Trial Outcomes & Findings for Immunotherapy (Nivolumab or Brentuximab Vedotin) Plus Combination Chemotherapy in Treating Patients With Newly Diagnosed Stage III-IV Classic Hodgkin Lymphoma (NCT NCT03907488)
NCT ID: NCT03907488
Last Updated: 2025-11-12
Results Overview
Will be reported as the number of participants who have experienced death or progression, measured at two years. Progression will be measured according to the 2014 Lugano classification. Will test the null hypothesis (HR=1) for PFS using stratified log-rank test with a one-sided alpha of 0.021. The analysis will be based on modified intent-to-treat and will include all eligible patients as randomized regardless of treatment received. The one-sided alpha of .021 will control of the overall type-one error of the study (including the 2 interim superiority analyses) to be less than .025.
Recruitment status
ACTIVE_NOT_RECRUITING
Study phase
PHASE3
Target enrollment
994 participants
Primary outcome timeframe
From date of registration to date of first observation of progressive disease, or death due to any cause, assessed at 2 years
Results posted on
2025-11-12
Participant Flow
Participant milestones
| Measure |
Arm I (Chemotherapy, Nivolumab, Radiation)
Patients receive doxorubicin hydrochloride IV, vinblastine sulfate IV, dacarbazine IV, and nivolumab IV over 30 minutes on days 1 and 15. Patients may receive pegfilgrastim SC on days 2 and 16, or filgrastim SC or IV on days 6-10 and 21-25. Treatment repeats every 28 days for 6 cycles in the absence of disease progression or unacceptable toxicity. After completion of cycle 6, patients may receive radiation therapy 5 days per week for approximately 4 weeks at the discretion of the treating physician. Patients also undergo peripheral blood specimen collection and CT, PET/CT and MRI on study.
Biospecimen Collection: Undergo peripheral blood collection
Computed Tomography: Undergo PET/CT or CT scan
Dacarbazine: Given IV
Doxorubicin Hydrochloride: Given IV
Filgrastim: Given SC or IV
Magnetic Resonance Imaging: Undergo MRI
Nivolumab: Given IV
Pegfilgrastim: Given SC
Positron Emission Tomography: Undergo PET/CT scan
Quality-of-Life Assessment: Ancillary studies
Questionnaire Administration: Ancillary studies
Radiation Therapy: Receive radiation therapy
Vinblastine Sulfate: Given IV
|
Arm II (Chemotherapy, Brentuximab Vedotin, Radiation)
Patients receive doxorubicin hydrochloride IV, vinblastine sulfate IV, dacarbazine IV, and brentuximab vedotin IV over 30 minutes on days 1 and 15. Patients may receive pegfilgrastim SC on days 2 and 16, or filgrastim SC or IV on days 6-10 and 21-25. Treatment repeats every 28 days for 6 cycles in the absence of disease progression or unacceptable toxicity. After completion of cycle 6, patients may receive radiation therapy 5 days per week for approximately 4 weeks at the discretion of the treating physician. Patients also undergo peripheral blood specimen collection and CT, PET/CT and MRI on study.
Biospecimen Collection: Undergo peripheral blood collection
Brentuximab Vedotin: Given IV
Computed Tomography: Undergo PET/CT or CT scan
Dacarbazine: Given IV
Doxorubicin Hydrochloride: Given IV
Filgrastim: Given SC or IV
Magnetic Resonance Imaging: Undergo MRI
Pegfilgrastim: Given SC
Positron Emission Tomography: Undergo PET/CT scan
Quality-of-Life Assessment: Ancillary studies
Questionnaire Administration: Ancillary studies
Radiation Therapy: Receive radiation therapy
Vinblastine Sulfate: Given IV
|
|---|---|---|
|
Overall Study
STARTED
|
496
|
498
|
|
Overall Study
COMPLETED
|
450
|
425
|
|
Overall Study
NOT COMPLETED
|
46
|
73
|
Reasons for withdrawal
| Measure |
Arm I (Chemotherapy, Nivolumab, Radiation)
Patients receive doxorubicin hydrochloride IV, vinblastine sulfate IV, dacarbazine IV, and nivolumab IV over 30 minutes on days 1 and 15. Patients may receive pegfilgrastim SC on days 2 and 16, or filgrastim SC or IV on days 6-10 and 21-25. Treatment repeats every 28 days for 6 cycles in the absence of disease progression or unacceptable toxicity. After completion of cycle 6, patients may receive radiation therapy 5 days per week for approximately 4 weeks at the discretion of the treating physician. Patients also undergo peripheral blood specimen collection and CT, PET/CT and MRI on study.
Biospecimen Collection: Undergo peripheral blood collection
Computed Tomography: Undergo PET/CT or CT scan
Dacarbazine: Given IV
Doxorubicin Hydrochloride: Given IV
Filgrastim: Given SC or IV
Magnetic Resonance Imaging: Undergo MRI
Nivolumab: Given IV
Pegfilgrastim: Given SC
Positron Emission Tomography: Undergo PET/CT scan
Quality-of-Life Assessment: Ancillary studies
Questionnaire Administration: Ancillary studies
Radiation Therapy: Receive radiation therapy
Vinblastine Sulfate: Given IV
|
Arm II (Chemotherapy, Brentuximab Vedotin, Radiation)
Patients receive doxorubicin hydrochloride IV, vinblastine sulfate IV, dacarbazine IV, and brentuximab vedotin IV over 30 minutes on days 1 and 15. Patients may receive pegfilgrastim SC on days 2 and 16, or filgrastim SC or IV on days 6-10 and 21-25. Treatment repeats every 28 days for 6 cycles in the absence of disease progression or unacceptable toxicity. After completion of cycle 6, patients may receive radiation therapy 5 days per week for approximately 4 weeks at the discretion of the treating physician. Patients also undergo peripheral blood specimen collection and CT, PET/CT and MRI on study.
Biospecimen Collection: Undergo peripheral blood collection
Brentuximab Vedotin: Given IV
Computed Tomography: Undergo PET/CT or CT scan
Dacarbazine: Given IV
Doxorubicin Hydrochloride: Given IV
Filgrastim: Given SC or IV
Magnetic Resonance Imaging: Undergo MRI
Pegfilgrastim: Given SC
Positron Emission Tomography: Undergo PET/CT scan
Quality-of-Life Assessment: Ancillary studies
Questionnaire Administration: Ancillary studies
Radiation Therapy: Receive radiation therapy
Vinblastine Sulfate: Given IV
|
|---|---|---|
|
Overall Study
Adverse Event
|
20
|
20
|
|
Overall Study
Withdrawal by Subject
|
9
|
13
|
|
Overall Study
Lack of Efficacy
|
0
|
9
|
|
Overall Study
Death
|
3
|
8
|
|
Overall Study
not protocol specified
|
5
|
8
|
|
Overall Study
Ineligible
|
9
|
15
|
Baseline Characteristics
Immunotherapy (Nivolumab or Brentuximab Vedotin) Plus Combination Chemotherapy in Treating Patients With Newly Diagnosed Stage III-IV Classic Hodgkin Lymphoma
Baseline characteristics by cohort
| Measure |
Arm I (Chemotherapy, Nivolumab, Radiation)
n=487 Participants
Patients receive doxorubicin hydrochloride IV, vinblastine sulfate IV, dacarbazine IV, and nivolumab IV over 30 minutes on days 1 and 15. Patients may receive pegfilgrastim SC on days 2 and 16, or filgrastim SC or IV on days 6-10 and 21-25. Treatment repeats every 28 days for 6 cycles in the absence of disease progression or unacceptable toxicity. After completion of cycle 6, patients may receive radiation therapy 5 days per week for approximately 4 weeks at the discretion of the treating physician. Patients also undergo peripheral blood specimen collection and CT, PET/CT and MRI on study.
Biospecimen Collection: Undergo peripheral blood collection
Computed Tomography: Undergo PET/CT or CT scan
Dacarbazine: Given IV
Doxorubicin Hydrochloride: Given IV
Filgrastim: Given SC or IV
Magnetic Resonance Imaging: Undergo MRI
Nivolumab: Given IV
Pegfilgrastim: Given SC
Positron Emission Tomography: Undergo PET/CT scan
Quality-of-Life Assessment: Ancillary studies
Questionnaire Administration: Ancillary studies
Radiation Therapy: Receive radiation therapy
Vinblastine Sulfate: Given IV
|
Arm II (Chemotherapy, Brentuximab Vedotin, Radiation)
n=483 Participants
Patients receive doxorubicin hydrochloride IV, vinblastine sulfate IV, dacarbazine IV, and brentuximab vedotin IV over 30 minutes on days 1 and 15. Patients may receive pegfilgrastim SC on days 2 and 16, or filgrastim SC or IV on days 6-10 and 21-25. Treatment repeats every 28 days for 6 cycles in the absence of disease progression or unacceptable toxicity. After completion of cycle 6, patients may receive radiation therapy 5 days per week for approximately 4 weeks at the discretion of the treating physician. Patients also undergo peripheral blood specimen collection and CT, PET/CT and MRI on study.
Biospecimen Collection: Undergo peripheral blood collection
Brentuximab Vedotin: Given IV
Computed Tomography: Undergo PET/CT or CT scan
Dacarbazine: Given IV
Doxorubicin Hydrochloride: Given IV
Filgrastim: Given SC or IV
Magnetic Resonance Imaging: Undergo MRI
Pegfilgrastim: Given SC
Positron Emission Tomography: Undergo PET/CT scan
Quality-of-Life Assessment: Ancillary studies
Questionnaire Administration: Ancillary studies
Radiation Therapy: Receive radiation therapy
Vinblastine Sulfate: Given IV
|
Total
n=970 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
27.6 years
n=10 Participants
|
26.8 years
n=10 Participants
|
27 years
n=20 Participants
|
|
Age, Customized
Age, Stratified · 12-17
|
118 Participants
n=10 Participants
|
118 Participants
n=10 Participants
|
236 Participants
n=20 Participants
|
|
Age, Customized
Age, Stratified · 18-60
|
321 Participants
n=10 Participants
|
318 Participants
n=10 Participants
|
639 Participants
n=20 Participants
|
|
Age, Customized
Age, Stratified · >60
|
48 Participants
n=10 Participants
|
47 Participants
n=10 Participants
|
95 Participants
n=20 Participants
|
|
Sex: Female, Male
Female
|
216 Participants
n=10 Participants
|
210 Participants
n=10 Participants
|
426 Participants
n=20 Participants
|
|
Sex: Female, Male
Male
|
271 Participants
n=10 Participants
|
273 Participants
n=10 Participants
|
544 Participants
n=20 Participants
|
|
Race/Ethnicity, Customized
White
|
372 Participants
n=10 Participants
|
361 Participants
n=10 Participants
|
733 Participants
n=20 Participants
|
|
Race/Ethnicity, Customized
Black
|
58 Participants
n=10 Participants
|
56 Participants
n=10 Participants
|
114 Participants
n=20 Participants
|
|
Race/Ethnicity, Customized
Asian
|
11 Participants
n=10 Participants
|
17 Participants
n=10 Participants
|
28 Participants
n=20 Participants
|
|
Race/Ethnicity, Customized
Other or unknown
|
46 Participants
n=10 Participants
|
49 Participants
n=10 Participants
|
95 Participants
n=20 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
66 Participants
n=10 Participants
|
58 Participants
n=10 Participants
|
124 Participants
n=20 Participants
|
PRIMARY outcome
Timeframe: From date of registration to date of first observation of progressive disease, or death due to any cause, assessed at 2 yearsPopulation: All the patients who underwent randomization except for those who were deemed to be ineligible by pathology review or owing to violation of the eligibility criteria.
Will be reported as the number of participants who have experienced death or progression, measured at two years. Progression will be measured according to the 2014 Lugano classification. Will test the null hypothesis (HR=1) for PFS using stratified log-rank test with a one-sided alpha of 0.021. The analysis will be based on modified intent-to-treat and will include all eligible patients as randomized regardless of treatment received. The one-sided alpha of .021 will control of the overall type-one error of the study (including the 2 interim superiority analyses) to be less than .025.
Outcome measures
| Measure |
Arm I (Chemotherapy, Nivolumab, Radiation)
n=487 Participants
Patients receive doxorubicin hydrochloride IV, vinblastine sulfate IV, dacarbazine IV, and nivolumab IV over 30 minutes on days 1 and 15. Patients may receive pegfilgrastim SC on days 2 and 16, or filgrastim SC or IV on days 6-10 and 21-25. Treatment repeats every 28 days for 6 cycles in the absence of disease progression or unacceptable toxicity. After completion of cycle 6, patients may receive radiation therapy 5 days per week for approximately 4 weeks at the discretion of the treating physician. Patients also undergo peripheral blood specimen collection and CT, PET/CT and MRI on study.
Biospecimen Collection: Undergo peripheral blood collection
Computed Tomography: Undergo PET/CT or CT scan
Dacarbazine: Given IV
Doxorubicin Hydrochloride: Given IV
Filgrastim: Given SC or IV
Magnetic Resonance Imaging: Undergo MRI
Nivolumab: Given IV
Pegfilgrastim: Given SC
Positron Emission Tomography: Undergo PET/CT scan
Quality-of-Life Assessment: Ancillary studies
Questionnaire Administration: Ancillary studies
Radiation Therapy: Receive radiation therapy
Vinblastine Sulfate: Given IV
|
Arm II (Chemotherapy, Brentuximab Vedotin, Radiation)
n=483 Participants
Patients receive doxorubicin hydrochloride IV, vinblastine sulfate IV, dacarbazine IV, and brentuximab vedotin IV over 30 minutes on days 1 and 15. Patients may receive pegfilgrastim SC on days 2 and 16, or filgrastim SC or IV on days 6-10 and 21-25. Treatment repeats every 28 days for 6 cycles in the absence of disease progression or unacceptable toxicity. After completion of cycle 6, patients may receive radiation therapy 5 days per week for approximately 4 weeks at the discretion of the treating physician. Patients also undergo peripheral blood specimen collection and CT, PET/CT and MRI on study.
Biospecimen Collection: Undergo peripheral blood collection
Brentuximab Vedotin: Given IV
Computed Tomography: Undergo PET/CT or CT scan
Dacarbazine: Given IV
Doxorubicin Hydrochloride: Given IV
Filgrastim: Given SC or IV
Magnetic Resonance Imaging: Undergo MRI
Pegfilgrastim: Given SC
Positron Emission Tomography: Undergo PET/CT scan
Quality-of-Life Assessment: Ancillary studies
Questionnaire Administration: Ancillary studies
Radiation Therapy: Receive radiation therapy
Vinblastine Sulfate: Given IV
|
|---|---|---|
|
Progression Free Survival (PFS)
|
41 Participants
|
81 Participants
|
SECONDARY outcome
Timeframe: From date of registration to two years or death.Population: All the patients who underwent randomization except for those who were deemed to be ineligible by pathology review or owing to violation of the eligibility criteria.
Will be reported as the count of participants who have died, measured at two years. Stratified log-rank test at two-sided alpha level of .05.
Outcome measures
| Measure |
Arm I (Chemotherapy, Nivolumab, Radiation)
n=487 Participants
Patients receive doxorubicin hydrochloride IV, vinblastine sulfate IV, dacarbazine IV, and nivolumab IV over 30 minutes on days 1 and 15. Patients may receive pegfilgrastim SC on days 2 and 16, or filgrastim SC or IV on days 6-10 and 21-25. Treatment repeats every 28 days for 6 cycles in the absence of disease progression or unacceptable toxicity. After completion of cycle 6, patients may receive radiation therapy 5 days per week for approximately 4 weeks at the discretion of the treating physician. Patients also undergo peripheral blood specimen collection and CT, PET/CT and MRI on study.
Biospecimen Collection: Undergo peripheral blood collection
Computed Tomography: Undergo PET/CT or CT scan
Dacarbazine: Given IV
Doxorubicin Hydrochloride: Given IV
Filgrastim: Given SC or IV
Magnetic Resonance Imaging: Undergo MRI
Nivolumab: Given IV
Pegfilgrastim: Given SC
Positron Emission Tomography: Undergo PET/CT scan
Quality-of-Life Assessment: Ancillary studies
Questionnaire Administration: Ancillary studies
Radiation Therapy: Receive radiation therapy
Vinblastine Sulfate: Given IV
|
Arm II (Chemotherapy, Brentuximab Vedotin, Radiation)
n=483 Participants
Patients receive doxorubicin hydrochloride IV, vinblastine sulfate IV, dacarbazine IV, and brentuximab vedotin IV over 30 minutes on days 1 and 15. Patients may receive pegfilgrastim SC on days 2 and 16, or filgrastim SC or IV on days 6-10 and 21-25. Treatment repeats every 28 days for 6 cycles in the absence of disease progression or unacceptable toxicity. After completion of cycle 6, patients may receive radiation therapy 5 days per week for approximately 4 weeks at the discretion of the treating physician. Patients also undergo peripheral blood specimen collection and CT, PET/CT and MRI on study.
Biospecimen Collection: Undergo peripheral blood collection
Brentuximab Vedotin: Given IV
Computed Tomography: Undergo PET/CT or CT scan
Dacarbazine: Given IV
Doxorubicin Hydrochloride: Given IV
Filgrastim: Given SC or IV
Magnetic Resonance Imaging: Undergo MRI
Pegfilgrastim: Given SC
Positron Emission Tomography: Undergo PET/CT scan
Quality-of-Life Assessment: Ancillary studies
Questionnaire Administration: Ancillary studies
Radiation Therapy: Receive radiation therapy
Vinblastine Sulfate: Given IV
|
|---|---|---|
|
Overall Survival
|
7 Participants
|
14 Participants
|
SECONDARY outcome
Timeframe: From date of registration to date of first occurrence of EFS event, assessed at 2 yearsPopulation: All the patients who underwent randomization except for those who were deemed to be ineligible by pathology review or owing to violation of the eligibility criteria.
Will be reported as count of participants who have experienced an EFS event or death at two years. EFS Events are defined as: * Disease progression/relapse * Administration of non-protocol specified systemic anti-lymphoma therapy (i.e. salvage therapy) at any time after initiation of protocol therapy. * Administration of any non-protocol specified radiation therapy at any time afterinitiation of protocol therapy Will be estimated using Kaplan-Meier method and compared between treatment arms using cox regression model.
Outcome measures
| Measure |
Arm I (Chemotherapy, Nivolumab, Radiation)
n=487 Participants
Patients receive doxorubicin hydrochloride IV, vinblastine sulfate IV, dacarbazine IV, and nivolumab IV over 30 minutes on days 1 and 15. Patients may receive pegfilgrastim SC on days 2 and 16, or filgrastim SC or IV on days 6-10 and 21-25. Treatment repeats every 28 days for 6 cycles in the absence of disease progression or unacceptable toxicity. After completion of cycle 6, patients may receive radiation therapy 5 days per week for approximately 4 weeks at the discretion of the treating physician. Patients also undergo peripheral blood specimen collection and CT, PET/CT and MRI on study.
Biospecimen Collection: Undergo peripheral blood collection
Computed Tomography: Undergo PET/CT or CT scan
Dacarbazine: Given IV
Doxorubicin Hydrochloride: Given IV
Filgrastim: Given SC or IV
Magnetic Resonance Imaging: Undergo MRI
Nivolumab: Given IV
Pegfilgrastim: Given SC
Positron Emission Tomography: Undergo PET/CT scan
Quality-of-Life Assessment: Ancillary studies
Questionnaire Administration: Ancillary studies
Radiation Therapy: Receive radiation therapy
Vinblastine Sulfate: Given IV
|
Arm II (Chemotherapy, Brentuximab Vedotin, Radiation)
n=483 Participants
Patients receive doxorubicin hydrochloride IV, vinblastine sulfate IV, dacarbazine IV, and brentuximab vedotin IV over 30 minutes on days 1 and 15. Patients may receive pegfilgrastim SC on days 2 and 16, or filgrastim SC or IV on days 6-10 and 21-25. Treatment repeats every 28 days for 6 cycles in the absence of disease progression or unacceptable toxicity. After completion of cycle 6, patients may receive radiation therapy 5 days per week for approximately 4 weeks at the discretion of the treating physician. Patients also undergo peripheral blood specimen collection and CT, PET/CT and MRI on study.
Biospecimen Collection: Undergo peripheral blood collection
Brentuximab Vedotin: Given IV
Computed Tomography: Undergo PET/CT or CT scan
Dacarbazine: Given IV
Doxorubicin Hydrochloride: Given IV
Filgrastim: Given SC or IV
Magnetic Resonance Imaging: Undergo MRI
Pegfilgrastim: Given SC
Positron Emission Tomography: Undergo PET/CT scan
Quality-of-Life Assessment: Ancillary studies
Questionnaire Administration: Ancillary studies
Radiation Therapy: Receive radiation therapy
Vinblastine Sulfate: Given IV
|
|---|---|---|
|
Event-free Survival (EFS)
|
52 Participants
|
91 Participants
|
SECONDARY outcome
Timeframe: Up to 2 yearsOnly adverse events that are possibly, probably or definitely related to study drug are reported.
Outcome measures
| Measure |
Arm I (Chemotherapy, Nivolumab, Radiation)
n=481 Participants
Patients receive doxorubicin hydrochloride IV, vinblastine sulfate IV, dacarbazine IV, and nivolumab IV over 30 minutes on days 1 and 15. Patients may receive pegfilgrastim SC on days 2 and 16, or filgrastim SC or IV on days 6-10 and 21-25. Treatment repeats every 28 days for 6 cycles in the absence of disease progression or unacceptable toxicity. After completion of cycle 6, patients may receive radiation therapy 5 days per week for approximately 4 weeks at the discretion of the treating physician. Patients also undergo peripheral blood specimen collection and CT, PET/CT and MRI on study.
Biospecimen Collection: Undergo peripheral blood collection
Computed Tomography: Undergo PET/CT or CT scan
Dacarbazine: Given IV
Doxorubicin Hydrochloride: Given IV
Filgrastim: Given SC or IV
Magnetic Resonance Imaging: Undergo MRI
Nivolumab: Given IV
Pegfilgrastim: Given SC
Positron Emission Tomography: Undergo PET/CT scan
Quality-of-Life Assessment: Ancillary studies
Questionnaire Administration: Ancillary studies
Radiation Therapy: Receive radiation therapy
Vinblastine Sulfate: Given IV
|
Arm II (Chemotherapy, Brentuximab Vedotin, Radiation)
n=476 Participants
Patients receive doxorubicin hydrochloride IV, vinblastine sulfate IV, dacarbazine IV, and brentuximab vedotin IV over 30 minutes on days 1 and 15. Patients may receive pegfilgrastim SC on days 2 and 16, or filgrastim SC or IV on days 6-10 and 21-25. Treatment repeats every 28 days for 6 cycles in the absence of disease progression or unacceptable toxicity. After completion of cycle 6, patients may receive radiation therapy 5 days per week for approximately 4 weeks at the discretion of the treating physician. Patients also undergo peripheral blood specimen collection and CT, PET/CT and MRI on study.
