Trial Outcomes & Findings for A Trial of Pembrolizumab in Combination With Chemotherapy and Radiotherapy in Stage III NSCLC (KEYNOTE-799, MK-3475-799) (NCT NCT03631784)
NCT ID: NCT03631784
Last Updated: 2025-03-25
Results Overview
Pneumonitis included the MedDRA preferred terms for radiation pneumonitis are acute interstitial pneumonitis, autoimmune lung disease, interstitial lung disease, pneumonitis, idiopathic pneumonia syndrome, organizing pneumonia, and immune-mediated pneumonitis. As per common terminology criteria for Adverse Events, version 4.0, pneumonitis was graded as follows: Grade (Gr) 1- asymptomatic, clinical or diagnostic observations only; intervention not indicated; Gr 2- symptomatic, medical intervention indicated, limiting instrumental activities of daily living (ADL); Gr 3- severe symptoms; limiting self-care activities of daily living (ADL), oxygen indicated; Gr 4- life-threatening respiratory compromise; urgent intervention indicated (e.g., tracheotomy or intubation); Gr 5- death.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
216 participants
Primary outcome timeframe
Up to approximately 3 years
Results posted on
2025-03-25
Participant Flow
Participants with unresectable, locally advanced, Stage III non-small cell lung cancer (NSCLC), who had received no prior anticancer therapy for their disease were recruited into two cohorts.
Of 216 participants enrolled/allocated in the trial, 214 received treatment.
Participant milestones
| Measure |
Pembrolizumab + cCRT + Paclitaxel + Carboplatin
Participants received 1 cycle of carboplatin area under the curve (AUC) 6 mg/mL/min with paclitaxel 200 mg/m\^2 and pembrolizumab 200 mg on Day 1. Approximately 3 weeks later, participants received carboplatin AUC 2 mg/mL/min with paclitaxel 45 mg/ m\^2 administered weekly for 6 weeks along with 2 cycles of pembrolizumab 200 mg administered every 3 weeks (Q3W) in conjunction with standard thoracic radiotherapy (TRT) (60 Gray \[Gy\] in 2 Gy fractions administered 5 days per week for 6 weeks). Participants then received 14 additional cycles of pembrolizumab 200 mg administered Q3W. 1 cycle=21 days.
|
Pembrolizumab + cCRT + Pemetrexed + Cisplatin
Participants received 3 cycles of cisplatin 75 mg/m\^2 with pemetrexed 500 mg/m\^2 and pembrolizumab 200 mg on Day 1 of each cycle. Treatment was given in conjunction with standard TRT (60 Gy in 2 Gy fractions administered 5 days per week for 6 weeks) in cycles 2 and 3. Participants then received 14 additional cycles of pembrolizumab 200 mg administered Q3W. 1 cycle=21 days.
|
|---|---|---|
|
Overall Study
STARTED
|
112
|
104
|
|
Overall Study
Treated
|
112
|
102
|
|
Overall Study
COMPLETED
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
112
|
104
|
Reasons for withdrawal
| Measure |
Pembrolizumab + cCRT + Paclitaxel + Carboplatin
Participants received 1 cycle of carboplatin area under the curve (AUC) 6 mg/mL/min with paclitaxel 200 mg/m\^2 and pembrolizumab 200 mg on Day 1. Approximately 3 weeks later, participants received carboplatin AUC 2 mg/mL/min with paclitaxel 45 mg/ m\^2 administered weekly for 6 weeks along with 2 cycles of pembrolizumab 200 mg administered every 3 weeks (Q3W) in conjunction with standard thoracic radiotherapy (TRT) (60 Gray \[Gy\] in 2 Gy fractions administered 5 days per week for 6 weeks). Participants then received 14 additional cycles of pembrolizumab 200 mg administered Q3W. 1 cycle=21 days.
|
Pembrolizumab + cCRT + Pemetrexed + Cisplatin
Participants received 3 cycles of cisplatin 75 mg/m\^2 with pemetrexed 500 mg/m\^2 and pembrolizumab 200 mg on Day 1 of each cycle. Treatment was given in conjunction with standard TRT (60 Gy in 2 Gy fractions administered 5 days per week for 6 weeks) in cycles 2 and 3. Participants then received 14 additional cycles of pembrolizumab 200 mg administered Q3W. 1 cycle=21 days.
|
|---|---|---|
|
Overall Study
Participants Ongoing
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
3
|
3
|
|
Overall Study
Sponsor's Decision
|
36
|
52
|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
|
Overall Study
Death
|
71
|
49
|
Baseline Characteristics
A Trial of Pembrolizumab in Combination With Chemotherapy and Radiotherapy in Stage III NSCLC (KEYNOTE-799, MK-3475-799)
Baseline characteristics by cohort
| Measure |
Pembrolizumab + cCRT + Paclitaxel + Carboplatin
n=112 Participants
Participants received 1 cycle of carboplatin area under the curve (AUC) 6 mg/mL/min with paclitaxel 200 mg/m\^2 and pembrolizumab 200 mg on Day 1. Approximately 3 weeks later, participants received carboplatin AUC 2 mg/mL/min with paclitaxel 45 mg/ m\^2 administered weekly for 6 weeks along with 2 cycles of pembrolizumab 200 mg administered every 3 weeks (Q3W) in conjunction with standard thoracic radiotherapy (TRT) (60 Gray \[Gy\] in 2 Gy fractions administered 5 days per week for 6 weeks). Participants then received 14 additional cycles of pembrolizumab 200 mg administered Q3W. 1 cycle=21 days.
|
Pembrolizumab + cCRT + Pemetrexed + Cisplatin
n=104 Participants
Participants received 3 cycles of cisplatin 75 mg/m\^2 with pemetrexed 500 mg/m\^2 and pembrolizumab 200 mg on Day 1 of each cycle. Treatment was given in conjunction with standard TRT (60 Gy in 2 Gy fractions administered 5 days per week for 6 weeks) in cycles 2 and 3. Participants then received 14 additional cycles of pembrolizumab 200 mg administered Q3W. 1 cycle=21 days.
|
Total
n=216 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
65.7 Years
STANDARD_DEVIATION 9.1 • n=5 Participants
|
63.2 Years
STANDARD_DEVIATION 9.4 • n=7 Participants
|
64.5 Years
STANDARD_DEVIATION 9.3 • n=5 Participants
|
|
Sex: Female, Male
Female
|
36 Participants
n=5 Participants
|
40 Participants
n=7 Participants
|
76 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
76 Participants
n=5 Participants
|
64 Participants
n=7 Participants
|
140 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
101 Participants
n=5 Participants
|
84 Participants
n=7 Participants
|
185 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
9 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
14 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
89 Participants
n=5 Participants
|
75 Participants
n=7 Participants
|
164 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
7 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to approximately 3 yearsPopulation: The analysis population consisted of all participants who received at least one dose of study drug.
Pneumonitis included the MedDRA preferred terms for radiation pneumonitis are acute interstitial pneumonitis, autoimmune lung disease, interstitial lung disease, pneumonitis, idiopathic pneumonia syndrome, organizing pneumonia, and immune-mediated pneumonitis. As per common terminology criteria for Adverse Events, version 4.0, pneumonitis was graded as follows: Grade (Gr) 1- asymptomatic, clinical or diagnostic observations only; intervention not indicated; Gr 2- symptomatic, medical intervention indicated, limiting instrumental activities of daily living (ADL); Gr 3- severe symptoms; limiting self-care activities of daily living (ADL), oxygen indicated; Gr 4- life-threatening respiratory compromise; urgent intervention indicated (e.g., tracheotomy or intubation); Gr 5- death.
Outcome measures
| Measure |
Pembrolizumab + cCRT + Paclitaxel + Carboplatin
n=112 Participants
Participants received 1 cycle of carboplatin area under the curve (AUC) 6 mg/mL/min with paclitaxel 200 mg/m\^2 and pembrolizumab 200 mg on Day 1. Approximately 3 weeks later, participants received carboplatin AUC 2 mg/mL/min with paclitaxel 45 mg/ m\^2 administered weekly for 6 weeks along with 2 cycles of pembrolizumab 200 mg administered every 3 weeks (Q3W) in conjunction with standard thoracic radiotherapy (TRT) (60 Gray \[Gy\] in 2 Gy fractions administered 5 days per week for 6 weeks). Participants then received 14 additional cycles of pembrolizumab 200 mg administered Q3W. 1 cycle=21 days.
|
Pembrolizumab + cCRT + Pemetrexed + Cisplatin
n=102 Participants
Participants received 3 cycles of cisplatin 75 mg/m\^2 with pemetrexed 500 mg/m\^2 and pembrolizumab 200 mg on Day 1 of each cycle. Treatment was given in conjunction with standard TRT (60 Gy in 2 Gy fractions administered 5 days per week for 6 weeks) in cycles 2 and 3. Participants then received 14 additional cycles of pembrolizumab 200 mg administered Q3W. 1 cycle=21 days.
|
|---|---|---|
|
Percentage of Participants Who Developed Grade 3 or Higher Pneumonitis
|
8.0 Percentage of Participants
Interval 4.3 to 13.6
|
6.9 Percentage of Participants
Interval 3.3 to 12.5
|
PRIMARY outcome
Timeframe: Up to approximately 3 yearsPopulation: The analysis population consisted of all participants who received at least 1 dose of study treatment.
