Trial Outcomes & Findings for Cisplatin/Carboplatin and Etoposide With or Without Nivolumab in Treating Patients With Extensive Stage Small Cell Lung Cancer (NCT NCT03382561)
NCT ID: NCT03382561
Last Updated: 2025-07-03
Results Overview
PFS is defined as the time from randomization to documented disease progression or death from any cause, whichever occurs first. Patients who have not experienced an event of interest by the time of analysis will be censored at the date they are last known to be alive and progression-free. Progression was evaluated using the revised Response Evaluation Criteria in Solid Tumors (RECIST) guideline (version 1.1). Progression was defined as appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions, or at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
160 participants
Primary outcome timeframe
Every 6 weeks for 6 months, then every 8 weeks until 1 year, and then every 12 weeks until being off treatment or end of observation. Thereafter every 3 months if < 2 years from registration, every 6 months for years 2-3, and yearly up to 3 years 9 months
Results posted on
2025-07-03
Participant Flow
This study activated on May 2, 2018, and closed to accrual on December 7, 2018 after enrolling a total of 160 patients.
Participant milestones
| Measure |
Arm A (Cisplatin/Carboplatin, Etoposide and Nivolumab; CEN)
Patients receive nivolumab IV at 360 mg over 30 minutes on day 1, carboplatin AUC 5 or 6 IV over 30-60 minutes on day 1 or cisplatin at 75 mg/m2 IV over 60-120 minutes on day 1, and etoposide at 100 mg/m2 IV over 60-120 minutes on days 1-3. Treatment repeats every 21 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity. Patients continue to receive nivolumab IV over 30 minutes every 2 weeks for up to 2 years.
|
Arm B (Cisplatin/Carboplatin and Etoposide; CE)
Patients receive carboplatin AUC 5 or 6 IV over 30-60 minutes on day 1 or cisplatin at 75 mg/m2 IV over 60-120 minutes on day 1, and etoposide at 100 mg/m2 IV over 60-120 minutes on days 1-3. Treatment repeats every 21 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity.
|
|---|---|---|
|
Overall Study
STARTED
|
80
|
80
|
|
Overall Study
Received Treatment
|
77
|
74
|
|
Overall Study
Eligible and Treated Patients
|
75
|
69
|
|
Overall Study
COMPLETED
|
4
|
47
|
|
Overall Study
NOT COMPLETED
|
76
|
33
|
Reasons for withdrawal
| Measure |
Arm A (Cisplatin/Carboplatin, Etoposide and Nivolumab; CEN)
Patients receive nivolumab IV at 360 mg over 30 minutes on day 1, carboplatin AUC 5 or 6 IV over 30-60 minutes on day 1 or cisplatin at 75 mg/m2 IV over 60-120 minutes on day 1, and etoposide at 100 mg/m2 IV over 60-120 minutes on days 1-3. Treatment repeats every 21 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity. Patients continue to receive nivolumab IV over 30 minutes every 2 weeks for up to 2 years.
|
Arm B (Cisplatin/Carboplatin and Etoposide; CE)
Patients receive carboplatin AUC 5 or 6 IV over 30-60 minutes on day 1 or cisplatin at 75 mg/m2 IV over 60-120 minutes on day 1, and etoposide at 100 mg/m2 IV over 60-120 minutes on days 1-3. Treatment repeats every 21 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity.
|
|---|---|---|
|
Overall Study
Disease progression
|
47
|
6
|
|
Overall Study
Adverse Event
|
10
|
2
|
|
Overall Study
Death
|
8
|
3
|
|
Overall Study
Withdrawal by Subject
|
6
|
5
|
|
Overall Study
Alternative therapy
|
2
|
8
|
|
Overall Study
Never started treatment
|
3
|
6
|
|
Overall Study
Lack of Efficacy
|
0
|
1
|
|
Overall Study
Physician Decision
|
0
|
1
|
|
Overall Study
Other complicating disease
|
0
|
1
|
Baseline Characteristics
Cisplatin/Carboplatin and Etoposide With or Without Nivolumab in Treating Patients With Extensive Stage Small Cell Lung Cancer
Baseline characteristics by cohort
| Measure |
Arm A (Cisplatin/Carboplatin, Etoposide and Nivolumab; CEN)
n=80 Participants
Patients receive nivolumab IV at 360 mg over 30 minutes on day 1, carboplatin AUC 5 or 6 IV over 30-60 minutes on day 1 or cisplatin at 75 mg/m2 IV over 60-120 minutes on day 1, and etoposide at 100 mg/m2 IV over 60-120 minutes on days 1-3. Treatment repeats every 21 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity. Patients continue to receive nivolumab IV over 30 minutes every 2 weeks for up to 2 years.
|
Arm B (Cisplatin/Carboplatin and Etoposide; CE)
n=80 Participants
Patients receive carboplatin AUC 5 or 6 IV over 30-60 minutes on day 1 or cisplatin at 75 mg/m2 IV over 60-120 minutes on day 1, and etoposide at 100 mg/m2 IV over 60-120 minutes on days 1-3. Treatment repeats every 21 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity.
|
Total
n=160 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
64 years
n=99 Participants
|
65 years
n=107 Participants
|
65 years
n=206 Participants
|
|
Sex: Female, Male
Female
|
45 Participants
n=99 Participants
|
44 Participants
n=107 Participants
|
89 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
35 Participants
n=99 Participants
|
36 Participants
n=107 Participants
|
71 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
78 Participants
n=99 Participants
|
78 Participants
n=107 Participants
|
156 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 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
|
|
Race (NIH/OMB)
Black or African American
|
7 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
73 Participants
n=99 Participants
|
76 Participants
n=107 Participants
|
149 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Every 6 weeks for 6 months, then every 8 weeks until 1 year, and then every 12 weeks until being off treatment or end of observation. Thereafter every 3 months if < 2 years from registration, every 6 months for years 2-3, and yearly up to 3 years 9 monthsPopulation: Eligible and treated patients were included in the analysis.
PFS is defined as the time from randomization to documented disease progression or death from any cause, whichever occurs first. Patients who have not experienced an event of interest by the time of analysis will be censored at the date they are last known to be alive and progression-free. Progression was evaluated using the revised Response Evaluation Criteria in Solid Tumors (RECIST) guideline (version 1.1). Progression was defined as appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions, or at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm.
Outcome measures
| Measure |
Arm A (Cisplatin/Carboplatin, Etoposide and Nivolumab; CEN)
n=75 Participants
Patients receive nivolumab IV at 360 mg over 30 minutes on day 1, carboplatin AUC 5 or 6 IV over 30-60 minutes on day 1 or cisplatin at 75 mg/m2 IV over 60-120 minutes on day 1, and etoposide at 100 mg/m2 IV over 60-120 minutes on days 1-3. Treatment repeats every 21 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity. Patients continue to receive nivolumab IV over 30 minutes every 2 weeks for up to 2 years.
|
Arm B (Cisplatin/Carboplatin and Etoposide; CE)
n=69 Participants
Patients receive carboplatin AUC 5 or 6 IV over 30-60 minutes on day 1 or cisplatin at 75 mg/m2 IV over 60-120 minutes on day 1, and etoposide at 100 mg/m2 IV over 60-120 minutes on days 1-3. Treatment repeats every 21 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity.
|
|---|---|---|
|
Progression-free Survival (PFS)
|
5.5 months
Interval 4.3 to 5.9
|
4.9 months
Interval 4.5 to 5.7
|
SECONDARY outcome
Timeframe: Every 6 weeks for 6 months, then every 8 weeks until 1 year, and then every 12 weeks until off treatment or end of observation. Then every 3 months if < 2 years from registration, every 6 months for years 2-3, and yearly up to 3 years 9 months.Population: Eligible and treated patients were included in this analysis.
OS is defined as the time from maintenance randomization until death of any cause.