Biospecimen Collection: Undergo peripheral blood collection
Brentuximab Vedotin: Given IV
Computed Tomography: Undergo PET/CT or CT scan
Dacarbazine: Given IV
Doxorubicin Hydrochloride: Given IV
Filgrastim: Given SC or IV
Magnetic Resonance Imaging: Undergo MRI
Pegfilgrastim: Given SC
Positron Emission Tomography: Undergo PET/CT scan
Quality-of-Life Assessment: Ancillary studies
Questionnaire Administration: Ancillary studies
Radiation Therapy: Receive radiation therapy
Vinblastine Sulfate: Given IV
|
|---|---|---|
|
Number of Participants With of Adverse Events
Allergic rhinitis
|
0 Participants
|
3 Participants
|
|
Number of Participants With of Adverse Events
Alopecia
|
103 Participants
|
127 Participants
|
|
Number of Participants With of Adverse Events
Amenorrhea
|
1 Participants
|
5 Participants
|
|
Number of Participants With of Adverse Events
Amnesia
|
1 Participants
|
0 Participants
|
|
Number of Participants With of Adverse Events
Anal fissure
|
0 Participants
|
1 Participants
|
|
Number of Participants With of Adverse Events
Anal fistula
|
0 Participants
|
1 Participants
|
|
Number of Participants With of Adverse Events
Anal hemorrhage
|
1 Participants
|
1 Participants
|
|
Number of Participants With of Adverse Events
Anemia
|
198 Participants
|
222 Participants
|
|
Number of Participants With of Adverse Events
Anorectal infection
|
1 Participants
|
0 Participants
|
|
Number of Participants With of Adverse Events
Anorexia
|
61 Participants
|
107 Participants
|
|
Number of Participants With of Adverse Events
Anosmia
|
3 Participants
|
1 Participants
|
|
Number of Participants With of Adverse Events
Anxiety
|
20 Participants
|
30 Participants
|
|
Number of Participants With of Adverse Events
Appendicitis
|
1 Participants
|
0 Participants
|
|
Number of Participants With of Adverse Events
Arthralgia
|
65 Participants
|
60 Participants
|
|
Number of Participants With of Adverse Events
Arthritis
|
3 Participants
|
0 Participants
|
|
Number of Participants With of Adverse Events
Ascites
|
1 Participants
|
0 Participants
|
|
Number of Participants With of Adverse Events
Aspartate aminotransferase increased
|
129 Participants
|
168 Participants
|
|
Number of Participants With of Adverse Events
Ataxia
|
0 Participants
|
3 Participants
|
|
Number of Participants With of Adverse Events
Atelectasis
|
1 Participants
|
1 Participants
|
|
Number of Participants With of Adverse Events
Atrial fibrillation
|
1 Participants
|
1 Participants
|
|
Number of Participants With of Adverse Events
Autoimmune disorder
|
1 Participants
|
0 Participants
|
|
Number of Participants With of Adverse Events
Back pain
|
27 Participants
|
35 Participants
|
|
Number of Participants With of Adverse Events
Bacteremia
|
0 Participants
|
2 Participants
|
|
Number of Participants With of Adverse Events
Belching
|
3 Participants
|
1 Participants
|
|
Number of Participants With of Adverse Events
Bladder infection
|
1 Participants
|
1 Participants
|
|
Number of Participants With of Adverse Events
Bloating
|
7 Participants
|
18 Participants
|
|
Number of Participants With of Adverse Events
Blood and lymphatic system disorders - Other, spec
|
3 Participants
|
5 Participants
|
|
Number of Participants With of Adverse Events
Blood bicarbonate decreased
|
3 Participants
|
5 Participants
|
|
Number of Participants With of Adverse Events
Blood bilirubin increased
|
14 Participants
|
14 Participants
|
|
Number of Participants With of Adverse Events
Blood lactate dehydrogenase increased
|
18 Participants
|
25 Participants
|
|
Number of Participants With of Adverse Events
Blurred vision
|
11 Participants
|
15 Participants
|
|
Number of Participants With of Adverse Events
Bone pain
|
41 Participants
|
99 Participants
|
|
Number of Participants With of Adverse Events
Brachial plexopathy
|
0 Participants
|
1 Participants
|
|
Number of Participants With of Adverse Events
Breast pain
|
0 Participants
|
1 Participants
|
|
Number of Participants With of Adverse Events
Bronchial infection
|
2 Participants
|
0 Participants
|
|
Number of Participants With of Adverse Events
Bronchospasm
|
1 Participants
|
0 Participants
|
|
Number of Participants With of Adverse Events
Bruising
|
2 Participants
|
8 Participants
|
|
Number of Participants With of Adverse Events
Bullous dermatitis
|
0 Participants
|
1 Participants
|
|
Number of Participants With of Adverse Events
Burn
|
0 Participants
|
1 Participants
|
|
Number of Participants With of Adverse Events
Buttock pain
|
1 Participants
|
0 Participants
|
|
Number of Participants With of Adverse Events
CD4 lymphocytes decreased
|
0 Participants
|
1 Participants
|
|
Number of Participants With of Adverse Events
CPK increased
|
1 Participants
|
1 Participants
|
|
Number of Participants With of Adverse Events
Cardiac arrest
|
0 Participants
|
2 Participants
|
|
Number of Participants With of Adverse Events
Cardiac troponin I increased
|
1 Participants
|
0 Participants
|
|
Number of Participants With of Adverse Events
Cardiac troponin T increased
|
1 Participants
|
0 Participants
|
|
Number of Participants With of Adverse Events
Catheter related infection
|
1 Participants
|
3 Participants
|
|
Number of Participants With of Adverse Events
Cheilitis
|
1 Participants
|
0 Participants
|
|
Number of Participants With of Adverse Events
Chest pain - cardiac
|
4 Participants
|
0 Participants
|
|
Number of Participants With of Adverse Events
Chest wall pain
|
2 Participants
|
1 Participants
|
|
Number of Participants With of Adverse Events
Chills
|
22 Participants
|
20 Participants
|
|
Number of Participants With of Adverse Events
Cholesterol high
|
0 Participants
|
1 Participants
|
|
Number of Participants With of Adverse Events
Chronic kidney disease
|
1 Participants
|
0 Participants
|
|
Number of Participants With of Adverse Events
Cognitive disturbance
|
3 Participants
|
0 Participants
|
|
Number of Participants With of Adverse Events
Colitis
|
6 Participants
|
6 Participants
|
|
Number of Participants With of Adverse Events
Colonic obstruction
|
0 Participants
|
1 Participants
|
|
Number of Participants With of Adverse Events
Concentration impairment
|
4 Participants
|
7 Participants
|
|
Number of Participants With of Adverse Events
Confusion
|
3 Participants
|
2 Participants
|
|
Number of Participants With of Adverse Events
Conjunctivitis
|
1 Participants
|
4 Participants
|
|
Number of Participants With of Adverse Events
Conjunctivitis infective
|
0 Participants
|
2 Participants
|
|
Number of Participants With of Adverse Events
Constipation
|
196 Participants
|
209 Participants
|
|
Number of Participants With of Adverse Events
Cyanosis
|
1 Participants
|
0 Participants
|
|
Number of Participants With of Adverse Events
Dehydration
|
14 Participants
|
32 Participants
|
|
Number of Participants With of Adverse Events
Delirium
|
0 Participants
|
1 Participants
|
|
Number of Participants With of Adverse Events
Depressed level of consciousness
|
1 Participants
|
2 Participants
|
|
Number of Participants With of Adverse Events
Depression
|
10 Participants
|
10 Participants
|
|
Number of Participants With of Adverse Events
Dermatitis radiation
|
0 Participants
|
2 Participants
|
|
Number of Participants With of Adverse Events
Diarrhea
|
101 Participants
|
130 Participants
|
|
Number of Participants With of Adverse Events
Disseminated intravascular coagulation
|
1 Participants
|
0 Participants
|
|
Number of Participants With of Adverse Events
Dizziness
|
29 Participants
|
40 Participants
|
|
Number of Participants With of Adverse Events
Dry eye
|
2 Participants
|
3 Participants
|
|
Number of Participants With of Adverse Events
Dry mouth
|
19 Participants
|
32 Participants
|
|
Number of Participants With of Adverse Events
Dry skin
|
15 Participants
|
17 Participants
|
|
Number of Participants With of Adverse Events
Dysarthria
|
1 Participants
|
0 Participants
|
|
Number of Participants With of Adverse Events
Dysesthesia
|
0 Participants
|
3 Participants
|
|
Number of Participants With of Adverse Events
Dysgeusia
|
37 Participants
|
60 Participants
|
|
Number of Participants With of Adverse Events
Dysmenorrhea
|
1 Participants
|
0 Participants
|
|
Number of Participants With of Adverse Events
Dyspepsia
|
34 Participants
|
21 Participants
|
|
Number of Participants With of Adverse Events
Dysphagia
|
8 Participants
|
7 Participants
|
|
Number of Participants With of Adverse Events
Dysphasia
|
0 Participants
|
1 Participants
|
|
Number of Participants With of Adverse Events
Dyspnea
|
43 Participants
|
58 Participants
|
|
Number of Participants With of Adverse Events
Dysuria
|
3 Participants
|
1 Participants
|
|
Number of Participants With of Adverse Events
Ear and labyrinth disorders - Other, specify
|
1 Participants
|
0 Participants
|
|
Number of Participants With of Adverse Events
Ear pain
|
0 Participants
|
1 Participants
|
|
Number of Participants With of Adverse Events
Eczema
|
3 Participants
|
7 Participants
|
|
Number of Participants With of Adverse Events
Edema face
|
1 Participants
|
5 Participants
|
|
Number of Participants With of Adverse Events
Edema limbs
|
17 Participants
|
17 Participants
|
|
Number of Participants With of Adverse Events
Ejection fraction decreased
|
3 Participants
|
3 Participants
|
|
Number of Participants With of Adverse Events
Electrocardiogram QT corrected interval prolonged
|
1 Participants
|
0 Participants
|
|
Number of Participants With of Adverse Events
Electrocardiogram T wave abnormal
|
1 Participants
|
0 Participants
|
|
Number of Participants With of Adverse Events
Endocrine disorders - Other, specify
|
9 Participants
|
0 Participants
|
|
Number of Participants With of Adverse Events
Enterocolitis
|
2 Participants
|
1 Participants
|
|
Number of Participants With of Adverse Events
Enterocolitis infectious
|
1 Participants
|
4 Participants
|
|
Number of Participants With of Adverse Events
Eosinophilia
|
12 Participants
|
16 Participants
|
|
Number of Participants With of Adverse Events
Epistaxis
|
10 Participants
|
16 Participants
|
|
Number of Participants With of Adverse Events
Erectile dysfunction
|
2 Participants
|
0 Participants
|
|
Number of Participants With of Adverse Events
Erythema multiforme
|
1 Participants
|
1 Participants
|
|
Number of Participants With of Adverse Events
Erythroderma
|
1 Participants
|
0 Participants
|
|
Number of Participants With of Adverse Events
Esophageal pain
|
1 Participants
|
0 Participants
|
|
Number of Participants With of Adverse Events
Esophagitis
|
2 Participants
|
3 Participants
|
|
Number of Participants With of Adverse Events
Extrapyramidal disorder
|
1 Participants
|
2 Participants
|
|
Number of Participants With of Adverse Events
Eye disorders - Other, specify
|
3 Participants
|
3 Participants
|
|
Number of Participants With of Adverse Events
Facial muscle weakness
|
1 Participants
|
0 Participants
|
|
Number of Participants With of Adverse Events
Facial pain
|
1 Participants
|
4 Participants
|
|
Number of Participants With of Adverse Events
Fall
|
5 Participants
|
9 Participants
|
|
Number of Participants With of Adverse Events
Fatigue
|
232 Participants
|
246 Participants
|
|
Number of Participants With of Adverse Events
Febrile neutropenia
|
28 Participants
|
33 Participants
|
|
Number of Participants With of Adverse Events
Fecal incontinence
|
0 Participants
|
1 Participants
|
|
Number of Participants With of Adverse Events
Fever
|
64 Participants
|
63 Participants
|
|
Number of Participants With of Adverse Events
Fibrinogen decreased
|
2 Participants
|
0 Participants
|
|
Number of Participants With of Adverse Events
Flank pain
|
1 Participants
|
3 Participants
|
|
Number of Participants With of Adverse Events
Flashing lights
|
1 Participants
|
1 Participants
|
|
Number of Participants With of Adverse Events
Flatulence
|
4 Participants
|
6 Participants
|
|
Number of Participants With of Adverse Events
Floaters
|
0 Participants
|
1 Participants
|
|
Number of Participants With of Adverse Events
Flu like symptoms
|
4 Participants
|
3 Participants
|
|
Number of Participants With of Adverse Events
Flushing
|
10 Participants
|
3 Participants
|
|
Number of Participants With of Adverse Events
Folliculitis
|
2 Participants
|
2 Participants
|
|
Number of Participants With of Adverse Events
Fracture
|
0 Participants
|
1 Participants
|
|
Number of Participants With of Adverse Events
GGT increased
|
4 Participants
|
4 Participants
|
|
Number of Participants With of Adverse Events
Gait disturbance
|
0 Participants
|
2 Participants
|
|
Number of Participants With of Adverse Events
Gastric hemorrhage
|
0 Participants
|
1 Participants
|
|
Number of Participants With of Adverse Events
Gastritis
|
9 Participants
|
8 Participants
|
|
Number of Participants With of Adverse Events
Gastroesophageal reflux disease
|
27 Participants
|
40 Participants
|
|
Number of Participants With of Adverse Events
Gastrointestinal disorders - Other, specify
|
10 Participants
|
14 Participants
|
|
Number of Participants With of Adverse Events
Gastrointestinal pain
|
1 Participants
|
0 Participants
|
|
Number of Participants With of Adverse Events
Gastroparesis
|
0 Participants
|
1 Participants
|
|
Number of Participants With of Adverse Events
General disorders and administration site conditio
|
7 Participants
|
6 Participants
|
|
Number of Participants With of Adverse Events
Generalized edema
|
1 Participants
|
0 Participants
|
|
Number of Participants With of Adverse Events
Glucose intolerance
|
1 Participants
|
0 Participants
|
|
Number of Participants With of Adverse Events
Glucosuria
|
2 Participants
|
2 Participants
|
|
Number of Participants With of Adverse Events
Guillain-Barre syndrome
|
0 Participants
|
1 Participants
|
|
Number of Participants With of Adverse Events
Gynecomastia
|
0 Participants
|
1 Participants
|
|
Number of Participants With of Adverse Events
Headache
|
71 Participants
|
77 Participants
|
|
Number of Participants With of Adverse Events
Heart failure
|
2 Participants
|
1 Participants
|
|
Number of Participants With of Adverse Events
Hematuria
|
4 Participants
|
0 Participants
|
|
Number of Participants With of Adverse Events
Hemolysis
|
1 Participants
|
0 Participants
|
|
Number of Participants With of Adverse Events
Hemorrhoidal hemorrhage
|
1 Participants
|
0 Participants
|
|
Number of Participants With of Adverse Events
Hemorrhoids
|
4 Participants
|
1 Participants
|
|
Number of Participants With of Adverse Events
Hepatic failure
|
2 Participants
|
0 Participants
|
|
Number of Participants With of Adverse Events
Hepatobiliary disorders - Other, specify
|
2 Participants
|
1 Participants
|
|
Number of Participants With of Adverse Events
Herpes simplex reactivation
|
1 Participants
|
3 Participants
|
|
Number of Participants With of Adverse Events
Hiccups
|
6 Participants
|
11 Participants
|
|
Number of Participants With of Adverse Events
Hoarseness
|
0 Participants
|
4 Participants
|
|
Number of Participants With of Adverse Events
Hot flashes
|
9 Participants
|
20 Participants
|
|
Number of Participants With of Adverse Events
Hypercalcemia
|
6 Participants
|
10 Participants
|
|
Number of Participants With of Adverse Events
Hyperglycemia
|
57 Participants
|
67 Participants
|
|
Number of Participants With of Adverse Events
Hyperhidrosis
|
14 Participants
|
16 Participants
|
|
Number of Participants With of Adverse Events
Hyperkalemia
|
5 Participants
|
4 Participants
|
|
Number of Participants With of Adverse Events
Hyperlipidemia
|
0 Participants
|
1 Participants
|
|
Number of Participants With of Adverse Events
Hypermagnesemia
|
4 Participants
|
3 Participants
|
|
Number of Participants With of Adverse Events
Hypernatremia
|
1 Participants
|
5 Participants
|
|
Number of Participants With of Adverse Events
Hyperphosphatemia
|
17 Participants
|
16 Participants
|
|
Number of Participants With of Adverse Events
Hypertension
|
41 Participants
|
43 Participants
|
|
Number of Participants With of Adverse Events
Hyperthyroidism
|
13 Participants
|
0 Participants
|
|
Number of Participants With of Adverse Events
Hypertriglyceridemia
|
2 Participants
|
2 Participants
|
|
Number of Participants With of Adverse Events
Hyperuricemia
|
6 Participants
|
9 Participants
|
|
Number of Participants With of Adverse Events
Hypoalbuminemia
|
43 Participants
|
41 Participants
|
|
Number of Participants With of Adverse Events
Hypocalcemia
|
34 Participants
|
35 Participants
|
|
Number of Participants With of Adverse Events
Hypokalemia
|
31 Participants
|
64 Participants
|
|
Number of Participants With of Adverse Events
Hypomagnesemia
|
5 Participants
|
22 Participants
|
|
Number of Participants With of Adverse Events
Hyponatremia
|
30 Participants
|
57 Participants
|
|
Number of Participants With of Adverse Events
Hypoparathyroidism
|
1 Participants
|
0 Participants
|
|
Number of Participants With of Adverse Events
Hypophosphatemia
|
11 Participants
|
19 Participants
|
|
Number of Participants With of Adverse Events
Hypotension
|
18 Participants
|
18 Participants
|
|
Number of Participants With of Adverse Events
Hypothyroidism
|
36 Participants
|
3 Participants
|
|
Number of Participants With of Adverse Events
Hypoxia
|
3 Participants
|
3 Participants
|
|
Number of Participants With of Adverse Events
INR increased
|
3 Participants
|
1 Participants
|
|
Number of Participants With of Adverse Events
Ileus
|
0 Participants
|
4 Participants
|
|
Number of Participants With of Adverse Events
Immune system disorders - Other, specify
|
1 Participants
|
1 Participants
|
|
Number of Participants With of Adverse Events
Infections and infestations - Other, specify
|
18 Participants
|
12 Participants
|
|
Number of Participants With of Adverse Events
Infusion related reaction
|
36 Participants
|
10 Participants
|
|
Number of Participants With of Adverse Events
Infusion site extravasation
|
2 Participants
|
2 Participants
|
|
Number of Participants With of Adverse Events
Injection site reaction
|
1 Participants
|
2 Participants
|
|
Number of Participants With of Adverse Events
Injury, poisoning and procedural complications - O
|
1 Participants
|
0 Participants
|
|
Number of Participants With of Adverse Events
Insomnia
|
30 Participants
|
54 Participants
|
|
Number of Participants With of Adverse Events
Investigations - Other, specify
|
13 Participants
|
10 Participants
|
|
Number of Participants With of Adverse Events
Irregular menstruation
|
4 Participants
|
5 Participants
|
|
Number of Participants With of Adverse Events
Irritability
|
1 Participants
|
1 Participants
|
|
Number of Participants With of Adverse Events
Joint range of motion decreased
|
0 Participants
|
2 Participants
|
|
Number of Participants With of Adverse Events
Laryngopharyngeal dysesthesia
|
1 Participants
|
0 Participants
|
|
Number of Participants With of Adverse Events
Lethargy
|
3 Participants
|
2 Participants
|
|
Number of Participants With of Adverse Events
Leukocytosis
|
2 Participants
|
6 Participants
|
|
Number of Participants With of Adverse Events
Libido decreased
|
6 Participants
|
3 Participants
|
|
Number of Participants With of Adverse Events
Lip infection
|
3 Participants
|
0 Participants
|
|
Number of Participants With of Adverse Events
Lipase increased
|
2 Participants
|
1 Participants
|
|
Number of Participants With of Adverse Events
Localized edema
|
3 Participants
|
3 Participants
|
|
Number of Participants With of Adverse Events
Lung infection
|
10 Participants
|
14 Participants
|
|
Number of Participants With of Adverse Events
Lymph gland infection
|
1 Participants
|
0 Participants
|
|
Number of Participants With of Adverse Events
Lymph node pain
|
1 Participants
|
3 Participants
|
|
Number of Participants With of Adverse Events
Lymphocyte count decreased
|
109 Participants
|
114 Participants
|
|
Number of Participants With of Adverse Events
Lymphocyte count increased
|
4 Participants
|
10 Participants
|
|
Number of Participants With of Adverse Events
Malaise
|
8 Participants
|
3 Participants
|
|
Number of Participants With of Adverse Events
Memory impairment
|
8 Participants
|
4 Participants
|
|
Number of Participants With of Adverse Events
Menorrhagia
|
1 Participants
|
1 Participants
|
|
Number of Participants With of Adverse Events
Metabolism and nutrition disorders - Other, specif
|
5 Participants
|
2 Participants
|
|
Number of Participants With of Adverse Events
Mitral valve disease
|
1 Participants
|
0 Participants
|
|
Number of Participants With of Adverse Events
Movements involuntary
|
1 Participants
|
2 Participants
|
|
Number of Participants With of Adverse Events
Mucosal infection
|
1 Participants
|
1 Participants
|
|
Number of Participants With of Adverse Events
Mucositis oral
|
109 Participants
|
100 Participants
|
|
Number of Participants With of Adverse Events
Muscle cramp
|
14 Participants
|
19 Participants
|
|
Number of Participants With of Adverse Events
Muscle weakness lower limb
|
5 Participants
|
7 Participants
|
|
Number of Participants With of Adverse Events
Muscle weakness trunk
|
1 Participants
|
0 Participants
|
|
Number of Participants With of Adverse Events
Muscle weakness upper limb
|
1 Participants
|
2 Participants
|
|
Number of Participants With of Adverse Events
Musculoskeletal and connective tissue disorder -
|
5 Participants
|
6 Participants
|
|
Number of Participants With of Adverse Events
Myalgia
|
54 Participants
|
58 Participants
|
|
Number of Participants With of Adverse Events
Myositis
|
2 Participants
|
0 Participants
|
|
Number of Participants With of Adverse Events
Nail changes
|
2 Participants
|
9 Participants
|
|
Number of Participants With of Adverse Events
Nail discoloration
|
7 Participants
|
16 Participants
|
|
Number of Participants With of Adverse Events
Nail infection
|
3 Participants
|
2 Participants
|
|
Number of Participants With of Adverse Events
Nail ridging
|
1 Participants
|
1 Participants
|
|
Number of Participants With of Adverse Events
Nasal congestion
|
6 Participants
|
12 Participants
|
|
Number of Participants With of Adverse Events
Nausea
|
317 Participants
|
331 Participants
|
|
Number of Participants With of Adverse Events
Neck edema
|
3 Participants
|
2 Participants
|
|
Number of Participants With of Adverse Events
Neck pain
|
4 Participants
|
3 Participants
|
|
Number of Participants With of Adverse Events
Neoplasms benign, malignant and unspecified (incl
|
2 Participants
|
0 Participants
|
|
Number of Participants With of Adverse Events
Nervous system disorders - Other, specify
|
5 Participants
|
8 Participants
|
|
Number of Participants With of Adverse Events
Neuralgia
|
2 Participants
|
3 Participants
|
|
Number of Participants With of Adverse Events
Neutrophil count decreased
|
275 Participants
|
166 Participants
|
|
Number of Participants With of Adverse Events
Non-cardiac chest pain
|
16 Participants
|
16 Participants
|
|
Number of Participants With of Adverse Events
Oral dysesthesia
|
6 Participants
|
6 Participants
|
|
Number of Participants With of Adverse Events
Oral hemorrhage
|
0 Participants
|
1 Participants
|
|
Number of Participants With of Adverse Events
Oral pain
|
30 Participants
|
24 Participants
|
|
Number of Participants With of Adverse Events
Pain
|
43 Participants
|
31 Participants
|
|
Number of Participants With of Adverse Events
Pain in extremity
|
22 Participants
|
36 Participants
|
|
Number of Participants With of Adverse Events
Palmar-plantar erythrodysesthesia syndrome
|
1 Participants
|
2 Participants
|
|
Number of Participants With of Adverse Events
Palpitations
|
7 Participants
|
2 Participants
|
|
Number of Participants With of Adverse Events
Pancreatic enzymes decreased
|
0 Participants
|
1 Participants
|
|
Number of Participants With of Adverse Events
Pancreatitis
|
4 Participants
|
1 Participants
|
|
Number of Participants With of Adverse Events
Papulopustular rash
|
4 Participants
|
3 Participants
|
|
Number of Participants With of Adverse Events
Paresthesia
|
36 Participants
|
43 Participants
|
|
Number of Participants With of Adverse Events
Paronychia
|
1 Participants
|
2 Participants
|
|
Number of Participants With of Adverse Events
Paroxysmal atrial tachycardia
|
2 Participants
|
0 Participants
|
|
Number of Participants With of Adverse Events
Pelvic pain
|
1 Participants
|
2 Participants
|
|
Number of Participants With of Adverse Events
Penile infection
|
0 Participants
|
1 Participants
|
|
Number of Participants With of Adverse Events
Pericardial effusion
|
1 Participants
|
0 Participants
|
|
Number of Participants With of Adverse Events
Pericarditis
|
3 Participants
|
0 Participants
|
|
Number of Participants With of Adverse Events
Peripheral motor neuropathy
|
21 Participants
|
36 Participants
|
|
Number of Participants With of Adverse Events
Peripheral sensory neuropathy
|
141 Participants
|
268 Participants
|
|
Number of Participants With of Adverse Events
Pharyngeal mucositis
|
1 Participants
|
0 Participants
|
|
Number of Participants With of Adverse Events
Pharyngitis
|
0 Participants
|
1 Participants
|
|
Number of Participants With of Adverse Events
Phlebitis
|
3 Participants
|
4 Participants
|
|
Number of Participants With of Adverse Events
Photophobia
|
1 Participants
|
2 Participants
|
|
Number of Participants With of Adverse Events
Photosensitivity
|
1 Participants
|
2 Participants
|
|
Number of Participants With of Adverse Events
Platelet count decreased
|
53 Participants
|
89 Participants
|
|
Number of Participants With of Adverse Events
Pleural effusion
|
2 Participants
|
1 Participants
|
|
Number of Participants With of Adverse Events
Postnasal drip
|
2 Participants
|
1 Participants
|
|
Number of Participants With of Adverse Events
Presyncope
|
2 Participants
|
3 Participants
|
|
Number of Participants With of Adverse Events
Productive cough
|
2 Participants
|
2 Participants
|
|
Number of Participants With of Adverse Events
Proteinuria
|
2 Participants
|
2 Participants
|
|
Number of Participants With of Adverse Events
Pruritus
|
48 Participants
|
25 Participants
|
|
Number of Participants With of Adverse Events
Psychiatric disorders - Other, specify
|
1 Participants
|
3 Participants
|
|
Number of Participants With of Adverse Events
Psychosis
|
0 Participants
|
1 Participants
|
|
Number of Participants With of Adverse Events
Pulmonary edema
|
1 Participants
|
1 Participants
|
|
Number of Participants With of Adverse Events
Rash acneiform
|
16 Participants
|
12 Participants
|
|
Number of Participants With of Adverse Events
Rash maculo-papular
|
55 Participants
|
59 Participants
|
|
Number of Participants With of Adverse Events
Rash pustular
|
0 Participants
|
1 Participants
|
|
Number of Participants With of Adverse Events
Rectal fissure
|
0 Participants
|
1 Participants
|
|
Number of Participants With of Adverse Events
Rectal hemorrhage
|
1 Participants
|
2 Participants
|
|
Number of Participants With of Adverse Events
Rectal pain
|
1 Participants
|
4 Participants
|
|
Number of Participants With of Adverse Events
Renal and urinary disorders - Other, specify
|
1 Participants
|
1 Participants
|
|
Number of Participants With of Adverse Events
Respiratory failure
|
0 Participants
|
3 Participants
|
|
Number of Participants With of Adverse Events
Restrictive cardiomyopathy
|
1 Participants
|
0 Participants
|
|
Number of Participants With of Adverse Events
Rhabdomyolysis
|
1 Participants
|
0 Participants
|
|
Number of Participants With of Adverse Events
Rhinorrhea
|
6 Participants
|
8 Participants
|
|
Number of Participants With of Adverse Events
Salivary duct inflammation
|
1 Participants
|
2 Participants
|
|
Number of Participants With of Adverse Events
Scalp pain
|
1 Participants
|
0 Participants
|
|
Number of Participants With of Adverse Events
Scrotal pain
|
0 Participants
|
1 Participants
|
|
Number of Participants With of Adverse Events
Seizure
|
2 Participants
|
1 Participants
|
|
Number of Participants With of Adverse Events
Sepsis
|
8 Participants
|
15 Participants
|
|
Number of Participants With of Adverse Events
Serum amylase increased
|
1 Participants
|
0 Participants
|
|
Number of Participants With of Adverse Events
Sinus bradycardia
|
1 Participants
|
3 Participants
|
|
Number of Participants With of Adverse Events
Sinus disorder
|
0 Participants
|
1 Participants
|
|
Number of Participants With of Adverse Events
Sinus tachycardia
|
17 Participants
|
25 Participants
|
|
Number of Participants With of Adverse Events
Skin and subcutaneous tissue disorders - Other, sp
|
16 Participants
|
18 Participants
|
|
Number of Participants With of Adverse Events
Skin hyperpigmentation
|
8 Participants
|
8 Participants
|
|
Number of Participants With of Adverse Events
Skin hypopigmentation
|
3 Participants
|
0 Participants
|
|
Number of Participants With of Adverse Events
Skin infection
|
6 Participants
|
10 Participants
|
|
Number of Participants With of Adverse Events
Skin ulceration
|
0 Participants
|
1 Participants
|
|
Number of Participants With of Adverse Events
Somnolence
|
0 Participants
|
1 Participants
|
|
Number of Participants With of Adverse Events
Sore throat
|
16 Participants
|
27 Participants
|
|
Number of Participants With of Adverse Events
Generalized muscle weakness
|
16 Participants
|
25 Participants
|
|
Number of Participants With of Adverse Events
Hypoglycemia
|
7 Participants
|
6 Participants
|
|
Number of Participants With of Adverse Events
Pleuritic pain
|
1 Participants
|
0 Participants
|
|
Number of Participants With of Adverse Events
Pneumonitis
|
11 Participants
|
15 Participants
|
|
Number of Participants With of Adverse Events
Watering eyes
|
1 Participants
|
5 Participants
|
|
Number of Participants With of Adverse Events
Weight gain
|
13 Participants
|
8 Participants
|
|