ORR was defined as the percentage of participants who experienced a complete response (CR; disappearance of all target lesions) or a partial response (PR; at least a 30% decrease in the sum of diameters of target lesions) and was assessed using modified RECIST 1.1 by blinded independent central review (BICR).
Outcome measures
| Measure |
Pembrolizumab + cCRT + Paclitaxel + Carboplatin
n=112 Participants
Participants received 1 cycle of carboplatin area under the curve (AUC) 6 mg/mL/min with paclitaxel 200 mg/m\^2 and pembrolizumab 200 mg on Day 1. Approximately 3 weeks later, participants received carboplatin AUC 2 mg/mL/min with paclitaxel 45 mg/ m\^2 administered weekly for 6 weeks along with 2 cycles of pembrolizumab 200 mg administered every 3 weeks (Q3W) in conjunction with standard thoracic radiotherapy (TRT) (60 Gray \[Gy\] in 2 Gy fractions administered 5 days per week for 6 weeks). Participants then received 14 additional cycles of pembrolizumab 200 mg administered Q3W. 1 cycle=21 days.
|
Pembrolizumab + cCRT + Pemetrexed + Cisplatin
n=102 Participants
Participants received 3 cycles of cisplatin 75 mg/m\^2 with pemetrexed 500 mg/m\^2 and pembrolizumab 200 mg on Day 1 of each cycle. Treatment was given in conjunction with standard TRT (60 Gy in 2 Gy fractions administered 5 days per week for 6 weeks) in cycles 2 and 3. Participants then received 14 additional cycles of pembrolizumab 200 mg administered Q3W. 1 cycle=21 days.
|
|---|---|---|
|
Overall Response Rate (ORR) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)
|
71.4 Percentage of Participants
Interval 62.1 to 79.6
|
75.5 Percentage of Participants
Interval 66.0 to 83.5
|
SECONDARY outcome
Timeframe: Up to approximately 5 1/2 yearsPopulation: The analysis population consisted of all participants who received at least 1 dose of study treatment.
PFS was defined as the time from the first dose of study treatment to the date of the first documentation of disease progression, as determined by BICR per RECIST 1.1 or death due to any cause (whichever occurred first). Disease progression was defined as at least 20 percent (%) increase (including an absolute increase of at least 5 millimeters \[mm\]) in the sum of diameter of target lesions, taking as reference the smallest sum, and/or unequivocal progression of existing non-target lesions, and/or appearance of 1 or more new lesions. PFS was estimated and analyzed using the product-limit (Kaplan-Meier) method for censored data.
Outcome measures
| Measure |
Pembrolizumab + cCRT + Paclitaxel + Carboplatin
n=112 Participants
Participants received 1 cycle of carboplatin area under the curve (AUC) 6 mg/mL/min with paclitaxel 200 mg/m\^2 and pembrolizumab 200 mg on Day 1. Approximately 3 weeks later, participants received carboplatin AUC 2 mg/mL/min with paclitaxel 45 mg/ m\^2 administered weekly for 6 weeks along with 2 cycles of pembrolizumab 200 mg administered every 3 weeks (Q3W) in conjunction with standard thoracic radiotherapy (TRT) (60 Gray \[Gy\] in 2 Gy fractions administered 5 days per week for 6 weeks). Participants then received 14 additional cycles of pembrolizumab 200 mg administered Q3W. 1 cycle=21 days.
|
Pembrolizumab + cCRT + Pemetrexed + Cisplatin
n=102 Participants
Participants received 3 cycles of cisplatin 75 mg/m\^2 with pemetrexed 500 mg/m\^2 and pembrolizumab 200 mg on Day 1 of each cycle. Treatment was given in conjunction with standard TRT (60 Gy in 2 Gy fractions administered 5 days per week for 6 weeks) in cycles 2 and 3. Participants then received 14 additional cycles of pembrolizumab 200 mg administered Q3W. 1 cycle=21 days.
|
|---|---|---|
|
Progression Free Survival (PFS) Per Response Criteria in Solid Tumors Version 1.1 (RECIST 1.1)
|
29.0 Months
Interval 16.6 to 48.5
|
45.3 Months
Interval 17.9 to
NA = Upper limit not reached at time of data cut-off due to insufficient number of participants with an event.
|
SECONDARY outcome
Timeframe: Up to approximately 5 1/2 yearsPopulation: The analysis population consisted of all participants who received at least 1 dose of study treatment.
OS is defined as the time from enrollment to death due to any cause. OS was estimated and analyzed using the product-limit (Kaplan-Meier) method for censored data.
Outcome measures
| Measure |
Pembrolizumab + cCRT + Paclitaxel + Carboplatin
n=112 Participants
Participants received 1 cycle of carboplatin area under the curve (AUC) 6 mg/mL/min with paclitaxel 200 mg/m\^2 and pembrolizumab 200 mg on Day 1. Approximately 3 weeks later, participants received carboplatin AUC 2 mg/mL/min with paclitaxel 45 mg/ m\^2 administered weekly for 6 weeks along with 2 cycles of pembrolizumab 200 mg administered every 3 weeks (Q3W) in conjunction with standard thoracic radiotherapy (TRT) (60 Gray \[Gy\] in 2 Gy fractions administered 5 days per week for 6 weeks). Participants then received 14 additional cycles of pembrolizumab 200 mg administered Q3W. 1 cycle=21 days.
|
Pembrolizumab + cCRT + Pemetrexed + Cisplatin
n=102 Participants
Participants received 3 cycles of cisplatin 75 mg/m\^2 with pemetrexed 500 mg/m\^2 and pembrolizumab 200 mg on Day 1 of each cycle. Treatment was given in conjunction with standard TRT (60 Gy in 2 Gy fractions administered 5 days per week for 6 weeks) in cycles 2 and 3. Participants then received 14 additional cycles of pembrolizumab 200 mg administered Q3W. 1 cycle=21 days.
|
|---|---|---|
|
Overall Survival (OS)
|
35.6 Months
Interval 26.1 to 44.2
|
56.7 Months
Interval 41.1 to
NA= Upper limit not reached at time of data cut-off due to insufficient number of participants with an event.
|
SECONDARY outcome
Timeframe: Up to approximately 1 1/2 yearsPopulation: The analysis population consisted of all participants who received at least one dose of study drug.
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The number of participants with at least one AE was assessed.
Outcome measures
| Measure |
Pembrolizumab + cCRT + Paclitaxel + Carboplatin
n=112 Participants
Participants received 1 cycle of carboplatin area under the curve (AUC) 6 mg/mL/min with paclitaxel 200 mg/m\^2 and pembrolizumab 200 mg on Day 1. Approximately 3 weeks later, participants received carboplatin AUC 2 mg/mL/min with paclitaxel 45 mg/ m\^2 administered weekly for 6 weeks along with 2 cycles of pembrolizumab 200 mg administered every 3 weeks (Q3W) in conjunction with standard thoracic radiotherapy (TRT) (60 Gray \[Gy\] in 2 Gy fractions administered 5 days per week for 6 weeks). Participants then received 14 additional cycles of pembrolizumab 200 mg administered Q3W. 1 cycle=21 days.
|
Pembrolizumab + cCRT + Pemetrexed + Cisplatin
n=102 Participants
Participants received 3 cycles of cisplatin 75 mg/m\^2 with pemetrexed 500 mg/m\^2 and pembrolizumab 200 mg on Day 1 of each cycle. Treatment was given in conjunction with standard TRT (60 Gy in 2 Gy fractions administered 5 days per week for 6 weeks) in cycles 2 and 3. Participants then received 14 additional cycles of pembrolizumab 200 mg administered Q3W. 1 cycle=21 days.
|
|---|---|---|
|
Number of Participants Who Experienced an Adverse Event (AE)
|
108 Participants
|
101 Participants
|
SECONDARY outcome
Timeframe: Up to approximately 1 yearPopulation: The analysis population consisted of all participants who received at least one dose of study drug.
