | Number of HIV-negative Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Inf (clin/microbio) w/Gr 3-4 neuts - UTI | 1 Participants |
| PET-positive: BEACOPP Escalated After 2 Cycles of ABVD | Number of HIV-negative Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Inf (clin/microbio) w/Gr 3-4 neuts - Upper airway | 1 Participants |
| PET-positive: BEACOPP Escalated After 2 Cycles of ABVD | Number of HIV-negative Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Inf (clin/microbio) w/Gr 3-4 neuts - Vagina | 0 Participants |
| PET-positive: BEACOPP Escalated After 2 Cycles of ABVD | Number of HIV-negative Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Inf w/normal ANC or Gr 1-2 neutrophils - Catheter | 0 Participants |
| PET-positive: BEACOPP Escalated After 2 Cycles of ABVD | Number of HIV-negative Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Inf w/normal ANC or Gr 1-2 neutrophils - Lung | 3 Participants |
| PET-positive: BEACOPP Escalated After 2 Cycles of ABVD | Number of HIV-negative Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Platelets | 0 Participants |
| PET-positive: BEACOPP Escalated After 2 Cycles of ABVD | Number of HIV-negative Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Inf w/normal ANC or Gr 1-2 neutrophils - Skin | 0 Participants |
| PET-positive: BEACOPP Escalated After 2 Cycles of ABVD | Number of HIV-negative Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Infection with normal ANC or Grade 1 or 2 neutroph | 0 Participants |
| PET-positive: BEACOPP Escalated After 2 Cycles of ABVD | Number of HIV-negative Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Infection with unknown ANC - Lung (pneumonia) | 1 Participants |
| PET-positive: BEACOPP Escalated After 2 Cycles of ABVD | Number of HIV-negative Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Left ventricular systolic dysfunction | 1 Participants |
| PET-positive: BEACOPP Escalated After 2 Cycles of ABVD | Number of HIV-negative Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Leukocytes (total WBC) | 86 Participants |
| PET-positive: BEACOPP Escalated After 2 Cycles of ABVD | Number of HIV-negative Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Lymphopenia | 30 Participants |
| PET-positive: BEACOPP Escalated After 2 Cycles of ABVD | Number of HIV-negative Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Metabolic/Laboratory-Other (Specify) | 0 Participants |
| PET-positive: BEACOPP Escalated After 2 Cycles of ABVD | Number of HIV-negative Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Mood alteration - agitation | 0 Participants |
| PET-positive: BEACOPP Escalated After 2 Cycles of ABVD | Number of HIV-negative Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Mood alteration - anxiety | 0 Participants |
| PET-positive: BEACOPP Escalated After 2 Cycles of ABVD | Number of HIV-negative Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Mood alteration - depression | 0 Participants |
| PET-positive: BEACOPP Escalated After 2 Cycles of ABVD | Number of HIV-negative Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Mucositis/stomatitis (clinical exam) - Oral cavity | 0 Participants |
| HIV-negative and PET-positive: BEACOPP Escalated | Number of HIV-negative Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Glucose, serum-high (hyperglycemia) | 1 Participants |
| HIV-negative and PET-positive: BEACOPP Escalated | Number of HIV-negative Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Potassium, serum-high (hyperkalemia) | 1 Participants |
| HIV-negative and PET-positive: BEACOPP Escalated | Number of HIV-negative Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Osteonecrosis (avascular necrosis) | 1 Participants |
| HIV-negative and PET-positive: BEACOPP Escalated | Number of HIV-negative Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Heartburn/dyspepsia | 0 Participants |
| HIV-negative and PET-positive: BEACOPP Escalated | Number of HIV-negative Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Pneumonitis/pulmonary infiltrates | 1 Participants |
| HIV-negative and PET-positive: BEACOPP Escalated | Number of HIV-negative Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Mood alteration - agitation | 0 Participants |
| HIV-negative and PET-positive: BEACOPP Escalated | Number of HIV-negative Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Hemoglobin | 37 Participants |
| HIV-negative and PET-positive: BEACOPP Escalated | Number of HIV-negative Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Phosphate, serum-low (hypophosphatemia) | 0 Participants |