Number of Participants With of Adverse Events
Respiratory, thoracic and mediastinal disorders -
|
3 Participants
|
6 Participants
|
|
Number of Participants With of Adverse Events
Urinary urgency
|
0 Participants
|
1 Participants
|
|
Number of Participants With of Adverse Events
Urticaria
|
1 Participants
|
2 Participants
|
|
Number of Participants With of Adverse Events
Vaginal discharge
|
2 Participants
|
0 Participants
|
|
Number of Participants With of Adverse Events
Vomiting
|
138 Participants
|
160 Participants
|
|
Number of Participants With of Adverse Events
Cardiac disorders - Other, specify
|
6 Participants
|
0 Participants
|
|
Number of Participants With of Adverse Events
Cough
|
33 Participants
|
32 Participants
|
|
Number of Participants With of Adverse Events
Creatinine increased
|
27 Participants
|
13 Participants
|
|
Number of Participants With of Adverse Events
Allergic reaction
|
4 Participants
|
6 Participants
|
|
Number of Participants With of Adverse Events
Abdominal distension
|
1 Participants
|
3 Participants
|
|
Number of Participants With of Adverse Events
Abdominal pain
|
61 Participants
|
110 Participants
|
|
Number of Participants With of Adverse Events
Activated partial thromboplastin time prolonged
|
2 Participants
|
3 Participants
|
|
Number of Participants With of Adverse Events
Acute kidney injury
|
3 Participants
|
3 Participants
|
|
Number of Participants With of Adverse Events
Adrenal insufficiency
|
2 Participants
|
0 Participants
|
|
Number of Participants With of Adverse Events
Agitation
|
4 Participants
|
0 Participants
|
|
Number of Participants With of Adverse Events
Akathisia
|
1 Participants
|
0 Participants
|
|
Number of Participants With of Adverse Events
Alanine aminotransferase increased
|
163 Participants
|
209 Participants
|
|
Number of Participants With of Adverse Events
Alkaline phosphatase increased
|
58 Participants
|
84 Participants
|
|
Number of Participants With of Adverse Events
Small intestinal obstruction
|
0 Participants
|
1 Participants
|
|
Number of Participants With of Adverse Events
Sneezing
|
0 Participants
|
1 Participants
|
|
Number of Participants With of Adverse Events
Spasticity
|
1 Participants
|
1 Participants
|
|
Number of Participants With of Adverse Events
Stomach pain
|
10 Participants
|
10 Participants
|
|
Number of Participants With of Adverse Events
Urinary tract pain
|
2 Participants
|
0 Participants
|
|
Number of Participants With of Adverse Events
Stroke
|
1 Participants
|
0 Participants
|
|
Number of Participants With of Adverse Events
Superficial thrombophlebitis
|
3 Participants
|
3 Participants
|
|
Number of Participants With of Adverse Events
Supraventricular tachycardia
|
0 Participants
|
1 Participants
|
|
Number of Participants With of Adverse Events
Syncope
|
1 Participants
|
2 Participants
|
|
Number of Participants With of Adverse Events
Tendon reflex decreased
|
1 Participants
|
1 Participants
|
|
Number of Participants With of Adverse Events
Testicular pain
|
0 Participants
|
2 Participants
|
|
Number of Participants With of Adverse Events
Thromboembolic event
|
12 Participants
|
10 Participants
|
|
Number of Participants With of Adverse Events
Thrush
|
7 Participants
|
14 Participants
|
|
Number of Participants With of Adverse Events
Ventricular arrhythmia
|
1 Participants
|
1 Participants
|
|
Number of Participants With of Adverse Events
Thyroid stimulating hormone increased
|
28 Participants
|
1 Participants
|
|
Number of Participants With of Adverse Events
Tinnitus
|
8 Participants
|
6 Participants
|
|
Number of Participants With of Adverse Events
Tooth discoloration
|
0 Participants
|
1 Participants
|
|
Number of Participants With of Adverse Events
Tooth infection
|
1 Participants
|
0 Participants
|
|
Number of Participants With of Adverse Events
Toothache
|
3 Participants
|
2 Participants
|
|
Number of Participants With of Adverse Events
Tracheal mucositis
|
0 Participants
|
1 Participants
|
|
Number of Participants With of Adverse Events
Tracheitis
|
1 Participants
|
0 Participants
|
|
Number of Participants With of Adverse Events
Tremor
|
4 Participants
|
3 Participants
|
|
Number of Participants With of Adverse Events
Tumor lysis syndrome
|
1 Participants
|
1 Participants
|
|
Number of Participants With of Adverse Events
Tumor pain
|
0 Participants
|
1 Participants
|
|
Number of Participants With of Adverse Events
Typhlitis
|
0 Participants
|
3 Participants
|
|
Number of Participants With of Adverse Events
Upper gastrointestinal hemorrhage
|
1 Participants
|
0 Participants
|
|
Number of Participants With of Adverse Events
Upper respiratory infection
|
7 Participants
|
8 Participants
|
|
Number of Participants With of Adverse Events
Urinary frequency
|
2 Participants
|
2 Participants
|
|
Number of Participants With of Adverse Events
Urinary incontinence
|
1 Participants
|
1 Participants
|
|
Number of Participants With of Adverse Events
Urinary retention
|
0 Participants
|
1 Participants
|
|
Number of Participants With of Adverse Events
Urinary tract infection
|
7 Participants
|
12 Participants
|
|
Number of Participants With of Adverse Events
Vaginal infection
|
2 Participants
|
4 Participants
|
|
Number of Participants With of Adverse Events
Vascular access complication
|
1 Participants
|
2 Participants
|
|
Number of Participants With of Adverse Events
Vascular disorders - Other, specify
|
3 Participants
|
1 Participants
|
|
Number of Participants With of Adverse Events
Vasovagal reaction
|
0 Participants
|
1 Participants
|
|
Number of Participants With of Adverse Events
Ventricular tachycardia
|
1 Participants
|
1 Participants
|
|
Number of Participants With of Adverse Events
Vertigo
|
2 Participants
|
1 Participants
|
|
Number of Participants With of Adverse Events
Vision decreased
|
3 Participants
|
0 Participants
|
|
Number of Participants With of Adverse Events
Voice alteration
|
1 Participants
|
2 Participants
|
|
Number of Participants With of Adverse Events
Weight loss
|
25 Participants
|
71 Participants
|
|
Number of Participants With of Adverse Events
Wheezing
|
2 Participants
|
1 Participants
|
|
Number of Participants With of Adverse Events
White blood cell decreased
|
202 Participants
|
136 Participants
|
|
Number of Participants With of Adverse Events
Wound infection
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: 4-8 weeks after last dose of study drugThis outcome measure will be reported by 11/5/2025.
Outcome measures
Outcome data not reported
Adverse Events
Arm I (Chemotherapy, Nivolumab, Radiation)
Serious events: 140 serious events
Other events: 468 other events
Deaths: 7 deaths
Arm II (Chemotherapy, Brentuximab Vedotin, Radiation)
Serious events: 18 serious events
Other events: 465 other events
Deaths: 14 deaths
Serious adverse events
| Measure |
Arm I (Chemotherapy, Nivolumab, Radiation)
n=481 participants at risk
Patients receive doxorubicin hydrochloride IV, vinblastine sulfate IV, dacarbazine IV, and nivolumab IV over 30 minutes on days 1 and 15. Patients may receive pegfilgrastim SC on days 2 and 16, or filgrastim SC or IV on days 6-10 and 21-25. Treatment repeats every 28 days for 6 cycles in the absence of disease progression or unacceptable toxicity. After completion of cycle 6, patients may receive radiation therapy 5 days per week for approximately 4 weeks at the discretion of the treating physician. Patients also undergo peripheral blood specimen collection and CT, PET/CT and MRI on study.
|
Arm II (Chemotherapy, Brentuximab Vedotin, Radiation)
n=476 participants at risk
Patients receive doxorubicin hydrochloride IV, vinblastine sulfate IV, dacarbazine IV, and brentuximab vedotin IV over 30 minutes on days 1 and 15. Patients may receive pegfilgrastim SC on days 2 and 16, or filgrastim SC or IV on days 6-10 and 21-25. Treatment repeats every 28 days for 6 cycles in the absence of disease progression or unacceptable toxicity. After completion of cycle 6, patients may receive radiation therapy 5 days per week for approximately 4 weeks at the discretion of the treating physician. Patients also undergo peripheral blood specimen collection and CT, PET/CT and MRI on study.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
0.21%
1/481 • Up to 2 years
Adverse events will be assessed using CTCAE version 5.0. All cause mortality will be reported as all cause mortality within the two year time frame that was analyzed for the primary endpoint. Please note that the number of participants at risk for all-cause mortality is greater than the number of participants at risk for adverse events. Only participants who received intervention are eligible for adverse events reporting.
|
0.21%
1/476 • Up to 2 years
Adverse events will be assessed using CTCAE version 5.0. All cause mortality will be reported as all cause mortality within the two year time frame that was analyzed for the primary endpoint. Please note that the number of participants at risk for all-cause mortality is greater than the number of participants at risk for adverse events. Only participants who received intervention are eligible for adverse events reporting.
|
|
Blood and lymphatic system disorders
Blood and lymphatic system disorders-Other
|
0.21%
1/481 • Up to 2 years
Adverse events will be assessed using CTCAE version 5.0. All cause mortality will be reported as all cause mortality within the two year time frame that was analyzed for the primary endpoint. Please note that the number of participants at risk for all-cause mortality is greater than the number of participants at risk for adverse events. Only participants who received intervention are eligible for adverse events reporting.
|
0.00%
0/476 • Up to 2 years
Adverse events will be assessed using CTCAE version 5.0. All cause mortality will be reported as all cause mortality within the two year time frame that was analyzed for the primary endpoint. Please note that the number of participants at risk for all-cause mortality is greater than the number of participants at risk for adverse events. Only participants who received intervention are eligible for adverse events reporting.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
5.2%
25/481 • Up to 2 years
Adverse events will be assessed using CTCAE version 5.0. All cause mortality will be reported as all cause mortality within the two year time frame that was analyzed for the primary endpoint. Please note that the number of participants at risk for all-cause mortality is greater than the number of participants at risk for adverse events. Only participants who received intervention are eligible for adverse events reporting.
|
0.84%
4/476 • Up to 2 years
Adverse events will be assessed using CTCAE version 5.0. All cause mortality will be reported as all cause mortality within the two year time frame that was analyzed for the primary endpoint. Please note that the number of participants at risk for all-cause mortality is greater than the number of participants at risk for adverse events. Only participants who received intervention are eligible for adverse events reporting.
|
|
Blood and lymphatic system disorders
Hemolysis
|
0.21%
1/481 • Up to 2 years
Adverse events will be assessed using CTCAE version 5.0. All cause mortality will be reported as all cause mortality within the two year time frame that was analyzed for the primary endpoint. Please note that the number of participants at risk for all-cause mortality is greater than the number of participants at risk for adverse events. Only participants who received intervention are eligible for adverse events reporting.
|
0.00%
0/476 • Up to 2 years
Adverse events will be assessed using CTCAE version 5.0. All cause mortality will be reported as all cause mortality within the two year time frame that was analyzed for the primary endpoint. Please note that the number of participants at risk for all-cause mortality is greater than the number of participants at risk for adverse events. Only participants who received intervention are eligible for adverse events reporting.
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.21%
1/481 • Up to 2 years
Adverse events will be assessed using CTCAE version 5.0. All cause mortality will be reported as all cause mortality within the two year time frame that was analyzed for the primary endpoint. Please note that the number of participants at risk for all-cause mortality is greater than the number of participants at risk for adverse events. Only participants who received intervention are eligible for adverse events reporting.
|
0.00%
0/476 • Up to 2 years
Adverse events will be assessed using CTCAE version 5.0. All cause mortality will be reported as all cause mortality within the two year time frame that was analyzed for the primary endpoint. Please note that the number of participants at risk for all-cause mortality is greater than the number of participants at risk for adverse events. Only participants who received intervention are eligible for adverse events reporting.
|
|
Cardiac disorders
Atrial fibrillation
|
0.42%
2/481 • Up to 2 years
Adverse events will be assessed using CTCAE version 5.0. All cause mortality will be reported as all cause mortality within the two year time frame that was analyzed for the primary endpoint. Please note that the number of participants at risk for all-cause mortality is greater than the number of participants at risk for adverse events. Only participants who received intervention are eligible for adverse events reporting.
|
0.21%
1/476 • Up to 2 years
Adverse events will be assessed using CTCAE version 5.0. All cause mortality will be reported as all cause mortality within the two year time frame that was analyzed for the primary endpoint. Please note that the number of participants at risk for all-cause mortality is greater than the number of participants at risk for adverse events. Only participants who received intervention are eligible for adverse events reporting.
|
|
Cardiac disorders
Cardiac arrest
|
0.00%
0/481 • Up to 2 years
Adverse events will be assessed using CTCAE version 5.0. All cause mortality will be reported as all cause mortality within the two year time frame that was analyzed for the primary endpoint. Please note that the number of participants at risk for all-cause mortality is greater than the number of participants at risk for adverse events. Only participants who received intervention are eligible for adverse events reporting.
|
0.42%
2/476 • Up to 2 years
Adverse events will be assessed using CTCAE version 5.0. All cause mortality will be reported as all cause mortality within the two year time frame that was analyzed for the primary endpoint. Please note that the number of participants at risk for all-cause mortality is greater than the number of participants at risk for adverse events. Only participants who received intervention are eligible for adverse events reporting.
|
|
Cardiac disorders
Cardiac disorders-Other
|
0.42%
2/481 • Up to 2 years
Adverse events will be assessed using CTCAE version 5.0. All cause mortality will be reported as all cause mortality within the two year time frame that was analyzed for the primary endpoint. Please note that the number of participants at risk for all-cause mortality is greater than the number of participants at risk for adverse events. Only participants who received intervention are eligible for adverse events reporting.
|
0.00%
0/476 • Up to 2 years
Adverse events will be assessed using CTCAE version 5.0. All cause mortality will be reported as all cause mortality within the two year time frame that was analyzed for the primary endpoint. Please note that the number of participants at risk for all-cause mortality is greater than the number of participants at risk for adverse events. Only participants who received intervention are eligible for adverse events reporting.
|
|
Cardiac disorders
Chest pain - cardiac
|
0.83%
4/481 • Up to 2 years
Adverse events will be assessed using CTCAE version 5.0. All cause mortality will be reported as all cause mortality within the two year time frame that was analyzed for the primary endpoint. Please note that the number of participants at risk for all-cause mortality is greater than the number of participants at risk for adverse events. Only participants who received intervention are eligible for adverse events reporting.
|
0.00%
0/476 • Up to 2 years
Adverse events will be assessed using CTCAE version 5.0. All cause mortality will be reported as all cause mortality within the two year time frame that was analyzed for the primary endpoint. Please note that the number of participants at risk for all-cause mortality is greater than the number of participants at risk for adverse events. Only participants who received intervention are eligible for adverse events reporting.
|
|
Cardiac disorders
Heart failure
|
0.42%
2/481 • Up to 2 years
Adverse events will be assessed using CTCAE version 5.0. All cause mortality will be reported as all cause mortality within the two year time frame that was analyzed for the primary endpoint. Please note that the number of participants at risk for all-cause mortality is greater than the number of participants at risk for adverse events. Only participants who received intervention are eligible for adverse events reporting.
|
0.00%
0/476 • Up to 2 years
Adverse events will be assessed using CTCAE version 5.0. All cause mortality will be reported as all cause mortality within the two year time frame that was analyzed for the primary endpoint. Please note that the number of participants at risk for all-cause mortality is greater than the number of participants at risk for adverse events. Only participants who received intervention are eligible for adverse events reporting.
|
|
Cardiac disorders
Palpitations
|
0.21%
1/481 • Up to 2 years
Adverse events will be assessed using CTCAE version 5.0. All cause mortality will be reported as all cause mortality within the two year time frame that was analyzed for the primary endpoint. Please note that the number of participants at risk for all-cause mortality is greater than the number of participants at risk for adverse events. Only participants who received intervention are eligible for adverse events reporting.
|
0.00%
0/476 • Up to 2 years
Adverse events will be assessed using CTCAE version 5.0. All cause mortality will be reported as all cause mortality within the two year time frame that was analyzed for the primary endpoint. Please note that the number of participants at risk for all-cause mortality is greater than the number of participants at risk for adverse events. Only participants who received intervention are eligible for adverse events reporting.
|
|
Cardiac disorders
Pericardial effusion
|
0.62%
3/481 • Up to 2 years
Adverse events will be assessed using CTCAE version 5.0. All cause mortality will be reported as all cause mortality within the two year time frame that was analyzed for the primary endpoint. Please note that the number of participants at risk for all-cause mortality is greater than the number of participants at risk for adverse events. Only participants who received intervention are eligible for adverse events reporting.
|
0.00%
0/476 • Up to 2 years
Adverse events will be assessed using CTCAE version 5.0. All cause mortality will be reported as all cause mortality within the two year time frame that was analyzed for the primary endpoint. Please note that the number of participants at risk for all-cause mortality is greater than the number of participants at risk for adverse events. Only participants who received intervention are eligible for adverse events reporting.
|
|
Cardiac disorders
Pericarditis
|
0.62%
3/481 • Up to 2 years
Adverse events will be assessed using CTCAE version 5.0. All cause mortality will be reported as all cause mortality within the two year time frame that was analyzed for the primary endpoint. Please note that the number of participants at risk for all-cause mortality is greater than the number of participants at risk for adverse events. Only participants who received intervention are eligible for adverse events reporting.
|
0.00%
0/476 • Up to 2 years
Adverse events will be assessed using CTCAE version 5.0. All cause mortality will be reported as all cause mortality within the two year time frame that was analyzed for the primary endpoint. Please note that the number of participants at risk for all-cause mortality is greater than the number of participants at risk for adverse events. Only participants who received intervention are eligible for adverse events reporting.
|
|
Cardiac disorders
Sinus bradycardia
|
0.00%
0/481 • Up to 2 years
Adverse events will be assessed using CTCAE version 5.0. All cause mortality will be reported as all cause mortality within the two year time frame that was analyzed for the primary endpoint. Please note that the number of participants at risk for all-cause mortality is greater than the number of participants at risk for adverse events. Only participants who received intervention are eligible for adverse events reporting.
|
0.21%
1/476 • Up to 2 years
Adverse events will be assessed using CTCAE version 5.0. All cause mortality will be reported as all cause mortality within the two year time frame that was analyzed for the primary endpoint. Please note that the number of participants at risk for all-cause mortality is greater than the number of participants at risk for adverse events. Only participants who received intervention are eligible for adverse events reporting.
|
|
Cardiac disorders
Sinus tachycardia
|
0.62%
3/481 • Up to 2 years
Adverse events will be assessed using CTCAE version 5.0. All cause mortality will be reported as all cause mortality within the two year time frame that was analyzed for the primary endpoint. Please note that the number of participants at risk for all-cause mortality is greater than the number of participants at risk for adverse events. Only participants who received intervention are eligible for adverse events reporting.
|
0.00%
0/476 • Up to 2 years
Adverse events will be assessed using CTCAE version 5.0. All cause mortality will be reported as all cause mortality within the two year time frame that was analyzed for the primary endpoint. Please note that the number of participants at risk for all-cause mortality is greater than the number of participants at risk for adverse events. Only participants who received intervention are eligible for adverse events reporting.
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.21%
1/481 • Up to 2 years
Adverse events will be assessed using CTCAE version 5.0. All cause mortality will be reported as all cause mortality within the two year time frame that was analyzed for the primary endpoint. Please note that the number of participants at risk for all-cause mortality is greater than the number of participants at risk for adverse events. Only participants who received intervention are eligible for adverse events reporting.
|
0.00%
0/476 • Up to 2 years
Adverse events will be assessed using CTCAE version 5.0. All cause mortality will be reported as all cause mortality within the two year time frame that was analyzed for the primary endpoint. Please note that the number of participants at risk for all-cause mortality is greater than the number of participants at risk for adverse events. Only participants who received intervention are eligible for adverse events reporting.
|
|
Cardiac disorders
Ventricular tachycardia
|
0.00%
0/481 • Up to 2 years
Adverse events will be assessed using CTCAE version 5.0. All cause mortality will be reported as all cause mortality within the two year time frame that was analyzed for the primary endpoint. Please note that the number of participants at risk for all-cause mortality is greater than the number of participants at risk for adverse events. Only participants who received intervention are eligible for adverse events reporting.
|
0.21%
1/476 • Up to 2 years
Adverse events will be assessed using CTCAE version 5.0. All cause mortality will be reported as all cause mortality within the two year time frame that was analyzed for the primary endpoint. Please note that the number of participants at risk for all-cause mortality is greater than the number of participants at risk for adverse events. Only participants who received intervention are eligible for adverse events reporting.
|
|
Endocrine disorders
Hypothyroidism
|
0.21%
1/481 • Up to 2 years
Adverse events will be assessed using CTCAE version 5.0. All cause mortality will be reported as all cause mortality within the two year time frame that was analyzed for the primary endpoint. Please note that the number of participants at risk for all-cause mortality is greater than the number of participants at risk for adverse events. Only participants who received intervention are eligible for adverse events reporting.
|
0.00%
0/476 • Up to 2 years
Adverse events will be assessed using CTCAE version 5.0. All cause mortality will be reported as all cause mortality within the two year time frame that was analyzed for the primary endpoint. Please note that the number of participants at risk for all-cause mortality is greater than the number of participants at risk for adverse events. Only participants who received intervention are eligible for adverse events reporting.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.42%
2/481 • Up to 2 years
Adverse events will be assessed using CTCAE version 5.0. All cause mortality will be reported as all cause mortality within the two year time frame that was analyzed for the primary endpoint. Please note that the number of participants at risk for all-cause mortality is greater than the number of participants at risk for adverse events. Only participants who received intervention are eligible for adverse events reporting.
|
0.00%
0/476 • Up to 2 years
Adverse events will be assessed using CTCAE version 5.0. All cause mortality will be reported as all cause mortality within the two year time frame that was analyzed for the primary endpoint. Please note that the number of participants at risk for all-cause mortality is greater than the number of participants at risk for adverse events. Only participants who received intervention are eligible for adverse events reporting.
|
|
Gastrointestinal disorders
Colitis
|
0.42%
2/481 • Up to 2 years
Adverse events will be assessed using CTCAE version 5.0. All cause mortality will be reported as all cause mortality within the two year time frame that was analyzed for the primary endpoint. Please note that the number of participants at risk for all-cause mortality is greater than the number of participants at risk for adverse events. Only participants who received intervention are eligible for adverse events reporting.
|
0.00%
0/476 • Up to 2 years
Adverse events will be assessed using CTCAE version 5.0. All cause mortality will be reported as all cause mortality within the two year time frame that was analyzed for the primary endpoint. Please note that the number of participants at risk for all-cause mortality is greater than the number of participants at risk for adverse events. Only participants who received intervention are eligible for adverse events reporting.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/481 • Up to 2 years
Adverse events will be assessed using CTCAE version 5.0. All cause mortality will be reported as all cause mortality within the two year time frame that was analyzed for the primary endpoint. Please note that the number of participants at risk for all-cause mortality is greater than the number of participants at risk for adverse events. Only participants who received intervention are eligible for adverse events reporting.
|
0.21%
1/476 • Up to 2 years
Adverse events will be assessed using CTCAE version 5.0. All cause mortality will be reported as all cause mortality within the two year time frame that was analyzed for the primary endpoint. Please note that the number of participants at risk for all-cause mortality is greater than the number of participants at risk for adverse events. Only participants who received intervention are eligible for adverse events reporting.
|
|
Gastrointestinal disorders
Diarrhea
|
0.42%
2/481 • Up to 2 years
Adverse events will be assessed using CTCAE version 5.0. All cause mortality will be reported as all cause mortality within the two year time frame that was analyzed for the primary endpoint. Please note that the number of participants at risk for all-cause mortality is greater than the number of participants at risk for adverse events. Only participants who received intervention are eligible for adverse events reporting.
|
0.00%
0/476 • Up to 2 years
Adverse events will be assessed using CTCAE version 5.0. All cause mortality will be reported as all cause mortality within the two year time frame that was analyzed for the primary endpoint. Please note that the number of participants at risk for all-cause mortality is greater than the number of participants at risk for adverse events. Only participants who received intervention are eligible for adverse events reporting.
|
|
Gastrointestinal disorders
Enterocolitis
|
0.42%
2/481 • Up to 2 years
Adverse events will be assessed using CTCAE version 5.0. All cause mortality will be reported as all cause mortality within the two year time frame that was analyzed for the primary endpoint. Please note that the number of participants at risk for all-cause mortality is greater than the number of participants at risk for adverse events. Only participants who received intervention are eligible for adverse events reporting.
