Trial Outcomes & Findings for Dose-Adjusted EPOCH Chemotherapy and Rituximab (CD20+) in Previously Untreated Aggressive Non-Hodgkin's Lymphoma (NCT NCT00001337)
NCT ID: NCT00001337
Last Updated: 2025-06-22
Results Overview
Overall response defined as a Complete Response + Partial Response was measured by the Response Criteria. Complete Response is disappearance of all signs and symptoms of lymphoma for a period of at least one month. Partial Response is 50% or greater decrease in the sum of the products of the longest perpendicular diameters of all measured lesions lasting for a period of at least one month.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
348 participants
Primary outcome timeframe
Time frame was from beginning of therapy until the end of therapy, an average of 6 months
Results posted on
2025-06-22
Participant Flow
Participant milestones
| Measure |
With EPOCH-R (Etoposide, Doxorubicin, Prednisone, Cyclophosphamide and Rituximab)
Subgroup 1 (SG1) - All participants who received combination Rituximab (EPOCH-R). Rituximab 375 mg/m\^2 intravenous (IV) on day 1, every 21 days, prednisone 100mg by mouth (PO) twice a day (bid) on days 1 through 5 every 21 days, and cyclophosphamide 750mg/m\^2 on day 5 every 21 days. Doxorubicin 10mg/m\^2/day, vincristine 0.4mg/m\^2/day, and etoposide 50mg/m\^2/day were delivered as continuous intravenous (CIV) infusions over 96 hours starting on day 1 every 21 days. Dose levels were adjusted on doxorubicin, etoposide, and cyclophosphamide each cycle based on neutrophil nadir.
|
EPOCH Alone (Etoposide, Doxorubicin, Prednisone, and Cyclophosphamide)
Subgroup 2 (SG2) - EPOCH alone: All participants who received Prednisone 100mg by mouth (PO) twice a day (bid) on days 1 through 5 every 21 days, and cyclophosphamide 750mg/m\^2 on day 5 every 21 days. Doxorubicin 10mg/m\^2/day, vincristine 0.4mg/m\^2/day, and etoposide 50mg/m\^2/day were delivered as continuous intravenous (CIV) infusions over 96 hours starting on day 1 every 21 days. Dose levels were adjusted on doxorubicin, etoposide, and cyclophosphamide each cycle based on neutrophil nadir.
|
Enrolled But Not Treated
One participant was enrolled and not treated.
|
|---|---|---|---|
|
Overall Study
STARTED
|
235
|
112
|
1
|
|
Overall Study
Follow-up Period Completed
|
148
|
43
|
0
|
|
Overall Study
COMPLETED
|
148
|
43
|
0
|
|
Overall Study
NOT COMPLETED
|
87
|
69
|
1
|
Reasons for withdrawal
| Measure |
With EPOCH-R (Etoposide, Doxorubicin, Prednisone, Cyclophosphamide and Rituximab)
Subgroup 1 (SG1) - All participants who received combination Rituximab (EPOCH-R). Rituximab 375 mg/m\^2 intravenous (IV) on day 1, every 21 days, prednisone 100mg by mouth (PO) twice a day (bid) on days 1 through 5 every 21 days, and cyclophosphamide 750mg/m\^2 on day 5 every 21 days. Doxorubicin 10mg/m\^2/day, vincristine 0.4mg/m\^2/day, and etoposide 50mg/m\^2/day were delivered as continuous intravenous (CIV) infusions over 96 hours starting on day 1 every 21 days. Dose levels were adjusted on doxorubicin, etoposide, and cyclophosphamide each cycle based on neutrophil nadir.
|
EPOCH Alone (Etoposide, Doxorubicin, Prednisone, and Cyclophosphamide)
Subgroup 2 (SG2) - EPOCH alone: All participants who received Prednisone 100mg by mouth (PO) twice a day (bid) on days 1 through 5 every 21 days, and cyclophosphamide 750mg/m\^2 on day 5 every 21 days. Doxorubicin 10mg/m\^2/day, vincristine 0.4mg/m\^2/day, and etoposide 50mg/m\^2/day were delivered as continuous intravenous (CIV) infusions over 96 hours starting on day 1 every 21 days. Dose levels were adjusted on doxorubicin, etoposide, and cyclophosphamide each cycle based on neutrophil nadir.
|
Enrolled But Not Treated
One participant was enrolled and not treated.
|
|---|---|---|---|
|
Overall Study
Switched to alternate treatment
|
2
|
2
|
0
|
|
Overall Study
Refused further treatment
|
2
|
1
|
0
|
|
Overall Study
Began other Tx
|
1
|
0
|
0
|
|
Overall Study
Physician Decision
|
3
|
1
|
0
|
|
Overall Study
Doesn't have NHL
|
0
|
1
|
0
|
|
Overall Study
Non protocol tx needed
|
3
|
1
|
0
|
|
Overall Study
Protocol change
|
1
|
0
|
0
|
|
Overall Study
2nd primary disease
|
0
|
0
|
1
|
|
Overall Study
Death during follow up period
|
9
|
4
|
0
|
|
Overall Study
Death on study
|
19
|
9
|
0
|
|
Overall Study
Disease progression during follow-up period
|
3
|
1
|
0
|
|
Overall Study
Disease progression on study
|
33
|
41
|
0
|
|
Overall Study
Lost to further follow-up
|
10
|
6
|
0
|
|
Overall Study
2nd malignancy
|
1
|
0
|
0
|
|
Overall Study
Treatment for second lymphoma
|
0
|
1
|
0
|
|
Overall Study
Transfer to transplant
|
0
|
1
|
0
|
Baseline Characteristics
Dose-Adjusted EPOCH Chemotherapy and Rituximab (CD20+) in Previously Untreated Aggressive Non-Hodgkin's Lymphoma
Baseline characteristics by cohort
| Measure |
With EPOCH-R (Etoposide, Doxorubicin, Prednisone, Cyclophosphamide and Rituximab)
n=235 Participants
Subgroup 1 (SG1) - All participants who received combination Rituximab (EPOCH-R). Rituximab 375 mg/m\^2 intravenous (IV) on day 1, every 21 days, prednisone 100mg by mouth (PO) twice a day (bid) on days 1 through 5 every 21 days, and cyclophosphamide 750mg/m\^2 on day 5 every 21 days. Doxorubicin 10mg/m\^2/day, vincristine 0.4mg/m\^2/day, and etoposide 50mg/m\^2/day were delivered as continuous intravenous (CIV) infusions over 96 hours starting on day 1 every 21 days. Dose levels were adjusted on doxorubicin, etoposide, and cyclophosphamide each cycle based on neutrophil nadir.
|
EPOCH Alone (Etoposide, Doxorubicin, Prednisone, and Cyclophosphamide)
n=112 Participants
Subgroup 2 (SG2) - EPOCH alone: All participants who received Prednisone 100mg by mouth (PO) twice a day (bid) on days 1 through 5 every 21 days, and cyclophosphamide 750mg/m\^2 on day 5 every 21 days. Doxorubicin 10mg/m\^2/day, vincristine 0.4mg/m\^2/day, and etoposide 50mg/m\^2/day were delivered as continuous intravenous (CIV) infusions over 96 hours starting on day 1 every 21 days. Dose levels were adjusted on doxorubicin, etoposide, and cyclophosphamide each cycle based on neutrophil nadir.
|
Enrolled But Not Treated
n=1 Participants
Participant was enrolled but not treated.
|
Total
n=348 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
5 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
5 Participants
n=7 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
200 Participants
n=99 Participants
|
102 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
303 Participants
n=7 Participants
|
|
Age, Categorical
>=65 years
|
30 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
40 Participants
n=7 Participants
|
|
Age, Continuous
|
43.97 years
STANDARD_DEVIATION 17.7 • n=99 Participants
|
47.2 years
STANDARD_DEVIATION 15.29 • n=107 Participants
|
62.6 years
STANDARD_DEVIATION 0 • n=206 Participants
|
45.06 years
STANDARD_DEVIATION 17 • n=7 Participants
|
|
Sex: Female, Male
Female
|
103 Participants
n=99 Participants
|
50 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
153 Participants
n=7 Participants
|
|
Sex: Female, Male
Male
|
132 Participants
n=99 Participants
|
62 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
195 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
17 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
18 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
211 Participants
n=99 Participants
|
108 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
320 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
7 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
10 Participants
n=7 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Asian
|
12 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
18 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Black or African American
|
37 Participants
n=99 Participants
|
13 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
51 Participants
n=7 Participants
|
|
Race (NIH/OMB)
White
|
169 Participants
n=99 Participants
|
91 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
260 Participants
n=7 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
17 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
19 Participants
n=7 Participants
|
|
Region of Enrollment
United States
|
235 participants
n=99 Participants
|
112 participants
n=107 Participants
|
1 participants
n=206 Participants
|
348 participants
n=7 Participants
|
PRIMARY outcome
Timeframe: Time frame was from beginning of therapy until the end of therapy, an average of 6 monthsPopulation: 347/348 participants were analyzed because 1 was inevaluable for response.