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The number of participants who discontinued treatment due to an AE was assessed.
Outcome measures
| Measure |
Pembrolizumab + cCRT + Paclitaxel + Carboplatin
n=112 Participants
Participants received 1 cycle of carboplatin area under the curve (AUC) 6 mg/mL/min with paclitaxel 200 mg/m\^2 and pembrolizumab 200 mg on Day 1. Approximately 3 weeks later, participants received carboplatin AUC 2 mg/mL/min with paclitaxel 45 mg/ m\^2 administered weekly for 6 weeks along with 2 cycles of pembrolizumab 200 mg administered every 3 weeks (Q3W) in conjunction with standard thoracic radiotherapy (TRT) (60 Gray \[Gy\] in 2 Gy fractions administered 5 days per week for 6 weeks). Participants then received 14 additional cycles of pembrolizumab 200 mg administered Q3W. 1 cycle=21 days.
|
Pembrolizumab + cCRT + Pemetrexed + Cisplatin
n=102 Participants
Participants received 3 cycles of cisplatin 75 mg/m\^2 with pemetrexed 500 mg/m\^2 and pembrolizumab 200 mg on Day 1 of each cycle. Treatment was given in conjunction with standard TRT (60 Gy in 2 Gy fractions administered 5 days per week for 6 weeks) in cycles 2 and 3. Participants then received 14 additional cycles of pembrolizumab 200 mg administered Q3W. 1 cycle=21 days.
|
|---|---|---|
|
Number of Participants Who Discontinued From Study Treatment Due to an AE
|
48 Participants
|
26 Participants
|
Adverse Events
Pembrolizumab + cCRT + Paclitaxel + Carboplatin
Serious events: 66 serious events
Other events: 106 other events
Deaths: 72 deaths
Pembrolizumab + cCRT + Pemetrexed + Cisplatin
Serious events: 46 serious events
Other events: 100 other events
Deaths: 49 deaths
Serious adverse events
| Measure |
Pembrolizumab + cCRT + Paclitaxel + Carboplatin
n=112 participants at risk
Participants received 1 cycle of carboplatin area under the curve (AUC) 6 mg/mL/min with paclitaxel 200 mg/m\^2 and pembrolizumab 200 mg on Day 1. Approximately 3 weeks later, participants received carboplatin AUC 2 mg/mL/min with paclitaxel 45 mg/ m\^2 administered weekly for 6 weeks along with 2 cycles of pembrolizumab 200 mg administered every 3 weeks (Q3W) in conjunction with standard thoracic radiotherapy (TRT) (60 Gray \[Gy\] in 2 Gy fractions administered 5 days per week for 6 weeks). Participants then received 14 additional cycles of pembrolizumab 200 mg administered Q3W. 1 cycle=21 days.
|
Pembrolizumab + cCRT + Pemetrexed + Cisplatin
n=102 participants at risk
Participants received 3 cycles of cisplatin 75 mg/m\^2 with pemetrexed 500 mg/m\^2 and pembrolizumab 200 mg on Day 1 of each cycle. Treatment was given in conjunction with standard TRT (60 Gy in 2 Gy fractions administered 5 days per week for 6 weeks) in cycles 2 and 3. Participants then received 14 additional cycles of pembrolizumab 200 mg administered Q3W. 1 cycle=21 days.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.89%
1/112 • Number of events 1 • For adverse events: Up to ~ 1 1/2 years. All-cause mortality (ACM): Up to ~ 5 1/2 years
All-cause mortality includes all enrolled participants. AEs include participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs.
|
2.9%
3/102 • Number of events 3 • For adverse events: Up to ~ 1 1/2 years. All-cause mortality (ACM): Up to ~ 5 1/2 years
All-cause mortality includes all enrolled participants. AEs include participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs.
|
|
Blood and lymphatic system disorders
Autoimmune haemolytic anaemia
|
0.89%
1/112 • Number of events 1 • For adverse events: Up to ~ 1 1/2 years. All-cause mortality (ACM): Up to ~ 5 1/2 years
All-cause mortality includes all enrolled participants. AEs include participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs.
|
0.00%
0/102 • For adverse events: Up to ~ 1 1/2 years. All-cause mortality (ACM): Up to ~ 5 1/2 years
All-cause mortality includes all enrolled participants. AEs include participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
4.5%
5/112 • Number of events 5 • For adverse events: Up to ~ 1 1/2 years. All-cause mortality (ACM): Up to ~ 5 1/2 years
All-cause mortality includes all enrolled participants. AEs include participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs.
|
0.00%
0/102 • For adverse events: Up to ~ 1 1/2 years. All-cause mortality (ACM): Up to ~ 5 1/2 years
All-cause mortality includes all enrolled participants. AEs include participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs.
|
|
Blood and lymphatic system disorders
Haematotoxicity
|
0.00%
0/112 • For adverse events: Up to ~ 1 1/2 years. All-cause mortality (ACM): Up to ~ 5 1/2 years
All-cause mortality includes all enrolled participants. AEs include participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs.
|
0.98%
1/102 • Number of events 1 • For adverse events: Up to ~ 1 1/2 years. All-cause mortality (ACM): Up to ~ 5 1/2 years
All-cause mortality includes all enrolled participants. AEs include participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs.
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.89%
1/112 • Number of events 1 • For adverse events: Up to ~ 1 1/2 years. All-cause mortality (ACM): Up to ~ 5 1/2 years
All-cause mortality includes all enrolled participants. AEs include participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs.
|
0.98%
1/102 • Number of events 1 • For adverse events: Up to ~ 1 1/2 years. All-cause mortality (ACM): Up to ~ 5 1/2 years
All-cause mortality includes all enrolled participants. AEs include participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs.
|
|
Blood and lymphatic system disorders
Pancytopenia
|
0.00%
0/112 • For adverse events: Up to ~ 1 1/2 years. All-cause mortality (ACM): Up to ~ 5 1/2 years
All-cause mortality includes all enrolled participants. AEs include participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs.
|
0.98%
1/102 • Number of events 1 • For adverse events: Up to ~ 1 1/2 years. All-cause mortality (ACM): Up to ~ 5 1/2 years
All-cause mortality includes all enrolled participants. AEs include participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.89%
1/112 • Number of events 1 • For adverse events: Up to ~ 1 1/2 years. All-cause mortality (ACM): Up to ~ 5 1/2 years
All-cause mortality includes all enrolled participants. AEs include participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs.
|
0.00%
0/102 • For adverse events: Up to ~ 1 1/2 years. All-cause mortality (ACM): Up to ~ 5 1/2 years
All-cause mortality includes all enrolled participants. AEs include participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.89%
1/112 • Number of events 1 • For adverse events: Up to ~ 1 1/2 years. All-cause mortality (ACM): Up to ~ 5 1/2 years
All-cause mortality includes all enrolled participants. AEs include participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs.
|
0.00%
0/102 • For adverse events: Up to ~ 1 1/2 years. All-cause mortality (ACM): Up to ~ 5 1/2 years
All-cause mortality includes all enrolled participants. AEs include participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/112 • For adverse events: Up to ~ 1 1/2 years. All-cause mortality (ACM): Up to ~ 5 1/2 years
All-cause mortality includes all enrolled participants. AEs include participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs.
|
0.98%
1/102 • Number of events 1 • For adverse events: Up to ~ 1 1/2 years. All-cause mortality (ACM): Up to ~ 5 1/2 years
All-cause mortality includes all enrolled participants. AEs include participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs.
|
|
Cardiac disorders
Cardiac failure
|
0.00%
0/112 • For adverse events: Up to ~ 1 1/2 years. All-cause mortality (ACM): Up to ~ 5 1/2 years
All-cause mortality includes all enrolled participants. AEs include participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs.
|
0.98%
1/102 • Number of events 1 • For adverse events: Up to ~ 1 1/2 years. All-cause mortality (ACM): Up to ~ 5 1/2 years
All-cause mortality includes all enrolled participants. AEs include participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs.
|
|
Cardiac disorders
Cardiac failure acute
|
0.89%
1/112 • Number of events 1 • For adverse events: Up to ~ 1 1/2 years. All-cause mortality (ACM): Up to ~ 5 1/2 years
All-cause mortality includes all enrolled participants. AEs include participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs.