| HIV-negative and PET-positive: BEACOPP Escalated | Number of HIV-negative Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Infection with normal ANC or Grade 1 or 2 neutroph | 0 Participants |
| HIV-negative and PET-positive: BEACOPP Escalated | Number of HIV-negative Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Hemolysis | 1 Participants |
| HIV-negative and PET-positive: BEACOPP Escalated | Number of HIV-negative Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Pancreatic endocrine: glucose intolerance | 0 Participants |
| HIV-negative and PET-positive: BEACOPP Escalated | Number of HIV-negative Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Neutrophils/granulocytes (ANC/AGC) | 38 Participants |
| HIV-negative and PET-positive: BEACOPP Escalated | Number of HIV-negative Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Hemorrhage, pulmonary/upper respiratory - Nose | 1 Participants |
| HIV-negative and PET-positive: BEACOPP Escalated | Number of HIV-negative Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Pain-Other (Specify) | 0 Participants |
| HIV-negative and PET-positive: BEACOPP Escalated | Number of HIV-negative Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Mucositis/stomatitis (functional/symp) - Oral cav | 1 Participants |
| HIV-negative and PET-positive: BEACOPP Escalated | Number of HIV-negative Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Hypotension | 1 Participants |
| HIV-negative and PET-positive: BEACOPP Escalated | Number of HIV-negative Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Pain - Tumor pain | 0 Participants |
| HIV-negative and PET-positive: BEACOPP Escalated | Number of HIV-negative Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Infection with unknown ANC - Lung (pneumonia) | 0 Participants |
| HIV-negative and PET-positive: BEACOPP Escalated | Number of HIV-negative Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Hypoxia | 1 Participants |
| HIV-negative and PET-positive: BEACOPP Escalated | Number of HIV-negative Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Pain - Throat/pharynx/larynx | 1 Participants |
| HIV-negative and PET-positive: BEACOPP Escalated | Number of HIV-negative Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Neuropathy: sensory | 4 Participants |
| HIV-negative and PET-positive: BEACOPP Escalated | Number of HIV-negative Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Inf (clin/microbio) w/Gr 3-4 neuts - Blood | 2 Participants |
| HIV-negative and PET-positive: BEACOPP Escalated | Number of HIV-negative Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Pain - Stomach | 0 Participants |
| HIV-negative and PET-positive: BEACOPP Escalated | Number of HIV-negative Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Platelets | 34 Participants |
| HIV-negative and PET-positive: BEACOPP Escalated | Number of HIV-negative Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Inf (clin/microbio) w/Gr 3-4 neuts - Colon | 1 Participants |
| HIV-negative and PET-positive: BEACOPP Escalated | Number of HIV-negative Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Pain - Skin | 0 Participants |
| HIV-negative and PET-positive: BEACOPP Escalated | Number of HIV-negative Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Left ventricular systolic dysfunction | 0 Participants |
| HIV-negative and PET-positive: BEACOPP Escalated | Number of HIV-negative Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Inf (clin/microbio) w/Gr 3-4 neuts - Lung | 2 Participants |
| HIV-negative and PET-positive: BEACOPP Escalated | Number of HIV-negative Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Pain - Oral cavity | 0 Participants |
| HIV-negative and PET-positive: BEACOPP Escalated | Number of HIV-negative Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Neuropathy: motor | 0 Participants |
| HIV-negative and PET-positive: BEACOPP Escalated | Number of HIV-negative Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Inf (clin/microbio) w/Gr 3-4 neuts - Meninges | 0 Participants |
| HIV-negative and PET-positive: BEACOPP Escalated | Number of HIV-negative Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Pain - Joint | 1 Participants |
| HIV-negative and PET-positive: BEACOPP Escalated | Number of HIV-negative Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Mood alteration - anxiety | 0 Participants |
| HIV-negative and PET-positive: BEACOPP Escalated | Number of HIV-negative Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Inf (clin/microbio) w/Gr 3-4 neuts - Mucosa | 0 Participants |
| HIV-negative and PET-positive: BEACOPP Escalated | Number of HIV-negative Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Pain - Head/headache | 0 Participants |