|
0.00%
0/476 • Up to 2 years
Adverse events will be assessed using CTCAE version 5.0. All cause mortality will be reported as all cause mortality within the two year time frame that was analyzed for the primary endpoint. Please note that the number of participants at risk for all-cause mortality is greater than the number of participants at risk for adverse events. Only participants who received intervention are eligible for adverse events reporting.
|
|
Gastrointestinal disorders
Esophagitis
|
0.21%
1/481 • Up to 2 years
Adverse events will be assessed using CTCAE version 5.0. All cause mortality will be reported as all cause mortality within the two year time frame that was analyzed for the primary endpoint. Please note that the number of participants at risk for all-cause mortality is greater than the number of participants at risk for adverse events. Only participants who received intervention are eligible for adverse events reporting.
|
0.00%
0/476 • Up to 2 years
Adverse events will be assessed using CTCAE version 5.0. All cause mortality will be reported as all cause mortality within the two year time frame that was analyzed for the primary endpoint. Please note that the number of participants at risk for all-cause mortality is greater than the number of participants at risk for adverse events. Only participants who received intervention are eligible for adverse events reporting.
|
|
Gastrointestinal disorders
Gastritis
|
0.62%
3/481 • Up to 2 years
Adverse events will be assessed using CTCAE version 5.0. All cause mortality will be reported as all cause mortality within the two year time frame that was analyzed for the primary endpoint. Please note that the number of participants at risk for all-cause mortality is greater than the number of participants at risk for adverse events. Only participants who received intervention are eligible for adverse events reporting.
|
0.00%
0/476 • Up to 2 years
Adverse events will be assessed using CTCAE version 5.0. All cause mortality will be reported as all cause mortality within the two year time frame that was analyzed for the primary endpoint. Please note that the number of participants at risk for all-cause mortality is greater than the number of participants at risk for adverse events. Only participants who received intervention are eligible for adverse events reporting.
|
|
Gastrointestinal disorders
Gastrointestinal disorders-Other
|
0.00%
0/481 • Up to 2 years
Adverse events will be assessed using CTCAE version 5.0. All cause mortality will be reported as all cause mortality within the two year time frame that was analyzed for the primary endpoint. Please note that the number of participants at risk for all-cause mortality is greater than the number of participants at risk for adverse events. Only participants who received intervention are eligible for adverse events reporting.
|
0.21%
1/476 • Up to 2 years
Adverse events will be assessed using CTCAE version 5.0. All cause mortality will be reported as all cause mortality within the two year time frame that was analyzed for the primary endpoint. Please note that the number of participants at risk for all-cause mortality is greater than the number of participants at risk for adverse events. Only participants who received intervention are eligible for adverse events reporting.
|
|
Gastrointestinal disorders
Ileus
|
0.21%
1/481 • Up to 2 years
Adverse events will be assessed using CTCAE version 5.0. All cause mortality will be reported as all cause mortality within the two year time frame that was analyzed for the primary endpoint. Please note that the number of participants at risk for all-cause mortality is greater than the number of participants at risk for adverse events. Only participants who received intervention are eligible for adverse events reporting.
|
0.00%
0/476 • Up to 2 years
Adverse events will be assessed using CTCAE version 5.0. All cause mortality will be reported as all cause mortality within the two year time frame that was analyzed for the primary endpoint. Please note that the number of participants at risk for all-cause mortality is greater than the number of participants at risk for adverse events. Only participants who received intervention are eligible for adverse events reporting.
|
|
Gastrointestinal disorders
Mucositis oral
|
0.83%
4/481 • Up to 2 years
Adverse events will be assessed using CTCAE version 5.0. All cause mortality will be reported as all cause mortality within the two year time frame that was analyzed for the primary endpoint. Please note that the number of participants at risk for all-cause mortality is greater than the number of participants at risk for adverse events. Only participants who received intervention are eligible for adverse events reporting.
|
0.00%
0/476 • Up to 2 years
Adverse events will be assessed using CTCAE version 5.0. All cause mortality will be reported as all cause mortality within the two year time frame that was analyzed for the primary endpoint. Please note that the number of participants at risk for all-cause mortality is greater than the number of participants at risk for adverse events. Only participants who received intervention are eligible for adverse events reporting.
|
|
Gastrointestinal disorders
Nausea
|
1.2%
6/481 • Up to 2 years
Adverse events will be assessed using CTCAE version 5.0. All cause mortality will be reported as all cause mortality within the two year time frame that was analyzed for the primary endpoint. Please note that the number of participants at risk for all-cause mortality is greater than the number of participants at risk for adverse events. Only participants who received intervention are eligible for adverse events reporting.
|
0.21%
1/476 • Up to 2 years
Adverse events will be assessed using CTCAE version 5.0. All cause mortality will be reported as all cause mortality within the two year time frame that was analyzed for the primary endpoint. Please note that the number of participants at risk for all-cause mortality is greater than the number of participants at risk for adverse events. Only participants who received intervention are eligible for adverse events reporting.
|
|
Gastrointestinal disorders
Pancreatitis
|
0.42%
2/481 • Up to 2 years
Adverse events will be assessed using CTCAE version 5.0. All cause mortality will be reported as all cause mortality within the two year time frame that was analyzed for the primary endpoint. Please note that the number of participants at risk for all-cause mortality is greater than the number of participants at risk for adverse events. Only participants who received intervention are eligible for adverse events reporting.
|
0.00%
0/476 • Up to 2 years
Adverse events will be assessed using CTCAE version 5.0. All cause mortality will be reported as all cause mortality within the two year time frame that was analyzed for the primary endpoint. Please note that the number of participants at risk for all-cause mortality is greater than the number of participants at risk for adverse events. Only participants who received intervention are eligible for adverse events reporting.
|
|
Gastrointestinal disorders
Proctitis
|
0.21%
1/481 • Up to 2 years
Adverse events will be assessed using CTCAE version 5.0. All cause mortality will be reported as all cause mortality within the two year time frame that was analyzed for the primary endpoint. Please note that the number of participants at risk for all-cause mortality is greater than the number of participants at risk for adverse events. Only participants who received intervention are eligible for adverse events reporting.
|
0.00%
0/476 • Up to 2 years
Adverse events will be assessed using CTCAE version 5.0. All cause mortality will be reported as all cause mortality within the two year time frame that was analyzed for the primary endpoint. Please note that the number of participants at risk for all-cause mortality is greater than the number of participants at risk for adverse events. Only participants who received intervention are eligible for adverse events reporting.
|
|
Gastrointestinal disorders
Rectal pain
|
0.21%
1/481 • Up to 2 years
Adverse events will be assessed using CTCAE version 5.0. All cause mortality will be reported as all cause mortality within the two year time frame that was analyzed for the primary endpoint. Please note that the number of participants at risk for all-cause mortality is greater than the number of participants at risk for adverse events. Only participants who received intervention are eligible for adverse events reporting.
|
0.00%
0/476 • Up to 2 years
Adverse events will be assessed using CTCAE version 5.0. All cause mortality will be reported as all cause mortality within the two year time frame that was analyzed for the primary endpoint. Please note that the number of participants at risk for all-cause mortality is greater than the number of participants at risk for adverse events. Only participants who received intervention are eligible for adverse events reporting.
|
|
Gastrointestinal disorders
Stomach pain
|
0.21%
1/481 • Up to 2 years
Adverse events will be assessed using CTCAE version 5.0. All cause mortality will be reported as all cause mortality within the two year time frame that was analyzed for the primary endpoint. Please note that the number of participants at risk for all-cause mortality is greater than the number of participants at risk for adverse events. Only participants who received intervention are eligible for adverse events reporting.
|
0.00%
0/476 • Up to 2 years
Adverse events will be assessed using CTCAE version 5.0. All cause mortality will be reported as all cause mortality within the two year time frame that was analyzed for the primary endpoint. Please note that the number of participants at risk for all-cause mortality is greater than the number of participants at risk for adverse events. Only participants who received intervention are eligible for adverse events reporting.
|
|
Gastrointestinal disorders
Upper gastrointestinal hemorrhage
|
0.21%
1/481 • Up to 2 years
Adverse events will be assessed using CTCAE version 5.0. All cause mortality will be reported as all cause mortality within the two year time frame that was analyzed for the primary endpoint. Please note that the number of participants at risk for all-cause mortality is greater than the number of participants at risk for adverse events. Only participants who received intervention are eligible for adverse events reporting.
|
0.00%
0/476 • Up to 2 years
Adverse events will be assessed using CTCAE version 5.0. All cause mortality will be reported as all cause mortality within the two year time frame that was analyzed for the primary endpoint. Please note that the number of participants at risk for all-cause mortality is greater than the number of participants at risk for adverse events. Only participants who received intervention are eligible for adverse events reporting.
|
|
Gastrointestinal disorders
Vomiting
|
1.7%
8/481 • Up to 2 years
Adverse events will be assessed using CTCAE version 5.0. All cause mortality will be reported as all cause mortality within the two year time frame that was analyzed for the primary endpoint. Please note that the number of participants at risk for all-cause mortality is greater than the number of participants at risk for adverse events. Only participants who received intervention are eligible for adverse events reporting.
|
0.42%
2/476 • Up to 2 years
Adverse events will be assessed using CTCAE version 5.0. All cause mortality will be reported as all cause mortality within the two year time frame that was analyzed for the primary endpoint. Please note that the number of participants at risk for all-cause mortality is greater than the number of participants at risk for adverse events. Only participants who received intervention are eligible for adverse events reporting.
|
|
General disorders
Chills
|
0.21%
1/481 • Up to 2 years
Adverse events will be assessed using CTCAE version 5.0. All cause mortality will be reported as all cause mortality within the two year time frame that was analyzed for the primary endpoint. Please note that the number of participants at risk for all-cause mortality is greater than the number of participants at risk for adverse events. Only participants who received intervention are eligible for adverse events reporting.
|
0.00%
0/476 • Up to 2 years
Adverse events will be assessed using CTCAE version 5.0. All cause mortality will be reported as all cause mortality within the two year time frame that was analyzed for the primary endpoint. Please note that the number of participants at risk for all-cause mortality is greater than the number of participants at risk for adverse events. Only participants who received intervention are eligible for adverse events reporting.
|
|
General disorders
Disease progression
|
0.00%
0/481 • Up to 2 years
Adverse events will be assessed using CTCAE version 5.0. All cause mortality will be reported as all cause mortality within the two year time frame that was analyzed for the primary endpoint. Please note that the number of participants at risk for all-cause mortality is greater than the number of participants at risk for adverse events. Only participants who received intervention are eligible for adverse events reporting.
|
0.21%
1/476 • Up to 2 years
Adverse events will be assessed using CTCAE version 5.0. All cause mortality will be reported as all cause mortality within the two year time frame that was analyzed for the primary endpoint. Please note that the number of participants at risk for all-cause mortality is greater than the number of participants at risk for adverse events. Only participants who received intervention are eligible for adverse events reporting.
|
|
General disorders
Edema limbs
|
0.21%
1/481 • Up to 2 years
Adverse events will be assessed using CTCAE version 5.0. All cause mortality will be reported as all cause mortality within the two year time frame that was analyzed for the primary endpoint. Please note that the number of participants at risk for all-cause mortality is greater than the number of participants at risk for adverse events. Only participants who received intervention are eligible for adverse events reporting.
|
0.00%
0/476 • Up to 2 years
Adverse events will be assessed using CTCAE version 5.0. All cause mortality will be reported as all cause mortality within the two year time frame that was analyzed for the primary endpoint. Please note that the number of participants at risk for all-cause mortality is greater than the number of participants at risk for adverse events. Only participants who received intervention are eligible for adverse events reporting.
|
|
General disorders
Fever
|
2.1%
10/481 • Up to 2 years
Adverse events will be assessed using CTCAE version 5.0. All cause mortality will be reported as all cause mortality within the two year time frame that was analyzed for the primary endpoint. Please note that the number of participants at risk for all-cause mortality is greater than the number of participants at risk for adverse events. Only participants who received intervention are eligible for adverse events reporting.
|
0.00%
0/476 • Up to 2 years
Adverse events will be assessed using CTCAE version 5.0. All cause mortality will be reported as all cause mortality within the two year time frame that was analyzed for the primary endpoint. Please note that the number of participants at risk for all-cause mortality is greater than the number of participants at risk for adverse events. Only participants who received intervention are eligible for adverse events reporting.
|
|
General disorders
Generalized edema
|
0.21%
1/481 • Up to 2 years
Adverse events will be assessed using CTCAE version 5.0. All cause mortality will be reported as all cause mortality within the two year time frame that was analyzed for the primary endpoint. Please note that the number of participants at risk for all-cause mortality is greater than the number of participants at risk for adverse events. Only participants who received intervention are eligible for adverse events reporting.
|
0.00%
0/476 • Up to 2 years
Adverse events will be assessed using CTCAE version 5.0. All cause mortality will be reported as all cause mortality within the two year time frame that was analyzed for the primary endpoint. Please note that the number of participants at risk for all-cause mortality is greater than the number of participants at risk for adverse events. Only participants who received intervention are eligible for adverse events reporting.
|
|
General disorders
Localized edema
|
0.21%
1/481 • Up to 2 years
Adverse events will be assessed using CTCAE version 5.0. All cause mortality will be reported as all cause mortality within the two year time frame that was analyzed for the primary endpoint. Please note that the number of participants at risk for all-cause mortality is greater than the number of participants at risk for adverse events. Only participants who received intervention are eligible for adverse events reporting.
|
0.00%
0/476 • Up to 2 years
Adverse events will be assessed using CTCAE version 5.0. All cause mortality will be reported as all cause mortality within the two year time frame that was analyzed for the primary endpoint. Please note that the number of participants at risk for all-cause mortality is greater than the number of participants at risk for adverse events. Only participants who received intervention are eligible for adverse events reporting.
|
|
General disorders
Non-cardiac chest pain
|
0.42%
2/481 • Up to 2 years
Adverse events will be assessed using CTCAE version 5.0. All cause mortality will be reported as all cause mortality within the two year time frame that was analyzed for the primary endpoint. Please note that the number of participants at risk for all-cause mortality is greater than the number of participants at risk for adverse events. Only participants who received intervention are eligible for adverse events reporting.
|
0.00%
0/476 • Up to 2 years
Adverse events will be assessed using CTCAE version 5.0. All cause mortality will be reported as all cause mortality within the two year time frame that was analyzed for the primary endpoint. Please note that the number of participants at risk for all-cause mortality is greater than the number of participants at risk for adverse events. Only participants who received intervention are eligible for adverse events reporting.
|
|
General disorders
Pain
|
0.62%
3/481 • Up to 2 years
Adverse events will be assessed using CTCAE version 5.0. All cause mortality will be reported as all cause mortality within the two year time frame that was analyzed for the primary endpoint. Please note that the number of participants at risk for all-cause mortality is greater than the number of participants at risk for adverse events. Only participants who received intervention are eligible for adverse events reporting.
|
0.00%
0/476 • Up to 2 years
Adverse events will be assessed using CTCAE version 5.0. All cause mortality will be reported as all cause mortality within the two year time frame that was analyzed for the primary endpoint. Please note that the number of participants at risk for all-cause mortality is greater than the number of participants at risk for adverse events. Only participants who received intervention are eligible for adverse events reporting.
|
|
Hepatobiliary disorders
Hepatic failure
|
0.42%
2/481 • Up to 2 years
Adverse events will be assessed using CTCAE version 5.0. All cause mortality will be reported as all cause mortality within the two year time frame that was analyzed for the primary endpoint. Please note that the number of participants at risk for all-cause mortality is greater than the number of participants at risk for adverse events. Only participants who received intervention are eligible for adverse events reporting.
|
0.00%
0/476 • Up to 2 years
Adverse events will be assessed using CTCAE version 5.0. All cause mortality will be reported as all cause mortality within the two year time frame that was analyzed for the primary endpoint. Please note that the number of participants at risk for all-cause mortality is greater than the number of participants at risk for adverse events. Only participants who received intervention are eligible for adverse events reporting.
|
|
Immune system disorders
Allergic reaction
|
0.62%
3/481 • Up to 2 years
Adverse events will be assessed using CTCAE version 5.0. All cause mortality will be reported as all cause mortality within the two year time frame that was analyzed for the primary endpoint. Please note that the number of participants at risk for all-cause mortality is greater than the number of participants at risk for adverse events. Only participants who received intervention are eligible for adverse events reporting.
|
0.00%
0/476 • Up to 2 years
Adverse events will be assessed using CTCAE version 5.0. All cause mortality will be reported as all cause mortality within the two year time frame that was analyzed for the primary endpoint. Please note that the number of participants at risk for all-cause mortality is greater than the number of participants at risk for adverse events. Only participants who received intervention are eligible for adverse events reporting.
|
|
Immune system disorders
Anaphylaxis
|
0.21%
1/481 • Up to 2 years
Adverse events will be assessed using CTCAE version 5.0. All cause mortality will be reported as all cause mortality within the two year time frame that was analyzed for the primary endpoint. Please note that the number of participants at risk for all-cause mortality is greater than the number of participants at risk for adverse events. Only participants who received intervention are eligible for adverse events reporting.
|
0.00%
0/476 • Up to 2 years
Adverse events will be assessed using CTCAE version 5.0. All cause mortality will be reported as all cause mortality within the two year time frame that was analyzed for the primary endpoint. Please note that the number of participants at risk for all-cause mortality is greater than the number of participants at risk for adverse events. Only participants who received intervention are eligible for adverse events reporting.
|
|
Infections and infestations
Anorectal infection
|
0.21%
1/481 • Up to 2 years
Adverse events will be assessed using CTCAE version 5.0. All cause mortality will be reported as all cause mortality within the two year time frame that was analyzed for the primary endpoint. Please note that the number of participants at risk for all-cause mortality is greater than the number of participants at risk for adverse events. Only participants who received intervention are eligible for adverse events reporting.
|
0.00%
0/476 • Up to 2 years
Adverse events will be assessed using CTCAE version 5.0. All cause mortality will be reported as all cause mortality within the two year time frame that was analyzed for the primary endpoint. Please note that the number of participants at risk for all-cause mortality is greater than the number of participants at risk for adverse events. Only participants who received intervention are eligible for adverse events reporting.
|
|
Infections and infestations
Appendicitis
|
0.21%
1/481 • Up to 2 years
Adverse events will be assessed using CTCAE version 5.0. All cause mortality will be reported as all cause mortality within the two year time frame that was analyzed for the primary endpoint. Please note that the number of participants at risk for all-cause mortality is greater than the number of participants at risk for adverse events. Only participants who received intervention are eligible for adverse events reporting.
|
0.00%
0/476 • Up to 2 years
Adverse events will be assessed using CTCAE version 5.0. All cause mortality will be reported as all cause mortality within the two year time frame that was analyzed for the primary endpoint. Please note that the number of participants at risk for all-cause mortality is greater than the number of participants at risk for adverse events. Only participants who received intervention are eligible for adverse events reporting.
|
|
Infections and infestations
Catheter related infection
|
0.21%
1/481 • Up to 2 years
Adverse events will be assessed using CTCAE version 5.0. All cause mortality will be reported as all cause mortality within the two year time frame that was analyzed for the primary endpoint. Please note that the number of participants at risk for all-cause mortality is greater than the number of participants at risk for adverse events. Only participants who received intervention are eligible for adverse events reporting.
|
0.00%
0/476 • Up to 2 years
Adverse events will be assessed using CTCAE version 5.0. All cause mortality will be reported as all cause mortality within the two year time frame that was analyzed for the primary endpoint. Please note that the number of participants at risk for all-cause mortality is greater than the number of participants at risk for adverse events. Only participants who received intervention are eligible for adverse events reporting.
|
|
Infections and infestations
Enterocolitis infectious
|
0.21%
1/481 • Up to 2 years
Adverse events will be assessed using CTCAE version 5.0. All cause mortality will be reported as all cause mortality within the two year time frame that was analyzed for the primary endpoint. Please note that the number of participants at risk for all-cause mortality is greater than the number of participants at risk for adverse events. Only participants who received intervention are eligible for adverse events reporting.
|
0.00%
0/476 • Up to 2 years
Adverse events will be assessed using CTCAE version 5.0. All cause mortality will be reported as all cause mortality within the two year time frame that was analyzed for the primary endpoint. Please note that the number of participants at risk for all-cause mortality is greater than the number of participants at risk for adverse events. Only participants who received intervention are eligible for adverse events reporting.
|
|
Infections and infestations
Infections and infestations-Other
|
3.7%
18/481 • Up to 2 years
Adverse events will be assessed using CTCAE version 5.0. All cause mortality will be reported as all cause mortality within the two year time frame that was analyzed for the primary endpoint. Please note that the number of participants at risk for all-cause mortality is greater than the number of participants at risk for adverse events. Only participants who received intervention are eligible for adverse events reporting.
|
0.00%
0/476 • Up to 2 years
Adverse events will be assessed using CTCAE version 5.0. All cause mortality will be reported as all cause mortality within the two year time frame that was analyzed for the primary endpoint. Please note that the number of participants at risk for all-cause mortality is greater than the number of participants at risk for adverse events. Only participants who received intervention are eligible for adverse events reporting.
|
|
Infections and infestations
Lung infection
|
1.0%
5/481 • Up to 2 years
Adverse events will be assessed using CTCAE version 5.0. All cause mortality will be reported as all cause mortality within the two year time frame that was analyzed for the primary endpoint. Please note that the number of participants at risk for all-cause mortality is greater than the number of participants at risk for adverse events. Only participants who received intervention are eligible for adverse events reporting.
|
0.21%
1/476 • Up to 2 years
Adverse events will be assessed using CTCAE version 5.0. All cause mortality will be reported as all cause mortality within the two year time frame that was analyzed for the primary endpoint. Please note that the number of participants at risk for all-cause mortality is greater than the number of participants at risk for adverse events. Only participants who received intervention are eligible for adverse events reporting.
|
|
Infections and infestations
Sepsis
|
2.3%
11/481 • Up to 2 years
Adverse events will be assessed using CTCAE version 5.0. All cause mortality will be reported as all cause mortality within the two year time frame that was analyzed for the primary endpoint. Please note that the number of participants at risk for all-cause mortality is greater than the number of participants at risk for adverse events. Only participants who received intervention are eligible for adverse events reporting.
|
1.3%
6/476 • Up to 2 years
Adverse events will be assessed using CTCAE version 5.0. All cause mortality will be reported as all cause mortality within the two year time frame that was analyzed for the primary endpoint. Please note that the number of participants at risk for all-cause mortality is greater than the number of participants at risk for adverse events. Only participants who received intervention are eligible for adverse events reporting.
|
|
Infections and infestations
Skin infection
|
0.42%
2/481 • Up to 2 years
Adverse events will be assessed using CTCAE version 5.0. All cause mortality will be reported as all cause mortality within the two year time frame that was analyzed for the primary endpoint. Please note that the number of participants at risk for all-cause mortality is greater than the number of participants at risk for adverse events. Only participants who received intervention are eligible for adverse events reporting.
|
0.00%
0/476 • Up to 2 years
Adverse events will be assessed using CTCAE version 5.0. All cause mortality will be reported as all cause mortality within the two year time frame that was analyzed for the primary endpoint. Please note that the number of participants at risk for all-cause mortality is greater than the number of participants at risk for adverse events. Only participants who received intervention are eligible for adverse events reporting.
|
|
Infections and infestations
Upper respiratory infection
|
0.21%
1/481 • Up to 2 years
Adverse events will be assessed using CTCAE version 5.0. All cause mortality will be reported as all cause mortality within the two year time frame that was analyzed for the primary endpoint. Please note that the number of participants at risk for all-cause mortality is greater than the number of participants at risk for adverse events. Only participants who received intervention are eligible for adverse events reporting.
|
0.00%
0/476 • Up to 2 years
Adverse events will be assessed using CTCAE version 5.0. All cause mortality will be reported as all cause mortality within the two year time frame that was analyzed for the primary endpoint. Please note that the number of participants at risk for all-cause mortality is greater than the number of participants at risk for adverse events. Only participants who received intervention are eligible for adverse events reporting.
|
|
Infections and infestations
Urinary tract infection
|
0.42%
2/481 • Up to 2 years
Adverse events will be assessed using CTCAE version 5.0. All cause mortality will be reported as all cause mortality within the two year time frame that was analyzed for the primary endpoint. Please note that the number of participants at risk for all-cause mortality is greater than the number of participants at risk for adverse events. Only participants who received intervention are eligible for adverse events reporting.
|
0.00%
0/476 • Up to 2 years
Adverse events will be assessed using CTCAE version 5.0. All cause mortality will be reported as all cause mortality within the two year time frame that was analyzed for the primary endpoint. Please note that the number of participants at risk for all-cause mortality is greater than the number of participants at risk for adverse events. Only participants who received intervention are eligible for adverse events reporting.
|
|
Infections and infestations
Wound infection
|
0.62%
3/481 • Up to 2 years
Adverse events will be assessed using CTCAE version 5.0. All cause mortality will be reported as all cause mortality within the two year time frame that was analyzed for the primary endpoint. Please note that the number of participants at risk for all-cause mortality is greater than the number of participants at risk for adverse events. Only participants who received intervention are eligible for adverse events reporting.
|
0.00%
0/476 • Up to 2 years
Adverse events will be assessed using CTCAE version 5.0. All cause mortality will be reported as all cause mortality within the two year time frame that was analyzed for the primary endpoint. Please note that the number of participants at risk for all-cause mortality is greater than the number of participants at risk for adverse events. Only participants who received intervention are eligible for adverse events reporting.
|
|
Injury, poisoning and procedural complications
Fall
|
0.21%
1/481 • Up to 2 years
Adverse events will be assessed using CTCAE version 5.0. All cause mortality will be reported as all cause mortality within the two year time frame that was analyzed for the primary endpoint. Please note that the number of participants at risk for all-cause mortality is greater than the number of participants at risk for adverse events. Only participants who received intervention are eligible for adverse events reporting.
|
0.00%
0/476 • Up to 2 years
Adverse events will be assessed using CTCAE version 5.0. All cause mortality will be reported as all cause mortality within the two year time frame that was analyzed for the primary endpoint. Please note that the number of participants at risk for all-cause mortality is greater than the number of participants at risk for adverse events. Only participants who received intervention are eligible for adverse events reporting.