|
0.00%
0/102 • For adverse events: Up to ~ 1 1/2 years. All-cause mortality (ACM): Up to ~ 5 1/2 years
All-cause mortality includes all enrolled participants. AEs include participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs.
|
|
Cardiac disorders
Myocardial ischaemia
|
0.00%
0/112 • For adverse events: Up to ~ 1 1/2 years. All-cause mortality (ACM): Up to ~ 5 1/2 years
All-cause mortality includes all enrolled participants. AEs include participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs.
|
0.98%
1/102 • Number of events 1 • For adverse events: Up to ~ 1 1/2 years. All-cause mortality (ACM): Up to ~ 5 1/2 years
All-cause mortality includes all enrolled participants. AEs include participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs.
|
|
Cardiac disorders
Myocarditis
|
0.00%
0/112 • For adverse events: Up to ~ 1 1/2 years. All-cause mortality (ACM): Up to ~ 5 1/2 years
All-cause mortality includes all enrolled participants. AEs include participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs.
|
0.98%
1/102 • Number of events 1 • For adverse events: Up to ~ 1 1/2 years. All-cause mortality (ACM): Up to ~ 5 1/2 years
All-cause mortality includes all enrolled participants. AEs include participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs.
|
|
Cardiac disorders
Pericardial effusion
|
0.00%
0/112 • For adverse events: Up to ~ 1 1/2 years. All-cause mortality (ACM): Up to ~ 5 1/2 years
All-cause mortality includes all enrolled participants. AEs include participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs.
|
0.98%
1/102 • Number of events 1 • For adverse events: Up to ~ 1 1/2 years. All-cause mortality (ACM): Up to ~ 5 1/2 years
All-cause mortality includes all enrolled participants. AEs include participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs.
|
|
Cardiac disorders
Supraventricular tachycardia
|
1.8%
2/112 • Number of events 2 • For adverse events: Up to ~ 1 1/2 years. All-cause mortality (ACM): Up to ~ 5 1/2 years
All-cause mortality includes all enrolled participants. AEs include participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs.
|
0.00%
0/102 • For adverse events: Up to ~ 1 1/2 years. All-cause mortality (ACM): Up to ~ 5 1/2 years
All-cause mortality includes all enrolled participants. AEs include participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs.
|
|
Congenital, familial and genetic disorders
Tracheo-oesophageal fistula
|
0.89%
1/112 • Number of events 1 • For adverse events: Up to ~ 1 1/2 years. All-cause mortality (ACM): Up to ~ 5 1/2 years
All-cause mortality includes all enrolled participants. AEs include participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs.
|
0.00%
0/102 • For adverse events: Up to ~ 1 1/2 years. All-cause mortality (ACM): Up to ~ 5 1/2 years
All-cause mortality includes all enrolled participants. AEs include participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs.
|
|
Endocrine disorders
Hyperthyroidism
|
0.89%
1/112 • Number of events 1 • For adverse events: Up to ~ 1 1/2 years. All-cause mortality (ACM): Up to ~ 5 1/2 years
All-cause mortality includes all enrolled participants. AEs include participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs.
|
0.00%
0/102 • For adverse events: Up to ~ 1 1/2 years. All-cause mortality (ACM): Up to ~ 5 1/2 years
All-cause mortality includes all enrolled participants. AEs include participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs.
|
|
Endocrine disorders
Hypophysitis
|
0.00%
0/112 • For adverse events: Up to ~ 1 1/2 years. All-cause mortality (ACM): Up to ~ 5 1/2 years
All-cause mortality includes all enrolled participants. AEs include participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs.
|
0.98%
1/102 • Number of events 1 • For adverse events: Up to ~ 1 1/2 years. All-cause mortality (ACM): Up to ~ 5 1/2 years
All-cause mortality includes all enrolled participants. AEs include participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs.
|
|
Endocrine disorders
Hypothyroidism
|
0.00%
0/112 • For adverse events: Up to ~ 1 1/2 years. All-cause mortality (ACM): Up to ~ 5 1/2 years
All-cause mortality includes all enrolled participants. AEs include participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs.
|
0.98%
1/102 • Number of events 1 • For adverse events: Up to ~ 1 1/2 years. All-cause mortality (ACM): Up to ~ 5 1/2 years
All-cause mortality includes all enrolled participants. AEs include participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.89%
1/112 • Number of events 1 • For adverse events: Up to ~ 1 1/2 years. All-cause mortality (ACM): Up to ~ 5 1/2 years
All-cause mortality includes all enrolled participants. AEs include participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs.
|
0.00%
0/102 • For adverse events: Up to ~ 1 1/2 years. All-cause mortality (ACM): Up to ~ 5 1/2 years
All-cause mortality includes all enrolled participants. AEs include participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs.
|
|
Gastrointestinal disorders
Diarrhoea
|
1.8%
2/112 • Number of events 2 • For adverse events: Up to ~ 1 1/2 years. All-cause mortality (ACM): Up to ~ 5 1/2 years
All-cause mortality includes all enrolled participants. AEs include participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs.
|
0.00%
0/102 • For adverse events: Up to ~ 1 1/2 years. All-cause mortality (ACM): Up to ~ 5 1/2 years
All-cause mortality includes all enrolled participants. AEs include participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs.
|
|
Gastrointestinal disorders
Dysphagia
|
0.89%
1/112 • Number of events 1 • For adverse events: Up to ~ 1 1/2 years. All-cause mortality (ACM): Up to ~ 5 1/2 years
All-cause mortality includes all enrolled participants. AEs include participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs.
|
0.00%
0/102 • For adverse events: Up to ~ 1 1/2 years. All-cause mortality (ACM): Up to ~ 5 1/2 years
All-cause mortality includes all enrolled participants. AEs include participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs.
|
|
Gastrointestinal disorders
Gastric ulcer
|
0.00%
0/112 • For adverse events: Up to ~ 1 1/2 years. All-cause mortality (ACM): Up to ~ 5 1/2 years
All-cause mortality includes all enrolled participants. AEs include participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs.
|
0.98%
1/102 • Number of events 1 • For adverse events: Up to ~ 1 1/2 years. All-cause mortality (ACM): Up to ~ 5 1/2 years
All-cause mortality includes all enrolled participants. AEs include participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs.
|
|
Gastrointestinal disorders
Gastritis
|
0.89%
1/112 • Number of events 1 • For adverse events: Up to ~ 1 1/2 years. All-cause mortality (ACM): Up to ~ 5 1/2 years
All-cause mortality includes all enrolled participants. AEs include participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs.
|
0.00%
0/102 • For adverse events: Up to ~ 1 1/2 years. All-cause mortality (ACM): Up to ~ 5 1/2 years
All-cause mortality includes all enrolled participants. AEs include participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.89%
1/112 • Number of events 1 • For adverse events: Up to ~ 1 1/2 years. All-cause mortality (ACM): Up to ~ 5 1/2 years
All-cause mortality includes all enrolled participants. AEs include participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs.
|
0.00%
0/102 • For adverse events: Up to ~ 1 1/2 years. All-cause mortality (ACM): Up to ~ 5 1/2 years
All-cause mortality includes all enrolled participants. AEs include participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs.
|
|
Gastrointestinal disorders
Impaired gastric emptying
|
0.89%
1/112 • Number of events 1 • For adverse events: Up to ~ 1 1/2 years. All-cause mortality (ACM): Up to ~ 5 1/2 years
All-cause mortality includes all enrolled participants. AEs include participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs.
|
0.00%
0/102 • For adverse events: Up to ~ 1 1/2 years. All-cause mortality (ACM): Up to ~ 5 1/2 years
All-cause mortality includes all enrolled participants. AEs include participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs.