| HIV-negative and PET-positive: BEACOPP Escalated | Number of HIV-negative Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Leukocytes (total WBC) | 42 Participants |
| HIV-negative and PET-positive: BEACOPP Escalated | Number of HIV-negative Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Inf (clin/microbio) w/Gr 3-4 neuts - Skin | 3 Participants |
| HIV-negative and PET-positive: BEACOPP Escalated | Number of HIV-negative Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Pain - Extremity-limb | 0 Participants |
| HIV-negative and PET-positive: BEACOPP Escalated | Number of HIV-negative Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Nausea | 2 Participants |
| HIV-negative and PET-positive: BEACOPP Escalated | Number of HIV-negative Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Inf (clin/microbio) w/Gr 3-4 neuts - Soft tissue | 0 Participants |
| HIV-negative and PET-positive: BEACOPP Escalated | Number of HIV-negative Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Pain - Chest/thorax NOS | 1 Participants |
| HIV-negative and PET-positive: BEACOPP Escalated | Number of HIV-negative Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Vomiting | 0 Participants |
| HIV-negative and PET-positive: BEACOPP Escalated | Number of HIV-negative Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Inf (clin/microbio) w/Gr 3-4 neuts - UTI | 1 Participants |
| HIV-negative and PET-positive: BEACOPP Escalated | Number of HIV-negative Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Pain - Muscle | 0 Participants |
| HIV-negative and PET-positive: BEACOPP Escalated | Number of HIV-negative Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Lymphopenia | 32 Participants |
| HIV-negative and PET-positive: BEACOPP Escalated | Number of HIV-negative Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Inf (clin/microbio) w/Gr 3-4 neuts - Upper airway | 1 Participants |
| HIV-negative and PET-positive: BEACOPP Escalated | Number of HIV-negative Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Carbon monoxide diffusion capacity (DL(co)) | 0 Participants |
| HIV-negative and PET-positive: BEACOPP Escalated | Number of HIV-negative Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Arthritis (non-septic) | 0 Participants |
| HIV-negative and PET-positive: BEACOPP Escalated | Number of HIV-negative Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Pain - Chest wall | 0 Participants |
| HIV-negative and PET-positive: BEACOPP Escalated | Number of HIV-negative Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Colitis | 0 Participants |
| HIV-negative and PET-positive: BEACOPP Escalated | Number of HIV-negative Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Anorexia | 0 Participants |
| HIV-negative and PET-positive: BEACOPP Escalated | Number of HIV-negative Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Musculoskeletal/Soft Tissue-Other (Specify) | 0 Participants |
| HIV-negative and PET-positive: BEACOPP Escalated | Number of HIV-negative Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Colitis, infectious (e.g., Clostridium difficile) | 1 Participants |
| HIV-negative and PET-positive: BEACOPP Escalated | Number of HIV-negative Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Allergic reaction/hypersensitivity | 0 Participants |
| HIV-negative and PET-positive: BEACOPP Escalated | Number of HIV-negative Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Inf (clin/microbio) w/Gr 3-4 neuts - Vagina | 0 Participants |
| HIV-negative and PET-positive: BEACOPP Escalated | Number of HIV-negative Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Constipation | 0 Participants |
| HIV-negative and PET-positive: BEACOPP Escalated | Number of HIV-negative Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Alkaline phosphatase | 0 Participants |
| HIV-negative and PET-positive: BEACOPP Escalated | Number of HIV-negative Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Pain - Cardiac/heart | 0 Participants |
| HIV-negative and PET-positive: BEACOPP Escalated | Number of HIV-negative Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Cough | 0 Participants |
| HIV-negative and PET-positive: BEACOPP Escalated | Number of HIV-negative Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Albumin, serum-low (hypoalbuminemia) | 0 Participants |
| HIV-negative and PET-positive: BEACOPP Escalated | Number of HIV-negative Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Mucositis/stomatitis (clinical exam) - Oral cavity | 2 Participants |