Outcome measures
| Measure |
Arm A (Cisplatin/Carboplatin, Etoposide and Nivolumab; CEN)
n=75 Participants
Patients receive nivolumab IV at 360 mg over 30 minutes on day 1, carboplatin AUC 5 or 6 IV over 30-60 minutes on day 1 or cisplatin at 75 mg/m2 IV over 60-120 minutes on day 1, and etoposide at 100 mg/m2 IV over 60-120 minutes on days 1-3. Treatment repeats every 21 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity. Patients continue to receive nivolumab IV over 30 minutes every 2 weeks for up to 2 years.
|
Arm B (Cisplatin/Carboplatin and Etoposide; CE)
n=69 Participants
Patients receive carboplatin AUC 5 or 6 IV over 30-60 minutes on day 1 or cisplatin at 75 mg/m2 IV over 60-120 minutes on day 1, and etoposide at 100 mg/m2 IV over 60-120 minutes on days 1-3. Treatment repeats every 21 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity.
|
|---|---|---|
|
Overall Survival (OS)
|
11.2 months
Interval 8.8 to 14.2
|
8.1 months
Interval 7.2 to 9.6
|
SECONDARY outcome
Timeframe: Every 6 weeks for 6 months, then every 8 weeks until 1 year, and then every 12 weeks until being off treatment or end of observation. Thereafter every 3 months if < 2 years from registration, every 6 months for years 2-3, and yearly up to 3 years 9 monthsPopulation: Eligible and treated patients were included in this analysis.
Best overall response was evaluated using the revised Response Evaluation Criteria in Solid Tumors (RECIST) guideline (version 1.1). Response was defined as complete response (CR) or partial response (PR). CR: Disappearance of all lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \< 10 mm. PR: At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters.
Outcome measures
| Measure |
Arm A (Cisplatin/Carboplatin, Etoposide and Nivolumab; CEN)
n=75 Participants
Patients receive nivolumab IV at 360 mg over 30 minutes on day 1, carboplatin AUC 5 or 6 IV over 30-60 minutes on day 1 or cisplatin at 75 mg/m2 IV over 60-120 minutes on day 1, and etoposide at 100 mg/m2 IV over 60-120 minutes on days 1-3. Treatment repeats every 21 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity. Patients continue to receive nivolumab IV over 30 minutes every 2 weeks for up to 2 years.
|
Arm B (Cisplatin/Carboplatin and Etoposide; CE)
n=69 Participants
Patients receive carboplatin AUC 5 or 6 IV over 30-60 minutes on day 1 or cisplatin at 75 mg/m2 IV over 60-120 minutes on day 1, and etoposide at 100 mg/m2 IV over 60-120 minutes on days 1-3. Treatment repeats every 21 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity.
|
|---|---|---|
|
Response Rate
|
0.77 proportion of participants
Interval 0.66 to 0.86
|
0.80 proportion of participants
Interval 0.68 to 0.88
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Assessed at baseline and 6 weeksOutcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: circulating tumor DNA was assessed at baseline and 6 weeks; clinical outcomes were assessed every 3 months for patients < 2 years from registration, every 6 months if patient is 2-3 years from registration, and annually until 5 years from registrationOutcome measures
Outcome data not reported
Adverse Events
Arm A (Cisplatin/Carboplatin, Etoposide and Nivolumab; CEN)
Serious events: 59 serious events
Other events: 76 other events
Deaths: 67 deaths
Arm B (Cisplatin/Carboplatin and Etoposide; CE)
Serious events: 49 serious events
Other events: 73 other events
Deaths: 74 deaths
Serious adverse events
| Measure |
Arm A (Cisplatin/Carboplatin, Etoposide and Nivolumab; CEN)
n=77 participants at risk
Patients receive nivolumab IV at 360 mg over 30 minutes on day 1, carboplatin AUC 5 or 6 IV over 30-60 minutes on day 1 or cisplatin at 75 mg/m2 IV over 60-120 minutes on day 1, and etoposide at 100 mg/m2 IV over 60-120 minutes on days 1-3. Treatment repeats every 21 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity. Patients continue to receive nivolumab IV over 30 minutes every 2 weeks for up to 2 years.
|
Arm B (Cisplatin/Carboplatin and Etoposide; CE)
n=74 participants at risk
Patients receive carboplatin AUC 5 or 6 IV over 30-60 minutes on day 1 or cisplatin at 75 mg/m2 IV over 60-120 minutes on day 1, and etoposide at 100 mg/m2 IV over 60-120 minutes on days 1-3. Treatment repeats every 21 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity.
|
|---|---|---|
|
Gastrointestinal disorders
Upper gastrointestinal hemorrhage
|
1.3%
1/77 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment for adverse events. All-cause mortality was assessed up to 4 years.
All patients were included in the all-cause mortality analysis. Only patients who received treatment were included in the analysis of adverse events.
|
0.00%
0/74 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment for adverse events. All-cause mortality was assessed up to 4 years.
All patients were included in the all-cause mortality analysis. Only patients who received treatment were included in the analysis of adverse events.
|
|
Ear and labyrinth disorders
Hearing impaired
|
1.3%
1/77 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment for adverse events. All-cause mortality was assessed up to 4 years.
All patients were included in the all-cause mortality analysis. Only patients who received treatment were included in the analysis of adverse events.
|
1.4%
1/74 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment for adverse events. All-cause mortality was assessed up to 4 years.
All patients were included in the all-cause mortality analysis. Only patients who received treatment were included in the analysis of adverse events.
|
|
Blood and lymphatic system disorders
Anemia
|
22.1%
17/77 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment for adverse events. All-cause mortality was assessed up to 4 years.
All patients were included in the all-cause mortality analysis. Only patients who received treatment were included in the analysis of adverse events.
|
14.9%
11/74 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment for adverse events. All-cause mortality was assessed up to 4 years.
All patients were included in the all-cause mortality analysis. Only patients who received treatment were included in the analysis of adverse events.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
5.2%
4/77 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment for adverse events. All-cause mortality was assessed up to 4 years.
All patients were included in the all-cause mortality analysis. Only patients who received treatment were included in the analysis of adverse events.
|
4.1%
3/74 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment for adverse events. All-cause mortality was assessed up to 4 years.
All patients were included in the all-cause mortality analysis. Only patients who received treatment were included in the analysis of adverse events.
|
|
Cardiac disorders
Atrial fibrillation
|
1.3%
1/77 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment for adverse events. All-cause mortality was assessed up to 4 years.
All patients were included in the all-cause mortality analysis. Only patients who received treatment were included in the analysis of adverse events.
|
1.4%
1/74 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment for adverse events. All-cause mortality was assessed up to 4 years.
All patients were included in the all-cause mortality analysis. Only patients who received treatment were included in the analysis of adverse events.
|
|
General disorders
Fatigue
|
13.0%
10/77 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment for adverse events. All-cause mortality was assessed up to 4 years.
All patients were included in the all-cause mortality analysis. Only patients who received treatment were included in the analysis of adverse events.
|
6.8%
5/74 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment for adverse events. All-cause mortality was assessed up to 4 years.
All patients were included in the all-cause mortality analysis. Only patients who received treatment were included in the analysis of adverse events.
|
|
General disorders
Infusion related reaction
|
1.3%
1/77 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment for adverse events. All-cause mortality was assessed up to 4 years.
All patients were included in the all-cause mortality analysis. Only patients who received treatment were included in the analysis of adverse events.
|
0.00%
0/74 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment for adverse events. All-cause mortality was assessed up to 4 years.
All patients were included in the all-cause mortality analysis. Only patients who received treatment were included in the analysis of adverse events.
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/77 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment for adverse events. All-cause mortality was assessed up to 4 years.
All patients were included in the all-cause mortality analysis. Only patients who received treatment were included in the analysis of adverse events.
|
1.4%
1/74 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment for adverse events. All-cause mortality was assessed up to 4 years.
All patients were included in the all-cause mortality analysis. Only patients who received treatment were included in the analysis of adverse events.
|
|
Skin and subcutaneous tissue disorders
Bullous dermatitis
|
1.3%
1/77 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment for adverse events. All-cause mortality was assessed up to 4 years.
All patients were included in the all-cause mortality analysis. Only patients who received treatment were included in the analysis of adverse events.
|
0.00%
0/74 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment for adverse events. All-cause mortality was assessed up to 4 years.
All patients were included in the all-cause mortality analysis. Only patients who received treatment were included in the analysis of adverse events.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
1.3%
1/77 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment for adverse events. All-cause mortality was assessed up to 4 years.