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.89%
1/112 • Number of events 1 • For adverse events: Up to ~ 1 1/2 years. All-cause mortality (ACM): Up to ~ 5 1/2 years
All-cause mortality includes all enrolled participants. AEs include participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs.
|
0.00%
0/102 • For adverse events: Up to ~ 1 1/2 years. All-cause mortality (ACM): Up to ~ 5 1/2 years
All-cause mortality includes all enrolled participants. AEs include participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs.
|
|
Gastrointestinal disorders
Nausea
|
1.8%
2/112 • Number of events 2 • For adverse events: Up to ~ 1 1/2 years. All-cause mortality (ACM): Up to ~ 5 1/2 years
All-cause mortality includes all enrolled participants. AEs include participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs.
|
0.98%
1/102 • Number of events 1 • For adverse events: Up to ~ 1 1/2 years. All-cause mortality (ACM): Up to ~ 5 1/2 years
All-cause mortality includes all enrolled participants. AEs include participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs.
|
|
Gastrointestinal disorders
Odynophagia
|
0.89%
1/112 • Number of events 1 • For adverse events: Up to ~ 1 1/2 years. All-cause mortality (ACM): Up to ~ 5 1/2 years
All-cause mortality includes all enrolled participants. AEs include participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs.
|
0.00%
0/102 • For adverse events: Up to ~ 1 1/2 years. All-cause mortality (ACM): Up to ~ 5 1/2 years
All-cause mortality includes all enrolled participants. AEs include participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs.
|
|
Gastrointestinal disorders
Oesophageal perforation
|
0.00%
0/112 • For adverse events: Up to ~ 1 1/2 years. All-cause mortality (ACM): Up to ~ 5 1/2 years
All-cause mortality includes all enrolled participants. AEs include participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs.
|
0.98%
1/102 • Number of events 1 • For adverse events: Up to ~ 1 1/2 years. All-cause mortality (ACM): Up to ~ 5 1/2 years
All-cause mortality includes all enrolled participants. AEs include participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs.
|
|
Gastrointestinal disorders
Oesophagitis
|
1.8%
2/112 • Number of events 2 • For adverse events: Up to ~ 1 1/2 years. All-cause mortality (ACM): Up to ~ 5 1/2 years
All-cause mortality includes all enrolled participants. AEs include participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs.
|
0.00%
0/102 • For adverse events: Up to ~ 1 1/2 years. All-cause mortality (ACM): Up to ~ 5 1/2 years
All-cause mortality includes all enrolled participants. AEs include participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs.
|
|
Gastrointestinal disorders
Stomatitis
|
0.89%
1/112 • Number of events 1 • For adverse events: Up to ~ 1 1/2 years. All-cause mortality (ACM): Up to ~ 5 1/2 years
All-cause mortality includes all enrolled participants. AEs include participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs.
|
0.00%
0/102 • For adverse events: Up to ~ 1 1/2 years. All-cause mortality (ACM): Up to ~ 5 1/2 years
All-cause mortality includes all enrolled participants. AEs include participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs.
|
|
Gastrointestinal disorders
Vomiting
|
0.89%
1/112 • Number of events 1 • For adverse events: Up to ~ 1 1/2 years. All-cause mortality (ACM): Up to ~ 5 1/2 years
All-cause mortality includes all enrolled participants. AEs include participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs.
|
0.98%
1/102 • Number of events 1 • For adverse events: Up to ~ 1 1/2 years. All-cause mortality (ACM): Up to ~ 5 1/2 years
All-cause mortality includes all enrolled participants. AEs include participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs.
|
|
General disorders
Asthenia
|
1.8%
2/112 • Number of events 2 • For adverse events: Up to ~ 1 1/2 years. All-cause mortality (ACM): Up to ~ 5 1/2 years
All-cause mortality includes all enrolled participants. AEs include participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs.
|
2.0%
2/102 • Number of events 2 • For adverse events: Up to ~ 1 1/2 years. All-cause mortality (ACM): Up to ~ 5 1/2 years
All-cause mortality includes all enrolled participants. AEs include participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs.
|
|
General disorders
Death
|
0.89%
1/112 • Number of events 1 • For adverse events: Up to ~ 1 1/2 years. All-cause mortality (ACM): Up to ~ 5 1/2 years
All-cause mortality includes all enrolled participants. AEs include participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs.
|
0.00%
0/102 • For adverse events: Up to ~ 1 1/2 years. All-cause mortality (ACM): Up to ~ 5 1/2 years
All-cause mortality includes all enrolled participants. AEs include participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs.
|
|
General disorders
Device related thrombosis
|
0.89%
1/112 • Number of events 1 • For adverse events: Up to ~ 1 1/2 years. All-cause mortality (ACM): Up to ~ 5 1/2 years
All-cause mortality includes all enrolled participants. AEs include participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs.
|
0.00%
0/102 • For adverse events: Up to ~ 1 1/2 years. All-cause mortality (ACM): Up to ~ 5 1/2 years
All-cause mortality includes all enrolled participants. AEs include participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs.
|
|
General disorders
Fatigue
|
1.8%
2/112 • Number of events 2 • For adverse events: Up to ~ 1 1/2 years. All-cause mortality (ACM): Up to ~ 5 1/2 years
All-cause mortality includes all enrolled participants. AEs include participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs.
|
0.00%
0/102 • For adverse events: Up to ~ 1 1/2 years. All-cause mortality (ACM): Up to ~ 5 1/2 years
All-cause mortality includes all enrolled participants. AEs include participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs.
|
|
General disorders
Pyrexia
|
0.89%
1/112 • Number of events 1 • For adverse events: Up to ~ 1 1/2 years. All-cause mortality (ACM): Up to ~ 5 1/2 years
All-cause mortality includes all enrolled participants. AEs include participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs.
|
6.9%
7/102 • Number of events 9 • For adverse events: Up to ~ 1 1/2 years. All-cause mortality (ACM): Up to ~ 5 1/2 years
All-cause mortality includes all enrolled participants. AEs include participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs.
|
|
General disorders
Sudden death
|
0.89%
1/112 • Number of events 1 • For adverse events: Up to ~ 1 1/2 years. All-cause mortality (ACM): Up to ~ 5 1/2 years
All-cause mortality includes all enrolled participants. AEs include participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs.
|
0.00%
0/102 • For adverse events: Up to ~ 1 1/2 years. All-cause mortality (ACM): Up to ~ 5 1/2 years
All-cause mortality includes all enrolled participants. AEs include participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs.
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.00%
0/112 • For adverse events: Up to ~ 1 1/2 years. All-cause mortality (ACM): Up to ~ 5 1/2 years
All-cause mortality includes all enrolled participants. AEs include participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs.
|
0.98%
1/102 • Number of events 1 • For adverse events: Up to ~ 1 1/2 years. All-cause mortality (ACM): Up to ~ 5 1/2 years
All-cause mortality includes all enrolled participants. AEs include participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs.
|
|
Hepatobiliary disorders
Drug-induced liver injury
|
0.00%
0/112 • For adverse events: Up to ~ 1 1/2 years. All-cause mortality (ACM): Up to ~ 5 1/2 years
All-cause mortality includes all enrolled participants. AEs include participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs.
|
0.98%
1/102 • Number of events 1 • For adverse events: Up to ~ 1 1/2 years. All-cause mortality (ACM): Up to ~ 5 1/2 years
All-cause mortality includes all enrolled participants. AEs include participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs.
|
|
Hepatobiliary disorders
Hepatitis acute
|
0.89%
1/112 • Number of events 1 • For adverse events: Up to ~ 1 1/2 years. All-cause mortality (ACM): Up to ~ 5 1/2 years
All-cause mortality includes all enrolled participants. AEs include participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs.
|
0.00%
0/102 • For adverse events: Up to ~ 1 1/2 years. All-cause mortality (ACM): Up to ~ 5 1/2 years
All-cause mortality includes all enrolled participants. AEs include participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs.
|
|
Hepatobiliary disorders
Hepatobiliary disease
|
0.00%
0/112 • For adverse events: Up to ~ 1 1/2 years. All-cause mortality (ACM): Up to ~ 5 1/2 years
All-cause mortality includes all enrolled participants. AEs include participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs.
|
0.98%
1/102 • Number of events 1 • For adverse events: Up to ~ 1 1/2 years. All-cause mortality (ACM): Up to ~ 5 1/2 years
All-cause mortality includes all enrolled participants. AEs include participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs.
|
|
Immune system disorders
Anaphylactic reaction
|
1.8%
2/112 • Number of events 2 • For adverse events: Up to ~ 1 1/2 years. All-cause mortality (ACM): Up to ~ 5 1/2 years
All-cause mortality includes all enrolled participants. AEs include participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs.
|
0.00%
0/102 • For adverse events: Up to ~ 1 1/2 years. All-cause mortality (ACM): Up to ~ 5 1/2 years
All-cause mortality includes all enrolled participants. AEs include participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs.