Overall response defined as a Complete Response + Partial Response was measured by the Response Criteria. Complete Response is disappearance of all signs and symptoms of lymphoma for a period of at least one month. Partial Response is 50% or greater decrease in the sum of the products of the longest perpendicular diameters of all measured lesions lasting for a period of at least one month.
Outcome measures
| Measure |
With EPOCH-R (Etoposide, Doxorubicin, Prednisone, Cyclophosphamide and Rituximab)
n=235 Participants
Subgroup 1 (SG1) - All participants who received combination Rituximab (EPOCH-R). Rituximab 375 mg/m\^2 intravenous (IV) on day 1, every 21 days, prednisone 100mg by mouth (PO) twice a day (bid) on days 1 through 5 every 21 days, and cyclophosphamide 750mg/m\^2 on day 5 every 21 days. Doxorubicin 10mg/m\^2/day, vincristine 0.4mg/m\^2/day, and etoposide 50mg/m\^2/day were delivered as continuous intravenous (CIV) infusions over 96 hours starting on day 1 every 21 days. Dose levels were adjusted on doxorubicin, etoposide, and cyclophosphamide each cycle based on neutrophil nadir.
|
EPOCH Alone (Etoposide, Doxorubicin, Prednisone, and Cyclophosphamide)
n=112 Participants
Subgroup 2 (SG2) - EPOCH alone: All participants who received Prednisone 100mg by mouth (PO) twice a day (bid) on days 1 through 5 every 21 days, and cyclophosphamide 750mg/m\^2 on day 5 every 21 days. Doxorubicin 10mg/m\^2/day, vincristine 0.4mg/m\^2/day, and etoposide 50mg/m\^2/day were delivered as continuous intravenous (CIV) infusions over 96 hours starting on day 1 every 21 days. Dose levels were adjusted on doxorubicin, etoposide, and cyclophosphamide each cycle based on neutrophil nadir.
|
|---|---|---|
|
Overall Response (Complete Response + Partial Response)
|
216 Participants
|
94 Participants
|
PRIMARY outcome
Timeframe: Progression free survival was calculated from study entry until progression or death from any cause. Median follow up of evaluable participants was 5 years (range 2-7 years)Population: 347/348 participants were analyzed because 1 was inevaluable for response.
The Dixon-Simon method will be used to determine whether large B-cell lymphomas expressing BCL-2 (+) participants may experience an improved progression free survival with Etoposide, VP-16, and Doxorubicin with Prednisone, Cyclophosphamide, and Rituximab (EPOCH-R) compared to EPOCH alone, and to obtain a concurrent, precisely determined measure of progression free survival. PFS is the time from start of treatment to documented evidence of disease progression. Progression is an increase of 25% or more in the sum of the products of the longest perpendicular diameters of all measured lesions, or the appearance of any new lesions measured by the Response Criteria.
Outcome measures
| Measure |
With EPOCH-R (Etoposide, Doxorubicin, Prednisone, Cyclophosphamide and Rituximab)
n=235 Participants
Subgroup 1 (SG1) - All participants who received combination Rituximab (EPOCH-R). Rituximab 375 mg/m\^2 intravenous (IV) on day 1, every 21 days, prednisone 100mg by mouth (PO) twice a day (bid) on days 1 through 5 every 21 days, and cyclophosphamide 750mg/m\^2 on day 5 every 21 days. Doxorubicin 10mg/m\^2/day, vincristine 0.4mg/m\^2/day, and etoposide 50mg/m\^2/day were delivered as continuous intravenous (CIV) infusions over 96 hours starting on day 1 every 21 days. Dose levels were adjusted on doxorubicin, etoposide, and cyclophosphamide each cycle based on neutrophil nadir.
|
EPOCH Alone (Etoposide, Doxorubicin, Prednisone, and Cyclophosphamide)
n=112 Participants
Subgroup 2 (SG2) - EPOCH alone: All participants who received Prednisone 100mg by mouth (PO) twice a day (bid) on days 1 through 5 every 21 days, and cyclophosphamide 750mg/m\^2 on day 5 every 21 days. Doxorubicin 10mg/m\^2/day, vincristine 0.4mg/m\^2/day, and etoposide 50mg/m\^2/day were delivered as continuous intravenous (CIV) infusions over 96 hours starting on day 1 every 21 days. Dose levels were adjusted on doxorubicin, etoposide, and cyclophosphamide each cycle based on neutrophil nadir.
|
|---|---|---|
|
Progression Free Survival (PFS)
|
73 Participants
|
41 Participants
|
SECONDARY outcome
Timeframe: Initiation of study drug until 30 days after treatment, an average of 6 monthsPopulation: 347/348 participants were analyzed because one participant was enrolled and not treated.
Here is the proportion of participants with adverse events leading to discontinuation of therapy. A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life-threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the participant and may require medical or surgical intervention to prevent one of the previous outcomes mentioned.
Outcome measures
| Measure |
With EPOCH-R (Etoposide, Doxorubicin, Prednisone, Cyclophosphamide and Rituximab)
n=235 Participants
Subgroup 1 (SG1) - All participants who received combination Rituximab (EPOCH-R). Rituximab 375 mg/m\^2 intravenous (IV) on day 1, every 21 days, prednisone 100mg by mouth (PO) twice a day (bid) on days 1 through 5 every 21 days, and cyclophosphamide 750mg/m\^2 on day 5 every 21 days. Doxorubicin 10mg/m\^2/day, vincristine 0.4mg/m\^2/day, and etoposide 50mg/m\^2/day were delivered as continuous intravenous (CIV) infusions over 96 hours starting on day 1 every 21 days. Dose levels were adjusted on doxorubicin, etoposide, and cyclophosphamide each cycle based on neutrophil nadir.
|
EPOCH Alone (Etoposide, Doxorubicin, Prednisone, and Cyclophosphamide)
n=112 Participants
Subgroup 2 (SG2) - EPOCH alone: All participants who received Prednisone 100mg by mouth (PO) twice a day (bid) on days 1 through 5 every 21 days, and cyclophosphamide 750mg/m\^2 on day 5 every 21 days. Doxorubicin 10mg/m\^2/day, vincristine 0.4mg/m\^2/day, and etoposide 50mg/m\^2/day were delivered as continuous intravenous (CIV) infusions over 96 hours starting on day 1 every 21 days. Dose levels were adjusted on doxorubicin, etoposide, and cyclophosphamide each cycle based on neutrophil nadir.
|
|---|---|---|
|
Proportion of Participants With Serious and/or Non-serious Adverse Events Leading to Discontinuation of Therapy
|
0.03 proportion of participants
|
0.04 proportion of participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Time frame is from study entry until 30 days after completing study therapy, approximately 5 years.Population: 347/348 participants were analyzed because one participant was enrolled and not treated.
Here is the number of participants with serious and/or non-serious adverse events assessed by the Common Terminology Criteria for Adverse Events (CTCAE v4.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life-threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned.
Outcome measures
| Measure |
With EPOCH-R (Etoposide, Doxorubicin, Prednisone, Cyclophosphamide and Rituximab)
n=235 Participants
Subgroup 1 (SG1) - All participants who received combination Rituximab (EPOCH-R). Rituximab 375 mg/m\^2 intravenous (IV) on day 1, every 21 days, prednisone 100mg by mouth (PO) twice a day (bid) on days 1 through 5 every 21 days, and cyclophosphamide 750mg/m\^2 on day 5 every 21 days. Doxorubicin 10mg/m\^2/day, vincristine 0.4mg/m\^2/day, and etoposide 50mg/m\^2/day were delivered as continuous intravenous (CIV) infusions over 96 hours starting on day 1 every 21 days. Dose levels were adjusted on doxorubicin, etoposide, and cyclophosphamide each cycle based on neutrophil nadir.
|
EPOCH Alone (Etoposide, Doxorubicin, Prednisone, and Cyclophosphamide)
n=112 Participants
Subgroup 2 (SG2) - EPOCH alone: All participants who received Prednisone 100mg by mouth (PO) twice a day (bid) on days 1 through 5 every 21 days, and cyclophosphamide 750mg/m\^2 on day 5 every 21 days. Doxorubicin 10mg/m\^2/day, vincristine 0.4mg/m\^2/day, and etoposide 50mg/m\^2/day were delivered as continuous intravenous (CIV) infusions over 96 hours starting on day 1 every 21 days. Dose levels were adjusted on doxorubicin, etoposide, and cyclophosphamide each cycle based on neutrophil nadir.