All patients were included in the all-cause mortality analysis. Only patients who received treatment were included in the analysis of adverse events.
|
0.00%
0/74 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment for adverse events. All-cause mortality was assessed up to 4 years.
All patients were included in the all-cause mortality analysis. Only patients who received treatment were included in the analysis of adverse events.
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, specify
|
1.3%
1/77 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment for adverse events. All-cause mortality was assessed up to 4 years.
All patients were included in the all-cause mortality analysis. Only patients who received treatment were included in the analysis of adverse events.
|
0.00%
0/74 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment for adverse events. All-cause mortality was assessed up to 4 years.
All patients were included in the all-cause mortality analysis. Only patients who received treatment were included in the analysis of adverse events.
|
|
Endocrine disorders
Endocrine disorders - Other, specify
|
1.3%
1/77 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment for adverse events. All-cause mortality was assessed up to 4 years.
All patients were included in the all-cause mortality analysis. Only patients who received treatment were included in the analysis of adverse events.
|
0.00%
0/74 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment for adverse events. All-cause mortality was assessed up to 4 years.
All patients were included in the all-cause mortality analysis. Only patients who received treatment were included in the analysis of adverse events.
|
|
Gastrointestinal disorders
Abdominal pain
|
2.6%
2/77 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment for adverse events. All-cause mortality was assessed up to 4 years.
All patients were included in the all-cause mortality analysis. Only patients who received treatment were included in the analysis of adverse events.
|
0.00%
0/74 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment for adverse events. All-cause mortality was assessed up to 4 years.
All patients were included in the all-cause mortality analysis. Only patients who received treatment were included in the analysis of adverse events.
|
|
Gastrointestinal disorders
Diarrhea
|
2.6%
2/77 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment for adverse events. All-cause mortality was assessed up to 4 years.
All patients were included in the all-cause mortality analysis. Only patients who received treatment were included in the analysis of adverse events.
|
0.00%
0/74 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment for adverse events. All-cause mortality was assessed up to 4 years.
All patients were included in the all-cause mortality analysis. Only patients who received treatment were included in the analysis of adverse events.
|
|
Gastrointestinal disorders
Enterocolitis
|
1.3%
1/77 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment for adverse events. All-cause mortality was assessed up to 4 years.
All patients were included in the all-cause mortality analysis. Only patients who received treatment were included in the analysis of adverse events.
|
0.00%
0/74 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment for adverse events. All-cause mortality was assessed up to 4 years.
All patients were included in the all-cause mortality analysis. Only patients who received treatment were included in the analysis of adverse events.
|
|
Gastrointestinal disorders
Mucositis oral
|
0.00%
0/77 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment for adverse events. All-cause mortality was assessed up to 4 years.
All patients were included in the all-cause mortality analysis. Only patients who received treatment were included in the analysis of adverse events.
|
1.4%
1/74 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment for adverse events. All-cause mortality was assessed up to 4 years.
All patients were included in the all-cause mortality analysis. Only patients who received treatment were included in the analysis of adverse events.
|
|
Gastrointestinal disorders
Nausea
|
5.2%
4/77 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment for adverse events. All-cause mortality was assessed up to 4 years.
All patients were included in the all-cause mortality analysis. Only patients who received treatment were included in the analysis of adverse events.
|
1.4%
1/74 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment for adverse events. All-cause mortality was assessed up to 4 years.
All patients were included in the all-cause mortality analysis. Only patients who received treatment were included in the analysis of adverse events.
|
|
Gastrointestinal disorders
Pancreatitis
|
1.3%
1/77 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment for adverse events. All-cause mortality was assessed up to 4 years.
All patients were included in the all-cause mortality analysis. Only patients who received treatment were included in the analysis of adverse events.
|
0.00%
0/74 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment for adverse events. All-cause mortality was assessed up to 4 years.
All patients were included in the all-cause mortality analysis. Only patients who received treatment were included in the analysis of adverse events.
|
|
Gastrointestinal disorders
Vomiting
|
5.2%
4/77 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment for adverse events. All-cause mortality was assessed up to 4 years.
All patients were included in the all-cause mortality analysis. Only patients who received treatment were included in the analysis of adverse events.
|
0.00%
0/74 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment for adverse events. All-cause mortality was assessed up to 4 years.
All patients were included in the all-cause mortality analysis. Only patients who received treatment were included in the analysis of adverse events.
|
|
Immune system disorders
Anaphylaxis
|
1.3%
1/77 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment for adverse events. All-cause mortality was assessed up to 4 years.
All patients were included in the all-cause mortality analysis. Only patients who received treatment were included in the analysis of adverse events.
|
0.00%
0/74 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment for adverse events. All-cause mortality was assessed up to 4 years.
All patients were included in the all-cause mortality analysis. Only patients who received treatment were included in the analysis of adverse events.
|
|
Immune system disorders
Immune system disorders - Other, specify
|
1.3%
1/77 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment for adverse events. All-cause mortality was assessed up to 4 years.
All patients were included in the all-cause mortality analysis. Only patients who received treatment were included in the analysis of adverse events.
|
0.00%
0/74 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment for adverse events. All-cause mortality was assessed up to 4 years.
All patients were included in the all-cause mortality analysis. Only patients who received treatment were included in the analysis of adverse events.
|
|
Infections and infestations
Enterocolitis infectious
|
1.3%
1/77 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment for adverse events. All-cause mortality was assessed up to 4 years.
All patients were included in the all-cause mortality analysis. Only patients who received treatment were included in the analysis of adverse events.
|
1.4%
1/74 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment for adverse events. All-cause mortality was assessed up to 4 years.
All patients were included in the all-cause mortality analysis. Only patients who received treatment were included in the analysis of adverse events.
|
|
Infections and infestations
Lung infection
|
5.2%
4/77 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment for adverse events. All-cause mortality was assessed up to 4 years.
All patients were included in the all-cause mortality analysis. Only patients who received treatment were included in the analysis of adverse events.
|
1.4%
1/74 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment for adverse events. All-cause mortality was assessed up to 4 years.
All patients were included in the all-cause mortality analysis. Only patients who received treatment were included in the analysis of adverse events.
|
|
Infections and infestations
Sepsis
|
0.00%
0/77 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment for adverse events. All-cause mortality was assessed up to 4 years.
All patients were included in the all-cause mortality analysis. Only patients who received treatment were included in the analysis of adverse events.
|
1.4%
1/74 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment for adverse events. All-cause mortality was assessed up to 4 years.
All patients were included in the all-cause mortality analysis. Only patients who received treatment were included in the analysis of adverse events.
|
|
Infections and infestations
Skin infection
|
1.3%
1/77 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment for adverse events. All-cause mortality was assessed up to 4 years.
All patients were included in the all-cause mortality analysis. Only patients who received treatment were included in the analysis of adverse events.
|
0.00%
0/74 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment for adverse events. All-cause mortality was assessed up to 4 years.
All patients were included in the all-cause mortality analysis. Only patients who received treatment were included in the analysis of adverse events.
|
|
Infections and infestations
Infections and infestations - Other, specify
|
1.3%
1/77 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment for adverse events. All-cause mortality was assessed up to 4 years.
All patients were included in the all-cause mortality analysis. Only patients who received treatment were included in the analysis of adverse events.
|
0.00%
0/74 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment for adverse events. All-cause mortality was assessed up to 4 years.
All patients were included in the all-cause mortality analysis. Only patients who received treatment were included in the analysis of adverse events.
|
|
Investigations
Alanine aminotransferase increased
|
2.6%
2/77 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment for adverse events. All-cause mortality was assessed up to 4 years.
All patients were included in the all-cause mortality analysis. Only patients who received treatment were included in the analysis of adverse events.
|
0.00%
0/74 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment for adverse events. All-cause mortality was assessed up to 4 years.
All patients were included in the all-cause mortality analysis. Only patients who received treatment were included in the analysis of adverse events.
|
|
Investigations
Alkaline phosphatase increased
|
2.6%
2/77 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment for adverse events. All-cause mortality was assessed up to 4 years.
All patients were included in the all-cause mortality analysis. Only patients who received treatment were included in the analysis of adverse events.
|
1.4%
1/74 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment for adverse events. All-cause mortality was assessed up to 4 years.