|
|
Immune system disorders
Drug hypersensitivity
|
0.89%
1/112 • Number of events 1 • For adverse events: Up to ~ 1 1/2 years. All-cause mortality (ACM): Up to ~ 5 1/2 years
All-cause mortality includes all enrolled participants. AEs include participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs.
|
0.00%
0/102 • For adverse events: Up to ~ 1 1/2 years. All-cause mortality (ACM): Up to ~ 5 1/2 years
All-cause mortality includes all enrolled participants. AEs include participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs.
|
|
Infections and infestations
Anal abscess
|
0.89%
1/112 • Number of events 1 • For adverse events: Up to ~ 1 1/2 years. All-cause mortality (ACM): Up to ~ 5 1/2 years
All-cause mortality includes all enrolled participants. AEs include participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs.
|
0.00%
0/102 • For adverse events: Up to ~ 1 1/2 years. All-cause mortality (ACM): Up to ~ 5 1/2 years
All-cause mortality includes all enrolled participants. AEs include participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs.
|
|
Infections and infestations
Biliary tract infection
|
0.00%
0/112 • For adverse events: Up to ~ 1 1/2 years. All-cause mortality (ACM): Up to ~ 5 1/2 years
All-cause mortality includes all enrolled participants. AEs include participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs.
|
0.98%
1/102 • Number of events 1 • For adverse events: Up to ~ 1 1/2 years. All-cause mortality (ACM): Up to ~ 5 1/2 years
All-cause mortality includes all enrolled participants. AEs include participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs.
|
|
Infections and infestations
Bronchitis
|
0.89%
1/112 • Number of events 1 • For adverse events: Up to ~ 1 1/2 years. All-cause mortality (ACM): Up to ~ 5 1/2 years
All-cause mortality includes all enrolled participants. AEs include participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs.
|
0.98%
1/102 • Number of events 1 • For adverse events: Up to ~ 1 1/2 years. All-cause mortality (ACM): Up to ~ 5 1/2 years
All-cause mortality includes all enrolled participants. AEs include participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs.
|
|
Infections and infestations
Bronchitis bacterial
|
0.89%
1/112 • Number of events 1 • For adverse events: Up to ~ 1 1/2 years. All-cause mortality (ACM): Up to ~ 5 1/2 years
All-cause mortality includes all enrolled participants. AEs include participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs.
|
0.00%
0/102 • For adverse events: Up to ~ 1 1/2 years. All-cause mortality (ACM): Up to ~ 5 1/2 years
All-cause mortality includes all enrolled participants. AEs include participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs.
|
|
Infections and infestations
COVID-19
|
0.00%
0/112 • For adverse events: Up to ~ 1 1/2 years. All-cause mortality (ACM): Up to ~ 5 1/2 years
All-cause mortality includes all enrolled participants. AEs include participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs.
|
0.98%
1/102 • Number of events 1 • For adverse events: Up to ~ 1 1/2 years. All-cause mortality (ACM): Up to ~ 5 1/2 years
All-cause mortality includes all enrolled participants. AEs include participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs.
|
|
Infections and infestations
COVID-19 pneumonia
|
0.00%
0/112 • For adverse events: Up to ~ 1 1/2 years. All-cause mortality (ACM): Up to ~ 5 1/2 years
All-cause mortality includes all enrolled participants. AEs include participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs.
|
2.0%
2/102 • Number of events 2 • For adverse events: Up to ~ 1 1/2 years. All-cause mortality (ACM): Up to ~ 5 1/2 years
All-cause mortality includes all enrolled participants. AEs include participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs.
|
|
Infections and infestations
Catheter site infection
|
0.89%
1/112 • Number of events 1 • For adverse events: Up to ~ 1 1/2 years. All-cause mortality (ACM): Up to ~ 5 1/2 years
All-cause mortality includes all enrolled participants. AEs include participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs.
|
0.00%
0/102 • For adverse events: Up to ~ 1 1/2 years. All-cause mortality (ACM): Up to ~ 5 1/2 years
All-cause mortality includes all enrolled participants. AEs include participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs.
|
|
Infections and infestations
Cellulitis
|
0.89%
1/112 • Number of events 1 • For adverse events: Up to ~ 1 1/2 years. All-cause mortality (ACM): Up to ~ 5 1/2 years
All-cause mortality includes all enrolled participants. AEs include participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs.
|
0.98%
1/102 • Number of events 1 • For adverse events: Up to ~ 1 1/2 years. All-cause mortality (ACM): Up to ~ 5 1/2 years
All-cause mortality includes all enrolled participants. AEs include participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs.
|
|
Infections and infestations
Cystitis
|
0.89%
1/112 • Number of events 1 • For adverse events: Up to ~ 1 1/2 years. All-cause mortality (ACM): Up to ~ 5 1/2 years
All-cause mortality includes all enrolled participants. AEs include participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs.
|
0.00%
0/102 • For adverse events: Up to ~ 1 1/2 years. All-cause mortality (ACM): Up to ~ 5 1/2 years
All-cause mortality includes all enrolled participants. AEs include participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs.
|
|
Infections and infestations
Device related infection
|
0.89%
1/112 • Number of events 1 • For adverse events: Up to ~ 1 1/2 years. All-cause mortality (ACM): Up to ~ 5 1/2 years
All-cause mortality includes all enrolled participants. AEs include participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs.
|
0.00%
0/102 • For adverse events: Up to ~ 1 1/2 years. All-cause mortality (ACM): Up to ~ 5 1/2 years
All-cause mortality includes all enrolled participants. AEs include participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs.
|
|
Infections and infestations
Encephalitis
|
0.00%
0/112 • For adverse events: Up to ~ 1 1/2 years. All-cause mortality (ACM): Up to ~ 5 1/2 years
All-cause mortality includes all enrolled participants. AEs include participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs.
|
0.98%
1/102 • Number of events 1 • For adverse events: Up to ~ 1 1/2 years. All-cause mortality (ACM): Up to ~ 5 1/2 years
All-cause mortality includes all enrolled participants. AEs include participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs.
|
|
Infections and infestations
Infectious pleural effusion
|
0.89%
1/112 • Number of events 1 • For adverse events: Up to ~ 1 1/2 years. All-cause mortality (ACM): Up to ~ 5 1/2 years
All-cause mortality includes all enrolled participants. AEs include participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs.
|
0.00%
0/102 • For adverse events: Up to ~ 1 1/2 years. All-cause mortality (ACM): Up to ~ 5 1/2 years
All-cause mortality includes all enrolled participants. AEs include participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs.
|
|
Infections and infestations
Infective exacerbation of chronic obstructive airways disease
|
0.00%
0/112 • For adverse events: Up to ~ 1 1/2 years. All-cause mortality (ACM): Up to ~ 5 1/2 years
All-cause mortality includes all enrolled participants. AEs include participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs.
|
0.98%
1/102 • Number of events 1 • For adverse events: Up to ~ 1 1/2 years. All-cause mortality (ACM): Up to ~ 5 1/2 years
All-cause mortality includes all enrolled participants. AEs include participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs.
|
|
Infections and infestations
Lower respiratory tract infection
|
0.00%
0/112 • For adverse events: Up to ~ 1 1/2 years. All-cause mortality (ACM): Up to ~ 5 1/2 years
All-cause mortality includes all enrolled participants. AEs include participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs.
|
0.98%
1/102 • Number of events 1 • For adverse events: Up to ~ 1 1/2 years. All-cause mortality (ACM): Up to ~ 5 1/2 years
All-cause mortality includes all enrolled participants. AEs include participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs.
|
|
Infections and infestations
Neutropenic sepsis
|
1.8%
2/112 • Number of events 3 • For adverse events: Up to ~ 1 1/2 years. All-cause mortality (ACM): Up to ~ 5 1/2 years
All-cause mortality includes all enrolled participants. AEs include participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs.
|
0.00%
0/102 • For adverse events: Up to ~ 1 1/2 years. All-cause mortality (ACM): Up to ~ 5 1/2 years
All-cause mortality includes all enrolled participants. AEs include participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs.
|
|
Infections and infestations
Orchitis
|
0.00%
0/112 • For adverse events: Up to ~ 1 1/2 years. All-cause mortality (ACM): Up to ~ 5 1/2 years
All-cause mortality includes all enrolled participants. AEs include participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs.
|
0.98%
1/102 • Number of events 1 • For adverse events: Up to ~ 1 1/2 years. All-cause mortality (ACM): Up to ~ 5 1/2 years
All-cause mortality includes all enrolled participants. AEs include participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs.