|
|---|---|---|
|
Number of Participants With Serious and/or Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v4.0)
|
235 Participants
|
112 Participants
|
Adverse Events
EPOCH Alone (Etoposide, Doxorubicin, Prednisone, and Cyclophosphamide)
Serious events: 44 serious events
Other events: 112 other events
Deaths: 13 deaths
With EPOCH-R (Etoposide, Doxorubicin, Prednisone, Cyclophosphamide and Rituximab)
Serious events: 146 serious events
Other events: 235 other events
Deaths: 28 deaths
Serious adverse events
| Measure |
EPOCH Alone (Etoposide, Doxorubicin, Prednisone, and Cyclophosphamide)
n=112 participants at risk
Subgroup 2 (SG2) - EPOCH alone: All participants who received Prednisone 100mg by mouth (PO) twice a day (bid) on days 1 through 5 every 21 days, and cyclophosphamide 750mg/m\^2 on day 5 every 21 days. Doxorubicin 10mg/m\^2/day, vincristine 0.4mg/m\^2/day, and etoposide 50mg/m\^2/day were delivered as continuous intravenous (CIV) infusions over 96 hours starting on day 1 every 21 days. Dose levels were adjusted on doxorubicin, etoposide, and cyclophosphamide each cycle based on neutrophil nadir.
|
With EPOCH-R (Etoposide, Doxorubicin, Prednisone, Cyclophosphamide and Rituximab)
n=235 participants at risk
Subgroup 1 (SG1) - All participants who received combination Rituximab (EPOCH-R). Rituximab 375 mg/m\^2 intravenous (IV) on day 1, every 21 days, prednisone 100mg by mouth (PO) twice a day (bid) on days 1 through 5 every 21 days, and cyclophosphamide 750mg/m\^2 on day 5 every 21 days. Doxorubicin 10mg/m\^2/day, vincristine 0.4mg/m\^2/day, and etoposide 50mg/m\^2/day were delivered as continuous intravenous (CIV) infusions over 96 hours starting on day 1 every 21 days. Dose levels were adjusted on doxorubicin, etoposide, and cyclophosphamide each cycle based on neutrophil nadir.
|
|---|---|---|
|
Metabolism and nutrition disorders
Acidosis (metabolic or respiratory)
|
0.00%
0/112 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
0.43%
1/235 • Number of events 1 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
|
Immune system disorders
Allergic reaction/hypersensitivity (including drug fever)
|
0.89%
1/112 • Number of events 1 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
0.85%
2/235 • Number of events 3 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
|
Gastrointestinal disorders
Anorexia
|
0.00%
0/112 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
0.43%
1/235 • Number of events 1 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
|
Nervous system disorders
CNS cerebrovascular ischemia
|
0.00%
0/112 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
0.43%
1/235 • Number of events 1 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
|
Cardiac disorders
Cardiac ischemia/infarction
|
0.00%
0/112 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
0.43%
1/235 • Number of events 1 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
|
Nervous system disorders
Confusion
|
0.00%
0/112 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
0.43%
1/235 • Number of events 1 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
|
Gastrointestinal disorders
Constipation
|
0.89%
1/112 • Number of events 1 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
3.0%
7/235 • Number of events 7 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/112 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
0.43%
1/235 • Number of events 1 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
|
General disorders
Cytokine release syndrome/acute infusion reaction
|
0.00%
0/112 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
0.43%
1/235 • Number of events 1 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
|
Gastrointestinal disorders
Dehydration
|
0.89%
1/112 • Number of events 1 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
1.3%
3/235 • Number of events 3 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/112 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
2.6%
6/235 • Number of events 9 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/112 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
1.3%
3/235 • Number of events 3 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea (shortness of breath)
|
0.00%
0/112 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
0.85%
2/235 • Number of events 2 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
|
Infections and infestations
Febrile neutropenia
|
31.2%
35/112 • Number of events 53 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
44.3%
104/235 • Number of events 170 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
|
General disorders
Fever (in the absence of neutropenia, where neutropenia is defined as ANC <1.0 x 10e9/L)
|
2.7%
3/112 • Number of events 3 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
4.7%
11/235 • Number of events 12 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
|
Gastrointestinal disorders
Gastrointestinal - Other (Esophageal Obstruction)
|
0.00%
0/112 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
0.43%
1/235 • Number of events 1 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
|
Gastrointestinal disorders
Gastrointestinal - Other (Hernia)
|
0.00%
0/112 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
0.43%
1/235 • Number of events 1 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
|
Blood and lymphatic system disorders
Hemoglobin
|
0.00%
0/112 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
1.7%
4/235 • Number of events 5 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
|
Nervous system disorders
Hemorrhage, CNS
|
0.00%
0/112 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
0.43%
1/235 • Number of events 1 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
|
Gastrointestinal disorders
Hemorrhage, GI::Upper GI NOS
|
0.00%
0/112 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
0.43%
1/235 • Number of events 1 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
|
Respiratory, thoracic and mediastinal disorders
Hemorrhage, pulmonary/upper respiratory::Nose
|
0.00%
0/112 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
0.43%
1/235 • Number of events 1 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
|
Respiratory, thoracic and mediastinal disorders
Hemorrhage, pulmonary/upper respiratory::Respiratory tract NOS
|
0.89%
1/112 • Number of events 1 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
0.43%
1/235 • Number of events 1 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
|
Cardiac disorders
Hypotension
|
1.8%
2/112 • Number of events 2 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
3.4%
8/235 • Number of events 10 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/112 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
0.43%
1/235 • Number of events 1 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
|
Gastrointestinal disorders
Ileus, GI (functional obstruction of bowel, i.e., neuroconstipation)
|
0.00%
0/112 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
3.0%
7/235 • Number of events 7 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
|
Infections and infestations
Infection (documented clinically or microbiologically) with Grade 3 or 4 neutrophils
|
0.00%
0/112 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
0.85%
2/235 • Number of events 2 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
|
Infections and infestations
Infection with normal ANC or Grade 1 or 2 neutrophils::Blood
|
0.89%
1/112 • Number of events 1 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
0.00%
0/235 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
|
Infections and infestations
Infection with normal ANC or Grade 1 or 2 neutrophils::Lung (pneumonia)
|
0.89%
1/112 • Number of events 1 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
0.00%
0/235 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
|
Infections and infestations
Infection with normal ANC or Grade 1 or 2 neutrophils::Rectum
|
0.00%
0/112 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
0.43%
1/235 • Number of events 1 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
|
Infections and infestations
Infection with unknown ANC::Urinary tract NOS
|
0.89%
1/112 • Number of events 1 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
0.00%
0/235 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
|
Blood and lymphatic system disorders
Leukocytes (total WBC)
|
0.00%
0/112 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
0.43%
1/235 • Number of events 1 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
|
Hepatobiliary disorders
Liver dysfunction/failure (clinical)
|
0.89%
1/112 • Number of events 1 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
0.00%
0/235 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
|
Metabolism and nutrition disorders
Magnesium, serum-low (hypomagnesemia)
|
0.00%
0/112 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
0.43%
1/235 • Number of events 1 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
|
Gastrointestinal disorders
Mucositis/stomatitis (clinical exam)::Oral cavity
|
0.00%
0/112 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
2.1%
5/235 • Number of events 6 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness, generalized or specific area (not due to neuropathy)::Whole body/generalized
|
0.00%
0/112 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
0.43%
1/235 • Number of events 1 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal/Soft Tissue - Other (Hip fracture)
|
0.00%
0/112 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
0.43%
1/235 • Number of events 1 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/112 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
2.1%
5/235 • Number of events 8 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
|
Nervous system disorders
Neurology - Other (subdural hygroma)
|
0.00%
0/112 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
0.43%
1/235 • Number of events 1 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
|
Nervous system disorders
Neuropathy: cranial::CN VII Motor-face; Sensory-taste
|
0.89%
1/112 • Number of events 1 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
0.00%
0/235 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
|
Nervous system disorders
Neuropathy: motor
|
0.00%
0/112 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
0.43%
1/235 • Number of events 1 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
|
Nervous system disorders
Neuropathy: sensory
|
0.89%
1/112 • Number of events 1 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
0.00%
0/235 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
|
Investigations
Neutrophils/granulocytes (ANC/AGC)
|
1.8%
2/112 • Number of events 2 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
2.1%
5/235 • Number of events 6 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
|
Blood and lymphatic system disorders
PTT (Partial Thromboplastin Time)
|
0.00%
0/112 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
0.43%
1/235 • Number of events 1 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
|
Skin and subcutaneous tissue disorders
Pain - Other (Incision)
|
0.00%
0/112 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
0.43%
1/235 • Number of events 1 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
|
Gastrointestinal disorders
Pain::Abdomen NOS
|
3.6%
4/112 • Number of events 5 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
0.43%
1/235 • Number of events 1 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
|
Musculoskeletal and connective tissue disorders
Pain::Bone
|
0.00%
0/112 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
1.3%
3/235 • Number of events 3 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
|
Musculoskeletal and connective tissue disorders
Pain::Chest/thorax NOS
|
0.00%
0/112 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
1.3%
3/235 • Number of events 3 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
|
Nervous system disorders
Pain::Head/headache
|
0.00%
0/112 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
0.85%
2/235 • Number of events 2 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
|
Musculoskeletal and connective tissue disorders
Pain::Muscle
|
0.00%
0/112 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
0.43%