All patients were included in the all-cause mortality analysis. Only patients who received treatment were included in the analysis of adverse events.
|
|
Investigations
Aspartate aminotransferase increased
|
3.9%
3/77 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment for adverse events. All-cause mortality was assessed up to 4 years.
All patients were included in the all-cause mortality analysis. Only patients who received treatment were included in the analysis of adverse events.
|
0.00%
0/74 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment for adverse events. All-cause mortality was assessed up to 4 years.
All patients were included in the all-cause mortality analysis. Only patients who received treatment were included in the analysis of adverse events.
|
|
Investigations
Blood bilirubin increased
|
1.3%
1/77 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment for adverse events. All-cause mortality was assessed up to 4 years.
All patients were included in the all-cause mortality analysis. Only patients who received treatment were included in the analysis of adverse events.
|
0.00%
0/74 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment for adverse events. All-cause mortality was assessed up to 4 years.
All patients were included in the all-cause mortality analysis. Only patients who received treatment were included in the analysis of adverse events.
|
|
Investigations
Lipase increased
|
1.3%
1/77 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment for adverse events. All-cause mortality was assessed up to 4 years.
All patients were included in the all-cause mortality analysis. Only patients who received treatment were included in the analysis of adverse events.
|
0.00%
0/74 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment for adverse events. All-cause mortality was assessed up to 4 years.
All patients were included in the all-cause mortality analysis. Only patients who received treatment were included in the analysis of adverse events.
|
|
Investigations
Lymphocyte count decreased
|
16.9%
13/77 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment for adverse events. All-cause mortality was assessed up to 4 years.
All patients were included in the all-cause mortality analysis. Only patients who received treatment were included in the analysis of adverse events.
|
17.6%
13/74 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment for adverse events. All-cause mortality was assessed up to 4 years.
All patients were included in the all-cause mortality analysis. Only patients who received treatment were included in the analysis of adverse events.
|
|
Investigations
Neutrophil count decreased
|
46.8%
36/77 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment for adverse events. All-cause mortality was assessed up to 4 years.
All patients were included in the all-cause mortality analysis. Only patients who received treatment were included in the analysis of adverse events.
|
51.4%
38/74 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment for adverse events. All-cause mortality was assessed up to 4 years.
All patients were included in the all-cause mortality analysis. Only patients who received treatment were included in the analysis of adverse events.
|
|
Investigations
Platelet count decreased
|
18.2%
14/77 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment for adverse events. All-cause mortality was assessed up to 4 years.
All patients were included in the all-cause mortality analysis. Only patients who received treatment were included in the analysis of adverse events.
|
16.2%
12/74 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment for adverse events. All-cause mortality was assessed up to 4 years.
All patients were included in the all-cause mortality analysis. Only patients who received treatment were included in the analysis of adverse events.
|
|
Investigations
Serum amylase increased
|
1.3%
1/77 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment for adverse events. All-cause mortality was assessed up to 4 years.
All patients were included in the all-cause mortality analysis. Only patients who received treatment were included in the analysis of adverse events.
|
0.00%
0/74 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment for adverse events. All-cause mortality was assessed up to 4 years.
All patients were included in the all-cause mortality analysis. Only patients who received treatment were included in the analysis of adverse events.
|
|
Investigations
Weight loss
|
1.3%
1/77 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment for adverse events. All-cause mortality was assessed up to 4 years.
All patients were included in the all-cause mortality analysis. Only patients who received treatment were included in the analysis of adverse events.
|
0.00%
0/74 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment for adverse events. All-cause mortality was assessed up to 4 years.
All patients were included in the all-cause mortality analysis. Only patients who received treatment were included in the analysis of adverse events.
|
|
Investigations
White blood cell decreased
|
16.9%
13/77 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment for adverse events. All-cause mortality was assessed up to 4 years.
All patients were included in the all-cause mortality analysis. Only patients who received treatment were included in the analysis of adverse events.
|
21.6%
16/74 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment for adverse events. All-cause mortality was assessed up to 4 years.
All patients were included in the all-cause mortality analysis. Only patients who received treatment were included in the analysis of adverse events.
|
|
Investigations
Investigations - Other, specify
|
0.00%
0/77 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment for adverse events. All-cause mortality was assessed up to 4 years.
All patients were included in the all-cause mortality analysis. Only patients who received treatment were included in the analysis of adverse events.
|
1.4%
1/74 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment for adverse events. All-cause mortality was assessed up to 4 years.
All patients were included in the all-cause mortality analysis. Only patients who received treatment were included in the analysis of adverse events.
|
|
Metabolism and nutrition disorders
Acidosis
|
1.3%
1/77 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment for adverse events. All-cause mortality was assessed up to 4 years.
All patients were included in the all-cause mortality analysis. Only patients who received treatment were included in the analysis of adverse events.
|
0.00%
0/74 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment for adverse events. All-cause mortality was assessed up to 4 years.
All patients were included in the all-cause mortality analysis. Only patients who received treatment were included in the analysis of adverse events.
|
|
Metabolism and nutrition disorders
Anorexia
|
2.6%
2/77 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment for adverse events. All-cause mortality was assessed up to 4 years.
All patients were included in the all-cause mortality analysis. Only patients who received treatment were included in the analysis of adverse events.
|
0.00%
0/74 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment for adverse events. All-cause mortality was assessed up to 4 years.
All patients were included in the all-cause mortality analysis. Only patients who received treatment were included in the analysis of adverse events.
|
|
Metabolism and nutrition disorders
Dehydration
|
3.9%
3/77 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment for adverse events. All-cause mortality was assessed up to 4 years.
All patients were included in the all-cause mortality analysis. Only patients who received treatment were included in the analysis of adverse events.
|
0.00%
0/74 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment for adverse events. All-cause mortality was assessed up to 4 years.
All patients were included in the all-cause mortality analysis. Only patients who received treatment were included in the analysis of adverse events.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
3.9%
3/77 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment for adverse events. All-cause mortality was assessed up to 4 years.
All patients were included in the all-cause mortality analysis. Only patients who received treatment were included in the analysis of adverse events.
|
0.00%
0/74 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment for adverse events. All-cause mortality was assessed up to 4 years.
All patients were included in the all-cause mortality analysis. Only patients who received treatment were included in the analysis of adverse events.
|
|
Metabolism and nutrition disorders
Hypermagnesemia
|
1.3%
1/77 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment for adverse events. All-cause mortality was assessed up to 4 years.
All patients were included in the all-cause mortality analysis. Only patients who received treatment were included in the analysis of adverse events.
|
0.00%
0/74 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment for adverse events. All-cause mortality was assessed up to 4 years.
All patients were included in the all-cause mortality analysis. Only patients who received treatment were included in the analysis of adverse events.
|
|
Metabolism and nutrition disorders
Hypernatremia
|
1.3%
1/77 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment for adverse events. All-cause mortality was assessed up to 4 years.
All patients were included in the all-cause mortality analysis. Only patients who received treatment were included in the analysis of adverse events.
|
0.00%
0/74 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment for adverse events. All-cause mortality was assessed up to 4 years.
All patients were included in the all-cause mortality analysis. Only patients who received treatment were included in the analysis of adverse events.
|
|
Metabolism and nutrition disorders
Hyperuricemia
|
0.00%
0/77 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment for adverse events. All-cause mortality was assessed up to 4 years.
All patients were included in the all-cause mortality analysis. Only patients who received treatment were included in the analysis of adverse events.
|
1.4%
1/74 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment for adverse events. All-cause mortality was assessed up to 4 years.
All patients were included in the all-cause mortality analysis. Only patients who received treatment were included in the analysis of adverse events.
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
1.3%
1/77 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment for adverse events. All-cause mortality was assessed up to 4 years.
All patients were included in the all-cause mortality analysis. Only patients who received treatment were included in the analysis of adverse events.
|
1.4%
1/74 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment for adverse events. All-cause mortality was assessed up to 4 years.
All patients were included in the all-cause mortality analysis. Only patients who received treatment were included in the analysis of adverse events.
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
0.00%
0/77 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment for adverse events. All-cause mortality was assessed up to 4 years.