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.21%
1/481 • Up to 2 years
Adverse events will be assessed using CTCAE version 5.0. All cause mortality will be reported as all cause mortality within the two year time frame that was analyzed for the primary endpoint. Please note that the number of participants at risk for all-cause mortality is greater than the number of participants at risk for adverse events. Only participants who received intervention are eligible for adverse events reporting.
|
0.00%
0/476 • Up to 2 years
Adverse events will be assessed using CTCAE version 5.0. All cause mortality will be reported as all cause mortality within the two year time frame that was analyzed for the primary endpoint. Please note that the number of participants at risk for all-cause mortality is greater than the number of participants at risk for adverse events. Only participants who received intervention are eligible for adverse events reporting.
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
1.0%
5/481 • Up to 2 years
Adverse events will be assessed using CTCAE version 5.0. All cause mortality will be reported as all cause mortality within the two year time frame that was analyzed for the primary endpoint. Please note that the number of participants at risk for all-cause mortality is greater than the number of participants at risk for adverse events. Only participants who received intervention are eligible for adverse events reporting.
|
0.00%
0/476 • Up to 2 years
Adverse events will be assessed using CTCAE version 5.0. All cause mortality will be reported as all cause mortality within the two year time frame that was analyzed for the primary endpoint. Please note that the number of participants at risk for all-cause mortality is greater than the number of participants at risk for adverse events. Only participants who received intervention are eligible for adverse events reporting.
|
|
Injury, poisoning and procedural complications
Vascular access complication
|
0.21%
1/481 • Up to 2 years
Adverse events will be assessed using CTCAE version 5.0. All cause mortality will be reported as all cause mortality within the two year time frame that was analyzed for the primary endpoint. Please note that the number of participants at risk for all-cause mortality is greater than the number of participants at risk for adverse events. Only participants who received intervention are eligible for adverse events reporting.
|
0.00%
0/476 • Up to 2 years
Adverse events will be assessed using CTCAE version 5.0. All cause mortality will be reported as all cause mortality within the two year time frame that was analyzed for the primary endpoint. Please note that the number of participants at risk for all-cause mortality is greater than the number of participants at risk for adverse events. Only participants who received intervention are eligible for adverse events reporting.
|
|
Injury, poisoning and procedural complications
Wound dehiscence
|
0.21%
1/481 • Up to 2 years
Adverse events will be assessed using CTCAE version 5.0. All cause mortality will be reported as all cause mortality within the two year time frame that was analyzed for the primary endpoint. Please note that the number of participants at risk for all-cause mortality is greater than the number of participants at risk for adverse events. Only participants who received intervention are eligible for adverse events reporting.
|
0.00%
0/476 • Up to 2 years
Adverse events will be assessed using CTCAE version 5.0. All cause mortality will be reported as all cause mortality within the two year time frame that was analyzed for the primary endpoint. Please note that the number of participants at risk for all-cause mortality is greater than the number of participants at risk for adverse events. Only participants who received intervention are eligible for adverse events reporting.
|
|
Investigations
Activated partial thromboplastin time prolonged
|
0.21%
1/481 • Up to 2 years
Adverse events will be assessed using CTCAE version 5.0. All cause mortality will be reported as all cause mortality within the two year time frame that was analyzed for the primary endpoint. Please note that the number of participants at risk for all-cause mortality is greater than the number of participants at risk for adverse events. Only participants who received intervention are eligible for adverse events reporting.
|
0.00%
0/476 • Up to 2 years
Adverse events will be assessed using CTCAE version 5.0. All cause mortality will be reported as all cause mortality within the two year time frame that was analyzed for the primary endpoint. Please note that the number of participants at risk for all-cause mortality is greater than the number of participants at risk for adverse events. Only participants who received intervention are eligible for adverse events reporting.
|
|
Investigations
Alanine aminotransferase increased
|
0.83%
4/481 • Up to 2 years
Adverse events will be assessed using CTCAE version 5.0. All cause mortality will be reported as all cause mortality within the two year time frame that was analyzed for the primary endpoint. Please note that the number of participants at risk for all-cause mortality is greater than the number of participants at risk for adverse events. Only participants who received intervention are eligible for adverse events reporting.
|
0.00%
0/476 • Up to 2 years
Adverse events will be assessed using CTCAE version 5.0. All cause mortality will be reported as all cause mortality within the two year time frame that was analyzed for the primary endpoint. Please note that the number of participants at risk for all-cause mortality is greater than the number of participants at risk for adverse events. Only participants who received intervention are eligible for adverse events reporting.
|
|
Investigations
Alkaline phosphatase increased
|
0.21%
1/481 • Up to 2 years
Adverse events will be assessed using CTCAE version 5.0. All cause mortality will be reported as all cause mortality within the two year time frame that was analyzed for the primary endpoint. Please note that the number of participants at risk for all-cause mortality is greater than the number of participants at risk for adverse events. Only participants who received intervention are eligible for adverse events reporting.
|
0.00%
0/476 • Up to 2 years
Adverse events will be assessed using CTCAE version 5.0. All cause mortality will be reported as all cause mortality within the two year time frame that was analyzed for the primary endpoint. Please note that the number of participants at risk for all-cause mortality is greater than the number of participants at risk for adverse events. Only participants who received intervention are eligible for adverse events reporting.
|
|
Investigations
Aspartate aminotransferase increased
|
0.62%
3/481 • Up to 2 years
Adverse events will be assessed using CTCAE version 5.0. All cause mortality will be reported as all cause mortality within the two year time frame that was analyzed for the primary endpoint. Please note that the number of participants at risk for all-cause mortality is greater than the number of participants at risk for adverse events. Only participants who received intervention are eligible for adverse events reporting.
|
0.21%
1/476 • Up to 2 years
Adverse events will be assessed using CTCAE version 5.0. All cause mortality will be reported as all cause mortality within the two year time frame that was analyzed for the primary endpoint. Please note that the number of participants at risk for all-cause mortality is greater than the number of participants at risk for adverse events. Only participants who received intervention are eligible for adverse events reporting.
|
|
Investigations
Blood bilirubin increased
|
0.42%
2/481 • Up to 2 years
Adverse events will be assessed using CTCAE version 5.0. All cause mortality will be reported as all cause mortality within the two year time frame that was analyzed for the primary endpoint. Please note that the number of participants at risk for all-cause mortality is greater than the number of participants at risk for adverse events. Only participants who received intervention are eligible for adverse events reporting.
|
0.00%
0/476 • Up to 2 years
Adverse events will be assessed using CTCAE version 5.0. All cause mortality will be reported as all cause mortality within the two year time frame that was analyzed for the primary endpoint. Please note that the number of participants at risk for all-cause mortality is greater than the number of participants at risk for adverse events. Only participants who received intervention are eligible for adverse events reporting.
|
|
Investigations
Cardiac troponin T increased
|
0.21%
1/481 • Up to 2 years
Adverse events will be assessed using CTCAE version 5.0. All cause mortality will be reported as all cause mortality within the two year time frame that was analyzed for the primary endpoint. Please note that the number of participants at risk for all-cause mortality is greater than the number of participants at risk for adverse events. Only participants who received intervention are eligible for adverse events reporting.
|
0.00%
0/476 • Up to 2 years
Adverse events will be assessed using CTCAE version 5.0. All cause mortality will be reported as all cause mortality within the two year time frame that was analyzed for the primary endpoint. Please note that the number of participants at risk for all-cause mortality is greater than the number of participants at risk for adverse events. Only participants who received intervention are eligible for adverse events reporting.
|
|
Investigations
Creatinine increased
|
0.21%
1/481 • Up to 2 years
Adverse events will be assessed using CTCAE version 5.0. All cause mortality will be reported as all cause mortality within the two year time frame that was analyzed for the primary endpoint. Please note that the number of participants at risk for all-cause mortality is greater than the number of participants at risk for adverse events. Only participants who received intervention are eligible for adverse events reporting.
|
0.00%
0/476 • Up to 2 years
Adverse events will be assessed using CTCAE version 5.0. All cause mortality will be reported as all cause mortality within the two year time frame that was analyzed for the primary endpoint. Please note that the number of participants at risk for all-cause mortality is greater than the number of participants at risk for adverse events. Only participants who received intervention are eligible for adverse events reporting.
|
|
Investigations
Ejection fraction decreased
|
0.21%
1/481 • Up to 2 years
Adverse events will be assessed using CTCAE version 5.0. All cause mortality will be reported as all cause mortality within the two year time frame that was analyzed for the primary endpoint. Please note that the number of participants at risk for all-cause mortality is greater than the number of participants at risk for adverse events. Only participants who received intervention are eligible for adverse events reporting.
|
0.00%
0/476 • Up to 2 years
Adverse events will be assessed using CTCAE version 5.0. All cause mortality will be reported as all cause mortality within the two year time frame that was analyzed for the primary endpoint. Please note that the number of participants at risk for all-cause mortality is greater than the number of participants at risk for adverse events. Only participants who received intervention are eligible for adverse events reporting.
|
|
Investigations
GGT increased
|
0.21%
1/481 • Up to 2 years
Adverse events will be assessed using CTCAE version 5.0. All cause mortality will be reported as all cause mortality within the two year time frame that was analyzed for the primary endpoint. Please note that the number of participants at risk for all-cause mortality is greater than the number of participants at risk for adverse events. Only participants who received intervention are eligible for adverse events reporting.
|
0.00%
0/476 • Up to 2 years
Adverse events will be assessed using CTCAE version 5.0. All cause mortality will be reported as all cause mortality within the two year time frame that was analyzed for the primary endpoint. Please note that the number of participants at risk for all-cause mortality is greater than the number of participants at risk for adverse events. Only participants who received intervention are eligible for adverse events reporting.
|
|
Investigations
INR increased
|
0.62%
3/481 • Up to 2 years
Adverse events will be assessed using CTCAE version 5.0. All cause mortality will be reported as all cause mortality within the two year time frame that was analyzed for the primary endpoint. Please note that the number of participants at risk for all-cause mortality is greater than the number of participants at risk for adverse events. Only participants who received intervention are eligible for adverse events reporting.
|
0.00%
0/476 • Up to 2 years
Adverse events will be assessed using CTCAE version 5.0. All cause mortality will be reported as all cause mortality within the two year time frame that was analyzed for the primary endpoint. Please note that the number of participants at risk for all-cause mortality is greater than the number of participants at risk for adverse events. Only participants who received intervention are eligible for adverse events reporting.
|
|
Investigations
Investigations-Other
|
0.21%
1/481 • Up to 2 years
Adverse events will be assessed using CTCAE version 5.0. All cause mortality will be reported as all cause mortality within the two year time frame that was analyzed for the primary endpoint. Please note that the number of participants at risk for all-cause mortality is greater than the number of participants at risk for adverse events. Only participants who received intervention are eligible for adverse events reporting.
|
0.00%
0/476 • Up to 2 years
Adverse events will be assessed using CTCAE version 5.0. All cause mortality will be reported as all cause mortality within the two year time frame that was analyzed for the primary endpoint. Please note that the number of participants at risk for all-cause mortality is greater than the number of participants at risk for adverse events. Only participants who received intervention are eligible for adverse events reporting.
|
|
Investigations
Lipase increased
|
0.21%
1/481 • Up to 2 years
Adverse events will be assessed using CTCAE version 5.0. All cause mortality will be reported as all cause mortality within the two year time frame that was analyzed for the primary endpoint. Please note that the number of participants at risk for all-cause mortality is greater than the number of participants at risk for adverse events. Only participants who received intervention are eligible for adverse events reporting.
|
0.00%
0/476 • Up to 2 years
Adverse events will be assessed using CTCAE version 5.0. All cause mortality will be reported as all cause mortality within the two year time frame that was analyzed for the primary endpoint. Please note that the number of participants at risk for all-cause mortality is greater than the number of participants at risk for adverse events. Only participants who received intervention are eligible for adverse events reporting.
|
|
Investigations
Lymphocyte count increased
|
0.21%
1/481 • Up to 2 years
Adverse events will be assessed using CTCAE version 5.0. All cause mortality will be reported as all cause mortality within the two year time frame that was analyzed for the primary endpoint. Please note that the number of participants at risk for all-cause mortality is greater than the number of participants at risk for adverse events. Only participants who received intervention are eligible for adverse events reporting.
|
0.00%
0/476 • Up to 2 years
Adverse events will be assessed using CTCAE version 5.0. All cause mortality will be reported as all cause mortality within the two year time frame that was analyzed for the primary endpoint. Please note that the number of participants at risk for all-cause mortality is greater than the number of participants at risk for adverse events. Only participants who received intervention are eligible for adverse events reporting.
|
|
Investigations
Neutrophil count decreased
|
6.2%
30/481 • Up to 2 years
Adverse events will be assessed using CTCAE version 5.0. All cause mortality will be reported as all cause mortality within the two year time frame that was analyzed for the primary endpoint. Please note that the number of participants at risk for all-cause mortality is greater than the number of participants at risk for adverse events. Only participants who received intervention are eligible for adverse events reporting.
|
0.63%
3/476 • Up to 2 years
Adverse events will be assessed using CTCAE version 5.0. All cause mortality will be reported as all cause mortality within the two year time frame that was analyzed for the primary endpoint. Please note that the number of participants at risk for all-cause mortality is greater than the number of participants at risk for adverse events. Only participants who received intervention are eligible for adverse events reporting.
|
|
Investigations
Platelet count decreased
|
1.5%
7/481 • Up to 2 years
Adverse events will be assessed using CTCAE version 5.0. All cause mortality will be reported as all cause mortality within the two year time frame that was analyzed for the primary endpoint. Please note that the number of participants at risk for all-cause mortality is greater than the number of participants at risk for adverse events. Only participants who received intervention are eligible for adverse events reporting.
|
0.21%
1/476 • Up to 2 years
Adverse events will be assessed using CTCAE version 5.0. All cause mortality will be reported as all cause mortality within the two year time frame that was analyzed for the primary endpoint. Please note that the number of participants at risk for all-cause mortality is greater than the number of participants at risk for adverse events. Only participants who received intervention are eligible for adverse events reporting.
|
|
Investigations
White blood cell decreased
|
2.3%
11/481 • Up to 2 years
Adverse events will be assessed using CTCAE version 5.0. All cause mortality will be reported as all cause mortality within the two year time frame that was analyzed for the primary endpoint. Please note that the number of participants at risk for all-cause mortality is greater than the number of participants at risk for adverse events. Only participants who received intervention are eligible for adverse events reporting.
|
0.00%
0/476 • Up to 2 years
Adverse events will be assessed using CTCAE version 5.0. All cause mortality will be reported as all cause mortality within the two year time frame that was analyzed for the primary endpoint. Please note that the number of participants at risk for all-cause mortality is greater than the number of participants at risk for adverse events. Only participants who received intervention are eligible for adverse events reporting.
|
|
Metabolism and nutrition disorders
Dehydration
|
1.5%
7/481 • Up to 2 years
Adverse events will be assessed using CTCAE version 5.0. All cause mortality will be reported as all cause mortality within the two year time frame that was analyzed for the primary endpoint. Please note that the number of participants at risk for all-cause mortality is greater than the number of participants at risk for adverse events. Only participants who received intervention are eligible for adverse events reporting.
|
0.00%
0/476 • Up to 2 years
Adverse events will be assessed using CTCAE version 5.0. All cause mortality will be reported as all cause mortality within the two year time frame that was analyzed for the primary endpoint. Please note that the number of participants at risk for all-cause mortality is greater than the number of participants at risk for adverse events. Only participants who received intervention are eligible for adverse events reporting.
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
0.21%
1/481 • Up to 2 years
Adverse events will be assessed using CTCAE version 5.0. All cause mortality will be reported as all cause mortality within the two year time frame that was analyzed for the primary endpoint. Please note that the number of participants at risk for all-cause mortality is greater than the number of participants at risk for adverse events. Only participants who received intervention are eligible for adverse events reporting.
|
0.00%
0/476 • Up to 2 years
Adverse events will be assessed using CTCAE version 5.0. All cause mortality will be reported as all cause mortality within the two year time frame that was analyzed for the primary endpoint. Please note that the number of participants at risk for all-cause mortality is greater than the number of participants at risk for adverse events. Only participants who received intervention are eligible for adverse events reporting.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
0.62%
3/481 • Up to 2 years
Adverse events will be assessed using CTCAE version 5.0. All cause mortality will be reported as all cause mortality within the two year time frame that was analyzed for the primary endpoint. Please note that the number of participants at risk for all-cause mortality is greater than the number of participants at risk for adverse events. Only participants who received intervention are eligible for adverse events reporting.
|
0.00%
0/476 • Up to 2 years
Adverse events will be assessed using CTCAE version 5.0. All cause mortality will be reported as all cause mortality within the two year time frame that was analyzed for the primary endpoint. Please note that the number of participants at risk for all-cause mortality is greater than the number of participants at risk for adverse events. Only participants who received intervention are eligible for adverse events reporting.
|
|
Metabolism and nutrition disorders
Hypermagnesemia
|
0.21%
1/481 • Up to 2 years
Adverse events will be assessed using CTCAE version 5.0. All cause mortality will be reported as all cause mortality within the two year time frame that was analyzed for the primary endpoint. Please note that the number of participants at risk for all-cause mortality is greater than the number of participants at risk for adverse events. Only participants who received intervention are eligible for adverse events reporting.
|
0.00%
0/476 • Up to 2 years
Adverse events will be assessed using CTCAE version 5.0. All cause mortality will be reported as all cause mortality within the two year time frame that was analyzed for the primary endpoint. Please note that the number of participants at risk for all-cause mortality is greater than the number of participants at risk for adverse events. Only participants who received intervention are eligible for adverse events reporting.
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
0.42%
2/481 • Up to 2 years
Adverse events will be assessed using CTCAE version 5.0. All cause mortality will be reported as all cause mortality within the two year time frame that was analyzed for the primary endpoint. Please note that the number of participants at risk for all-cause mortality is greater than the number of participants at risk for adverse events. Only participants who received intervention are eligible for adverse events reporting.
|
0.00%
0/476 • Up to 2 years
Adverse events will be assessed using CTCAE version 5.0. All cause mortality will be reported as all cause mortality within the two year time frame that was analyzed for the primary endpoint. Please note that the number of participants at risk for all-cause mortality is greater than the number of participants at risk for adverse events. Only participants who received intervention are eligible for adverse events reporting.
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
0.21%
1/481 • Up to 2 years
Adverse events will be assessed using CTCAE version 5.0. All cause mortality will be reported as all cause mortality within the two year time frame that was analyzed for the primary endpoint. Please note that the number of participants at risk for all-cause mortality is greater than the number of participants at risk for adverse events. Only participants who received intervention are eligible for adverse events reporting.
|
0.00%
0/476 • Up to 2 years
Adverse events will be assessed using CTCAE version 5.0. All cause mortality will be reported as all cause mortality within the two year time frame that was analyzed for the primary endpoint. Please note that the number of participants at risk for all-cause mortality is greater than the number of participants at risk for adverse events. Only participants who received intervention are eligible for adverse events reporting.
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
0.21%
1/481 • Up to 2 years
Adverse events will be assessed using CTCAE version 5.0. All cause mortality will be reported as all cause mortality within the two year time frame that was analyzed for the primary endpoint. Please note that the number of participants at risk for all-cause mortality is greater than the number of participants at risk for adverse events. Only participants who received intervention are eligible for adverse events reporting.
|
0.00%
0/476 • Up to 2 years
Adverse events will be assessed using CTCAE version 5.0. All cause mortality will be reported as all cause mortality within the two year time frame that was analyzed for the primary endpoint. Please note that the number of participants at risk for all-cause mortality is greater than the number of participants at risk for adverse events. Only participants who received intervention are eligible for adverse events reporting.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
0.83%
4/481 • Up to 2 years
Adverse events will be assessed using CTCAE version 5.0. All cause mortality will be reported as all cause mortality within the two year time frame that was analyzed for the primary endpoint. Please note that the number of participants at risk for all-cause mortality is greater than the number of participants at risk for adverse events. Only participants who received intervention are eligible for adverse events reporting.
|
0.00%
0/476 • Up to 2 years
Adverse events will be assessed using CTCAE version 5.0. All cause mortality will be reported as all cause mortality within the two year time frame that was analyzed for the primary endpoint. Please note that the number of participants at risk for all-cause mortality is greater than the number of participants at risk for adverse events. Only participants who received intervention are eligible for adverse events reporting.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
0.62%
3/481 • Up to 2 years
Adverse events will be assessed using CTCAE version 5.0. All cause mortality will be reported as all cause mortality within the two year time frame that was analyzed for the primary endpoint. Please note that the number of participants at risk for all-cause mortality is greater than the number of participants at risk for adverse events. Only participants who received intervention are eligible for adverse events reporting.
|
0.00%
0/476 • Up to 2 years
Adverse events will be assessed using CTCAE version 5.0. All cause mortality will be reported as all cause mortality within the two year time frame that was analyzed for the primary endpoint. Please note that the number of participants at risk for all-cause mortality is greater than the number of participants at risk for adverse events. Only participants who received intervention are eligible for adverse events reporting.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.21%
1/481 • Up to 2 years
Adverse events will be assessed using CTCAE version 5.0. All cause mortality will be reported as all cause mortality within the two year time frame that was analyzed for the primary endpoint. Please note that the number of participants at risk for all-cause mortality is greater than the number of participants at risk for adverse events. Only participants who received intervention are eligible for adverse events reporting.
|
0.00%
0/476 • Up to 2 years
Adverse events will be assessed using CTCAE version 5.0. All cause mortality will be reported as all cause mortality within the two year time frame that was analyzed for the primary endpoint. Please note that the number of participants at risk for all-cause mortality is greater than the number of participants at risk for adverse events. Only participants who received intervention are eligible for adverse events reporting.
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness lower limb
|
0.21%
1/481 • Up to 2 years
Adverse events will be assessed using CTCAE version 5.0. All cause mortality will be reported as all cause mortality within the two year time frame that was analyzed for the primary endpoint. Please note that the number of participants at risk for all-cause mortality is greater than the number of participants at risk for adverse events. Only participants who received intervention are eligible for adverse events reporting.
|
0.00%
0/476 • Up to 2 years
Adverse events will be assessed using CTCAE version 5.0. All cause mortality will be reported as all cause mortality within the two year time frame that was analyzed for the primary endpoint. Please note that the number of participants at risk for all-cause mortality is greater than the number of participants at risk for adverse events. Only participants who received intervention are eligible for adverse events reporting.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.21%
1/481 • Up to 2 years
Adverse events will be assessed using CTCAE version 5.0. All cause mortality will be reported as all cause mortality within the two year time frame that was analyzed for the primary endpoint. Please note that the number of participants at risk for all-cause mortality is greater than the number of participants at risk for adverse events. Only participants who received intervention are eligible for adverse events reporting.
|
0.00%
0/476 • Up to 2 years
Adverse events will be assessed using CTCAE version 5.0. All cause mortality will be reported as all cause mortality within the two year time frame that was analyzed for the primary endpoint. Please note that the number of participants at risk for all-cause mortality is greater than the number of participants at risk for adverse events. Only participants who received intervention are eligible for adverse events reporting.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Treatment related secondary malignancy
|
0.21%
1/481 • Up to 2 years
Adverse events will be assessed using CTCAE version 5.0. All cause mortality will be reported as all cause mortality within the two year time frame that was analyzed for the primary endpoint. Please note that the number of participants at risk for all-cause mortality is greater than the number of participants at risk for adverse events. Only participants who received intervention are eligible for adverse events reporting.
|
0.00%
0/476 • Up to 2 years
Adverse events will be assessed using CTCAE version 5.0. All cause mortality will be reported as all cause mortality within the two year time frame that was analyzed for the primary endpoint. Please note that the number of participants at risk for all-cause mortality is greater than the number of participants at risk for adverse events. Only participants who received intervention are eligible for adverse events reporting.
|
|
Nervous system disorders
Depressed level of consciousness
|
0.00%
0/481 • Up to 2 years
Adverse events will be assessed using CTCAE version 5.0. All cause mortality will be reported as all cause mortality within the two year time frame that was analyzed for the primary endpoint. Please note that the number of participants at risk for all-cause mortality is greater than the number of participants at risk for adverse events. Only participants who received intervention are eligible for adverse events reporting.
|
0.42%
2/476 • Up to 2 years
Adverse events will be assessed using CTCAE version 5.0. All cause mortality will be reported as all cause mortality within the two year time frame that was analyzed for the primary endpoint. Please note that the number of participants at risk for all-cause mortality is greater than the number of participants at risk for adverse events. Only participants who received intervention are eligible for adverse events reporting.
|
|
Nervous system disorders
Encephalopathy
|
0.00%
0/481 • Up to 2 years
Adverse events will be assessed using CTCAE version 5.0. All cause mortality will be reported as all cause mortality within the two year time frame that was analyzed for the primary endpoint. Please note that the number of participants at risk for all-cause mortality is greater than the number of participants at risk for adverse events. Only participants who received intervention are eligible for adverse events reporting.
|
0.21%
1/476 • Up to 2 years
Adverse events will be assessed using CTCAE version 5.0. All cause mortality will be reported as all cause mortality within the two year time frame that was analyzed for the primary endpoint. Please note that the number of participants at risk for all-cause mortality is greater than the number of participants at risk for adverse events. Only participants who received intervention are eligible for adverse events reporting.
|
|
Nervous system disorders
Guillain-Barre syndrome
|
0.00%
0/481 • Up to 2 years
Adverse events will be assessed using CTCAE version 5.0. All cause mortality will be reported as all cause mortality within the two year time frame that was analyzed for the primary endpoint. Please note that the number of participants at risk for all-cause mortality is greater than the number of participants at risk for adverse events. Only participants who received intervention are eligible for adverse events reporting.
|
0.21%
1/476 • Up to 2 years
Adverse events will be assessed using CTCAE version 5.0. All cause mortality will be reported as all cause mortality within the two year time frame that was analyzed for the primary endpoint. Please note that the number of participants at risk for all-cause mortality is greater than the number of participants at risk for adverse events. Only participants who received intervention are eligible for adverse events reporting.