1/235 • Number of events 1 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
|
Hepatobiliary disorders
Pancreatitis
|
0.89%
1/112 • Number of events 1 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
0.00%
0/235 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
|
Gastrointestinal disorders
Perforation, GI::Duodenum
|
0.00%
0/112 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
0.43%
1/235 • Number of events 1 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
|
Gastrointestinal disorders
Perforation, GI::Esophagus
|
0.00%
0/112 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
0.43%
1/235 • Number of events 1 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
|
Gastrointestinal disorders
Perforation, GI::Small bowel NOS
|
0.00%
0/112 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
0.43%
1/235 • Number of events 1 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
|
Gastrointestinal disorders
Perforation, GI::Stomach
|
0.00%
0/112 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
0.43%
1/235 • Number of events 1 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
|
Blood and lymphatic system disorders
Platelets
|
0.00%
0/112 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
0.85%
2/235 • Number of events 2 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
|
Metabolism and nutrition disorders
Potassium, serum-low (hypokalemia)
|
0.00%
0/112 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
0.85%
2/235 • Number of events 4 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
|
Skin and subcutaneous tissue disorders
Rash: dermatitis associated with radiation::Radiation
|
0.00%
0/112 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
0.43%
1/235 • Number of events 1 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
|
Renal and urinary disorders
Renal failure
|
0.00%
0/112 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
0.43%
1/235 • Number of events 1 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
|
General disorders
Rigors/chills
|
0.00%
0/112 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
0.43%
1/235 • Number of events 1 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Secondary Malignancy - possibly related to cancer treatment (Specify, __)
|
0.00%
0/112 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
0.43%
1/235 • Number of events 1 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
|
Cardiac disorders
Supraventricular and nodal arrhythmia::Sinus arrhythmia
|
0.00%
0/112 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
0.43%
1/235 • Number of events 1 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
|
Cardiac disorders
Supraventricular and nodal arrhythmia::Sinus tachycardia
|
0.00%
0/112 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
0.43%
1/235 • Number of events 1 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
|
Nervous system disorders
Syncope (fainting)
|
0.00%
0/112 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
0.85%
2/235 • Number of events 2 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
|
Vascular disorders
Thrombosis/thrombus/embolism
|
3.6%
4/112 • Number of events 4 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
2.1%
5/235 • Number of events 5 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
|
Gastrointestinal disorders
Vomiting
|
0.89%
1/112 • Number of events 1 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
1.7%
4/235 • Number of events 5 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
Other adverse events
| Measure |
EPOCH Alone (Etoposide, Doxorubicin, Prednisone, and Cyclophosphamide)
n=112 participants at risk
Subgroup 2 (SG2) - EPOCH alone: All participants who received Prednisone 100mg by mouth (PO) twice a day (bid) on days 1 through 5 every 21 days, and cyclophosphamide 750mg/m\^2 on day 5 every 21 days. Doxorubicin 10mg/m\^2/day, vincristine 0.4mg/m\^2/day, and etoposide 50mg/m\^2/day were delivered as continuous intravenous (CIV) infusions over 96 hours starting on day 1 every 21 days. Dose levels were adjusted on doxorubicin, etoposide, and cyclophosphamide each cycle based on neutrophil nadir.
|
With EPOCH-R (Etoposide, Doxorubicin, Prednisone, Cyclophosphamide and Rituximab)
n=235 participants at risk
Subgroup 1 (SG1) - All participants who received combination Rituximab (EPOCH-R). Rituximab 375 mg/m\^2 intravenous (IV) on day 1, every 21 days, prednisone 100mg by mouth (PO) twice a day (bid) on days 1 through 5 every 21 days, and cyclophosphamide 750mg/m\^2 on day 5 every 21 days. Doxorubicin 10mg/m\^2/day, vincristine 0.4mg/m\^2/day, and etoposide 50mg/m\^2/day were delivered as continuous intravenous (CIV) infusions over 96 hours starting on day 1 every 21 days. Dose levels were adjusted on doxorubicin, etoposide, and cyclophosphamide each cycle based on neutrophil nadir.
|
|---|---|---|
|
Metabolism and nutrition disorders
ALT, SGPT (serum glutamic pyruvic transaminase)
|
17.0%
19/112 • Number of events 27 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
52.8%
124/235 • Number of events 210 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
|
Metabolism and nutrition disorders
AST, SGOT(serum glutamic oxaloacetic transaminase)
|
10.7%
12/112 • Number of events 17 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
35.3%
83/235 • Number of events 121 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
|
Metabolism and nutrition disorders
Albumin, serum-low (hypoalbuminemia)
|
13.4%
15/112 • Number of events 29 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
54.0%
127/235 • Number of events 231 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
|
Metabolism and nutrition disorders
Alkaline phosphatase
|
12.5%
14/112 • Number of events 16 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
21.3%
50/235 • Number of events 72 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
|
Immune system disorders
Allergic reaction/hypersensitivity (including drug fever)
|
0.00%
0/112 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
8.5%
20/235 • Number of events 24 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
|
Immune system disorders
Allergic rhinitis (including sneezing, nasal stuffiness, postnasal drip)
|
10.7%
12/112 • Number of events 14 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
26.4%
62/235 • Number of events 74 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
|
Metabolism and nutrition disorders
Amylase
|
0.00%
0/112 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
1.7%
4/235 • Number of events 4 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
|
Gastrointestinal disorders
Anorexia
|
16.1%
18/112 • Number of events 22 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
31.9%
75/235 • Number of events 122 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
|
Musculoskeletal and connective tissue disorders
Arthritis (non-septic)
|
0.00%
0/112 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
0.85%
2/235 • Number of events 3 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
0.89%
1/112 • Number of events 1 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
0.00%
0/235 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
|
Ear and labyrinth disorders
Auditory/Ear - Other (decreased hearing)
|
0.00%
0/112 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
0.43%
1/235 • Number of events 1 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
|
Metabolism and nutrition disorders
Bicarbonate, serum-low
|
1.8%
2/112 • Number of events 5 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
6.8%
16/235 • Number of events 34 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
|
Metabolism and nutrition disorders
Bilirubin (hyperbilirubinemia)
|
6.2%
7/112 • Number of events 13 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
17.4%
41/235 • Number of events 62 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm, wheezing
|
0.00%
0/112 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
1.3%
3/235 • Number of events 4 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
|
Skin and subcutaneous tissue disorders
Bruising (in absence of Grade 3 or 4 thrombocytopenia)
|
1.8%
2/112 • Number of events 3 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
1.3%
3/235 • Number of events 3 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
|
Nervous system disorders
CNS cerebrovascular ischemia
|
0.00%
0/112 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
0.43%
1/235 • Number of events 1 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
|
Metabolism and nutrition disorders
CPK (creatine phosphokinase)
|
0.00%
0/112 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
0.43%
1/235 • Number of events 1 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
|
Metabolism and nutrition disorders
Calcium, serum-high (hypercalcemia)
|
1.8%
2/112 • Number of events 2 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
4.3%
10/235 • Number of events 17 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
|
Metabolism and nutrition disorders
Calcium, serum-low (hypocalcemia)
|
7.1%
8/112 • Number of events 8 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
25.5%
60/235 • Number of events 88 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
|
Cardiac disorders
Cardiac General - Other (Fluid overload)
|
0.00%
0/112 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
0.43%
1/235 • Number of events 1 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
|
Cardiac disorders
Cardiac ischemia/infarction
|
0.00%
0/112 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
0.43%
1/235 • Number of events 1 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
|
Nervous system disorders
Cognitive disturbance
|
0.00%
0/112 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
0.43%
1/235 • Number of events 1 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
|
Gastrointestinal disorders
Colitis, infectious (e.g., Clostridium difficile)
|
0.00%
0/112 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
0.85%
2/235 • Number of events 2 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
|
Nervous system disorders
Confusion
|
0.89%
1/112 • Number of events 2 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
2.6%
6/235 • Number of events 6 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
|
Gastrointestinal disorders
Constipation
|
40.2%
45/112 • Number of events 65 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
62.1%
146/235 • Number of events 267 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
|
General disorders
Constitutional Symptoms - Other (Intolerance to cold)
|
0.00%
0/112 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
0.43%
1/235 • Number of events 1 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
8.9%
10/112 • Number of events 12 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
28.1%
66/235 • Number of events 81 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
|
Metabolism and nutrition disorders
Creatinine
|
1.8%
2/112 • Number of events 2 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
11.1%
26/235 • Number of events 40 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
|
Renal and urinary disorders
Cystitis
|
0.89%
1/112 • Number of events 1 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
0.43%
1/235 • Number of events 1 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
|
Blood and lymphatic system disorders
DIC (disseminated intravascular coagulation)
|
0.89%
1/112 • Number of events 1 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
0.00%
0/235 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
|
Gastrointestinal disorders
Dehydration
|
5.4%
6/112 • Number of events 6 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
10.2%
24/235 • Number of events 28 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
|
Skin and subcutaneous tissue disorders
Dermatology/Skin - Other (Blisters-toes)
|
0.00%
0/112 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
0.43%
1/235 • Number of events 1 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
|
Skin and subcutaneous tissue disorders
Dermatology/Skin - Other (Cold sore)
|
0.00%
0/112 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
0.43%
1/235 • Number of events 1 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
|
Gastrointestinal disorders
Diarrhea
|
38.4%
43/112 • Number of events 71 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