All patients were included in the all-cause mortality analysis. Only patients who received treatment were included in the analysis of adverse events.
|
2.7%
2/74 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment for adverse events. All-cause mortality was assessed up to 4 years.
All patients were included in the all-cause mortality analysis. Only patients who received treatment were included in the analysis of adverse events.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
2.6%
2/77 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment for adverse events. All-cause mortality was assessed up to 4 years.
All patients were included in the all-cause mortality analysis. Only patients who received treatment were included in the analysis of adverse events.
|
1.4%
1/74 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment for adverse events. All-cause mortality was assessed up to 4 years.
All patients were included in the all-cause mortality analysis. Only patients who received treatment were included in the analysis of adverse events.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
5.2%
4/77 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment for adverse events. All-cause mortality was assessed up to 4 years.
All patients were included in the all-cause mortality analysis. Only patients who received treatment were included in the analysis of adverse events.
|
0.00%
0/74 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment for adverse events. All-cause mortality was assessed up to 4 years.
All patients were included in the all-cause mortality analysis. Only patients who received treatment were included in the analysis of adverse events.
|
|
Metabolism and nutrition disorders
Metabolism and nutrition disorders - Other, specify
|
1.3%
1/77 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment for adverse events. All-cause mortality was assessed up to 4 years.
All patients were included in the all-cause mortality analysis. Only patients who received treatment were included in the analysis of adverse events.
|
0.00%
0/74 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment for adverse events. All-cause mortality was assessed up to 4 years.
All patients were included in the all-cause mortality analysis. Only patients who received treatment were included in the analysis of adverse events.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
2.6%
2/77 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment for adverse events. All-cause mortality was assessed up to 4 years.
All patients were included in the all-cause mortality analysis. Only patients who received treatment were included in the analysis of adverse events.
|
0.00%
0/74 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment for adverse events. All-cause mortality was assessed up to 4 years.
All patients were included in the all-cause mortality analysis. Only patients who received treatment were included in the analysis of adverse events.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/77 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment for adverse events. All-cause mortality was assessed up to 4 years.
All patients were included in the all-cause mortality analysis. Only patients who received treatment were included in the analysis of adverse events.
|
1.4%
1/74 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment for adverse events. All-cause mortality was assessed up to 4 years.
All patients were included in the all-cause mortality analysis. Only patients who received treatment were included in the analysis of adverse events.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
1.3%
1/77 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment for adverse events. All-cause mortality was assessed up to 4 years.
All patients were included in the all-cause mortality analysis. Only patients who received treatment were included in the analysis of adverse events.
|
0.00%
0/74 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment for adverse events. All-cause mortality was assessed up to 4 years.
All patients were included in the all-cause mortality analysis. Only patients who received treatment were included in the analysis of adverse events.
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
1.3%
1/77 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment for adverse events. All-cause mortality was assessed up to 4 years.
All patients were included in the all-cause mortality analysis. Only patients who received treatment were included in the analysis of adverse events.
|
0.00%
0/74 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment for adverse events. All-cause mortality was assessed up to 4 years.
All patients were included in the all-cause mortality analysis. Only patients who received treatment were included in the analysis of adverse events.
|
|
Nervous system disorders
Cognitive disturbance
|
0.00%
0/77 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment for adverse events. All-cause mortality was assessed up to 4 years.
All patients were included in the all-cause mortality analysis. Only patients who received treatment were included in the analysis of adverse events.
|
1.4%
1/74 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment for adverse events. All-cause mortality was assessed up to 4 years.
All patients were included in the all-cause mortality analysis. Only patients who received treatment were included in the analysis of adverse events.
|
|
Nervous system disorders
Encephalopathy
|
1.3%
1/77 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment for adverse events. All-cause mortality was assessed up to 4 years.
All patients were included in the all-cause mortality analysis. Only patients who received treatment were included in the analysis of adverse events.
|
0.00%
0/74 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment for adverse events. All-cause mortality was assessed up to 4 years.
All patients were included in the all-cause mortality analysis. Only patients who received treatment were included in the analysis of adverse events.
|
|
Psychiatric disorders
Confusion
|
1.3%
1/77 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment for adverse events. All-cause mortality was assessed up to 4 years.
All patients were included in the all-cause mortality analysis. Only patients who received treatment were included in the analysis of adverse events.
|
1.4%
1/74 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment for adverse events. All-cause mortality was assessed up to 4 years.
All patients were included in the all-cause mortality analysis. Only patients who received treatment were included in the analysis of adverse events.
|
|
Psychiatric disorders
Hallucinations
|
1.3%
1/77 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment for adverse events. All-cause mortality was assessed up to 4 years.
All patients were included in the all-cause mortality analysis. Only patients who received treatment were included in the analysis of adverse events.
|
0.00%
0/74 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment for adverse events. All-cause mortality was assessed up to 4 years.
All patients were included in the all-cause mortality analysis. Only patients who received treatment were included in the analysis of adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
3.9%
3/77 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment for adverse events. All-cause mortality was assessed up to 4 years.
All patients were included in the all-cause mortality analysis. Only patients who received treatment were included in the analysis of adverse events.
|
0.00%
0/74 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment for adverse events. All-cause mortality was assessed up to 4 years.
All patients were included in the all-cause mortality analysis. Only patients who received treatment were included in the analysis of adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
1.3%
1/77 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment for adverse events. All-cause mortality was assessed up to 4 years.
All patients were included in the all-cause mortality analysis. Only patients who received treatment were included in the analysis of adverse events.
|
0.00%
0/74 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment for adverse events. All-cause mortality was assessed up to 4 years.
All patients were included in the all-cause mortality analysis. Only patients who received treatment were included in the analysis of adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
1.3%
1/77 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment for adverse events. All-cause mortality was assessed up to 4 years.
All patients were included in the all-cause mortality analysis. Only patients who received treatment were included in the analysis of adverse events.
|
0.00%
0/74 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment for adverse events. All-cause mortality was assessed up to 4 years.
All patients were included in the all-cause mortality analysis. Only patients who received treatment were included in the analysis of adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
1.3%
1/77 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment for adverse events. All-cause mortality was assessed up to 4 years.
All patients were included in the all-cause mortality analysis. Only patients who received treatment were included in the analysis of adverse events.
|
0.00%
0/74 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment for adverse events. All-cause mortality was assessed up to 4 years.
All patients were included in the all-cause mortality analysis. Only patients who received treatment were included in the analysis of adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
1.3%
1/77 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment for adverse events. All-cause mortality was assessed up to 4 years.
All patients were included in the all-cause mortality analysis. Only patients who received treatment were included in the analysis of adverse events.
|
0.00%
0/74 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment for adverse events. All-cause mortality was assessed up to 4 years.
All patients were included in the all-cause mortality analysis. Only patients who received treatment were included in the analysis of adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary edema
|
1.3%
1/77 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment for adverse events. All-cause mortality was assessed up to 4 years.
All patients were included in the all-cause mortality analysis. Only patients who received treatment were included in the analysis of adverse events.
|
0.00%
0/74 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment for adverse events. All-cause mortality was assessed up to 4 years.
All patients were included in the all-cause mortality analysis. Only patients who received treatment were included in the analysis of adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/77 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment for adverse events. All-cause mortality was assessed up to 4 years.
All patients were included in the all-cause mortality analysis. Only patients who received treatment were included in the analysis of adverse events.
|
1.4%
1/74 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment for adverse events. All-cause mortality was assessed up to 4 years.
All patients were included in the all-cause mortality analysis. Only patients who received treatment were included in the analysis of adverse events.
|
|
Renal and urinary disorders
Acute kidney injury
|
2.6%
2/77 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment for adverse events. All-cause mortality was assessed up to 4 years.
All patients were included in the all-cause mortality analysis. Only patients who received treatment were included in the analysis of adverse events.
|
0.00%
0/74 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment for adverse events. All-cause mortality was assessed up to 4 years.
All patients were included in the all-cause mortality analysis. Only patients who received treatment were included in the analysis of adverse events.
|
|
Vascular disorders
Hypertension
|
0.00%
0/77 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment for adverse events. All-cause mortality was assessed up to 4 years.