|
|
Infections and infestations
Pneumocystis jirovecii pneumonia
|
0.00%
0/112 • For adverse events: Up to ~ 1 1/2 years. All-cause mortality (ACM): Up to ~ 5 1/2 years
All-cause mortality includes all enrolled participants. AEs include participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs.
|
2.0%
2/102 • Number of events 2 • For adverse events: Up to ~ 1 1/2 years. All-cause mortality (ACM): Up to ~ 5 1/2 years
All-cause mortality includes all enrolled participants. AEs include participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs.
|
|
Infections and infestations
Pneumonia
|
12.5%
14/112 • Number of events 15 • For adverse events: Up to ~ 1 1/2 years. All-cause mortality (ACM): Up to ~ 5 1/2 years
All-cause mortality includes all enrolled participants. AEs include participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs.
|
8.8%
9/102 • Number of events 11 • For adverse events: Up to ~ 1 1/2 years. All-cause mortality (ACM): Up to ~ 5 1/2 years
All-cause mortality includes all enrolled participants. AEs include participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs.
|
|
Infections and infestations
Pneumonia necrotising
|
0.00%
0/112 • For adverse events: Up to ~ 1 1/2 years. All-cause mortality (ACM): Up to ~ 5 1/2 years
All-cause mortality includes all enrolled participants. AEs include participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs.
|
0.98%
1/102 • Number of events 1 • For adverse events: Up to ~ 1 1/2 years. All-cause mortality (ACM): Up to ~ 5 1/2 years
All-cause mortality includes all enrolled participants. AEs include participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs.
|
|
Infections and infestations
Pneumonia pneumococcal
|
0.89%
1/112 • Number of events 1 • For adverse events: Up to ~ 1 1/2 years. All-cause mortality (ACM): Up to ~ 5 1/2 years
All-cause mortality includes all enrolled participants. AEs include participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs.
|
0.00%
0/102 • For adverse events: Up to ~ 1 1/2 years. All-cause mortality (ACM): Up to ~ 5 1/2 years
All-cause mortality includes all enrolled participants. AEs include participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs.
|
|
Infections and infestations
Pyelonephritis
|
0.89%
1/112 • Number of events 1 • For adverse events: Up to ~ 1 1/2 years. All-cause mortality (ACM): Up to ~ 5 1/2 years
All-cause mortality includes all enrolled participants. AEs include participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs.
|
0.00%
0/102 • For adverse events: Up to ~ 1 1/2 years. All-cause mortality (ACM): Up to ~ 5 1/2 years
All-cause mortality includes all enrolled participants. AEs include participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs.
|
|
Infections and infestations
Respiratory tract infection
|
0.00%
0/112 • For adverse events: Up to ~ 1 1/2 years. All-cause mortality (ACM): Up to ~ 5 1/2 years
All-cause mortality includes all enrolled participants. AEs include participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs.
|
0.98%
1/102 • Number of events 1 • For adverse events: Up to ~ 1 1/2 years. All-cause mortality (ACM): Up to ~ 5 1/2 years
All-cause mortality includes all enrolled participants. AEs include participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs.
|
|
Infections and infestations
Sepsis
|
3.6%
4/112 • Number of events 5 • For adverse events: Up to ~ 1 1/2 years. All-cause mortality (ACM): Up to ~ 5 1/2 years
All-cause mortality includes all enrolled participants. AEs include participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs.
|
0.00%
0/102 • For adverse events: Up to ~ 1 1/2 years. All-cause mortality (ACM): Up to ~ 5 1/2 years
All-cause mortality includes all enrolled participants. AEs include participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs.
|
|
Infections and infestations
Urinary tract infection
|
0.89%
1/112 • Number of events 1 • For adverse events: Up to ~ 1 1/2 years. All-cause mortality (ACM): Up to ~ 5 1/2 years
All-cause mortality includes all enrolled participants. AEs include participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs.
|
0.00%
0/102 • For adverse events: Up to ~ 1 1/2 years. All-cause mortality (ACM): Up to ~ 5 1/2 years
All-cause mortality includes all enrolled participants. AEs include participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs.
|
|
Injury, poisoning and procedural complications
Radiation oesophagitis
|
2.7%
3/112 • Number of events 3 • For adverse events: Up to ~ 1 1/2 years. All-cause mortality (ACM): Up to ~ 5 1/2 years
All-cause mortality includes all enrolled participants. AEs include participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs.
|
0.00%
0/102 • For adverse events: Up to ~ 1 1/2 years. All-cause mortality (ACM): Up to ~ 5 1/2 years
All-cause mortality includes all enrolled participants. AEs include participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs.
|
|
Injury, poisoning and procedural complications
Radiation pneumonitis
|
2.7%
3/112 • Number of events 3 • For adverse events: Up to ~ 1 1/2 years. All-cause mortality (ACM): Up to ~ 5 1/2 years
All-cause mortality includes all enrolled participants. AEs include participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs.
|
0.98%
1/102 • Number of events 1 • For adverse events: Up to ~ 1 1/2 years. All-cause mortality (ACM): Up to ~ 5 1/2 years
All-cause mortality includes all enrolled participants. AEs include participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs.
|
|
Injury, poisoning and procedural complications
Spinal compression fracture
|
0.89%
1/112 • Number of events 1 • For adverse events: Up to ~ 1 1/2 years. All-cause mortality (ACM): Up to ~ 5 1/2 years
All-cause mortality includes all enrolled participants. AEs include participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs.
|
0.00%
0/102 • For adverse events: Up to ~ 1 1/2 years. All-cause mortality (ACM): Up to ~ 5 1/2 years
All-cause mortality includes all enrolled participants. AEs include participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs.
|
|
Injury, poisoning and procedural complications
Tibia fracture
|
0.89%
1/112 • Number of events 1 • For adverse events: Up to ~ 1 1/2 years. All-cause mortality (ACM): Up to ~ 5 1/2 years
All-cause mortality includes all enrolled participants. AEs include participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs.
|
0.00%
0/102 • For adverse events: Up to ~ 1 1/2 years. All-cause mortality (ACM): Up to ~ 5 1/2 years
All-cause mortality includes all enrolled participants. AEs include participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs.
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/112 • For adverse events: Up to ~ 1 1/2 years. All-cause mortality (ACM): Up to ~ 5 1/2 years
All-cause mortality includes all enrolled participants. AEs include participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs.
|
0.98%
1/102 • Number of events 1 • For adverse events: Up to ~ 1 1/2 years. All-cause mortality (ACM): Up to ~ 5 1/2 years
All-cause mortality includes all enrolled participants. AEs include participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs.
|
|
Investigations
Platelet count decreased
|
0.89%
1/112 • Number of events 1 • For adverse events: Up to ~ 1 1/2 years. All-cause mortality (ACM): Up to ~ 5 1/2 years
All-cause mortality includes all enrolled participants. AEs include participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs.
|
0.98%
1/102 • Number of events 1 • For adverse events: Up to ~ 1 1/2 years. All-cause mortality (ACM): Up to ~ 5 1/2 years
All-cause mortality includes all enrolled participants. AEs include participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.89%
1/112 • Number of events 1 • For adverse events: Up to ~ 1 1/2 years. All-cause mortality (ACM): Up to ~ 5 1/2 years
All-cause mortality includes all enrolled participants. AEs include participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs.
|
2.0%
2/102 • Number of events 2 • For adverse events: Up to ~ 1 1/2 years. All-cause mortality (ACM): Up to ~ 5 1/2 years
All-cause mortality includes all enrolled participants. AEs include participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs.
|
|
Metabolism and nutrition disorders
Electrolyte imbalance
|
0.89%
1/112 • Number of events 1 • For adverse events: Up to ~ 1 1/2 years. All-cause mortality (ACM): Up to ~ 5 1/2 years
All-cause mortality includes all enrolled participants. AEs include participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs.
|
0.00%
0/102 • For adverse events: Up to ~ 1 1/2 years. All-cause mortality (ACM): Up to ~ 5 1/2 years
All-cause mortality includes all enrolled participants. AEs include participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs.
|
|
Metabolism and nutrition disorders
Failure to thrive
|
0.89%
1/112 • Number of events 1 • For adverse events: Up to ~ 1 1/2 years. All-cause mortality (ACM): Up to ~ 5 1/2 years
All-cause mortality includes all enrolled participants. AEs include participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs.