| HIV-negative and PET-positive: BEACOPP Escalated | Number of HIV-negative Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Creatinine | 1 Participants |
| HIV-negative and PET-positive: BEACOPP Escalated | Number of HIV-negative Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Adult respiratory distress syndrome (ARDS) | 0 Participants |
| HIV-negative and PET-positive: BEACOPP Escalated | Number of HIV-negative Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Inf w/normal ANC or Gr 1-2 neutrophils - Catheter | 0 Participants |
| HIV-negative and PET-positive: BEACOPP Escalated | Number of HIV-negative Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Cytokine release syndrome/acute infusion reaction | 0 Participants |
| HIV-negative and PET-positive: BEACOPP Escalated | Number of HIV-negative Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | AST, SGOT | 0 Participants |
| HIV-negative and PET-positive: BEACOPP Escalated | Number of HIV-negative Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Pain - Bone | 5 Participants |
| HIV-negative and PET-positive: BEACOPP Escalated | Number of HIV-negative Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Dehydration | 1 Participants |
| HIV-negative and PET-positive: BEACOPP Escalated | Number of HIV-negative Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | ALT, SGPT (serum glutamic pyruvic transaminase) | 0 Participants |
| HIV-negative and PET-positive: BEACOPP Escalated | Number of HIV-negative Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Metabolic/Laboratory-Other (Specify) | 0 Participants |
| HIV-negative and PET-positive: BEACOPP Escalated | Number of HIV-negative Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Diarrhea | 0 Participants |
| HIV-negative and PET-positive: BEACOPP Escalated | Number of HIV-negative Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Weight gain | 0 Participants |
| HIV-negative and PET-positive: BEACOPP Escalated | Number of HIV-negative Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Inf w/normal ANC or Gr 1-2 neutrophils - Lung | 0 Participants |
| HIV-negative and PET-positive: BEACOPP Escalated | Number of HIV-negative Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Dizziness | 1 Participants |
| HIV-negative and PET-positive: BEACOPP Escalated | Number of HIV-negative Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Thrombosis/thrombus/embolism | 0 Participants |
| HIV-negative and PET-positive: BEACOPP Escalated | Number of HIV-negative Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Pain - Back | 3 Participants |
| HIV-negative and PET-positive: BEACOPP Escalated | Number of HIV-negative Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Dyspnea (shortness of breath) | 1 Participants |
| HIV-negative and PET-positive: BEACOPP Escalated | Number of HIV-negative Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Syncope (fainting) | 1 Participants |
| HIV-negative and PET-positive: BEACOPP Escalated | Number of HIV-negative Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Muscle weakness, not d/t neuropathy - body/general | 1 Participants |
| HIV-negative and PET-positive: BEACOPP Escalated | Number of HIV-negative Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | FEV(1) | 0 Participants |
| HIV-negative and PET-positive: BEACOPP Escalated | Number of HIV-negative Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Sodium, serum-low (hyponatremia) | 1 Participants |
| HIV-negative and PET-positive: BEACOPP Escalated | Number of HIV-negative Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Inf w/normal ANC or Gr 1-2 neutrophils - Oral cav | 1 Participants |
| HIV-negative and PET-positive: BEACOPP Escalated | Number of HIV-negative Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Fatigue (asthenia, lethargy, malaise) | 3 Participants |
| HIV-negative and PET-positive: BEACOPP Escalated | Number of HIV-negative Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Rigors/chills | 2 Participants |
| HIV-negative and PET-positive: BEACOPP Escalated | Number of HIV-negative Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Pain - Abdomen NOS | 1 Participants |
| HIV-negative and PET-positive: BEACOPP Escalated | Number of HIV-negative Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Febrile neutropenia | 17 Participants |
| HIV-negative and PET-positive: BEACOPP Escalated | Number of HIV-negative Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Rash/desquamation | 0 Participants |
| HIV-negative and PET-positive: BEACOPP Escalated | Number of HIV-negative Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Mood alteration - depression | 0 Participants |