All patients were included in the all-cause mortality analysis. Only patients who received treatment were included in the analysis of adverse events.
|
1.4%
1/74 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment for adverse events. All-cause mortality was assessed up to 4 years.
All patients were included in the all-cause mortality analysis. Only patients who received treatment were included in the analysis of adverse events.
|
|
Vascular disorders
Hypotension
|
0.00%
0/77 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment for adverse events. All-cause mortality was assessed up to 4 years.
All patients were included in the all-cause mortality analysis. Only patients who received treatment were included in the analysis of adverse events.
|
2.7%
2/74 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment for adverse events. All-cause mortality was assessed up to 4 years.
All patients were included in the all-cause mortality analysis. Only patients who received treatment were included in the analysis of adverse events.
|
|
Vascular disorders
Thromboembolic event
|
2.6%
2/77 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment for adverse events. All-cause mortality was assessed up to 4 years.
All patients were included in the all-cause mortality analysis. Only patients who received treatment were included in the analysis of adverse events.
|
0.00%
0/74 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment for adverse events. All-cause mortality was assessed up to 4 years.
All patients were included in the all-cause mortality analysis. Only patients who received treatment were included in the analysis of adverse events.
|
Other adverse events
| Measure |
Arm A (Cisplatin/Carboplatin, Etoposide and Nivolumab; CEN)
n=77 participants at risk
Patients receive nivolumab IV at 360 mg over 30 minutes on day 1, carboplatin AUC 5 or 6 IV over 30-60 minutes on day 1 or cisplatin at 75 mg/m2 IV over 60-120 minutes on day 1, and etoposide at 100 mg/m2 IV over 60-120 minutes on days 1-3. Treatment repeats every 21 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity. Patients continue to receive nivolumab IV over 30 minutes every 2 weeks for up to 2 years.
|
Arm B (Cisplatin/Carboplatin and Etoposide; CE)
n=74 participants at risk
Patients receive carboplatin AUC 5 or 6 IV over 30-60 minutes on day 1 or cisplatin at 75 mg/m2 IV over 60-120 minutes on day 1, and etoposide at 100 mg/m2 IV over 60-120 minutes on days 1-3. Treatment repeats every 21 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
76.6%
59/77 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment for adverse events. All-cause mortality was assessed up to 4 years.
All patients were included in the all-cause mortality analysis. Only patients who received treatment were included in the analysis of adverse events.
|
77.0%
57/74 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment for adverse events. All-cause mortality was assessed up to 4 years.
All patients were included in the all-cause mortality analysis. Only patients who received treatment were included in the analysis of adverse events.
|
|
General disorders
Edema limbs
|
6.5%
5/77 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment for adverse events. All-cause mortality was assessed up to 4 years.
All patients were included in the all-cause mortality analysis. Only patients who received treatment were included in the analysis of adverse events.
|
4.1%
3/74 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment for adverse events. All-cause mortality was assessed up to 4 years.
All patients were included in the all-cause mortality analysis. Only patients who received treatment were included in the analysis of adverse events.
|
|
General disorders
Fatigue
|
68.8%
53/77 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment for adverse events. All-cause mortality was assessed up to 4 years.
All patients were included in the all-cause mortality analysis. Only patients who received treatment were included in the analysis of adverse events.
|
74.3%
55/74 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment for adverse events. All-cause mortality was assessed up to 4 years.
All patients were included in the all-cause mortality analysis. Only patients who received treatment were included in the analysis of adverse events.
|
|
General disorders
Fever
|
7.8%
6/77 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment for adverse events. All-cause mortality was assessed up to 4 years.
All patients were included in the all-cause mortality analysis. Only patients who received treatment were included in the analysis of adverse events.
|
8.1%
6/74 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment for adverse events. All-cause mortality was assessed up to 4 years.
All patients were included in the all-cause mortality analysis. Only patients who received treatment were included in the analysis of adverse events.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
32.5%
25/77 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment for adverse events. All-cause mortality was assessed up to 4 years.
All patients were included in the all-cause mortality analysis. Only patients who received treatment were included in the analysis of adverse events.
|
37.8%
28/74 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment for adverse events. All-cause mortality was assessed up to 4 years.
All patients were included in the all-cause mortality analysis. Only patients who received treatment were included in the analysis of adverse events.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
6.5%
5/77 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment for adverse events. All-cause mortality was assessed up to 4 years.
All patients were included in the all-cause mortality analysis. Only patients who received treatment were included in the analysis of adverse events.
|
2.7%
2/74 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment for adverse events. All-cause mortality was assessed up to 4 years.
All patients were included in the all-cause mortality analysis. Only patients who received treatment were included in the analysis of adverse events.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
23.4%
18/77 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment for adverse events. All-cause mortality was assessed up to 4 years.
All patients were included in the all-cause mortality analysis. Only patients who received treatment were included in the analysis of adverse events.
|
2.7%
2/74 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment for adverse events. All-cause mortality was assessed up to 4 years.
All patients were included in the all-cause mortality analysis. Only patients who received treatment were included in the analysis of adverse events.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
16.9%
13/77 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment for adverse events. All-cause mortality was assessed up to 4 years.
All patients were included in the all-cause mortality analysis. Only patients who received treatment were included in the analysis of adverse events.
|
1.4%
1/74 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment for adverse events. All-cause mortality was assessed up to 4 years.
All patients were included in the all-cause mortality analysis. Only patients who received treatment were included in the analysis of adverse events.
|
|
Endocrine disorders
Hyperthyroidism
|
5.2%
4/77 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment for adverse events. All-cause mortality was assessed up to 4 years.
All patients were included in the all-cause mortality analysis. Only patients who received treatment were included in the analysis of adverse events.
|
0.00%
0/74 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment for adverse events. All-cause mortality was assessed up to 4 years.
All patients were included in the all-cause mortality analysis. Only patients who received treatment were included in the analysis of adverse events.
|
|
Endocrine disorders
Hypothyroidism
|
11.7%
9/77 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment for adverse events. All-cause mortality was assessed up to 4 years.
All patients were included in the all-cause mortality analysis. Only patients who received treatment were included in the analysis of adverse events.
|
0.00%
0/74 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment for adverse events. All-cause mortality was assessed up to 4 years.
All patients were included in the all-cause mortality analysis. Only patients who received treatment were included in the analysis of adverse events.
|
|
Gastrointestinal disorders
Abdominal pain
|
6.5%
5/77 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment for adverse events. All-cause mortality was assessed up to 4 years.
All patients were included in the all-cause mortality analysis. Only patients who received treatment were included in the analysis of adverse events.
|
5.4%
4/74 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment for adverse events. All-cause mortality was assessed up to 4 years.
All patients were included in the all-cause mortality analysis. Only patients who received treatment were included in the analysis of adverse events.
|
|
Gastrointestinal disorders
Constipation
|
11.7%
9/77 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment for adverse events. All-cause mortality was assessed up to 4 years.
All patients were included in the all-cause mortality analysis. Only patients who received treatment were included in the analysis of adverse events.
|
12.2%
9/74 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment for adverse events. All-cause mortality was assessed up to 4 years.
All patients were included in the all-cause mortality analysis. Only patients who received treatment were included in the analysis of adverse events.
|
|
Gastrointestinal disorders
Diarrhea
|
29.9%
23/77 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment for adverse events. All-cause mortality was assessed up to 4 years.
All patients were included in the all-cause mortality analysis. Only patients who received treatment were included in the analysis of adverse events.
|
16.2%
12/74 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment for adverse events. All-cause mortality was assessed up to 4 years.
All patients were included in the all-cause mortality analysis. Only patients who received treatment were included in the analysis of adverse events.
|
|
Gastrointestinal disorders
Dry mouth
|
9.1%
7/77 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment for adverse events. All-cause mortality was assessed up to 4 years.
All patients were included in the all-cause mortality analysis. Only patients who received treatment were included in the analysis of adverse events.
|
10.8%
8/74 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment for adverse events. All-cause mortality was assessed up to 4 years.
All patients were included in the all-cause mortality analysis. Only patients who received treatment were included in the analysis of adverse events.