46.0%
108/235 • Number of events 184 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
|
Gastrointestinal disorders
Distension/bloating, abdominal
|
0.00%
0/112 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
0.43%
1/235 • Number of events 1 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
|
Nervous system disorders
Dizziness
|
10.7%
12/112 • Number of events 19 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
25.5%
60/235 • Number of events 84 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
|
Eye disorders
Dry eye syndrome
|
4.5%
5/112 • Number of events 6 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
5.5%
13/235 • Number of events 13 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
|
Gastrointestinal disorders
Dry mouth/salivary gland (xerostomia)
|
1.8%
2/112 • Number of events 2 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
1.7%
4/235 • Number of events 4 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
1.8%
2/112 • Number of events 2 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
3.4%
8/235 • Number of events 8 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
|
Gastrointestinal disorders
Dysphagia (difficulty swallowing)
|
3.6%
4/112 • Number of events 6 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
4.7%
11/235 • Number of events 12 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea (shortness of breath)
|
14.3%
16/112 • Number of events 24 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
28.9%
68/235 • Number of events 94 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
|
Blood and lymphatic system disorders
Edema: limb
|
9.8%
11/112 • Number of events 16 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
17.9%
42/235 • Number of events 52 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
|
Reproductive system and breast disorders
Erectile dysfunction
|
1.8%
2/112 • Number of events 2 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
4.3%
10/235 • Number of events 17 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
|
Gastrointestinal disorders
Esophagitis
|
2.7%
3/112 • Number of events 5 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
4.7%
11/235 • Number of events 12 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
|
Nervous system disorders
Extrapyramidal/involuntary movement/restlessness
|
0.00%
0/112 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
0.85%
2/235 • Number of events 2 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
|
General disorders
Fatigue (asthenia, lethargy, malaise)
|
69.6%
78/112 • Number of events 179 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
83.0%
195/235 • Number of events 417 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
|
Infections and infestations
Febrile neutropenia
|
9.8%
11/112 • Number of events 11 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
17.4%
41/235 • Number of events 52 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
|
General disorders
Fever (in the absence of neutropenia, where neutropenia is defined as ANC <1.0 x 10e9/L)
|
25.9%
29/112 • Number of events 45 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
32.8%
77/235 • Number of events 99 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
|
Gastrointestinal disorders
Fistula, GI::Rectum
|
0.89%
1/112 • Number of events 1 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
0.00%
0/235 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
|
Gastrointestinal disorders
Flatulence
|
0.89%
1/112 • Number of events 1 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
5.1%
12/235 • Number of events 16 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
|
Skin and subcutaneous tissue disorders
Flushing
|
1.8%
2/112 • Number of events 2 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
4.3%
10/235 • Number of events 11 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
|
Metabolism and nutrition disorders
GGT (gamma-Glutamyl transpeptidase)
|
0.00%
0/112 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
0.43%
1/235 • Number of events 1 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
|
Gastrointestinal disorders
Gastritis (including bile reflux gastritis)
|
0.00%
0/112 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
1.3%
3/235 • Number of events 3 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
|
Gastrointestinal disorders
Gastrointestinal - Other (Bloating)
|
0.00%
0/112 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
0.43%
1/235 • Number of events 1 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
|
Gastrointestinal disorders
Gastrointestinal - Other (Early satiety)
|
0.00%
0/112 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
0.43%
1/235 • Number of events 1 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
|
Gastrointestinal disorders
Gastrointestinal - Other (Esophageal Stenosis)
|
0.00%
0/112 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
0.43%
1/235 • Number of events 1 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
|
Gastrointestinal disorders
Gastrointestinal - Other (Hernia)
|
0.00%
0/112 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
0.43%
1/235 • Number of events 1 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
|
Metabolism and nutrition disorders
Glucose, serum-high (hyperglycemia)
|
17.0%
19/112 • Number of events 37 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
43.8%
103/235 • Number of events 194 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
|
Metabolism and nutrition disorders
Glucose, serum-low (hypoglycemia)
|
3.6%
4/112 • Number of events 4 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
6.0%
14/235 • Number of events 17 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
|
Skin and subcutaneous tissue disorders
Hair loss/alopecia (scalp or body)
|
71.4%
80/112 • Number of events 98 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
59.1%
139/235 • Number of events 154 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
|
Ear and labyrinth disorders
Hearing: patients with/without baseline audiogram and enrolled in a monitoring program
|
0.00%
0/112 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
0.43%
1/235 • Number of events 1 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
|
Ear and labyrinth disorders
Hearing: patients without baseline audiogram and not enrolled in a monitoring program
|
0.00%
0/112 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
2.6%
6/235 • Number of events 7 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
|
Gastrointestinal disorders
Heartburn/dyspepsia
|
7.1%
8/112 • Number of events 9 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
23.4%
55/235 • Number of events 66 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
|
Blood and lymphatic system disorders
Hemoglobin
|
32.1%
36/112 • Number of events 107 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
86.0%
202/235 • Number of events 580 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
|
Gastrointestinal disorders
Hemorrhage, GI::Anus
|
0.00%
0/112 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
0.85%
2/235 • Number of events 3 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
|
Gastrointestinal disorders
Hemorrhage, GI::Oral cavity
|
0.89%
1/112 • Number of events 1 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
0.00%
0/235 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
|
Gastrointestinal disorders
Hemorrhage, GI::Rectum
|
3.6%
4/112 • Number of events 4 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
6.0%
14/235 • Number of events 15 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
|
Gastrointestinal disorders
Hemorrhage, GI::Upper GI NOS
|
0.00%
0/112 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
0.43%
1/235 • Number of events 1 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
|
Gastrointestinal disorders
Hemorrhage, GI::Varices (rectal)
|
0.00%
0/112 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
0.85%
2/235 • Number of events 2 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
|
Renal and urinary disorders
Hemorrhage, GU::Urethra
|
0.00%
0/112 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
0.43%
1/235 • Number of events 3 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
|
Renal and urinary disorders
Hemorrhage, GU::Urinary NOS
|
1.8%
2/112 • Number of events 2 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
3.0%
7/235 • Number of events 7 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
|
Reproductive system and breast disorders
Hemorrhage, GU::Vagina
|
1.8%
2/112 • Number of events 2 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
0.00%
0/235 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
|
Respiratory, thoracic and mediastinal disorders
Hemorrhage, pulmonary/upper respiratory::Bronchopulmonary NOS
|
0.00%
0/112 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
0.43%
1/235 • Number of events 1 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
|
Respiratory, thoracic and mediastinal disorders
Hemorrhage, pulmonary/upper respiratory::Nose
|
2.7%
3/112 • Number of events 3 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
5.5%
13/235 • Number of events 14 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
|
Respiratory, thoracic and mediastinal disorders
Hemorrhage, pulmonary/upper respiratory::Respiratory tract NOS
|
0.00%
0/112 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
0.43%
1/235 • Number of events 1 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
|
Skin and subcutaneous tissue disorders
Hemorrhage/Bleeding - Other (Ecchymosis)
|
0.00%
0/112 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
0.43%
1/235 • Number of events 1 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
|
Musculoskeletal and connective tissue disorders
Hemorrhage/Bleeding - Other (Gluteal muscle;Compartment syndrome)
|
0.00%
0/112 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
0.43%
1/235 • Number of events 1 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
|
Blood and lymphatic system disorders
Hemorrhoids
|
0.89%
1/112 • Number of events 1 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
3.0%
7/235 • Number of events 12 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
|
Respiratory, thoracic and mediastinal disorders
Hiccoughs (hiccups, singultus)
|
0.89%
1/112 • Number of events 1 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
0.43%
1/235 • Number of events 1 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
|
Endocrine disorders
Hot flashes/flushes
|
0.89%
1/112 • Number of events 1 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
2.1%
5/235 • Number of events 5 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
|
Skin and subcutaneous tissue disorders
Hyperpigmentation
|
1.8%
2/112 • Number of events 2 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
4.7%
11/235 • Number of events 12 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
|
Cardiac disorders
Hypertension
|
4.5%
5/112 • Number of events 5 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
2.1%
5/235 • Number of events 5 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
|
Skin and subcutaneous tissue disorders
Hypopigmentation
|
0.89%
1/112 • Number of events 1 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
0.00%
0/235 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
|
Cardiac disorders
Hypotension
|
8.0%
9/112 • Number of events 11 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
13.6%
32/235 • Number of events 40 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
1.8%
2/112 • Number of events 2 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
0.85%
2/235 • Number of events 2 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
|
Gastrointestinal disorders
Ileus, GI (functional obstruction of bowel, i.e., neuroconstipation)
|
8.0%
9/112 • Number of events 10 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
2.1%
5/235 • Number of events 5 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
|
Renal and urinary disorders
Incontinence, urinary
|
0.00%
0/112 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
3.4%
8/235 • Number of events 8 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
|
Infections and infestations
Infection (documented clinically or microbiologically) with Grade 3 or 4 neutrophils