| HIV-negative and PET-positive: BEACOPP Escalated | Number of HIV-negative Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Fever in absence of neutropenia, ANC lt1.0x10e9/L | 1 Participants |
| HIV-negative and PET-positive: BEACOPP Escalated | Number of HIV-negative Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Potassium, serum-low (hypokalemia) | 4 Participants |
| HIV-negative and PET-positive: BEACOPP Escalated | Number of HIV-negative Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Inf w/normal ANC or Gr 1-2 neutrophils - Skin | 1 Participants |
Secondary
Number of HIV-positive Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Adverse Events (AEs) are reported by the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. For each patient, worst grade of each event type is reported. Grade 3 = Severe, Grade 4 = Life-threatening, Grade 5 = Fatal.
Time frame: Up to 1 year
Population: Eligible HIV-positive patients who had received any treatment were included in the adverse event summaries. Any CTCAE 4.0 event of Grade 3 (severe), Grade 4 (life threatening), or Grade 5 (fatal) which deemed to be related to protocol treatment are included.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| HIV-negative: 2 Cycles of ABVD Followed by PET-directed Therap | Number of HIV-positive Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Infection with unknown ANC - Urinary tract NOS | 0 Participants |
| HIV-negative: 2 Cycles of ABVD Followed by PET-directed Therap | Number of HIV-positive Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Fatigue (asthenia, lethargy, malaise) | 1 Participants |
| HIV-negative: 2 Cycles of ABVD Followed by PET-directed Therap | Number of HIV-positive Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Neuropathy: motor | 0 Participants |
| HIV-negative: 2 Cycles of ABVD Followed by PET-directed Therap | Number of HIV-positive Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Insomnia | 1 Participants |
| HIV-negative: 2 Cycles of ABVD Followed by PET-directed Therap | Number of HIV-positive Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Thrombosis/thrombus/embolism | 0 Participants |
| HIV-negative: 2 Cycles of ABVD Followed by PET-directed Therap | Number of HIV-positive Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Muscle weakness, not d/t neuropathy - body/general | 1 Participants |
| HIV-negative: 2 Cycles of ABVD Followed by PET-directed Therap | Number of HIV-positive Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Leukocytes (total WBC) | 7 Participants |
| HIV-negative: 2 Cycles of ABVD Followed by PET-directed Therap | Number of HIV-positive Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Phosphate, serum-low (hypophosphatemia) | 1 Participants |
| HIV-negative: 2 Cycles of ABVD Followed by PET-directed Therap | Number of HIV-positive Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Mood alteration - anxiety | 1 Participants |
| HIV-negative: 2 Cycles of ABVD Followed by PET-directed Therap | Number of HIV-positive Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Lymphopenia | 1 Participants |
| HIV-negative: 2 Cycles of ABVD Followed by PET-directed Therap | Number of HIV-positive Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Febrile neutropenia | 3 Participants |
| HIV-negative: 2 Cycles of ABVD Followed by PET-directed Therap | Number of HIV-positive Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Mood alteration - agitation | 1 Participants |
| HIV-negative: 2 Cycles of ABVD Followed by PET-directed Therap | Number of HIV-positive Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Sodium, serum-low (hyponatremia) | 1 Participants |
| HIV-negative: 2 Cycles of ABVD Followed by PET-directed Therap | Number of HIV-positive Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Pain - Joint | 1 Participants |
| HIV-negative: 2 Cycles of ABVD Followed by PET-directed Therap | Number of HIV-positive Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Hemoglobin | 1 Participants |
| HIV-negative: 2 Cycles of ABVD Followed by PET-directed Therap | Number of HIV-positive Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Dizziness | 0 Participants |
| HIV-negative: 2 Cycles of ABVD Followed by PET-directed Therap | Number of HIV-positive Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Pain - Bone | 1 Participants |
| HIV-negative: 2 Cycles of ABVD Followed by PET-directed Therap | Number of HIV-positive Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Inf (clin/microbio) w/Gr 3-4 neuts - Eye NOS | 1 Participants |