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
3.9%
3/77 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment for adverse events. All-cause mortality was assessed up to 4 years.
All patients were included in the all-cause mortality analysis. Only patients who received treatment were included in the analysis of adverse events.
|
5.4%
4/74 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment for adverse events. All-cause mortality was assessed up to 4 years.
All patients were included in the all-cause mortality analysis. Only patients who received treatment were included in the analysis of adverse events.
|
|
Gastrointestinal disorders
Mucositis oral
|
6.5%
5/77 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment for adverse events. All-cause mortality was assessed up to 4 years.
All patients were included in the all-cause mortality analysis. Only patients who received treatment were included in the analysis of adverse events.
|
5.4%
4/74 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment for adverse events. All-cause mortality was assessed up to 4 years.
All patients were included in the all-cause mortality analysis. Only patients who received treatment were included in the analysis of adverse events.
|
|
Gastrointestinal disorders
Nausea
|
50.6%
39/77 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment for adverse events. All-cause mortality was assessed up to 4 years.
All patients were included in the all-cause mortality analysis. Only patients who received treatment were included in the analysis of adverse events.
|
45.9%
34/74 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment for adverse events. All-cause mortality was assessed up to 4 years.
All patients were included in the all-cause mortality analysis. Only patients who received treatment were included in the analysis of adverse events.
|
|
Gastrointestinal disorders
Vomiting
|
10.4%
8/77 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment for adverse events. All-cause mortality was assessed up to 4 years.
All patients were included in the all-cause mortality analysis. Only patients who received treatment were included in the analysis of adverse events.
|
8.1%
6/74 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment for adverse events. All-cause mortality was assessed up to 4 years.
All patients were included in the all-cause mortality analysis. Only patients who received treatment were included in the analysis of adverse events.
|
|
Investigations
Alanine aminotransferase increased
|
9.1%
7/77 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment for adverse events. All-cause mortality was assessed up to 4 years.
All patients were included in the all-cause mortality analysis. Only patients who received treatment were included in the analysis of adverse events.
|
10.8%
8/74 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment for adverse events. All-cause mortality was assessed up to 4 years.
All patients were included in the all-cause mortality analysis. Only patients who received treatment were included in the analysis of adverse events.
|
|
Investigations
Alkaline phosphatase increased
|
18.2%
14/77 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment for adverse events. All-cause mortality was assessed up to 4 years.
All patients were included in the all-cause mortality analysis. Only patients who received treatment were included in the analysis of adverse events.
|
2.7%
2/74 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment for adverse events. All-cause mortality was assessed up to 4 years.
All patients were included in the all-cause mortality analysis. Only patients who received treatment were included in the analysis of adverse events.
|
|
Investigations
Aspartate aminotransferase increased
|
15.6%
12/77 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment for adverse events. All-cause mortality was assessed up to 4 years.
All patients were included in the all-cause mortality analysis. Only patients who received treatment were included in the analysis of adverse events.
|
12.2%
9/74 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment for adverse events. All-cause mortality was assessed up to 4 years.
All patients were included in the all-cause mortality analysis. Only patients who received treatment were included in the analysis of adverse events.
|
|
Renal and urinary disorders
Creatinine increased
|
15.6%
12/77 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment for adverse events. All-cause mortality was assessed up to 4 years.
All patients were included in the all-cause mortality analysis. Only patients who received treatment were included in the analysis of adverse events.
|
14.9%
11/74 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment for adverse events. All-cause mortality was assessed up to 4 years.
All patients were included in the all-cause mortality analysis. Only patients who received treatment were included in the analysis of adverse events.
|
|
Investigations
Lymphocyte count decreased
|
39.0%
30/77 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment for adverse events. All-cause mortality was assessed up to 4 years.
All patients were included in the all-cause mortality analysis. Only patients who received treatment were included in the analysis of adverse events.
|
27.0%
20/74 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment for adverse events. All-cause mortality was assessed up to 4 years.
All patients were included in the all-cause mortality analysis. Only patients who received treatment were included in the analysis of adverse events.
|
|
Investigations
Neutrophil count decreased
|
31.2%
24/77 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment for adverse events. All-cause mortality was assessed up to 4 years.
All patients were included in the all-cause mortality analysis. Only patients who received treatment were included in the analysis of adverse events.
|
31.1%
23/74 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment for adverse events. All-cause mortality was assessed up to 4 years.
All patients were included in the all-cause mortality analysis. Only patients who received treatment were included in the analysis of adverse events.
|
|
Investigations
Platelet count decreased
|
35.1%
27/77 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment for adverse events. All-cause mortality was assessed up to 4 years.
All patients were included in the all-cause mortality analysis. Only patients who received treatment were included in the analysis of adverse events.
|
40.5%
30/74 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment for adverse events. All-cause mortality was assessed up to 4 years.
All patients were included in the all-cause mortality analysis. Only patients who received treatment were included in the analysis of adverse events.
|
|
Investigations
Weight loss
|
15.6%
12/77 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment for adverse events. All-cause mortality was assessed up to 4 years.
All patients were included in the all-cause mortality analysis. Only patients who received treatment were included in the analysis of adverse events.
|
8.1%
6/74 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment for adverse events. All-cause mortality was assessed up to 4 years.
All patients were included in the all-cause mortality analysis. Only patients who received treatment were included in the analysis of adverse events.
|
|
Investigations
White blood cell decreased
|
32.5%
25/77 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment for adverse events. All-cause mortality was assessed up to 4 years.
All patients were included in the all-cause mortality analysis. Only patients who received treatment were included in the analysis of adverse events.
|
23.0%
17/74 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment for adverse events. All-cause mortality was assessed up to 4 years.
All patients were included in the all-cause mortality analysis. Only patients who received treatment were included in the analysis of adverse events.
|
|
Investigations
Investigations - Other, specify
|
5.2%
4/77 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment for adverse events. All-cause mortality was assessed up to 4 years.
All patients were included in the all-cause mortality analysis. Only patients who received treatment were included in the analysis of adverse events.
|
6.8%
5/74 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment for adverse events. All-cause mortality was assessed up to 4 years.
All patients were included in the all-cause mortality analysis. Only patients who received treatment were included in the analysis of adverse events.
|
|
Metabolism and nutrition disorders
Anorexia
|
40.3%
31/77 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment for adverse events. All-cause mortality was assessed up to 4 years.
All patients were included in the all-cause mortality analysis. Only patients who received treatment were included in the analysis of adverse events.
|
35.1%
26/74 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment for adverse events. All-cause mortality was assessed up to 4 years.
All patients were included in the all-cause mortality analysis. Only patients who received treatment were included in the analysis of adverse events.
|
|
Metabolism and nutrition disorders
Dehydration
|
1.3%
1/77 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment for adverse events. All-cause mortality was assessed up to 4 years.
All patients were included in the all-cause mortality analysis. Only patients who received treatment were included in the analysis of adverse events.
|
6.8%
5/74 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment for adverse events. All-cause mortality was assessed up to 4 years.
All patients were included in the all-cause mortality analysis. Only patients who received treatment were included in the analysis of adverse events.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
9.1%
7/77 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment for adverse events. All-cause mortality was assessed up to 4 years.
All patients were included in the all-cause mortality analysis. Only patients who received treatment were included in the analysis of adverse events.
|
8.1%
6/74 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment for adverse events. All-cause mortality was assessed up to 4 years.
All patients were included in the all-cause mortality analysis. Only patients who received treatment were included in the analysis of adverse events.
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
13.0%
10/77 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment for adverse events. All-cause mortality was assessed up to 4 years.
All patients were included in the all-cause mortality analysis. Only patients who received treatment were included in the analysis of adverse events.
|
14.9%
11/74 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment for adverse events. All-cause mortality was assessed up to 4 years.
All patients were included in the all-cause mortality analysis. Only patients who received treatment were included in the analysis of adverse events.
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
7.8%
6/77 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment for adverse events. All-cause mortality was assessed up to 4 years.
All patients were included in the all-cause mortality analysis. Only patients who received treatment were included in the analysis of adverse events.
|
4.1%
3/74 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment for adverse events. All-cause mortality was assessed up to 4 years.