|
0.00%
0/112 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
0.85%
2/235 • Number of events 2 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
|
Infections and infestations
Infection - Other (PAC; blood-yeast)
|
0.00%
0/112 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
0.43%
1/235 • Number of events 1 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
|
Infections and infestations
Infection - Other (R axilla)
|
0.00%
0/112 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
0.43%
1/235 • Number of events 1 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
|
Infections and infestations
Infection - Other (foot - tinea pedis)
|
0.00%
0/112 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
0.43%
1/235 • Number of events 1 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
|
Infections and infestations
Infection - Other (fungal, tinea pedis)
|
0.00%
0/112 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
0.43%
1/235 • Number of events 1 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
|
Infections and infestations
Infection with normal ANC or Grade 1 or 2 neutrophils::Abdomen NOS
|
0.00%
0/112 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
0.43%
1/235 • Number of events 1 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
|
Infections and infestations
Infection with normal ANC or Grade 1 or 2 neutrophils::Blood
|
0.89%
1/112 • Number of events 1 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
3.0%
7/235 • Number of events 7 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
|
Infections and infestations
Infection with normal ANC or Grade 1 or 2 neutrophils::Catheter-related
|
1.8%
2/112 • Number of events 2 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
0.43%
1/235 • Number of events 1 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
|
Infections and infestations
Infection with normal ANC or Grade 1 or 2 neutrophils::Colon
|
0.00%
0/112 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
0.43%
1/235 • Number of events 1 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
|
Infections and infestations
Infection with normal ANC or Grade 1 or 2 neutrophils::Conjunctiva
|
0.89%
1/112 • Number of events 1 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
0.85%
2/235 • Number of events 2 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
|
Infections and infestations
Infection with normal ANC or Grade 1 or 2 neutrophils::External ear (otitis externa)
|
0.00%
0/112 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
0.43%
1/235 • Number of events 1 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
|
Infections and infestations
Infection with normal ANC or Grade 1 or 2 neutrophils::Eye NOS
|
0.00%
0/112 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
0.85%
2/235 • Number of events 2 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
|
Infections and infestations
Infection with normal ANC or Grade 1 or 2 neutrophils::Lip/perioral
|
0.00%
0/112 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
0.85%
2/235 • Number of events 3 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
|
Infections and infestations
Infection with normal ANC or Grade 1 or 2 neutrophils::Liver
|
0.00%
0/112 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
0.43%
1/235 • Number of events 1 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
|
Infections and infestations
Infection with normal ANC or Grade 1 or 2 neutrophils::Lung (pneumonia)
|
0.00%
0/112 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
3.0%
7/235 • Number of events 8 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
|
Infections and infestations
Infection with normal ANC or Grade 1 or 2 neutrophils::Middle ear (otitis media)
|
0.00%
0/112 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
0.43%
1/235 • Number of events 1 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
|
Infections and infestations
Infection with normal ANC or Grade 1 or 2 neutrophils::Mucosa
|
0.00%
0/112 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
5.5%
13/235 • Number of events 15 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
|
Infections and infestations
Infection with normal ANC or Grade 1 or 2 neutrophils::Nerve-peripheral
|
0.00%
0/112 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
0.43%
1/235 • Number of events 1 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
|
Infections and infestations
Infection with normal ANC or Grade 1 or 2 neutrophils::Nose
|
0.89%
1/112 • Number of events 1 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
0.43%
1/235 • Number of events 1 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
|
Infections and infestations
Infection with normal ANC or Grade 1 or 2 neutrophils::Rectum
|
0.00%
0/112 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
3.0%
7/235 • Number of events 7 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
|
Infections and infestations
Infection with normal ANC or Grade 1 or 2 neutrophils::Salivary gland
|
0.00%
0/112 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
0.43%
1/235 • Number of events 1 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
|
Infections and infestations
Infection with normal ANC or Grade 1 or 2 neutrophils::Scrotum
|
0.00%
0/112 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
0.43%
1/235 • Number of events 1 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
|
Infections and infestations
Infection with normal ANC or Grade 1 or 2 neutrophils::Sinus
|
1.8%
2/112 • Number of events 2 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
1.7%
4/235 • Number of events 4 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
|
Infections and infestations
Infection with normal ANC or Grade 1 or 2 neutrophils::Skin (cellulitis)
|
0.89%
1/112 • Number of events 1 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
1.3%
3/235 • Number of events 3 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
|
Infections and infestations
Infection with normal ANC or Grade 1 or 2 neutrophils::Small bowel NOS
|
0.89%
1/112 • Number of events 1 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
0.00%
0/235 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
|
Infections and infestations
Infection with normal ANC or Grade 1 or 2 neutrophils::Ungual (nails)
|
0.00%
0/112 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
0.85%
2/235 • Number of events 2 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
|
Infections and infestations
Infection with normal ANC or Grade 1 or 2 neutrophils::Upper aerodigestive NOS
|
0.00%
0/112 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
0.43%
1/235 • Number of events 1 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
|
Infections and infestations
Infection with normal ANC or Grade 1 or 2 neutrophils::Upper airway NOS
|
2.7%
3/112 • Number of events 3 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
7.7%
18/235 • Number of events 19 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
|
Infections and infestations
Infection with normal ANC or Grade 1 or 2 neutrophils::Urinary tract NOS
|
0.89%
1/112 • Number of events 2 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
3.4%
8/235 • Number of events 8 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
|
Infections and infestations
Infection with normal ANC or Grade 1 or 2 neutrophils::Vagina
|
0.00%
0/112 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
0.85%
2/235 • Number of events 2 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
|
Infections and infestations
Infection with normal ANC or Grade 1 or 2 neutrophils::Wound
|
0.89%
1/112 • Number of events 1 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
0.85%
2/235 • Number of events 2 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
|
Infections and infestations
Infection with unknown ANC::Blood
|
0.89%
1/112 • Number of events 1 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
0.00%
0/235 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
|
Infections and infestations
Infection with unknown ANC::Conjunctiva
|
0.89%
1/112 • Number of events 1 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
0.43%
1/235 • Number of events 1 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
|
Infections and infestations
Infection with unknown ANC::Rectum
|
0.89%
1/112 • Number of events 1 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
0.00%
0/235 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
|
Infections and infestations
Infection with unknown ANC::Urinary tract NOS
|
0.89%
1/112 • Number of events 1 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
0.00%
0/235 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
|
Skin and subcutaneous tissue disorders
Injection site reaction/extravasation changes
|
0.89%
1/112 • Number of events 1 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
1.7%
4/235 • Number of events 4 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
|
Gastrointestinal disorders
Insomnia
|
12.5%
14/112 • Number of events 17 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
22.6%
53/235 • Number of events 75 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
|
Reproductive system and breast disorders
Irregular menses (change from baseline)
|
0.00%
0/112 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
3.0%
7/235 • Number of events 7 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
|
Blood and lymphatic system disorders
Leukocytes (total WBC)
|
30.4%
34/112 • Number of events 142 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
87.2%
205/235 • Number of events 1002 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
|
Metabolism and nutrition disorders
Lipase
|
0.00%
0/112 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
0.85%
2/235 • Number of events 4 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
|
Blood and lymphatic system disorders
Lymphopenia
|
26.8%
30/112 • Number of events 100 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
78.7%
185/235 • Number of events 676 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
|
Metabolism and nutrition disorders
Magnesium, serum-high (hypermagnesemia)
|
6.2%
7/112 • Number of events 12 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
23.0%
54/235 • Number of events 72 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
|
Metabolism and nutrition disorders
Magnesium, serum-low (hypomagnesemia)
|
8.0%
9/112 • Number of events 16 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
24.3%
57/235 • Number of events 98 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
|
Nervous system disorders
Memory impairment
|
2.7%
3/112 • Number of events 4 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
0.43%
1/235 • Number of events 1 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
|
Nervous system disorders
Mood alteration::Agitation
|
2.7%
3/112 • Number of events 3 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
1.7%
4/235 • Number of events 4 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
|
Nervous system disorders
Mood alteration::Anxiety
|
5.4%
6/112 • Number of events 9 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
8.5%
20/235 • Number of events 31 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
|
Nervous system disorders
Mood alteration::Depression
|
4.5%
5/112 • Number of events 5 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
7.7%
18/235 • Number of events 32 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
|
Gastrointestinal disorders
Mucositis/stomatitis (clinical exam)::Large bowel
|
0.00%
0/112 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
0.43%
1/235 • Number of events 1 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
|
Gastrointestinal disorders
Mucositis/stomatitis (clinical exam)::Larynx
|
0.00%
0/112 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
0.43%
1/235 • Number of events 1 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
|
Gastrointestinal disorders
Mucositis/stomatitis (clinical exam)::Oral cavity
|
78.6%
88/112 • Number of events 222 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
80.0%
188/235 • Number of events 520 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
|
Gastrointestinal disorders
Mucositis/stomatitis (clinical exam)::Stomach
|
0.00%
0/112 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