| HIV-negative: 2 Cycles of ABVD Followed by PET-directed Therap | Number of HIV-positive Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Anorexia | 0 Participants |
| HIV-negative: 2 Cycles of ABVD Followed by PET-directed Therap | Number of HIV-positive Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Neutrophils/granulocytes (ANC/AGC) | 8 Participants |
| HIV-negative: 2 Cycles of ABVD Followed by PET-directed Therap | Number of HIV-positive Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Inf (clin/microbio) w/Gr 3-4 neuts - Lung | 0 Participants |
| HIV-negative: 2 Cycles of ABVD Followed by PET-directed Therap | Number of HIV-positive Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Platelets | 0 Participants |
| HIV-negative: 2 Cycles of ABVD Followed by PET-directed Therap | Number of HIV-positive Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Neuropathy: sensory | 1 Participants |
| PET-positive: BEACOPP Escalated After 2 Cycles of ABVD | Number of HIV-positive Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Phosphate, serum-low (hypophosphatemia) | 1 Participants |
| PET-positive: BEACOPP Escalated After 2 Cycles of ABVD | Number of HIV-positive Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Anorexia | 1 Participants |
| PET-positive: BEACOPP Escalated After 2 Cycles of ABVD | Number of HIV-positive Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Dizziness | 1 Participants |
| PET-positive: BEACOPP Escalated After 2 Cycles of ABVD | Number of HIV-positive Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Fatigue (asthenia, lethargy, malaise) | 1 Participants |
| PET-positive: BEACOPP Escalated After 2 Cycles of ABVD | Number of HIV-positive Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Febrile neutropenia | 3 Participants |
| PET-positive: BEACOPP Escalated After 2 Cycles of ABVD | Number of HIV-positive Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Hemoglobin | 3 Participants |
| PET-positive: BEACOPP Escalated After 2 Cycles of ABVD | Number of HIV-positive Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Inf (clin/microbio) w/Gr 3-4 neuts - Eye NOS | 0 Participants |
| PET-positive: BEACOPP Escalated After 2 Cycles of ABVD | Number of HIV-positive Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Inf (clin/microbio) w/Gr 3-4 neuts - Lung | 1 Participants |
| PET-positive: BEACOPP Escalated After 2 Cycles of ABVD | Number of HIV-positive Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Infection with unknown ANC - Urinary tract NOS | 0 Participants |
| PET-positive: BEACOPP Escalated After 2 Cycles of ABVD | Number of HIV-positive Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Insomnia | 0 Participants |
| PET-positive: BEACOPP Escalated After 2 Cycles of ABVD | Number of HIV-positive Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Leukocytes (total WBC) | 6 Participants |
| PET-positive: BEACOPP Escalated After 2 Cycles of ABVD | Number of HIV-positive Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Lymphopenia | 2 Participants |
| PET-positive: BEACOPP Escalated After 2 Cycles of ABVD | Number of HIV-positive Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Mood alteration - agitation | 0 Participants |
| PET-positive: BEACOPP Escalated After 2 Cycles of ABVD | Number of HIV-positive Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Mood alteration - anxiety | 0 Participants |
| PET-positive: BEACOPP Escalated After 2 Cycles of ABVD | Number of HIV-positive Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Muscle weakness, not d/t neuropathy - body/general | 0 Participants |
| PET-positive: BEACOPP Escalated After 2 Cycles of ABVD | Number of HIV-positive Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Neuropathy: motor | 1 Participants |
| PET-positive: BEACOPP Escalated After 2 Cycles of ABVD | Number of HIV-positive Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Neuropathy: sensory | 1 Participants |
| PET-positive: BEACOPP Escalated After 2 Cycles of ABVD | Number of HIV-positive Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Neutrophils/granulocytes (ANC/AGC) | 7 Participants |
| PET-positive: BEACOPP Escalated After 2 Cycles of ABVD | Number of HIV-positive Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Pain - Bone | 0 Participants |
| PET-positive: BEACOPP Escalated After 2 Cycles of ABVD | Number of HIV-positive Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Pain - Joint | 1 Participants |
| PET-positive: BEACOPP Escalated After 2 Cycles of ABVD | Number of HIV-positive Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Thrombosis/thrombus/embolism | 1 Participants |