All patients were included in the all-cause mortality analysis. Only patients who received treatment were included in the analysis of adverse events.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
11.7%
9/77 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment for adverse events. All-cause mortality was assessed up to 4 years.
All patients were included in the all-cause mortality analysis. Only patients who received treatment were included in the analysis of adverse events.
|
16.2%
12/74 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment for adverse events. All-cause mortality was assessed up to 4 years.
All patients were included in the all-cause mortality analysis. Only patients who received treatment were included in the analysis of adverse events.
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
9.1%
7/77 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment for adverse events. All-cause mortality was assessed up to 4 years.
All patients were included in the all-cause mortality analysis. Only patients who received treatment were included in the analysis of adverse events.
|
13.5%
10/74 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment for adverse events. All-cause mortality was assessed up to 4 years.
All patients were included in the all-cause mortality analysis. Only patients who received treatment were included in the analysis of adverse events.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
11.7%
9/77 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment for adverse events. All-cause mortality was assessed up to 4 years.
All patients were included in the all-cause mortality analysis. Only patients who received treatment were included in the analysis of adverse events.
|
10.8%
8/74 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment for adverse events. All-cause mortality was assessed up to 4 years.
All patients were included in the all-cause mortality analysis. Only patients who received treatment were included in the analysis of adverse events.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
6.5%
5/77 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment for adverse events. All-cause mortality was assessed up to 4 years.
All patients were included in the all-cause mortality analysis. Only patients who received treatment were included in the analysis of adverse events.
|
6.8%
5/74 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment for adverse events. All-cause mortality was assessed up to 4 years.
All patients were included in the all-cause mortality analysis. Only patients who received treatment were included in the analysis of adverse events.
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
10.4%
8/77 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment for adverse events. All-cause mortality was assessed up to 4 years.
All patients were included in the all-cause mortality analysis. Only patients who received treatment were included in the analysis of adverse events.
|
5.4%
4/74 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment for adverse events. All-cause mortality was assessed up to 4 years.
All patients were included in the all-cause mortality analysis. Only patients who received treatment were included in the analysis of adverse events.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
2.6%
2/77 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment for adverse events. All-cause mortality was assessed up to 4 years.
All patients were included in the all-cause mortality analysis. Only patients who received treatment were included in the analysis of adverse events.
|
6.8%
5/74 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment for adverse events. All-cause mortality was assessed up to 4 years.
All patients were included in the all-cause mortality analysis. Only patients who received treatment were included in the analysis of adverse events.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
1.3%
1/77 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment for adverse events. All-cause mortality was assessed up to 4 years.
All patients were included in the all-cause mortality analysis. Only patients who received treatment were included in the analysis of adverse events.
|
5.4%
4/74 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment for adverse events. All-cause mortality was assessed up to 4 years.
All patients were included in the all-cause mortality analysis. Only patients who received treatment were included in the analysis of adverse events.
|
|
Nervous system disorders
Dizziness
|
15.6%
12/77 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment for adverse events. All-cause mortality was assessed up to 4 years.
All patients were included in the all-cause mortality analysis. Only patients who received treatment were included in the analysis of adverse events.
|
8.1%
6/74 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment for adverse events. All-cause mortality was assessed up to 4 years.
All patients were included in the all-cause mortality analysis. Only patients who received treatment were included in the analysis of adverse events.
|
|
Nervous system disorders
Dysgeusia
|
14.3%
11/77 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment for adverse events. All-cause mortality was assessed up to 4 years.
All patients were included in the all-cause mortality analysis. Only patients who received treatment were included in the analysis of adverse events.
|
12.2%
9/74 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment for adverse events. All-cause mortality was assessed up to 4 years.
All patients were included in the all-cause mortality analysis. Only patients who received treatment were included in the analysis of adverse events.
|
|
Nervous system disorders
Headache
|
5.2%
4/77 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment for adverse events. All-cause mortality was assessed up to 4 years.
All patients were included in the all-cause mortality analysis. Only patients who received treatment were included in the analysis of adverse events.
|
5.4%
4/74 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment for adverse events. All-cause mortality was assessed up to 4 years.
All patients were included in the all-cause mortality analysis. Only patients who received treatment were included in the analysis of adverse events.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
11.7%
9/77 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment for adverse events. All-cause mortality was assessed up to 4 years.
All patients were included in the all-cause mortality analysis. Only patients who received treatment were included in the analysis of adverse events.
|
10.8%
8/74 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment for adverse events. All-cause mortality was assessed up to 4 years.
All patients were included in the all-cause mortality analysis. Only patients who received treatment were included in the analysis of adverse events.
|
|
Psychiatric disorders
Insomnia
|
7.8%
6/77 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment for adverse events. All-cause mortality was assessed up to 4 years.
All patients were included in the all-cause mortality analysis. Only patients who received treatment were included in the analysis of adverse events.
|
2.7%
2/74 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment for adverse events. All-cause mortality was assessed up to 4 years.
All patients were included in the all-cause mortality analysis. Only patients who received treatment were included in the analysis of adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
7.8%
6/77 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment for adverse events. All-cause mortality was assessed up to 4 years.
All patients were included in the all-cause mortality analysis. Only patients who received treatment were included in the analysis of adverse events.
|
5.4%
4/74 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment for adverse events. All-cause mortality was assessed up to 4 years.
All patients were included in the all-cause mortality analysis. Only patients who received treatment were included in the analysis of adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
16.9%
13/77 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment for adverse events. All-cause mortality was assessed up to 4 years.
All patients were included in the all-cause mortality analysis. Only patients who received treatment were included in the analysis of adverse events.
|
4.1%
3/74 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment for adverse events. All-cause mortality was assessed up to 4 years.
All patients were included in the all-cause mortality analysis. Only patients who received treatment were included in the analysis of adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
2.6%
2/77 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment for adverse events. All-cause mortality was assessed up to 4 years.
All patients were included in the all-cause mortality analysis. Only patients who received treatment were included in the analysis of adverse events.
|
5.4%
4/74 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment for adverse events. All-cause mortality was assessed up to 4 years.
All patients were included in the all-cause mortality analysis. Only patients who received treatment were included in the analysis of adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
9.1%
7/77 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment for adverse events. All-cause mortality was assessed up to 4 years.
All patients were included in the all-cause mortality analysis. Only patients who received treatment were included in the analysis of adverse events.
|
1.4%
1/74 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment for adverse events. All-cause mortality was assessed up to 4 years.
All patients were included in the all-cause mortality analysis. Only patients who received treatment were included in the analysis of adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
3.9%
3/77 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment for adverse events. All-cause mortality was assessed up to 4 years.
All patients were included in the all-cause mortality analysis. Only patients who received treatment were included in the analysis of adverse events.
|
5.4%
4/74 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment for adverse events. All-cause mortality was assessed up to 4 years.
All patients were included in the all-cause mortality analysis. Only patients who received treatment were included in the analysis of adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
1.3%
1/77 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment for adverse events. All-cause mortality was assessed up to 4 years.
All patients were included in the all-cause mortality analysis. Only patients who received treatment were included in the analysis of adverse events.
|
6.8%
5/74 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment for adverse events. All-cause mortality was assessed up to 4 years.
All patients were included in the all-cause mortality analysis. Only patients who received treatment were included in the analysis of adverse events.
|
|
Renal and urinary disorders
Proteinuria
|
5.2%
4/77 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment for adverse events. All-cause mortality was assessed up to 4 years.
All patients were included in the all-cause mortality analysis. Only patients who received treatment were included in the analysis of adverse events.
|
2.7%
2/74 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment for adverse events. All-cause mortality was assessed up to 4 years.
All patients were included in the all-cause mortality analysis. Only patients who received treatment were included in the analysis of adverse events.
|
|
Vascular disorders
Hypotension
|
6.5%
5/77 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment for adverse events. All-cause mortality was assessed up to 4 years.
All patients were included in the all-cause mortality analysis. Only patients who received treatment were included in the analysis of adverse events.
|
5.4%
4/74 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment for adverse events. All-cause mortality was assessed up to 4 years.
All patients were included in the all-cause mortality analysis. Only patients who received treatment were included in the analysis of adverse events.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60