|
|
Nervous system disorders
Headache
|
0.62%
3/481 • Up to 2 years
Adverse events will be assessed using CTCAE version 5.0. All cause mortality will be reported as all cause mortality within the two year time frame that was analyzed for the primary endpoint. Please note that the number of participants at risk for all-cause mortality is greater than the number of participants at risk for adverse events. Only participants who received intervention are eligible for adverse events reporting.
|
0.00%
0/476 • Up to 2 years
Adverse events will be assessed using CTCAE version 5.0. All cause mortality will be reported as all cause mortality within the two year time frame that was analyzed for the primary endpoint. Please note that the number of participants at risk for all-cause mortality is greater than the number of participants at risk for adverse events. Only participants who received intervention are eligible for adverse events reporting.
|
|
Nervous system disorders
Lethargy
|
0.21%
1/481 • Up to 2 years
Adverse events will be assessed using CTCAE version 5.0. All cause mortality will be reported as all cause mortality within the two year time frame that was analyzed for the primary endpoint. Please note that the number of participants at risk for all-cause mortality is greater than the number of participants at risk for adverse events. Only participants who received intervention are eligible for adverse events reporting.
|
0.00%
0/476 • Up to 2 years
Adverse events will be assessed using CTCAE version 5.0. All cause mortality will be reported as all cause mortality within the two year time frame that was analyzed for the primary endpoint. Please note that the number of participants at risk for all-cause mortality is greater than the number of participants at risk for adverse events. Only participants who received intervention are eligible for adverse events reporting.
|
|
Nervous system disorders
Nervous system disorders-Other
|
0.83%
4/481 • Up to 2 years
Adverse events will be assessed using CTCAE version 5.0. All cause mortality will be reported as all cause mortality within the two year time frame that was analyzed for the primary endpoint. Please note that the number of participants at risk for all-cause mortality is greater than the number of participants at risk for adverse events. Only participants who received intervention are eligible for adverse events reporting.
|
0.00%
0/476 • Up to 2 years
Adverse events will be assessed using CTCAE version 5.0. All cause mortality will be reported as all cause mortality within the two year time frame that was analyzed for the primary endpoint. Please note that the number of participants at risk for all-cause mortality is greater than the number of participants at risk for adverse events. Only participants who received intervention are eligible for adverse events reporting.
|
|
Nervous system disorders
Peripheral motor neuropathy
|
0.21%
1/481 • Up to 2 years
Adverse events will be assessed using CTCAE version 5.0. All cause mortality will be reported as all cause mortality within the two year time frame that was analyzed for the primary endpoint. Please note that the number of participants at risk for all-cause mortality is greater than the number of participants at risk for adverse events. Only participants who received intervention are eligible for adverse events reporting.
|
0.00%
0/476 • Up to 2 years
Adverse events will be assessed using CTCAE version 5.0. All cause mortality will be reported as all cause mortality within the two year time frame that was analyzed for the primary endpoint. Please note that the number of participants at risk for all-cause mortality is greater than the number of participants at risk for adverse events. Only participants who received intervention are eligible for adverse events reporting.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
0.21%
1/481 • Up to 2 years
Adverse events will be assessed using CTCAE version 5.0. All cause mortality will be reported as all cause mortality within the two year time frame that was analyzed for the primary endpoint. Please note that the number of participants at risk for all-cause mortality is greater than the number of participants at risk for adverse events. Only participants who received intervention are eligible for adverse events reporting.
|
0.00%
0/476 • Up to 2 years
Adverse events will be assessed using CTCAE version 5.0. All cause mortality will be reported as all cause mortality within the two year time frame that was analyzed for the primary endpoint. Please note that the number of participants at risk for all-cause mortality is greater than the number of participants at risk for adverse events. Only participants who received intervention are eligible for adverse events reporting.
|
|
Nervous system disorders
Seizure
|
0.42%
2/481 • Up to 2 years
Adverse events will be assessed using CTCAE version 5.0. All cause mortality will be reported as all cause mortality within the two year time frame that was analyzed for the primary endpoint. Please note that the number of participants at risk for all-cause mortality is greater than the number of participants at risk for adverse events. Only participants who received intervention are eligible for adverse events reporting.
|
0.00%
0/476 • Up to 2 years
Adverse events will be assessed using CTCAE version 5.0. All cause mortality will be reported as all cause mortality within the two year time frame that was analyzed for the primary endpoint. Please note that the number of participants at risk for all-cause mortality is greater than the number of participants at risk for adverse events. Only participants who received intervention are eligible for adverse events reporting.
|
|
Nervous system disorders
Stroke
|
0.21%
1/481 • Up to 2 years
Adverse events will be assessed using CTCAE version 5.0. All cause mortality will be reported as all cause mortality within the two year time frame that was analyzed for the primary endpoint. Please note that the number of participants at risk for all-cause mortality is greater than the number of participants at risk for adverse events. Only participants who received intervention are eligible for adverse events reporting.
|
0.00%
0/476 • Up to 2 years
Adverse events will be assessed using CTCAE version 5.0. All cause mortality will be reported as all cause mortality within the two year time frame that was analyzed for the primary endpoint. Please note that the number of participants at risk for all-cause mortality is greater than the number of participants at risk for adverse events. Only participants who received intervention are eligible for adverse events reporting.
|
|
Nervous system disorders
Syncope
|
0.21%
1/481 • Up to 2 years
Adverse events will be assessed using CTCAE version 5.0. All cause mortality will be reported as all cause mortality within the two year time frame that was analyzed for the primary endpoint. Please note that the number of participants at risk for all-cause mortality is greater than the number of participants at risk for adverse events. Only participants who received intervention are eligible for adverse events reporting.
|
0.00%
0/476 • Up to 2 years
Adverse events will be assessed using CTCAE version 5.0. All cause mortality will be reported as all cause mortality within the two year time frame that was analyzed for the primary endpoint. Please note that the number of participants at risk for all-cause mortality is greater than the number of participants at risk for adverse events. Only participants who received intervention are eligible for adverse events reporting.
|
|
Pregnancy, puerperium and perinatal conditions
Pregnancy, puerperium and perinatal conditions-Oth
|
0.62%
3/481 • Up to 2 years
Adverse events will be assessed using CTCAE version 5.0. All cause mortality will be reported as all cause mortality within the two year time frame that was analyzed for the primary endpoint. Please note that the number of participants at risk for all-cause mortality is greater than the number of participants at risk for adverse events. Only participants who received intervention are eligible for adverse events reporting.
|
0.00%
0/476 • Up to 2 years
Adverse events will be assessed using CTCAE version 5.0. All cause mortality will be reported as all cause mortality within the two year time frame that was analyzed for the primary endpoint. Please note that the number of participants at risk for all-cause mortality is greater than the number of participants at risk for adverse events. Only participants who received intervention are eligible for adverse events reporting.
|
|
Psychiatric disorders
Confusion
|
0.21%
1/481 • Up to 2 years
Adverse events will be assessed using CTCAE version 5.0. All cause mortality will be reported as all cause mortality within the two year time frame that was analyzed for the primary endpoint. Please note that the number of participants at risk for all-cause mortality is greater than the number of participants at risk for adverse events. Only participants who received intervention are eligible for adverse events reporting.
|
0.00%
0/476 • Up to 2 years
Adverse events will be assessed using CTCAE version 5.0. All cause mortality will be reported as all cause mortality within the two year time frame that was analyzed for the primary endpoint. Please note that the number of participants at risk for all-cause mortality is greater than the number of participants at risk for adverse events. Only participants who received intervention are eligible for adverse events reporting.
|
|
Psychiatric disorders
Suicidal ideation
|
0.21%
1/481 • Up to 2 years
Adverse events will be assessed using CTCAE version 5.0. All cause mortality will be reported as all cause mortality within the two year time frame that was analyzed for the primary endpoint. Please note that the number of participants at risk for all-cause mortality is greater than the number of participants at risk for adverse events. Only participants who received intervention are eligible for adverse events reporting.
|
0.00%
0/476 • Up to 2 years
Adverse events will be assessed using CTCAE version 5.0. All cause mortality will be reported as all cause mortality within the two year time frame that was analyzed for the primary endpoint. Please note that the number of participants at risk for all-cause mortality is greater than the number of participants at risk for adverse events. Only participants who received intervention are eligible for adverse events reporting.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.83%
4/481 • Up to 2 years
Adverse events will be assessed using CTCAE version 5.0. All cause mortality will be reported as all cause mortality within the two year time frame that was analyzed for the primary endpoint. Please note that the number of participants at risk for all-cause mortality is greater than the number of participants at risk for adverse events. Only participants who received intervention are eligible for adverse events reporting.
|
0.42%
2/476 • Up to 2 years
Adverse events will be assessed using CTCAE version 5.0. All cause mortality will be reported as all cause mortality within the two year time frame that was analyzed for the primary endpoint. Please note that the number of participants at risk for all-cause mortality is greater than the number of participants at risk for adverse events. Only participants who received intervention are eligible for adverse events reporting.
|
|
Renal and urinary disorders
Hematuria
|
0.21%
1/481 • Up to 2 years
Adverse events will be assessed using CTCAE version 5.0. All cause mortality will be reported as all cause mortality within the two year time frame that was analyzed for the primary endpoint. Please note that the number of participants at risk for all-cause mortality is greater than the number of participants at risk for adverse events. Only participants who received intervention are eligible for adverse events reporting.
|
0.00%
0/476 • Up to 2 years
Adverse events will be assessed using CTCAE version 5.0. All cause mortality will be reported as all cause mortality within the two year time frame that was analyzed for the primary endpoint. Please note that the number of participants at risk for all-cause mortality is greater than the number of participants at risk for adverse events. Only participants who received intervention are eligible for adverse events reporting.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.21%
1/481 • Up to 2 years
Adverse events will be assessed using CTCAE version 5.0. All cause mortality will be reported as all cause mortality within the two year time frame that was analyzed for the primary endpoint. Please note that the number of participants at risk for all-cause mortality is greater than the number of participants at risk for adverse events. Only participants who received intervention are eligible for adverse events reporting.
|
0.00%
0/476 • Up to 2 years
Adverse events will be assessed using CTCAE version 5.0. All cause mortality will be reported as all cause mortality within the two year time frame that was analyzed for the primary endpoint. Please note that the number of participants at risk for all-cause mortality is greater than the number of participants at risk for adverse events. Only participants who received intervention are eligible for adverse events reporting.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
1.5%
7/481 • Up to 2 years
Adverse events will be assessed using CTCAE version 5.0. All cause mortality will be reported as all cause mortality within the two year time frame that was analyzed for the primary endpoint. Please note that the number of participants at risk for all-cause mortality is greater than the number of participants at risk for adverse events. Only participants who received intervention are eligible for adverse events reporting.
|
0.42%
2/476 • Up to 2 years
Adverse events will be assessed using CTCAE version 5.0. All cause mortality will be reported as all cause mortality within the two year time frame that was analyzed for the primary endpoint. Please note that the number of participants at risk for all-cause mortality is greater than the number of participants at risk for adverse events. Only participants who received intervention are eligible for adverse events reporting.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.21%
1/481 • Up to 2 years
Adverse events will be assessed using CTCAE version 5.0. All cause mortality will be reported as all cause mortality within the two year time frame that was analyzed for the primary endpoint. Please note that the number of participants at risk for all-cause mortality is greater than the number of participants at risk for adverse events. Only participants who received intervention are eligible for adverse events reporting.
|
0.21%
1/476 • Up to 2 years
Adverse events will be assessed using CTCAE version 5.0. All cause mortality will be reported as all cause mortality within the two year time frame that was analyzed for the primary endpoint. Please note that the number of participants at risk for all-cause mortality is greater than the number of participants at risk for adverse events. Only participants who received intervention are eligible for adverse events reporting.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.42%
2/481 • Up to 2 years
Adverse events will be assessed using CTCAE version 5.0. All cause mortality will be reported as all cause mortality within the two year time frame that was analyzed for the primary endpoint. Please note that the number of participants at risk for all-cause mortality is greater than the number of participants at risk for adverse events. Only participants who received intervention are eligible for adverse events reporting.
|
0.21%
1/476 • Up to 2 years
Adverse events will be assessed using CTCAE version 5.0. All cause mortality will be reported as all cause mortality within the two year time frame that was analyzed for the primary endpoint. Please note that the number of participants at risk for all-cause mortality is greater than the number of participants at risk for adverse events. Only participants who received intervention are eligible for adverse events reporting.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.83%
4/481 • Up to 2 years
Adverse events will be assessed using CTCAE version 5.0. All cause mortality will be reported as all cause mortality within the two year time frame that was analyzed for the primary endpoint. Please note that the number of participants at risk for all-cause mortality is greater than the number of participants at risk for adverse events. Only participants who received intervention are eligible for adverse events reporting.
|
0.21%
1/476 • Up to 2 years
Adverse events will be assessed using CTCAE version 5.0. All cause mortality will be reported as all cause mortality within the two year time frame that was analyzed for the primary endpoint. Please note that the number of participants at risk for all-cause mortality is greater than the number of participants at risk for adverse events. Only participants who received intervention are eligible for adverse events reporting.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary edema
|
0.21%
1/481 • Up to 2 years
Adverse events will be assessed using CTCAE version 5.0. All cause mortality will be reported as all cause mortality within the two year time frame that was analyzed for the primary endpoint. Please note that the number of participants at risk for all-cause mortality is greater than the number of participants at risk for adverse events. Only participants who received intervention are eligible for adverse events reporting.
|
0.21%
1/476 • Up to 2 years
Adverse events will be assessed using CTCAE version 5.0. All cause mortality will be reported as all cause mortality within the two year time frame that was analyzed for the primary endpoint. Please note that the number of participants at risk for all-cause mortality is greater than the number of participants at risk for adverse events. Only participants who received intervention are eligible for adverse events reporting.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/481 • Up to 2 years
Adverse events will be assessed using CTCAE version 5.0. All cause mortality will be reported as all cause mortality within the two year time frame that was analyzed for the primary endpoint. Please note that the number of participants at risk for all-cause mortality is greater than the number of participants at risk for adverse events. Only participants who received intervention are eligible for adverse events reporting.
|
0.63%
3/476 • Up to 2 years
Adverse events will be assessed using CTCAE version 5.0. All cause mortality will be reported as all cause mortality within the two year time frame that was analyzed for the primary endpoint. Please note that the number of participants at risk for all-cause mortality is greater than the number of participants at risk for adverse events. Only participants who received intervention are eligible for adverse events reporting.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders-Ot
|
0.21%
1/481 • Up to 2 years
Adverse events will be assessed using CTCAE version 5.0. All cause mortality will be reported as all cause mortality within the two year time frame that was analyzed for the primary endpoint. Please note that the number of participants at risk for all-cause mortality is greater than the number of participants at risk for adverse events. Only participants who received intervention are eligible for adverse events reporting.
|
0.00%
0/476 • Up to 2 years
Adverse events will be assessed using CTCAE version 5.0. All cause mortality will be reported as all cause mortality within the two year time frame that was analyzed for the primary endpoint. Please note that the number of participants at risk for all-cause mortality is greater than the number of participants at risk for adverse events. Only participants who received intervention are eligible for adverse events reporting.
|
|
Skin and subcutaneous tissue disorders
Erythroderma
|
0.21%
1/481 • Up to 2 years
Adverse events will be assessed using CTCAE version 5.0. All cause mortality will be reported as all cause mortality within the two year time frame that was analyzed for the primary endpoint. Please note that the number of participants at risk for all-cause mortality is greater than the number of participants at risk for adverse events. Only participants who received intervention are eligible for adverse events reporting.
|
0.00%
0/476 • Up to 2 years
Adverse events will be assessed using CTCAE version 5.0. All cause mortality will be reported as all cause mortality within the two year time frame that was analyzed for the primary endpoint. Please note that the number of participants at risk for all-cause mortality is greater than the number of participants at risk for adverse events. Only participants who received intervention are eligible for adverse events reporting.
|
|
Vascular disorders
Hypertension
|
0.21%
1/481 • Up to 2 years
Adverse events will be assessed using CTCAE version 5.0. All cause mortality will be reported as all cause mortality within the two year time frame that was analyzed for the primary endpoint. Please note that the number of participants at risk for all-cause mortality is greater than the number of participants at risk for adverse events. Only participants who received intervention are eligible for adverse events reporting.
|
0.00%
0/476 • Up to 2 years
Adverse events will be assessed using CTCAE version 5.0. All cause mortality will be reported as all cause mortality within the two year time frame that was analyzed for the primary endpoint. Please note that the number of participants at risk for all-cause mortality is greater than the number of participants at risk for adverse events. Only participants who received intervention are eligible for adverse events reporting.
|
|
Vascular disorders
Hypotension
|
1.0%
5/481 • Up to 2 years
Adverse events will be assessed using CTCAE version 5.0. All cause mortality will be reported as all cause mortality within the two year time frame that was analyzed for the primary endpoint. Please note that the number of participants at risk for all-cause mortality is greater than the number of participants at risk for adverse events. Only participants who received intervention are eligible for adverse events reporting.
|
0.21%
1/476 • Up to 2 years
Adverse events will be assessed using CTCAE version 5.0. All cause mortality will be reported as all cause mortality within the two year time frame that was analyzed for the primary endpoint. Please note that the number of participants at risk for all-cause mortality is greater than the number of participants at risk for adverse events. Only participants who received intervention are eligible for adverse events reporting.
|
|
Vascular disorders
Thromboembolic event
|
2.1%
10/481 • Up to 2 years
Adverse events will be assessed using CTCAE version 5.0. All cause mortality will be reported as all cause mortality within the two year time frame that was analyzed for the primary endpoint. Please note that the number of participants at risk for all-cause mortality is greater than the number of participants at risk for adverse events. Only participants who received intervention are eligible for adverse events reporting.
|
0.00%
0/476 • Up to 2 years
Adverse events will be assessed using CTCAE version 5.0. All cause mortality will be reported as all cause mortality within the two year time frame that was analyzed for the primary endpoint. Please note that the number of participants at risk for all-cause mortality is greater than the number of participants at risk for adverse events. Only participants who received intervention are eligible for adverse events reporting.
|
|
Vascular disorders
Vascular disorders-Other
|
0.21%
1/481 • Up to 2 years
Adverse events will be assessed using CTCAE version 5.0. All cause mortality will be reported as all cause mortality within the two year time frame that was analyzed for the primary endpoint. Please note that the number of participants at risk for all-cause mortality is greater than the number of participants at risk for adverse events. Only participants who received intervention are eligible for adverse events reporting.
|
0.00%
0/476 • Up to 2 years
Adverse events will be assessed using CTCAE version 5.0. All cause mortality will be reported as all cause mortality within the two year time frame that was analyzed for the primary endpoint. Please note that the number of participants at risk for all-cause mortality is greater than the number of participants at risk for adverse events. Only participants who received intervention are eligible for adverse events reporting.
|
Other adverse events
| Measure |
Arm I (Chemotherapy, Nivolumab, Radiation)
n=481 participants at risk
Patients receive doxorubicin hydrochloride IV, vinblastine sulfate IV, dacarbazine IV, and nivolumab IV over 30 minutes on days 1 and 15. Patients may receive pegfilgrastim SC on days 2 and 16, or filgrastim SC or IV on days 6-10 and 21-25. Treatment repeats every 28 days for 6 cycles in the absence of disease progression or unacceptable toxicity. After completion of cycle 6, patients may receive radiation therapy 5 days per week for approximately 4 weeks at the discretion of the treating physician. Patients also undergo peripheral blood specimen collection and CT, PET/CT and MRI on study.
|
Arm II (Chemotherapy, Brentuximab Vedotin, Radiation)
n=476 participants at risk
Patients receive doxorubicin hydrochloride IV, vinblastine sulfate IV, dacarbazine IV, and brentuximab vedotin IV over 30 minutes on days 1 and 15. Patients may receive pegfilgrastim SC on days 2 and 16, or filgrastim SC or IV on days 6-10 and 21-25. Treatment repeats every 28 days for 6 cycles in the absence of disease progression or unacceptable toxicity. After completion of cycle 6, patients may receive radiation therapy 5 days per week for approximately 4 weeks at the discretion of the treating physician. Patients also undergo peripheral blood specimen collection and CT, PET/CT and MRI on study.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
52.2%
251/481 • Up to 2 years
Adverse events will be assessed using CTCAE version 5.0. All cause mortality will be reported as all cause mortality within the two year time frame that was analyzed for the primary endpoint. Please note that the number of participants at risk for all-cause mortality is greater than the number of participants at risk for adverse events. Only participants who received intervention are eligible for adverse events reporting.
|
52.9%
252/476 • Up to 2 years
Adverse events will be assessed using CTCAE version 5.0. All cause mortality will be reported as all cause mortality within the two year time frame that was analyzed for the primary endpoint. Please note that the number of participants at risk for all-cause mortality is greater than the number of participants at risk for adverse events. Only participants who received intervention are eligible for adverse events reporting.
|
|
Blood and lymphatic system disorders
Eosinophilia
|
4.8%
23/481 • Up to 2 years
Adverse events will be assessed using CTCAE version 5.0. All cause mortality will be reported as all cause mortality within the two year time frame that was analyzed for the primary endpoint. Please note that the number of participants at risk for all-cause mortality is greater than the number of participants at risk for adverse events. Only participants who received intervention are eligible for adverse events reporting.
|
5.9%
28/476 • Up to 2 years
Adverse events will be assessed using CTCAE version 5.0. All cause mortality will be reported as all cause mortality within the two year time frame that was analyzed for the primary endpoint. Please note that the number of participants at risk for all-cause mortality is greater than the number of participants at risk for adverse events. Only participants who received intervention are eligible for adverse events reporting.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
1.7%
8/481 • Up to 2 years
Adverse events will be assessed using CTCAE version 5.0. All cause mortality will be reported as all cause mortality within the two year time frame that was analyzed for the primary endpoint. Please note that the number of participants at risk for all-cause mortality is greater than the number of participants at risk for adverse events. Only participants who received intervention are eligible for adverse events reporting.
|
6.3%
30/476 • Up to 2 years
Adverse events will be assessed using CTCAE version 5.0. All cause mortality will be reported as all cause mortality within the two year time frame that was analyzed for the primary endpoint. Please note that the number of participants at risk for all-cause mortality is greater than the number of participants at risk for adverse events. Only participants who received intervention are eligible for adverse events reporting.
|
|
Cardiac disorders
Sinus tachycardia
|
9.6%
46/481 • Up to 2 years
Adverse events will be assessed using CTCAE version 5.0. All cause mortality will be reported as all cause mortality within the two year time frame that was analyzed for the primary endpoint. Please note that the number of participants at risk for all-cause mortality is greater than the number of participants at risk for adverse events. Only participants who received intervention are eligible for adverse events reporting.
|
14.9%
71/476 • Up to 2 years
Adverse events will be assessed using CTCAE version 5.0. All cause mortality will be reported as all cause mortality within the two year time frame that was analyzed for the primary endpoint. Please note that the number of participants at risk for all-cause mortality is greater than the number of participants at risk for adverse events. Only participants who received intervention are eligible for adverse events reporting.
|
|
Endocrine disorders
Hypothyroidism
|
7.9%
38/481 • Up to 2 years
Adverse events will be assessed using CTCAE version 5.0. All cause mortality will be reported as all cause mortality within the two year time frame that was analyzed for the primary endpoint. Please note that the number of participants at risk for all-cause mortality is greater than the number of participants at risk for adverse events. Only participants who received intervention are eligible for adverse events reporting.
|
0.63%
3/476 • Up to 2 years
Adverse events will be assessed using CTCAE version 5.0. All cause mortality will be reported as all cause mortality within the two year time frame that was analyzed for the primary endpoint. Please note that the number of participants at risk for all-cause mortality is greater than the number of participants at risk for adverse events. Only participants who received intervention are eligible for adverse events reporting.
|
|
Eye disorders
Blurred vision
|
5.8%
28/481 • Up to 2 years
Adverse events will be assessed using CTCAE version 5.0. All cause mortality will be reported as all cause mortality within the two year time frame that was analyzed for the primary endpoint. Please note that the number of participants at risk for all-cause mortality is greater than the number of participants at risk for adverse events. Only participants who received intervention are eligible for adverse events reporting.
|
5.0%
24/476 • Up to 2 years
Adverse events will be assessed using CTCAE version 5.0. All cause mortality will be reported as all cause mortality within the two year time frame that was analyzed for the primary endpoint. Please note that the number of participants at risk for all-cause mortality is greater than the number of participants at risk for adverse events. Only participants who received intervention are eligible for adverse events reporting.
|
|
Gastrointestinal disorders
Abdominal pain
|
19.3%
93/481 • Up to 2 years
Adverse events will be assessed using CTCAE version 5.0. All cause mortality will be reported as all cause mortality within the two year time frame that was analyzed for the primary endpoint. Please note that the number of participants at risk for all-cause mortality is greater than the number of participants at risk for adverse events. Only participants who received intervention are eligible for adverse events reporting.
|
34.5%
164/476 • Up to 2 years
Adverse events will be assessed using CTCAE version 5.0. All cause mortality will be reported as all cause mortality within the two year time frame that was analyzed for the primary endpoint. Please note that the number of participants at risk for all-cause mortality is greater than the number of participants at risk for adverse events. Only participants who received intervention are eligible for adverse events reporting.
|
|
Gastrointestinal disorders
Bloating
|
2.7%
13/481 • Up to 2 years
Adverse events will be assessed using CTCAE version 5.0. All cause mortality will be reported as all cause mortality within the two year time frame that was analyzed for the primary endpoint. Please note that the number of participants at risk for all-cause mortality is greater than the number of participants at risk for adverse events. Only participants who received intervention are eligible for adverse events reporting.
|
5.7%
27/476 • Up to 2 years
Adverse events will be assessed using CTCAE version 5.0. All cause mortality will be reported as all cause mortality within the two year time frame that was analyzed for the primary endpoint. Please note that the number of participants at risk for all-cause mortality is greater than the number of participants at risk for adverse events. Only participants who received intervention are eligible for adverse events reporting.
|
|
Gastrointestinal disorders
Constipation
|
49.5%
238/481 • Up to 2 years
Adverse events will be assessed using CTCAE version 5.0. All cause mortality will be reported as all cause mortality within the two year time frame that was analyzed for the primary endpoint. Please note that the number of participants at risk for all-cause mortality is greater than the number of participants at risk for adverse events. Only participants who received intervention are eligible for adverse events reporting.
|
50.4%
240/476 • Up to 2 years
Adverse events will be assessed using CTCAE version 5.0. All cause mortality will be reported as all cause mortality within the two year time frame that was analyzed for the primary endpoint. Please note that the number of participants at risk for all-cause mortality is greater than the number of participants at risk for adverse events. Only participants who received intervention are eligible for adverse events reporting.
|
|
Gastrointestinal disorders
Diarrhea
|
27.0%
130/481 • Up to 2 years
Adverse events will be assessed using CTCAE version 5.0. All cause mortality will be reported as all cause mortality within the two year time frame that was analyzed for the primary endpoint. Please note that the number of participants at risk for all-cause mortality is greater than the number of participants at risk for adverse events. Only participants who received intervention are eligible for adverse events reporting.
|
36.3%
173/476 • Up to 2 years
Adverse events will be assessed using CTCAE version 5.0. All cause mortality will be reported as all cause mortality within the two year time frame that was analyzed for the primary endpoint. Please note that the number of participants at risk for all-cause mortality is greater than the number of participants at risk for adverse events. Only participants who received intervention are eligible for adverse events reporting.
|
|
Gastrointestinal disorders
Dry mouth
|
5.4%
26/481 • Up to 2 years
Adverse events will be assessed using CTCAE version 5.0. All cause mortality will be reported as all cause mortality within the two year time frame that was analyzed for the primary endpoint. Please note that the number of participants at risk for all-cause mortality is greater than the number of participants at risk for adverse events. Only participants who received intervention are eligible for adverse events reporting.
|
8.0%
38/476 • Up to 2 years
Adverse events will be assessed using CTCAE version 5.0. All cause mortality will be reported as all cause mortality within the two year time frame that was analyzed for the primary endpoint. Please note that the number of participants at risk for all-cause mortality is greater than the number of participants at risk for adverse events. Only participants who received intervention are eligible for adverse events reporting.
|
|
Gastrointestinal disorders
Dyspepsia
|
10.2%
49/481 • Up to 2 years
Adverse events will be assessed using CTCAE version 5.0. All cause mortality will be reported as all cause mortality within the two year time frame that was analyzed for the primary endpoint. Please note that the number of participants at risk for all-cause mortality is greater than the number of participants at risk for adverse events. Only participants who received intervention are eligible for adverse events reporting.
|
6.9%
33/476 • Up to 2 years
Adverse events will be assessed using CTCAE version 5.0. All cause mortality will be reported as all cause mortality within the two year time frame that was analyzed for the primary endpoint. Please note that the number of participants at risk for all-cause mortality is greater than the number of participants at risk for adverse events. Only participants who received intervention are eligible for adverse events reporting.