| PET-positive: BEACOPP Escalated After 2 Cycles of ABVD | Number of HIV-positive Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Platelets | 1 Participants |
| PET-positive: BEACOPP Escalated After 2 Cycles of ABVD | Number of HIV-positive Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Sodium, serum-low (hyponatremia) | 0 Participants |
| HIV-negative and PET-positive: BEACOPP Escalated | Number of HIV-positive Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Neuropathy: motor | 0 Participants |
| HIV-negative and PET-positive: BEACOPP Escalated | Number of HIV-positive Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Inf (clin/microbio) w/Gr 3-4 neuts - Lung | 0 Participants |
| HIV-negative and PET-positive: BEACOPP Escalated | Number of HIV-positive Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Dizziness | 0 Participants |
| HIV-negative and PET-positive: BEACOPP Escalated | Number of HIV-positive Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Neuropathy: sensory | 0 Participants |
| HIV-negative and PET-positive: BEACOPP Escalated | Number of HIV-positive Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Inf (clin/microbio) w/Gr 3-4 neuts - Eye NOS | 0 Participants |
| HIV-negative and PET-positive: BEACOPP Escalated | Number of HIV-positive Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Pain - Bone | 0 Participants |
| HIV-negative and PET-positive: BEACOPP Escalated | Number of HIV-positive Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Sodium, serum-low (hyponatremia) | 0 Participants |
| HIV-negative and PET-positive: BEACOPP Escalated | Number of HIV-positive Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Neutrophils/granulocytes (ANC/AGC) | 1 Participants |
| HIV-negative and PET-positive: BEACOPP Escalated | Number of HIV-positive Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Hemoglobin | 1 Participants |
| HIV-negative and PET-positive: BEACOPP Escalated | Number of HIV-positive Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Platelets | 0 Participants |
| HIV-negative and PET-positive: BEACOPP Escalated | Number of HIV-positive Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Febrile neutropenia | 0 Participants |
| HIV-negative and PET-positive: BEACOPP Escalated | Number of HIV-positive Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Anorexia | 0 Participants |
| HIV-negative and PET-positive: BEACOPP Escalated | Number of HIV-positive Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Lymphopenia | 1 Participants |
| HIV-negative and PET-positive: BEACOPP Escalated | Number of HIV-positive Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Pain - Joint | 0 Participants |
| HIV-negative and PET-positive: BEACOPP Escalated | Number of HIV-positive Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Mood alteration - agitation | 0 Participants |
| HIV-negative and PET-positive: BEACOPP Escalated | Number of HIV-positive Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Leukocytes (total WBC) | 1 Participants |
| HIV-negative and PET-positive: BEACOPP Escalated | Number of HIV-positive Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Fatigue (asthenia, lethargy, malaise) | 0 Participants |
| HIV-negative and PET-positive: BEACOPP Escalated | Number of HIV-positive Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Mood alteration - anxiety | 0 Participants |
| HIV-negative and PET-positive: BEACOPP Escalated | Number of HIV-positive Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Insomnia | 0 Participants |
| HIV-negative and PET-positive: BEACOPP Escalated | Number of HIV-positive Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Thrombosis/thrombus/embolism | 0 Participants |
| HIV-negative and PET-positive: BEACOPP Escalated | Number of HIV-positive Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Muscle weakness, not d/t neuropathy - body/general | 0 Participants |
| HIV-negative and PET-positive: BEACOPP Escalated | Number of HIV-positive Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Infection with unknown ANC - Urinary tract NOS | 1 Participants |
| HIV-negative and PET-positive: BEACOPP Escalated | Number of HIV-positive Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Phosphate, serum-low (hypophosphatemia) | 0 Participants |
Secondary
Percentage of HIV-negative Patients With 2-year Overall Survival (OS) Treated With 2 Initial Cycles of ABVD Followed by Response-Adapted Therapy Based on Interim FDG-PET Imaging
Measured from date of registration to date of death due to any cause. Patients last known to be alive and are censored at date of last contact.