1.3%
3/235 • Number of events 6 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
|
Gastrointestinal disorders
Mucositis/stomatitis (functional/symptomatic)::Oral cavity
|
0.00%
0/112 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
0.85%
2/235 • Number of events 2 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness, generalized or specific area (not due to neuropathy)::Extremity-lower
|
0.89%
1/112 • Number of events 1 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
1.7%
4/235 • Number of events 4 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness, generalized or specific area (not due to neuropathy)::Whole body/generalized
|
8.9%
10/112 • Number of events 12 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
16.2%
38/235 • Number of events 45 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal/Soft Tissue - Other (Finger injury)
|
0.89%
1/112 • Number of events 1 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
0.00%
0/235 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal/Soft Tissue - Other (Hand cramps)
|
0.00%
0/112 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
0.43%
1/235 • Number of events 1 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal/Soft Tissue - Other (Hip fracture)
|
0.00%
0/112 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
0.43%
1/235 • Number of events 1 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal/Soft Tissue - Other (Spasms)
|
0.00%
0/112 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
0.43%
1/235 • Number of events 1 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal/Soft Tissue - Other (Sprain)
|
0.00%
0/112 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
0.43%
1/235 • Number of events 1 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
|
Skin and subcutaneous tissue disorders
Nail changes
|
2.7%
3/112 • Number of events 3 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
10.2%
24/235 • Number of events 27 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
|
Gastrointestinal disorders
Nausea
|
52.7%
59/112 • Number of events 123 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
66.0%
155/235 • Number of events 382 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
|
Nervous system disorders
Neurology - Other (antonomic neuropathy)
|
0.00%
0/112 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
0.43%
1/235 • Number of events 1 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
|
Nervous system disorders
Neuropathy: motor
|
16.1%
18/112 • Number of events 23 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
12.3%
29/235 • Number of events 34 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
|
Nervous system disorders
Neuropathy: sensory
|
78.6%
88/112 • Number of events 125 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
87.7%
206/235 • Number of events 301 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
|
Blood and lymphatic system disorders
Neutrophils/granulocytes (ANC/AGC)
|
34.8%
39/112 • Number of events 148 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
88.1%
207/235 • Number of events 917 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
|
Gastrointestinal disorders
Obstruction, GI::Small bowel NOS
|
0.89%
1/112 • Number of events 1 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
0.00%
0/235 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
|
Eye disorders
Ocular/Visual - Other (Red eye)
|
0.00%
0/112 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
0.43%
1/235 • Number of events 1 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
|
Eye disorders
Ocular/Visual - Other (Uveitis)
|
0.00%
0/112 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
0.43%
1/235 • Number of events 1 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
|
Eye disorders
Ophthalmoplegia/diplopia (double vision)
|
0.00%
0/112 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
1.3%
3/235 • Number of events 3 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
|
Blood and lymphatic system disorders
PTT (Partial Thromboplastin Time)
|
7.1%
8/112 • Number of events 9 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
18.3%
43/235 • Number of events 61 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
|
General disorders
Pain - Other (Biopsy site)
|
0.89%
1/112 • Number of events 1 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
0.00%
0/235 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
|
Gastrointestinal disorders
Pain - Other (Epigastric)
|
1.8%
2/112 • Number of events 2 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
0.00%
0/235 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
|
Musculoskeletal and connective tissue disorders
Pain - Other (Flank)
|
0.00%
0/112 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
0.43%
1/235 • Number of events 1 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
|
Reproductive system and breast disorders
Pain - Other (Groin)
|
0.89%
1/112 • Number of events 1 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
0.00%
0/235 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
|
Respiratory, thoracic and mediastinal disorders
Pain - Other (Lung)
|
0.89%
1/112 • Number of events 1 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
0.00%
0/235 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
|
Musculoskeletal and connective tissue disorders
Pain - Other (Ribs)
|
0.00%
0/112 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
0.43%
1/235 • Number of events 1 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
|
General disorders
Pain - Other (VAD site)
|
0.00%
0/112 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
0.43%
1/235 • Number of events 1 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
|
Gastrointestinal disorders
Pain::Abdomen NOS
|
19.6%
22/112 • Number of events 32 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
26.4%
62/235 • Number of events 79 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
|
Musculoskeletal and connective tissue disorders
Pain::Back
|
7.1%
8/112 • Number of events 8 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
9.8%
23/235 • Number of events 34 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
|
Renal and urinary disorders
Pain::Bladder
|
0.00%
0/112 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
0.43%
1/235 • Number of events 1 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
|
Musculoskeletal and connective tissue disorders
Pain::Bone
|
21.4%
24/112 • Number of events 46 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
65.1%
153/235 • Number of events 373 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
|
Reproductive system and breast disorders
Pain::Breast
|
0.89%
1/112 • Number of events 1 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
0.00%
0/235 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
|
Musculoskeletal and connective tissue disorders
Pain::Buttock
|
0.00%
0/112 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
0.43%
1/235 • Number of events 1 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
|
Musculoskeletal and connective tissue disorders
Pain::Chest wall
|
1.8%
2/112 • Number of events 2 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
3.8%
9/235 • Number of events 11 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
|
Musculoskeletal and connective tissue disorders
Pain::Chest/thorax NOS
|
1.8%
2/112 • Number of events 2 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
7.2%
17/235 • Number of events 19 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
|
Gastrointestinal disorders
Pain::Dental/teeth/peridontal
|
1.8%
2/112 • Number of events 2 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
0.85%
2/235 • Number of events 2 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
|
Ear and labyrinth disorders
Pain::External ear
|
0.89%
1/112 • Number of events 1 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
1.3%
3/235 • Number of events 3 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
|
Musculoskeletal and connective tissue disorders
Pain::Extremity-limb
|
6.2%
7/112 • Number of events 7 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
8.1%
19/235 • Number of events 21 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
|
Eye disorders
Pain::Eye
|
0.89%
1/112 • Number of events 1 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
0.43%
1/235 • Number of events 1 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
|
Skin and subcutaneous tissue disorders
Pain::Face
|
4.5%
5/112 • Number of events 6 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
4.3%
10/235 • Number of events 12 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
|
Nervous system disorders
Pain::Head/headache
|
26.8%
30/112 • Number of events 45 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
42.1%
99/235 • Number of events 179 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
|
Musculoskeletal and connective tissue disorders
Pain::Joint
|
25.9%
29/112 • Number of events 41 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
23.0%
54/235 • Number of events 105 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
|
Respiratory, thoracic and mediastinal disorders
Pain::Larynx
|
0.00%
0/112 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
0.43%
1/235 • Number of events 1 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
|
Ear and labyrinth disorders
Pain::Middle ear
|
0.00%
0/112 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
1.3%
3/235 • Number of events 4 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
|
Musculoskeletal and connective tissue disorders
Pain::Muscle
|
25.9%
29/112 • Number of events 50 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
34.0%
80/235 • Number of events 125 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
|
Musculoskeletal and connective tissue disorders
Pain::Neck
|
0.89%
1/112 • Number of events 1 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
1.7%
4/235 • Number of events 6 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
|
Nervous system disorders
Pain::Neuralgia/peripheral nerve
|
0.00%
0/112 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
2.6%
6/235 • Number of events 6 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
|
Gastrointestinal disorders
Pain::Oral cavity
|
0.00%
0/112 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
0.43%
1/235 • Number of events 1 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
|
General disorders
Pain::Pain NOS
|
0.00%
0/112 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
0.85%
2/235 • Number of events 3 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
|
Reproductive system and breast disorders
Pain::Pelvis
|
0.00%
0/112 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
1.7%
4/235 • Number of events 4 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
|
Gastrointestinal disorders
Pain::Rectum
|
0.89%
1/112 • Number of events 1 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
1.7%
4/235 • Number of events 4 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
|
Respiratory, thoracic and mediastinal disorders
Pain::Throat/pharynx/larynx
|
5.4%
6/112 • Number of events 6 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
3.4%
8/235 • Number of events 9 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
|
Renal and urinary disorders
Pain::Urethra
|
2.7%
3/112 • Number of events 3 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
3.4%
8/235 • Number of events 8 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
|
Reproductive system and breast disorders
Pain::Vagina
|
0.00%
0/112 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
0.43%
1/235 • Number of events 1 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
|
Cardiac disorders
Palpitations
|
2.7%
3/112 • Number of events 4 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
7.2%
17/235 • Number of events 21 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
|
Cardiac disorders
Pericardial effusion (non-malignant)
|
0.00%
0/112 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
0.43%
1/235 • Number of events 1 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
|
Blood and lymphatic system disorders
Petechiae/purpura (hemorrhage/bleeding into skin or mucosa)
|
0.00%
0/112 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