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
9.8%
47/481 • Up to 2 years
Adverse events will be assessed using CTCAE version 5.0. All cause mortality will be reported as all cause mortality within the two year time frame that was analyzed for the primary endpoint. Please note that the number of participants at risk for all-cause mortality is greater than the number of participants at risk for adverse events. Only participants who received intervention are eligible for adverse events reporting.
|
11.3%
54/476 • Up to 2 years
Adverse events will be assessed using CTCAE version 5.0. All cause mortality will be reported as all cause mortality within the two year time frame that was analyzed for the primary endpoint. Please note that the number of participants at risk for all-cause mortality is greater than the number of participants at risk for adverse events. Only participants who received intervention are eligible for adverse events reporting.
|
|
Gastrointestinal disorders
Mucositis oral
|
24.9%
120/481 • Up to 2 years
Adverse events will be assessed using CTCAE version 5.0. All cause mortality will be reported as all cause mortality within the two year time frame that was analyzed for the primary endpoint. Please note that the number of participants at risk for all-cause mortality is greater than the number of participants at risk for adverse events. Only participants who received intervention are eligible for adverse events reporting.
|
22.7%
108/476 • Up to 2 years
Adverse events will be assessed using CTCAE version 5.0. All cause mortality will be reported as all cause mortality within the two year time frame that was analyzed for the primary endpoint. Please note that the number of participants at risk for all-cause mortality is greater than the number of participants at risk for adverse events. Only participants who received intervention are eligible for adverse events reporting.
|
|
Gastrointestinal disorders
Nausea
|
70.3%
338/481 • Up to 2 years
Adverse events will be assessed using CTCAE version 5.0. All cause mortality will be reported as all cause mortality within the two year time frame that was analyzed for the primary endpoint. Please note that the number of participants at risk for all-cause mortality is greater than the number of participants at risk for adverse events. Only participants who received intervention are eligible for adverse events reporting.
|
74.4%
354/476 • Up to 2 years
Adverse events will be assessed using CTCAE version 5.0. All cause mortality will be reported as all cause mortality within the two year time frame that was analyzed for the primary endpoint. Please note that the number of participants at risk for all-cause mortality is greater than the number of participants at risk for adverse events. Only participants who received intervention are eligible for adverse events reporting.
|
|
Gastrointestinal disorders
Oral pain
|
7.7%
37/481 • Up to 2 years
Adverse events will be assessed using CTCAE version 5.0. All cause mortality will be reported as all cause mortality within the two year time frame that was analyzed for the primary endpoint. Please note that the number of participants at risk for all-cause mortality is greater than the number of participants at risk for adverse events. Only participants who received intervention are eligible for adverse events reporting.
|
5.7%
27/476 • Up to 2 years
Adverse events will be assessed using CTCAE version 5.0. All cause mortality will be reported as all cause mortality within the two year time frame that was analyzed for the primary endpoint. Please note that the number of participants at risk for all-cause mortality is greater than the number of participants at risk for adverse events. Only participants who received intervention are eligible for adverse events reporting.
|
|
Gastrointestinal disorders
Vomiting
|
32.4%
156/481 • Up to 2 years
Adverse events will be assessed using CTCAE version 5.0. All cause mortality will be reported as all cause mortality within the two year time frame that was analyzed for the primary endpoint. Please note that the number of participants at risk for all-cause mortality is greater than the number of participants at risk for adverse events. Only participants who received intervention are eligible for adverse events reporting.
|
38.2%
182/476 • Up to 2 years
Adverse events will be assessed using CTCAE version 5.0. All cause mortality will be reported as all cause mortality within the two year time frame that was analyzed for the primary endpoint. Please note that the number of participants at risk for all-cause mortality is greater than the number of participants at risk for adverse events. Only participants who received intervention are eligible for adverse events reporting.
|
|
General disorders
Chills
|
6.7%
32/481 • Up to 2 years
Adverse events will be assessed using CTCAE version 5.0. All cause mortality will be reported as all cause mortality within the two year time frame that was analyzed for the primary endpoint. Please note that the number of participants at risk for all-cause mortality is greater than the number of participants at risk for adverse events. Only participants who received intervention are eligible for adverse events reporting.
|
6.1%
29/476 • Up to 2 years
Adverse events will be assessed using CTCAE version 5.0. All cause mortality will be reported as all cause mortality within the two year time frame that was analyzed for the primary endpoint. Please note that the number of participants at risk for all-cause mortality is greater than the number of participants at risk for adverse events. Only participants who received intervention are eligible for adverse events reporting.
|
|
General disorders
Edema limbs
|
6.9%
33/481 • Up to 2 years
Adverse events will be assessed using CTCAE version 5.0. All cause mortality will be reported as all cause mortality within the two year time frame that was analyzed for the primary endpoint. Please note that the number of participants at risk for all-cause mortality is greater than the number of participants at risk for adverse events. Only participants who received intervention are eligible for adverse events reporting.
|
6.9%
33/476 • Up to 2 years
Adverse events will be assessed using CTCAE version 5.0. All cause mortality will be reported as all cause mortality within the two year time frame that was analyzed for the primary endpoint. Please note that the number of participants at risk for all-cause mortality is greater than the number of participants at risk for adverse events. Only participants who received intervention are eligible for adverse events reporting.
|
|
General disorders
Fatigue
|
58.8%
283/481 • Up to 2 years
Adverse events will be assessed using CTCAE version 5.0. All cause mortality will be reported as all cause mortality within the two year time frame that was analyzed for the primary endpoint. Please note that the number of participants at risk for all-cause mortality is greater than the number of participants at risk for adverse events. Only participants who received intervention are eligible for adverse events reporting.
|
58.2%
277/476 • Up to 2 years
Adverse events will be assessed using CTCAE version 5.0. All cause mortality will be reported as all cause mortality within the two year time frame that was analyzed for the primary endpoint. Please note that the number of participants at risk for all-cause mortality is greater than the number of participants at risk for adverse events. Only participants who received intervention are eligible for adverse events reporting.
|
|
General disorders
Fever
|
20.0%
96/481 • Up to 2 years
Adverse events will be assessed using CTCAE version 5.0. All cause mortality will be reported as all cause mortality within the two year time frame that was analyzed for the primary endpoint. Please note that the number of participants at risk for all-cause mortality is greater than the number of participants at risk for adverse events. Only participants who received intervention are eligible for adverse events reporting.
|
20.8%
99/476 • Up to 2 years
Adverse events will be assessed using CTCAE version 5.0. All cause mortality will be reported as all cause mortality within the two year time frame that was analyzed for the primary endpoint. Please note that the number of participants at risk for all-cause mortality is greater than the number of participants at risk for adverse events. Only participants who received intervention are eligible for adverse events reporting.
|
|
General disorders
Non-cardiac chest pain
|
9.8%
47/481 • Up to 2 years
Adverse events will be assessed using CTCAE version 5.0. All cause mortality will be reported as all cause mortality within the two year time frame that was analyzed for the primary endpoint. Please note that the number of participants at risk for all-cause mortality is greater than the number of participants at risk for adverse events. Only participants who received intervention are eligible for adverse events reporting.
|
8.8%
42/476 • Up to 2 years
Adverse events will be assessed using CTCAE version 5.0. All cause mortality will be reported as all cause mortality within the two year time frame that was analyzed for the primary endpoint. Please note that the number of participants at risk for all-cause mortality is greater than the number of participants at risk for adverse events. Only participants who received intervention are eligible for adverse events reporting.
|
|
General disorders
Pain
|
15.0%
72/481 • Up to 2 years
Adverse events will be assessed using CTCAE version 5.0. All cause mortality will be reported as all cause mortality within the two year time frame that was analyzed for the primary endpoint. Please note that the number of participants at risk for all-cause mortality is greater than the number of participants at risk for adverse events. Only participants who received intervention are eligible for adverse events reporting.
|
14.7%
70/476 • Up to 2 years
Adverse events will be assessed using CTCAE version 5.0. All cause mortality will be reported as all cause mortality within the two year time frame that was analyzed for the primary endpoint. Please note that the number of participants at risk for all-cause mortality is greater than the number of participants at risk for adverse events. Only participants who received intervention are eligible for adverse events reporting.
|
|
Infections and infestations
Infections and infestations-Other
|
12.9%
62/481 • Up to 2 years
Adverse events will be assessed using CTCAE version 5.0. All cause mortality will be reported as all cause mortality within the two year time frame that was analyzed for the primary endpoint. Please note that the number of participants at risk for all-cause mortality is greater than the number of participants at risk for adverse events. Only participants who received intervention are eligible for adverse events reporting.
|
14.9%
71/476 • Up to 2 years
Adverse events will be assessed using CTCAE version 5.0. All cause mortality will be reported as all cause mortality within the two year time frame that was analyzed for the primary endpoint. Please note that the number of participants at risk for all-cause mortality is greater than the number of participants at risk for adverse events. Only participants who received intervention are eligible for adverse events reporting.
|
|
Infections and infestations
Upper respiratory infection
|
4.4%
21/481 • Up to 2 years
Adverse events will be assessed using CTCAE version 5.0. All cause mortality will be reported as all cause mortality within the two year time frame that was analyzed for the primary endpoint. Please note that the number of participants at risk for all-cause mortality is greater than the number of participants at risk for adverse events. Only participants who received intervention are eligible for adverse events reporting.
|
5.3%
25/476 • Up to 2 years
Adverse events will be assessed using CTCAE version 5.0. All cause mortality will be reported as all cause mortality within the two year time frame that was analyzed for the primary endpoint. Please note that the number of participants at risk for all-cause mortality is greater than the number of participants at risk for adverse events. Only participants who received intervention are eligible for adverse events reporting.
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
8.1%
39/481 • Up to 2 years
Adverse events will be assessed using CTCAE version 5.0. All cause mortality will be reported as all cause mortality within the two year time frame that was analyzed for the primary endpoint. Please note that the number of participants at risk for all-cause mortality is greater than the number of participants at risk for adverse events. Only participants who received intervention are eligible for adverse events reporting.
|
3.4%
16/476 • Up to 2 years
Adverse events will be assessed using CTCAE version 5.0. All cause mortality will be reported as all cause mortality within the two year time frame that was analyzed for the primary endpoint. Please note that the number of participants at risk for all-cause mortality is greater than the number of participants at risk for adverse events. Only participants who received intervention are eligible for adverse events reporting.
|
|
Investigations
Alanine aminotransferase increased
|
37.4%
180/481 • Up to 2 years
Adverse events will be assessed using CTCAE version 5.0. All cause mortality will be reported as all cause mortality within the two year time frame that was analyzed for the primary endpoint. Please note that the number of participants at risk for all-cause mortality is greater than the number of participants at risk for adverse events. Only participants who received intervention are eligible for adverse events reporting.
|
48.7%
232/476 • Up to 2 years
Adverse events will be assessed using CTCAE version 5.0. All cause mortality will be reported as all cause mortality within the two year time frame that was analyzed for the primary endpoint. Please note that the number of participants at risk for all-cause mortality is greater than the number of participants at risk for adverse events. Only participants who received intervention are eligible for adverse events reporting.
|
|
Investigations
Alkaline phosphatase increased
|
17.7%
85/481 • Up to 2 years
Adverse events will be assessed using CTCAE version 5.0. All cause mortality will be reported as all cause mortality within the two year time frame that was analyzed for the primary endpoint. Please note that the number of participants at risk for all-cause mortality is greater than the number of participants at risk for adverse events. Only participants who received intervention are eligible for adverse events reporting.
|
22.9%
109/476 • Up to 2 years
Adverse events will be assessed using CTCAE version 5.0. All cause mortality will be reported as all cause mortality within the two year time frame that was analyzed for the primary endpoint. Please note that the number of participants at risk for all-cause mortality is greater than the number of participants at risk for adverse events. Only participants who received intervention are eligible for adverse events reporting.
|
|
Investigations
Aspartate aminotransferase increased
|
30.8%
148/481 • Up to 2 years
Adverse events will be assessed using CTCAE version 5.0. All cause mortality will be reported as all cause mortality within the two year time frame that was analyzed for the primary endpoint. Please note that the number of participants at risk for all-cause mortality is greater than the number of participants at risk for adverse events. Only participants who received intervention are eligible for adverse events reporting.
|
39.3%
187/476 • Up to 2 years
Adverse events will be assessed using CTCAE version 5.0. All cause mortality will be reported as all cause mortality within the two year time frame that was analyzed for the primary endpoint. Please note that the number of participants at risk for all-cause mortality is greater than the number of participants at risk for adverse events. Only participants who received intervention are eligible for adverse events reporting.
|
|
Investigations
Blood lactate dehydrogenase increased
|
6.0%
29/481 • Up to 2 years
Adverse events will be assessed using CTCAE version 5.0. All cause mortality will be reported as all cause mortality within the two year time frame that was analyzed for the primary endpoint. Please note that the number of participants at risk for all-cause mortality is greater than the number of participants at risk for adverse events. Only participants who received intervention are eligible for adverse events reporting.
|
8.2%
39/476 • Up to 2 years
Adverse events will be assessed using CTCAE version 5.0. All cause mortality will be reported as all cause mortality within the two year time frame that was analyzed for the primary endpoint. Please note that the number of participants at risk for all-cause mortality is greater than the number of participants at risk for adverse events. Only participants who received intervention are eligible for adverse events reporting.
|
|
Investigations
Creatinine increased
|
8.7%
42/481 • Up to 2 years
Adverse events will be assessed using CTCAE version 5.0. All cause mortality will be reported as all cause mortality within the two year time frame that was analyzed for the primary endpoint. Please note that the number of participants at risk for all-cause mortality is greater than the number of participants at risk for adverse events. Only participants who received intervention are eligible for adverse events reporting.
|
4.8%
23/476 • Up to 2 years
Adverse events will be assessed using CTCAE version 5.0. All cause mortality will be reported as all cause mortality within the two year time frame that was analyzed for the primary endpoint. Please note that the number of participants at risk for all-cause mortality is greater than the number of participants at risk for adverse events. Only participants who received intervention are eligible for adverse events reporting.
|
|
Investigations
Lymphocyte count decreased
|
25.6%
123/481 • Up to 2 years
Adverse events will be assessed using CTCAE version 5.0. All cause mortality will be reported as all cause mortality within the two year time frame that was analyzed for the primary endpoint. Please note that the number of participants at risk for all-cause mortality is greater than the number of participants at risk for adverse events. Only participants who received intervention are eligible for adverse events reporting.
|
26.5%
126/476 • Up to 2 years
Adverse events will be assessed using CTCAE version 5.0. All cause mortality will be reported as all cause mortality within the two year time frame that was analyzed for the primary endpoint. Please note that the number of participants at risk for all-cause mortality is greater than the number of participants at risk for adverse events. Only participants who received intervention are eligible for adverse events reporting.
|
|
Investigations
Neutrophil count decreased
|
57.6%
277/481 • Up to 2 years
Adverse events will be assessed using CTCAE version 5.0. All cause mortality will be reported as all cause mortality within the two year time frame that was analyzed for the primary endpoint. Please note that the number of participants at risk for all-cause mortality is greater than the number of participants at risk for adverse events. Only participants who received intervention are eligible for adverse events reporting.
|
35.9%
171/476 • Up to 2 years
Adverse events will be assessed using CTCAE version 5.0. All cause mortality will be reported as all cause mortality within the two year time frame that was analyzed for the primary endpoint. Please note that the number of participants at risk for all-cause mortality is greater than the number of participants at risk for adverse events. Only participants who received intervention are eligible for adverse events reporting.
|
|
Investigations
Platelet count decreased
|
11.4%
55/481 • Up to 2 years
Adverse events will be assessed using CTCAE version 5.0. All cause mortality will be reported as all cause mortality within the two year time frame that was analyzed for the primary endpoint. Please note that the number of participants at risk for all-cause mortality is greater than the number of participants at risk for adverse events. Only participants who received intervention are eligible for adverse events reporting.
|
19.3%
92/476 • Up to 2 years
Adverse events will be assessed using CTCAE version 5.0. All cause mortality will be reported as all cause mortality within the two year time frame that was analyzed for the primary endpoint. Please note that the number of participants at risk for all-cause mortality is greater than the number of participants at risk for adverse events. Only participants who received intervention are eligible for adverse events reporting.
|
|
Investigations
Thyroid stimulating hormone increased
|
6.2%
30/481 • Up to 2 years
Adverse events will be assessed using CTCAE version 5.0. All cause mortality will be reported as all cause mortality within the two year time frame that was analyzed for the primary endpoint. Please note that the number of participants at risk for all-cause mortality is greater than the number of participants at risk for adverse events. Only participants who received intervention are eligible for adverse events reporting.
|
1.3%
6/476 • Up to 2 years
Adverse events will be assessed using CTCAE version 5.0. All cause mortality will be reported as all cause mortality within the two year time frame that was analyzed for the primary endpoint. Please note that the number of participants at risk for all-cause mortality is greater than the number of participants at risk for adverse events. Only participants who received intervention are eligible for adverse events reporting.
|
|
Investigations
Weight gain
|
10.8%
52/481 • Up to 2 years
Adverse events will be assessed using CTCAE version 5.0. All cause mortality will be reported as all cause mortality within the two year time frame that was analyzed for the primary endpoint. Please note that the number of participants at risk for all-cause mortality is greater than the number of participants at risk for adverse events. Only participants who received intervention are eligible for adverse events reporting.
|
6.9%
33/476 • Up to 2 years
Adverse events will be assessed using CTCAE version 5.0. All cause mortality will be reported as all cause mortality within the two year time frame that was analyzed for the primary endpoint. Please note that the number of participants at risk for all-cause mortality is greater than the number of participants at risk for adverse events. Only participants who received intervention are eligible for adverse events reporting.
|
|
Investigations
Weight loss
|
9.4%
45/481 • Up to 2 years
Adverse events will be assessed using CTCAE version 5.0. All cause mortality will be reported as all cause mortality within the two year time frame that was analyzed for the primary endpoint. Please note that the number of participants at risk for all-cause mortality is greater than the number of participants at risk for adverse events. Only participants who received intervention are eligible for adverse events reporting.
|
18.5%
88/476 • Up to 2 years
Adverse events will be assessed using CTCAE version 5.0. All cause mortality will be reported as all cause mortality within the two year time frame that was analyzed for the primary endpoint. Please note that the number of participants at risk for all-cause mortality is greater than the number of participants at risk for adverse events. Only participants who received intervention are eligible for adverse events reporting.
|
|
Investigations
White blood cell decreased
|
42.8%
206/481 • Up to 2 years
Adverse events will be assessed using CTCAE version 5.0. All cause mortality will be reported as all cause mortality within the two year time frame that was analyzed for the primary endpoint. Please note that the number of participants at risk for all-cause mortality is greater than the number of participants at risk for adverse events. Only participants who received intervention are eligible for adverse events reporting.
|
29.6%
141/476 • Up to 2 years
Adverse events will be assessed using CTCAE version 5.0. All cause mortality will be reported as all cause mortality within the two year time frame that was analyzed for the primary endpoint. Please note that the number of participants at risk for all-cause mortality is greater than the number of participants at risk for adverse events. Only participants who received intervention are eligible for adverse events reporting.
|
|
Metabolism and nutrition disorders
Anorexia
|
16.2%
78/481 • Up to 2 years
Adverse events will be assessed using CTCAE version 5.0. All cause mortality will be reported as all cause mortality within the two year time frame that was analyzed for the primary endpoint. Please note that the number of participants at risk for all-cause mortality is greater than the number of participants at risk for adverse events. Only participants who received intervention are eligible for adverse events reporting.
|
25.6%
122/476 • Up to 2 years
Adverse events will be assessed using CTCAE version 5.0. All cause mortality will be reported as all cause mortality within the two year time frame that was analyzed for the primary endpoint. Please note that the number of participants at risk for all-cause mortality is greater than the number of participants at risk for adverse events. Only participants who received intervention are eligible for adverse events reporting.
|
|
Metabolism and nutrition disorders
Dehydration
|
3.3%
16/481 • Up to 2 years
Adverse events will be assessed using CTCAE version 5.0. All cause mortality will be reported as all cause mortality within the two year time frame that was analyzed for the primary endpoint. Please note that the number of participants at risk for all-cause mortality is greater than the number of participants at risk for adverse events. Only participants who received intervention are eligible for adverse events reporting.
|
9.5%
45/476 • Up to 2 years
Adverse events will be assessed using CTCAE version 5.0. All cause mortality will be reported as all cause mortality within the two year time frame that was analyzed for the primary endpoint. Please note that the number of participants at risk for all-cause mortality is greater than the number of participants at risk for adverse events. Only participants who received intervention are eligible for adverse events reporting.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
29.3%
141/481 • Up to 2 years
Adverse events will be assessed using CTCAE version 5.0. All cause mortality will be reported as all cause mortality within the two year time frame that was analyzed for the primary endpoint. Please note that the number of participants at risk for all-cause mortality is greater than the number of participants at risk for adverse events. Only participants who received intervention are eligible for adverse events reporting.
|
31.1%
148/476 • Up to 2 years
Adverse events will be assessed using CTCAE version 5.0. All cause mortality will be reported as all cause mortality within the two year time frame that was analyzed for the primary endpoint. Please note that the number of participants at risk for all-cause mortality is greater than the number of participants at risk for adverse events. Only participants who received intervention are eligible for adverse events reporting.
|
|
Metabolism and nutrition disorders
Hyperphosphatemia
|
6.9%
33/481 • Up to 2 years
Adverse events will be assessed using CTCAE version 5.0. All cause mortality will be reported as all cause mortality within the two year time frame that was analyzed for the primary endpoint. Please note that the number of participants at risk for all-cause mortality is greater than the number of participants at risk for adverse events. Only participants who received intervention are eligible for adverse events reporting.
|
6.3%
30/476 • Up to 2 years
Adverse events will be assessed using CTCAE version 5.0. All cause mortality will be reported as all cause mortality within the two year time frame that was analyzed for the primary endpoint. Please note that the number of participants at risk for all-cause mortality is greater than the number of participants at risk for adverse events. Only participants who received intervention are eligible for adverse events reporting.
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
17.7%
85/481 • Up to 2 years
Adverse events will be assessed using CTCAE version 5.0. All cause mortality will be reported as all cause mortality within the two year time frame that was analyzed for the primary endpoint. Please note that the number of participants at risk for all-cause mortality is greater than the number of participants at risk for adverse events. Only participants who received intervention are eligible for adverse events reporting.
|
16.2%
77/476 • Up to 2 years
Adverse events will be assessed using CTCAE version 5.0. All cause mortality will be reported as all cause mortality within the two year time frame that was analyzed for the primary endpoint. Please note that the number of participants at risk for all-cause mortality is greater than the number of participants at risk for adverse events. Only participants who received intervention are eligible for adverse events reporting.