Time frame: 2 years
Population: Eligible and evaluable HIV-negative patients who started initial ABVD were included in the analysis regardless the response-adapted therapy after 2 initial cycles of ABVD was administered.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| HIV-negative: 2 Cycles of ABVD Followed by PET-directed Therap | Percentage of HIV-negative Patients With 2-year Overall Survival (OS) Treated With 2 Initial Cycles of ABVD Followed by Response-Adapted Therapy Based on Interim FDG-PET Imaging | 98 percentage of participants |
Secondary
Percentage of HIV-positive Patients With 2-year Progression-free Survival (PFS) Treated With Initial 2 Cycles of Adriamycin, Bleomycin, Vnblastine, and Dacarbazine (ABVD) Followed by Response-adapted Therapy Based on Interim FDG-PET Imaging.
Disease progression is defined using the 2007 revised Cheson et al. criteria that is at least 50% increase in sum of the product of the diameters (SPD) of target measurable nodal lesions over the smallest sum observed, or \>= 50% increase in greatest transverse diameter (GTD) of any nodal \> 1 cm in shortest axis, or \>= 50% increase in the SPD of other target measurable lesions over the smallest sum observed, any new bone marrow involvement, any new lesion, lymph node with long axis is \>1.5 cm or if both long and short axes are \> 1 cm, PET positive if patients with no pretreatment PET scan or when PET scan was positive before therapy. progression-free survival is measured from date of registration to date of first observation of progressive disease, or death due to any cause. Patients last known to be alive and progression-free are censored at date of last contact.
Time frame: 2 years
Population: Eligible and evaluable HIV-positive patients who started the initial ABVD were included in the analysis regardless the response-adapted therapy after 2 initial cycles of ABVD was administered.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| HIV-negative: 2 Cycles of ABVD Followed by PET-directed Therap | Percentage of HIV-positive Patients With 2-year Progression-free Survival (PFS) Treated With Initial 2 Cycles of Adriamycin, Bleomycin, Vnblastine, and Dacarbazine (ABVD) Followed by Response-adapted Therapy Based on Interim FDG-PET Imaging. | 83 percentage of patients |
Secondary
Percentage of HIV-positive Patients With 5-year Overall Survival (OS) Treated With 2 Initial Cycles of ABVD Followed by Response-Adapted Therapy Based on Interim FDG-PET Imaging.
Measured from date of registration to date of death due to any cause. Patients last known to be alive and are censored at date of last contact.
Time frame: 5 years
Population: Eligible and evaluable HIV-positive patients who started initial ABVD were included in the analysis regardless the response-adapted therapy after 2 initial cycles of ABVD was administered.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| HIV-negative: 2 Cycles of ABVD Followed by PET-directed Therap | Percentage of HIV-positive Patients With 5-year Overall Survival (OS) Treated With 2 Initial Cycles of ABVD Followed by Response-Adapted Therapy Based on Interim FDG-PET Imaging. | 89 percentage of participants |