0.85%
2/235 • Number of events 2 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
|
Vascular disorders
Phlebitis (including superficial thrombosis)
|
0.89%
1/112 • Number of events 1 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
3.8%
9/235 • Number of events 10 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
|
Metabolism and nutrition disorders
Phosphate, serum-low (hypophosphatemia)
|
4.5%
5/112 • Number of events 10 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
16.6%
39/235 • Number of events 64 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
|
Blood and lymphatic system disorders
Platelets
|
32.1%
36/112 • Number of events 134 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
86.4%
203/235 • Number of events 841 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion (non-malignant)
|
0.89%
1/112 • Number of events 1 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
1.7%
4/235 • Number of events 4 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis/pulmonary infiltrates
|
0.00%
0/112 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
0.85%
2/235 • Number of events 2 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/112 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
0.43%
1/235 • Number of events 1 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
|
Metabolism and nutrition disorders
Potassium, serum-high (hyperkalemia)
|
6.2%
7/112 • Number of events 7 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
6.0%
14/235 • Number of events 19 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
|
Metabolism and nutrition disorders
Potassium, serum-low (hypokalemia)
|
8.0%
9/112 • Number of events 14 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
28.9%
68/235 • Number of events 130 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
|
Gastrointestinal disorders
Proctitis
|
0.00%
0/112 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
2.6%
6/235 • Number of events 7 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
|
Metabolism and nutrition disorders
Proteinuria
|
0.00%
0/112 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
0.85%
2/235 • Number of events 3 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
|
Skin and subcutaneous tissue disorders
Pruritus/itching
|
0.89%
1/112 • Number of events 1 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
4.3%
10/235 • Number of events 14 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
|
Nervous system disorders
Psychosis (hallucinations/delusions)
|
0.00%
0/112 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
0.43%
1/235 • Number of events 1 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
|
Skin and subcutaneous tissue disorders
Rash/desquamation
|
15.2%
17/112 • Number of events 18 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
20.0%
47/235 • Number of events 56 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
|
Skin and subcutaneous tissue disorders
Rash: acne/acneiform
|
1.8%
2/112 • Number of events 5 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
0.00%
0/235 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
|
Skin and subcutaneous tissue disorders
Rash: hand-foot skin reaction
|
0.89%
1/112 • Number of events 1 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
3.0%
7/235 • Number of events 9 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
|
Renal and urinary disorders
Renal failure
|
0.89%
1/112 • Number of events 1 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
0.43%
1/235 • Number of events 1 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
|
Renal and urinary disorders
Renal/Genitourinary - Other (Nocturia)
|
0.89%
1/112 • Number of events 1 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
0.00%
0/235 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
|
Renal and urinary disorders
Renal/Genitourinary - Other (dysuria)
|
0.00%
0/112 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
0.43%
1/235 • Number of events 1 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
|
General disorders
Rigors/chills
|
4.5%
5/112 • Number of events 10 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
9.4%
22/235 • Number of events 23 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Secondary Malignancy - possibly related to cancer treatment (Specify, __)
|
0.00%
0/112 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
0.43%
1/235 • Number of events 1 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
|
Nervous system disorders
Seizure
|
0.89%
1/112 • Number of events 1 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
0.43%
1/235 • Number of events 1 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
|
Skin and subcutaneous tissue disorders
Skin breakdown/decubitus ulcer
|
0.00%
0/112 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
0.43%
1/235 • Number of events 1 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
|
Metabolism and nutrition disorders
Sodium, serum-high (hypernatremia)
|
6.2%
7/112 • Number of events 12 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
8.1%
19/235 • Number of events 25 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
|
Metabolism and nutrition disorders
Sodium, serum-low (hyponatremia)
|
8.9%
10/112 • Number of events 13 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
37.0%
87/235 • Number of events 143 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
|
Nervous system disorders
Somnolence/depressed level of consciousness
|
0.00%
0/112 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
0.85%
2/235 • Number of events 2 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
|
Nervous system disorders
Speech impairment (e.g., dysphasia or aphasia)
|
0.89%
1/112 • Number of events 1 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
0.00%
0/235 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
|
Cardiac disorders
Supraventricular and nodal arrhythmia::Atrial fibrillation
|
0.89%
1/112 • Number of events 1 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
0.43%
1/235 • Number of events 1 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
|
Cardiac disorders
Supraventricular and nodal arrhythmia::Sinus arrhythmia
|
0.00%
0/112 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
0.85%
2/235 • Number of events 2 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
|
Cardiac disorders
Supraventricular and nodal arrhythmia::Sinus bradycardia
|
0.89%
1/112 • Number of events 1 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
1.3%
3/235 • Number of events 3 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
|
Cardiac disorders
Supraventricular and nodal arrhythmia::Sinus tachycardia
|
3.6%
4/112 • Number of events 4 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
10.6%
25/235 • Number of events 32 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
|
Cardiac disorders
Supraventricular and nodal arrhythmia::Supraventricular arrhythmia NOS
|
0.00%
0/112 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
0.85%
2/235 • Number of events 3 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
|
General disorders
Sweating (diaphoresis)
|
4.5%
5/112 • Number of events 7 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
6.4%
15/235 • Number of events 17 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
|
Nervous system disorders
Syncope (fainting)
|
0.00%
0/112 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
5.1%
12/235 • Number of events 12 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
|
Nervous system disorders
Syndromes - Other (Akathisia)
|
0.89%
1/112 • Number of events 1 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
0.00%
0/235 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
|
Gastrointestinal disorders
Taste alteration (dysgeusia)
|
8.0%
9/112 • Number of events 12 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
32.3%
76/235 • Number of events 127 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
|
Vascular disorders
Thrombosis/embolism (vascular access-related)
|
0.00%
0/112 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
0.43%
1/235 • Number of events 1 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
|
Vascular disorders
Thrombosis/thrombus/embolism
|
7.1%
8/112 • Number of events 9 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
10.2%
24/235 • Number of events 26 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
|
Ear and labyrinth disorders
Tinnitus
|
0.89%
1/112 • Number of events 1 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
2.1%
5/235 • Number of events 6 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
|
General disorders
Tumor lysis syndrome
|
0.00%
0/112 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
0.43%
1/235 • Number of events 1 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
|
Metabolism and nutrition disorders
Uric acid, serum-high (hyperuricemia)
|
0.00%
0/112 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
2.6%
6/235 • Number of events 7 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
|
Renal and urinary disorders
Urinary frequency/urgency
|
2.7%
3/112 • Number of events 4 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
5.1%
12/235 • Number of events 15 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
|
Renal and urinary disorders
Urinary retention (including neurogenic bladder)
|
0.89%
1/112 • Number of events 1 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
1.3%
3/235 • Number of events 3 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
|
Renal and urinary disorders
Urine color change
|
0.00%
0/112 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
0.43%
1/235 • Number of events 1 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
|
Skin and subcutaneous tissue disorders
Urticaria (hives, welts, wheals)
|
0.00%
0/112 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
0.43%
1/235 • Number of events 2 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
|
Reproductive system and breast disorders
Vaginal discharge (non-infectious)
|
0.00%
0/112 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
0.43%
1/235 • Number of events 1 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
|
Cardiac disorders
Vasovagal episode
|
0.00%
0/112 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
0.43%
1/235 • Number of events 1 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
|
Cardiac disorders
Ventricular arrhythmia::Ventricular arrhythmia NOS
|
0.00%
0/112 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
0.43%
1/235 • Number of events 1 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
|
Eye disorders
Vision-blurred vision
|
4.5%
5/112 • Number of events 6 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
9.4%
22/235 • Number of events 28 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
|
Eye disorders
Vision-flashing lights/floaters
|
0.00%
0/112 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
0.43%
1/235 • Number of events 1 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
|
Eye disorders
Vision-photophobia
|
0.00%
0/112 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
1.7%
4/235 • Number of events 4 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
|
Respiratory, thoracic and mediastinal disorders
Voice changes/dysarthria (e.g., hoarseness, loss or alteration in voice, laryngitis)
|
0.89%
1/112 • Number of events 1 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
6.0%
14/235 • Number of events 14 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
|
Gastrointestinal disorders
Vomiting
|
27.7%
31/112 • Number of events 54 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
39.1%
92/235 • Number of events 147 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
|
Eye disorders
Watery eye (epiphora, tearing)
|
2.7%
3/112 • Number of events 3 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
11.1%
26/235 • Number of events 27 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
|
General disorders
Weight gain
|
0.00%
0/112 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
1.3%
3/235 • Number of events 3 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
|
General disorders
Weight loss
|
9.8%
11/112 • Number of events 13 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
8.9%
21/235 • Number of events 22 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place