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
13.1%
63/481 • Up to 2 years
Adverse events will be assessed using CTCAE version 5.0. All cause mortality will be reported as all cause mortality within the two year time frame that was analyzed for the primary endpoint. Please note that the number of participants at risk for all-cause mortality is greater than the number of participants at risk for adverse events. Only participants who received intervention are eligible for adverse events reporting.
|
12.4%
59/476 • Up to 2 years
Adverse events will be assessed using CTCAE version 5.0. All cause mortality will be reported as all cause mortality within the two year time frame that was analyzed for the primary endpoint. Please note that the number of participants at risk for all-cause mortality is greater than the number of participants at risk for adverse events. Only participants who received intervention are eligible for adverse events reporting.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
10.4%
50/481 • Up to 2 years
Adverse events will be assessed using CTCAE version 5.0. All cause mortality will be reported as all cause mortality within the two year time frame that was analyzed for the primary endpoint. Please note that the number of participants at risk for all-cause mortality is greater than the number of participants at risk for adverse events. Only participants who received intervention are eligible for adverse events reporting.
|
20.2%
96/476 • Up to 2 years
Adverse events will be assessed using CTCAE version 5.0. All cause mortality will be reported as all cause mortality within the two year time frame that was analyzed for the primary endpoint. Please note that the number of participants at risk for all-cause mortality is greater than the number of participants at risk for adverse events. Only participants who received intervention are eligible for adverse events reporting.
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
2.5%
12/481 • Up to 2 years
Adverse events will be assessed using CTCAE version 5.0. All cause mortality will be reported as all cause mortality within the two year time frame that was analyzed for the primary endpoint. Please note that the number of participants at risk for all-cause mortality is greater than the number of participants at risk for adverse events. Only participants who received intervention are eligible for adverse events reporting.
|
8.4%
40/476 • Up to 2 years
Adverse events will be assessed using CTCAE version 5.0. All cause mortality will be reported as all cause mortality within the two year time frame that was analyzed for the primary endpoint. Please note that the number of participants at risk for all-cause mortality is greater than the number of participants at risk for adverse events. Only participants who received intervention are eligible for adverse events reporting.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
12.1%
58/481 • Up to 2 years
Adverse events will be assessed using CTCAE version 5.0. All cause mortality will be reported as all cause mortality within the two year time frame that was analyzed for the primary endpoint. Please note that the number of participants at risk for all-cause mortality is greater than the number of participants at risk for adverse events. Only participants who received intervention are eligible for adverse events reporting.
|
20.6%
98/476 • Up to 2 years
Adverse events will be assessed using CTCAE version 5.0. All cause mortality will be reported as all cause mortality within the two year time frame that was analyzed for the primary endpoint. Please note that the number of participants at risk for all-cause mortality is greater than the number of participants at risk for adverse events. Only participants who received intervention are eligible for adverse events reporting.
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
3.5%
17/481 • Up to 2 years
Adverse events will be assessed using CTCAE version 5.0. All cause mortality will be reported as all cause mortality within the two year time frame that was analyzed for the primary endpoint. Please note that the number of participants at risk for all-cause mortality is greater than the number of participants at risk for adverse events. Only participants who received intervention are eligible for adverse events reporting.
|
6.7%
32/476 • Up to 2 years
Adverse events will be assessed using CTCAE version 5.0. All cause mortality will be reported as all cause mortality within the two year time frame that was analyzed for the primary endpoint. Please note that the number of participants at risk for all-cause mortality is greater than the number of participants at risk for adverse events. Only participants who received intervention are eligible for adverse events reporting.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
18.5%
89/481 • Up to 2 years
Adverse events will be assessed using CTCAE version 5.0. All cause mortality will be reported as all cause mortality within the two year time frame that was analyzed for the primary endpoint. Please note that the number of participants at risk for all-cause mortality is greater than the number of participants at risk for adverse events. Only participants who received intervention are eligible for adverse events reporting.
|
16.6%
79/476 • Up to 2 years
Adverse events will be assessed using CTCAE version 5.0. All cause mortality will be reported as all cause mortality within the two year time frame that was analyzed for the primary endpoint. Please note that the number of participants at risk for all-cause mortality is greater than the number of participants at risk for adverse events. Only participants who received intervention are eligible for adverse events reporting.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
13.5%
65/481 • Up to 2 years
Adverse events will be assessed using CTCAE version 5.0. All cause mortality will be reported as all cause mortality within the two year time frame that was analyzed for the primary endpoint. Please note that the number of participants at risk for all-cause mortality is greater than the number of participants at risk for adverse events. Only participants who received intervention are eligible for adverse events reporting.
|
16.4%
78/476 • Up to 2 years
Adverse events will be assessed using CTCAE version 5.0. All cause mortality will be reported as all cause mortality within the two year time frame that was analyzed for the primary endpoint. Please note that the number of participants at risk for all-cause mortality is greater than the number of participants at risk for adverse events. Only participants who received intervention are eligible for adverse events reporting.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
14.8%
71/481 • Up to 2 years
Adverse events will be assessed using CTCAE version 5.0. All cause mortality will be reported as all cause mortality within the two year time frame that was analyzed for the primary endpoint. Please note that the number of participants at risk for all-cause mortality is greater than the number of participants at risk for adverse events. Only participants who received intervention are eligible for adverse events reporting.
|
29.0%
138/476 • Up to 2 years
Adverse events will be assessed using CTCAE version 5.0. All cause mortality will be reported as all cause mortality within the two year time frame that was analyzed for the primary endpoint. Please note that the number of participants at risk for all-cause mortality is greater than the number of participants at risk for adverse events. Only participants who received intervention are eligible for adverse events reporting.
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
3.7%
18/481 • Up to 2 years
Adverse events will be assessed using CTCAE version 5.0. All cause mortality will be reported as all cause mortality within the two year time frame that was analyzed for the primary endpoint. Please note that the number of participants at risk for all-cause mortality is greater than the number of participants at risk for adverse events. Only participants who received intervention are eligible for adverse events reporting.
|
7.1%
34/476 • Up to 2 years
Adverse events will be assessed using CTCAE version 5.0. All cause mortality will be reported as all cause mortality within the two year time frame that was analyzed for the primary endpoint. Please note that the number of participants at risk for all-cause mortality is greater than the number of participants at risk for adverse events. Only participants who received intervention are eligible for adverse events reporting.
|
|
Musculoskeletal and connective tissue disorders
Muscle cramp
|
5.8%
28/481 • Up to 2 years
Adverse events will be assessed using CTCAE version 5.0. All cause mortality will be reported as all cause mortality within the two year time frame that was analyzed for the primary endpoint. Please note that the number of participants at risk for all-cause mortality is greater than the number of participants at risk for adverse events. Only participants who received intervention are eligible for adverse events reporting.
|
5.7%
27/476 • Up to 2 years
Adverse events will be assessed using CTCAE version 5.0. All cause mortality will be reported as all cause mortality within the two year time frame that was analyzed for the primary endpoint. Please note that the number of participants at risk for all-cause mortality is greater than the number of participants at risk for adverse events. Only participants who received intervention are eligible for adverse events reporting.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
15.8%
76/481 • Up to 2 years
Adverse events will be assessed using CTCAE version 5.0. All cause mortality will be reported as all cause mortality within the two year time frame that was analyzed for the primary endpoint. Please note that the number of participants at risk for all-cause mortality is greater than the number of participants at risk for adverse events. Only participants who received intervention are eligible for adverse events reporting.
|
16.6%
79/476 • Up to 2 years
Adverse events will be assessed using CTCAE version 5.0. All cause mortality will be reported as all cause mortality within the two year time frame that was analyzed for the primary endpoint. Please note that the number of participants at risk for all-cause mortality is greater than the number of participants at risk for adverse events. Only participants who received intervention are eligible for adverse events reporting.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
9.1%
44/481 • Up to 2 years
Adverse events will be assessed using CTCAE version 5.0. All cause mortality will be reported as all cause mortality within the two year time frame that was analyzed for the primary endpoint. Please note that the number of participants at risk for all-cause mortality is greater than the number of participants at risk for adverse events. Only participants who received intervention are eligible for adverse events reporting.
|
14.9%
71/476 • Up to 2 years
Adverse events will be assessed using CTCAE version 5.0. All cause mortality will be reported as all cause mortality within the two year time frame that was analyzed for the primary endpoint. Please note that the number of participants at risk for all-cause mortality is greater than the number of participants at risk for adverse events. Only participants who received intervention are eligible for adverse events reporting.
|
|
Nervous system disorders
Dizziness
|
11.4%
55/481 • Up to 2 years
Adverse events will be assessed using CTCAE version 5.0. All cause mortality will be reported as all cause mortality within the two year time frame that was analyzed for the primary endpoint. Please note that the number of participants at risk for all-cause mortality is greater than the number of participants at risk for adverse events. Only participants who received intervention are eligible for adverse events reporting.
|
13.4%
64/476 • Up to 2 years
Adverse events will be assessed using CTCAE version 5.0. All cause mortality will be reported as all cause mortality within the two year time frame that was analyzed for the primary endpoint. Please note that the number of participants at risk for all-cause mortality is greater than the number of participants at risk for adverse events. Only participants who received intervention are eligible for adverse events reporting.
|
|
Nervous system disorders
Dysgeusia
|
10.0%
48/481 • Up to 2 years
Adverse events will be assessed using CTCAE version 5.0. All cause mortality will be reported as all cause mortality within the two year time frame that was analyzed for the primary endpoint. Please note that the number of participants at risk for all-cause mortality is greater than the number of participants at risk for adverse events. Only participants who received intervention are eligible for adverse events reporting.
|
13.7%
65/476 • Up to 2 years
Adverse events will be assessed using CTCAE version 5.0. All cause mortality will be reported as all cause mortality within the two year time frame that was analyzed for the primary endpoint. Please note that the number of participants at risk for all-cause mortality is greater than the number of participants at risk for adverse events. Only participants who received intervention are eligible for adverse events reporting.
|
|
Nervous system disorders
Headache
|
22.9%
110/481 • Up to 2 years
Adverse events will be assessed using CTCAE version 5.0. All cause mortality will be reported as all cause mortality within the two year time frame that was analyzed for the primary endpoint. Please note that the number of participants at risk for all-cause mortality is greater than the number of participants at risk for adverse events. Only participants who received intervention are eligible for adverse events reporting.
|
25.8%
123/476 • Up to 2 years
Adverse events will be assessed using CTCAE version 5.0. All cause mortality will be reported as all cause mortality within the two year time frame that was analyzed for the primary endpoint. Please note that the number of participants at risk for all-cause mortality is greater than the number of participants at risk for adverse events. Only participants who received intervention are eligible for adverse events reporting.
|
|
Nervous system disorders
Paresthesia
|
8.9%
43/481 • Up to 2 years
Adverse events will be assessed using CTCAE version 5.0. All cause mortality will be reported as all cause mortality within the two year time frame that was analyzed for the primary endpoint. Please note that the number of participants at risk for all-cause mortality is greater than the number of participants at risk for adverse events. Only participants who received intervention are eligible for adverse events reporting.
|
9.7%
46/476 • Up to 2 years
Adverse events will be assessed using CTCAE version 5.0. All cause mortality will be reported as all cause mortality within the two year time frame that was analyzed for the primary endpoint. Please note that the number of participants at risk for all-cause mortality is greater than the number of participants at risk for adverse events. Only participants who received intervention are eligible for adverse events reporting.
|
|
Nervous system disorders
Peripheral motor neuropathy
|
5.2%
25/481 • Up to 2 years
Adverse events will be assessed using CTCAE version 5.0. All cause mortality will be reported as all cause mortality within the two year time frame that was analyzed for the primary endpoint. Please note that the number of participants at risk for all-cause mortality is greater than the number of participants at risk for adverse events. Only participants who received intervention are eligible for adverse events reporting.
|
8.0%
38/476 • Up to 2 years
Adverse events will be assessed using CTCAE version 5.0. All cause mortality will be reported as all cause mortality within the two year time frame that was analyzed for the primary endpoint. Please note that the number of participants at risk for all-cause mortality is greater than the number of participants at risk for adverse events. Only participants who received intervention are eligible for adverse events reporting.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
32.8%
158/481 • Up to 2 years
Adverse events will be assessed using CTCAE version 5.0. All cause mortality will be reported as all cause mortality within the two year time frame that was analyzed for the primary endpoint. Please note that the number of participants at risk for all-cause mortality is greater than the number of participants at risk for adverse events. Only participants who received intervention are eligible for adverse events reporting.
|
58.8%
280/476 • Up to 2 years
Adverse events will be assessed using CTCAE version 5.0. All cause mortality will be reported as all cause mortality within the two year time frame that was analyzed for the primary endpoint. Please note that the number of participants at risk for all-cause mortality is greater than the number of participants at risk for adverse events. Only participants who received intervention are eligible for adverse events reporting.
|
|
Psychiatric disorders
Anxiety
|
19.8%
95/481 • Up to 2 years
Adverse events will be assessed using CTCAE version 5.0. All cause mortality will be reported as all cause mortality within the two year time frame that was analyzed for the primary endpoint. Please note that the number of participants at risk for all-cause mortality is greater than the number of participants at risk for adverse events. Only participants who received intervention are eligible for adverse events reporting.
|
21.2%
101/476 • Up to 2 years
Adverse events will be assessed using CTCAE version 5.0. All cause mortality will be reported as all cause mortality within the two year time frame that was analyzed for the primary endpoint. Please note that the number of participants at risk for all-cause mortality is greater than the number of participants at risk for adverse events. Only participants who received intervention are eligible for adverse events reporting.
|
|
Psychiatric disorders
Depression
|
7.3%
35/481 • Up to 2 years
Adverse events will be assessed using CTCAE version 5.0. All cause mortality will be reported as all cause mortality within the two year time frame that was analyzed for the primary endpoint. Please note that the number of participants at risk for all-cause mortality is greater than the number of participants at risk for adverse events. Only participants who received intervention are eligible for adverse events reporting.
|
7.4%
35/476 • Up to 2 years
Adverse events will be assessed using CTCAE version 5.0. All cause mortality will be reported as all cause mortality within the two year time frame that was analyzed for the primary endpoint. Please note that the number of participants at risk for all-cause mortality is greater than the number of participants at risk for adverse events. Only participants who received intervention are eligible for adverse events reporting.
|
|
Psychiatric disorders
Insomnia
|
17.0%
82/481 • Up to 2 years
Adverse events will be assessed using CTCAE version 5.0. All cause mortality will be reported as all cause mortality within the two year time frame that was analyzed for the primary endpoint. Please note that the number of participants at risk for all-cause mortality is greater than the number of participants at risk for adverse events. Only participants who received intervention are eligible for adverse events reporting.
|
22.7%
108/476 • Up to 2 years
Adverse events will be assessed using CTCAE version 5.0. All cause mortality will be reported as all cause mortality within the two year time frame that was analyzed for the primary endpoint. Please note that the number of participants at risk for all-cause mortality is greater than the number of participants at risk for adverse events. Only participants who received intervention are eligible for adverse events reporting.
|
|
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis
|
4.4%
21/481 • Up to 2 years
Adverse events will be assessed using CTCAE version 5.0. All cause mortality will be reported as all cause mortality within the two year time frame that was analyzed for the primary endpoint. Please note that the number of participants at risk for all-cause mortality is greater than the number of participants at risk for adverse events. Only participants who received intervention are eligible for adverse events reporting.
|
5.7%
27/476 • Up to 2 years
Adverse events will be assessed using CTCAE version 5.0. All cause mortality will be reported as all cause mortality within the two year time frame that was analyzed for the primary endpoint. Please note that the number of participants at risk for all-cause mortality is greater than the number of participants at risk for adverse events. Only participants who received intervention are eligible for adverse events reporting.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
24.5%
118/481 • Up to 2 years
Adverse events will be assessed using CTCAE version 5.0. All cause mortality will be reported as all cause mortality within the two year time frame that was analyzed for the primary endpoint. Please note that the number of participants at risk for all-cause mortality is greater than the number of participants at risk for adverse events. Only participants who received intervention are eligible for adverse events reporting.
|
22.7%
108/476 • Up to 2 years
Adverse events will be assessed using CTCAE version 5.0. All cause mortality will be reported as all cause mortality within the two year time frame that was analyzed for the primary endpoint. Please note that the number of participants at risk for all-cause mortality is greater than the number of participants at risk for adverse events. Only participants who received intervention are eligible for adverse events reporting.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
20.0%
96/481 • Up to 2 years
Adverse events will be assessed using CTCAE version 5.0. All cause mortality will be reported as all cause mortality within the two year time frame that was analyzed for the primary endpoint. Please note that the number of participants at risk for all-cause mortality is greater than the number of participants at risk for adverse events. Only participants who received intervention are eligible for adverse events reporting.
|
22.9%
109/476 • Up to 2 years
Adverse events will be assessed using CTCAE version 5.0. All cause mortality will be reported as all cause mortality within the two year time frame that was analyzed for the primary endpoint. Please note that the number of participants at risk for all-cause mortality is greater than the number of participants at risk for adverse events. Only participants who received intervention are eligible for adverse events reporting.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
4.8%
23/481 • Up to 2 years
Adverse events will be assessed using CTCAE version 5.0. All cause mortality will be reported as all cause mortality within the two year time frame that was analyzed for the primary endpoint. Please note that the number of participants at risk for all-cause mortality is greater than the number of participants at risk for adverse events. Only participants who received intervention are eligible for adverse events reporting.
|
5.9%
28/476 • Up to 2 years
Adverse events will be assessed using CTCAE version 5.0. All cause mortality will be reported as all cause mortality within the two year time frame that was analyzed for the primary endpoint. Please note that the number of participants at risk for all-cause mortality is greater than the number of participants at risk for adverse events. Only participants who received intervention are eligible for adverse events reporting.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
7.1%
34/481 • Up to 2 years
Adverse events will be assessed using CTCAE version 5.0. All cause mortality will be reported as all cause mortality within the two year time frame that was analyzed for the primary endpoint. Please note that the number of participants at risk for all-cause mortality is greater than the number of participants at risk for adverse events. Only participants who received intervention are eligible for adverse events reporting.
|
8.8%
42/476 • Up to 2 years
Adverse events will be assessed using CTCAE version 5.0. All cause mortality will be reported as all cause mortality within the two year time frame that was analyzed for the primary endpoint. Please note that the number of participants at risk for all-cause mortality is greater than the number of participants at risk for adverse events. Only participants who received intervention are eligible for adverse events reporting.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhea
|
5.6%
27/481 • Up to 2 years
Adverse events will be assessed using CTCAE version 5.0. All cause mortality will be reported as all cause mortality within the two year time frame that was analyzed for the primary endpoint. Please note that the number of participants at risk for all-cause mortality is greater than the number of participants at risk for adverse events. Only participants who received intervention are eligible for adverse events reporting.
|
9.2%
44/476 • Up to 2 years
Adverse events will be assessed using CTCAE version 5.0. All cause mortality will be reported as all cause mortality within the two year time frame that was analyzed for the primary endpoint. Please note that the number of participants at risk for all-cause mortality is greater than the number of participants at risk for adverse events. Only participants who received intervention are eligible for adverse events reporting.
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
8.3%
40/481 • Up to 2 years
Adverse events will be assessed using CTCAE version 5.0. All cause mortality will be reported as all cause mortality within the two year time frame that was analyzed for the primary endpoint. Please note that the number of participants at risk for all-cause mortality is greater than the number of participants at risk for adverse events. Only participants who received intervention are eligible for adverse events reporting.
|
11.8%
56/476 • Up to 2 years
Adverse events will be assessed using CTCAE version 5.0. All cause mortality will be reported as all cause mortality within the two year time frame that was analyzed for the primary endpoint. Please note that the number of participants at risk for all-cause mortality is greater than the number of participants at risk for adverse events. Only participants who received intervention are eligible for adverse events reporting.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
22.5%
108/481 • Up to 2 years
Adverse events will be assessed using CTCAE version 5.0. All cause mortality will be reported as all cause mortality within the two year time frame that was analyzed for the primary endpoint. Please note that the number of participants at risk for all-cause mortality is greater than the number of participants at risk for adverse events. Only participants who received intervention are eligible for adverse events reporting.
|
28.6%
136/476 • Up to 2 years
Adverse events will be assessed using CTCAE version 5.0. All cause mortality will be reported as all cause mortality within the two year time frame that was analyzed for the primary endpoint. Please note that the number of participants at risk for all-cause mortality is greater than the number of participants at risk for adverse events. Only participants who received intervention are eligible for adverse events reporting.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
5.6%
27/481 • Up to 2 years
Adverse events will be assessed using CTCAE version 5.0. All cause mortality will be reported as all cause mortality within the two year time frame that was analyzed for the primary endpoint. Please note that the number of participants at risk for all-cause mortality is greater than the number of participants at risk for adverse events. Only participants who received intervention are eligible for adverse events reporting.
|
7.1%
34/476 • Up to 2 years
Adverse events will be assessed using CTCAE version 5.0. All cause mortality will be reported as all cause mortality within the two year time frame that was analyzed for the primary endpoint. Please note that the number of participants at risk for all-cause mortality is greater than the number of participants at risk for adverse events. Only participants who received intervention are eligible for adverse events reporting.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
7.7%
37/481 • Up to 2 years
Adverse events will be assessed using CTCAE version 5.0. All cause mortality will be reported as all cause mortality within the two year time frame that was analyzed for the primary endpoint. Please note that the number of participants at risk for all-cause mortality is greater than the number of participants at risk for adverse events. Only participants who received intervention are eligible for adverse events reporting.
|
11.6%
55/476 • Up to 2 years
Adverse events will be assessed using CTCAE version 5.0. All cause mortality will be reported as all cause mortality within the two year time frame that was analyzed for the primary endpoint. Please note that the number of participants at risk for all-cause mortality is greater than the number of participants at risk for adverse events. Only participants who received intervention are eligible for adverse events reporting.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
17.5%
84/481 • Up to 2 years
Adverse events will be assessed using CTCAE version 5.0. All cause mortality will be reported as all cause mortality within the two year time frame that was analyzed for the primary endpoint. Please note that the number of participants at risk for all-cause mortality is greater than the number of participants at risk for adverse events. Only participants who received intervention are eligible for adverse events reporting.
|
14.1%
67/476 • Up to 2 years
Adverse events will be assessed using CTCAE version 5.0. All cause mortality will be reported as all cause mortality within the two year time frame that was analyzed for the primary endpoint. Please note that the number of participants at risk for all-cause mortality is greater than the number of participants at risk for adverse events. Only participants who received intervention are eligible for adverse events reporting.
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
5.4%
26/481 • Up to 2 years
Adverse events will be assessed using CTCAE version 5.0. All cause mortality will be reported as all cause mortality within the two year time frame that was analyzed for the primary endpoint. Please note that the number of participants at risk for all-cause mortality is greater than the number of participants at risk for adverse events. Only participants who received intervention are eligible for adverse events reporting.
|
7.1%
34/476 • Up to 2 years
Adverse events will be assessed using CTCAE version 5.0. All cause mortality will be reported as all cause mortality within the two year time frame that was analyzed for the primary endpoint. Please note that the number of participants at risk for all-cause mortality is greater than the number of participants at risk for adverse events. Only participants who received intervention are eligible for adverse events reporting.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
17.5%
84/481 • Up to 2 years
Adverse events will be assessed using CTCAE version 5.0. All cause mortality will be reported as all cause mortality within the two year time frame that was analyzed for the primary endpoint. Please note that the number of participants at risk for all-cause mortality is greater than the number of participants at risk for adverse events. Only participants who received intervention are eligible for adverse events reporting.
|
19.7%
94/476 • Up to 2 years
Adverse events will be assessed using CTCAE version 5.0. All cause mortality will be reported as all cause mortality within the two year time frame that was analyzed for the primary endpoint. Please note that the number of participants at risk for all-cause mortality is greater than the number of participants at risk for adverse events. Only participants who received intervention are eligible for adverse events reporting.
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders-Other
|
8.7%
42/481 • Up to 2 years
Adverse events will be assessed using CTCAE version 5.0. All cause mortality will be reported as all cause mortality within the two year time frame that was analyzed for the primary endpoint. Please note that the number of participants at risk for all-cause mortality is greater than the number of participants at risk for adverse events. Only participants who received intervention are eligible for adverse events reporting.
|
8.2%
39/476 • Up to 2 years
Adverse events will be assessed using CTCAE version 5.0. All cause mortality will be reported as all cause mortality within the two year time frame that was analyzed for the primary endpoint. Please note that the number of participants at risk for all-cause mortality is greater than the number of participants at risk for adverse events. Only participants who received intervention are eligible for adverse events reporting.
|
|
Vascular disorders
Hot flashes
|
5.6%
27/481 • Up to 2 years
Adverse events will be assessed using CTCAE version 5.0. All cause mortality will be reported as all cause mortality within the two year time frame that was analyzed for the primary endpoint. Please note that the number of participants at risk for all-cause mortality is greater than the number of participants at risk for adverse events. Only participants who received intervention are eligible for adverse events reporting.
|
6.7%
32/476 • Up to 2 years
Adverse events will be assessed using CTCAE version 5.0. All cause mortality will be reported as all cause mortality within the two year time frame that was analyzed for the primary endpoint. Please note that the number of participants at risk for all-cause mortality is greater than the number of participants at risk for adverse events. Only participants who received intervention are eligible for adverse events reporting.
|
|
Vascular disorders
Hypertension
|
16.4%
79/481 • Up to 2 years
Adverse events will be assessed using CTCAE version 5.0. All cause mortality will be reported as all cause mortality within the two year time frame that was analyzed for the primary endpoint. Please note that the number of participants at risk for all-cause mortality is greater than the number of participants at risk for adverse events. Only participants who received intervention are eligible for adverse events reporting.
|
17.4%
83/476 • Up to 2 years
Adverse events will be assessed using CTCAE version 5.0. All cause mortality will be reported as all cause mortality within the two year time frame that was analyzed for the primary endpoint. Please note that the number of participants at risk for all-cause mortality is greater than the number of participants at risk for adverse events. Only participants who received intervention are eligible for adverse events reporting.
|
|
Vascular disorders
Hypotension
|
3.7%
18/481 • Up to 2 years
Adverse events will be assessed using CTCAE version 5.0. All cause mortality will be reported as all cause mortality within the two year time frame that was analyzed for the primary endpoint. Please note that the number of participants at risk for all-cause mortality is greater than the number of participants at risk for adverse events. Only participants who received intervention are eligible for adverse events reporting.
|
6.9%
33/476 • Up to 2 years
Adverse events will be assessed using CTCAE version 5.0. All cause mortality will be reported as all cause mortality within the two year time frame that was analyzed for the primary endpoint. Please note that the number of participants at risk for all-cause mortality is greater than the number of participants at risk for adverse events. Only participants who received intervention are eligible for adverse events reporting.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60