|
0.00%
0/102 • For adverse events: Up to ~ 1 1/2 years. All-cause mortality (ACM): Up to ~ 5 1/2 years
All-cause mortality includes all enrolled participants. AEs include participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/112 • For adverse events: Up to ~ 1 1/2 years. All-cause mortality (ACM): Up to ~ 5 1/2 years
All-cause mortality includes all enrolled participants. AEs include participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs.
|
0.98%
1/102 • Number of events 1 • For adverse events: Up to ~ 1 1/2 years. All-cause mortality (ACM): Up to ~ 5 1/2 years
All-cause mortality includes all enrolled participants. AEs include participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs.
|
|
Metabolism and nutrition disorders
Hypophagia
|
0.00%
0/112 • For adverse events: Up to ~ 1 1/2 years. All-cause mortality (ACM): Up to ~ 5 1/2 years
All-cause mortality includes all enrolled participants. AEs include participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs.
|
0.98%
1/102 • Number of events 1 • For adverse events: Up to ~ 1 1/2 years. All-cause mortality (ACM): Up to ~ 5 1/2 years
All-cause mortality includes all enrolled participants. AEs include participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs.
|
|
Metabolism and nutrition disorders
Type 2 diabetes mellitus
|
0.00%
0/112 • For adverse events: Up to ~ 1 1/2 years. All-cause mortality (ACM): Up to ~ 5 1/2 years
All-cause mortality includes all enrolled participants. AEs include participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs.
|
0.98%
1/102 • Number of events 1 • For adverse events: Up to ~ 1 1/2 years. All-cause mortality (ACM): Up to ~ 5 1/2 years
All-cause mortality includes all enrolled participants. AEs include participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs.
|
|
Musculoskeletal and connective tissue disorders
Hypertrophic osteoarthropathy
|
0.00%
0/112 • For adverse events: Up to ~ 1 1/2 years. All-cause mortality (ACM): Up to ~ 5 1/2 years
All-cause mortality includes all enrolled participants. AEs include participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs.
|
0.98%
1/102 • Number of events 2 • For adverse events: Up to ~ 1 1/2 years. All-cause mortality (ACM): Up to ~ 5 1/2 years
All-cause mortality includes all enrolled participants. AEs include participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-Hodgkin's lymphoma
|
0.89%
1/112 • Number of events 1 • For adverse events: Up to ~ 1 1/2 years. All-cause mortality (ACM): Up to ~ 5 1/2 years
All-cause mortality includes all enrolled participants. AEs include participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs.
|
0.00%
0/102 • For adverse events: Up to ~ 1 1/2 years. All-cause mortality (ACM): Up to ~ 5 1/2 years
All-cause mortality includes all enrolled participants. AEs include participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs.
|
|
Nervous system disorders
Dizziness
|
0.89%
1/112 • Number of events 1 • For adverse events: Up to ~ 1 1/2 years. All-cause mortality (ACM): Up to ~ 5 1/2 years
All-cause mortality includes all enrolled participants. AEs include participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs.
|
0.00%
0/102 • For adverse events: Up to ~ 1 1/2 years. All-cause mortality (ACM): Up to ~ 5 1/2 years
All-cause mortality includes all enrolled participants. AEs include participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs.
|
|
Nervous system disorders
Hypertensive encephalopathy
|
0.00%
0/112 • For adverse events: Up to ~ 1 1/2 years. All-cause mortality (ACM): Up to ~ 5 1/2 years
All-cause mortality includes all enrolled participants. AEs include participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs.
|
0.98%
1/102 • Number of events 1 • For adverse events: Up to ~ 1 1/2 years. All-cause mortality (ACM): Up to ~ 5 1/2 years
All-cause mortality includes all enrolled participants. AEs include participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs.
|
|
Nervous system disorders
Ischaemic stroke
|
0.89%
1/112 • Number of events 1 • For adverse events: Up to ~ 1 1/2 years. All-cause mortality (ACM): Up to ~ 5 1/2 years
All-cause mortality includes all enrolled participants. AEs include participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs.
|
0.00%
0/102 • For adverse events: Up to ~ 1 1/2 years. All-cause mortality (ACM): Up to ~ 5 1/2 years
All-cause mortality includes all enrolled participants. AEs include participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs.
|
|
Nervous system disorders
Metabolic encephalopathy
|
0.89%
1/112 • Number of events 1 • For adverse events: Up to ~ 1 1/2 years. All-cause mortality (ACM): Up to ~ 5 1/2 years
All-cause mortality includes all enrolled participants. AEs include participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs.
|
0.00%
0/102 • For adverse events: Up to ~ 1 1/2 years. All-cause mortality (ACM): Up to ~ 5 1/2 years
All-cause mortality includes all enrolled participants. AEs include participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs.
|
|
Nervous system disorders
Syncope
|
0.89%
1/112 • Number of events 1 • For adverse events: Up to ~ 1 1/2 years. All-cause mortality (ACM): Up to ~ 5 1/2 years
All-cause mortality includes all enrolled participants. AEs include participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs.
|
0.00%
0/102 • For adverse events: Up to ~ 1 1/2 years. All-cause mortality (ACM): Up to ~ 5 1/2 years
All-cause mortality includes all enrolled participants. AEs include participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs.
|
|
Nervous system disorders
Transient ischaemic attack
|
0.89%
1/112 • Number of events 1 • For adverse events: Up to ~ 1 1/2 years. All-cause mortality (ACM): Up to ~ 5 1/2 years
All-cause mortality includes all enrolled participants. AEs include participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs.
|
0.98%
1/102 • Number of events 1 • For adverse events: Up to ~ 1 1/2 years. All-cause mortality (ACM): Up to ~ 5 1/2 years
All-cause mortality includes all enrolled participants. AEs include participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.89%
1/112 • Number of events 1 • For adverse events: Up to ~ 1 1/2 years. All-cause mortality (ACM): Up to ~ 5 1/2 years
All-cause mortality includes all enrolled participants. AEs include participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs.
|
2.0%
2/102 • Number of events 2 • For adverse events: Up to ~ 1 1/2 years. All-cause mortality (ACM): Up to ~ 5 1/2 years
All-cause mortality includes all enrolled participants. AEs include participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs.
|
|
Renal and urinary disorders
Chronic kidney disease
|
0.00%
0/112 • For adverse events: Up to ~ 1 1/2 years. All-cause mortality (ACM): Up to ~ 5 1/2 years
All-cause mortality includes all enrolled participants. AEs include participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs.
|
0.98%
1/102 • Number of events 1 • For adverse events: Up to ~ 1 1/2 years. All-cause mortality (ACM): Up to ~ 5 1/2 years
All-cause mortality includes all enrolled participants. AEs include participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs.
|
|
Renal and urinary disorders
Prerenal failure
|
0.00%
0/112 • For adverse events: Up to ~ 1 1/2 years. All-cause mortality (ACM): Up to ~ 5 1/2 years
All-cause mortality includes all enrolled participants. AEs include participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs.
|
0.98%
1/102 • Number of events 1 • For adverse events: Up to ~ 1 1/2 years. All-cause mortality (ACM): Up to ~ 5 1/2 years
All-cause mortality includes all enrolled participants. AEs include participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
0.89%
1/112 • Number of events 1 • For adverse events: Up to ~ 1 1/2 years. All-cause mortality (ACM): Up to ~ 5 1/2 years
All-cause mortality includes all enrolled participants. AEs include participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs.
|
0.00%
0/102 • For adverse events: Up to ~ 1 1/2 years. All-cause mortality (ACM): Up to ~ 5 1/2 years
All-cause mortality includes all enrolled participants. AEs include participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.89%
1/112 • Number of events 1 • For adverse events: Up to ~ 1 1/2 years. All-cause mortality (ACM): Up to ~ 5 1/2 years
All-cause mortality includes all enrolled participants. AEs include participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs.
|
0.98%
1/102 • Number of events 1 • For adverse events: Up to ~ 1 1/2 years. All-cause mortality (ACM): Up to ~ 5 1/2 years
All-cause mortality includes all enrolled participants. AEs include participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease
|
0.00%
0/112 • For adverse events: Up to ~ 1 1/2 years. All-cause mortality (ACM): Up to ~ 5 1/2 years
All-cause mortality includes all enrolled participants. AEs include participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs.
|
0.98%
1/102 • Number of events 1 • For adverse events: Up to ~ 1 1/2 years. All-cause mortality (ACM): Up to ~ 5 1/2 years
All-cause mortality includes all enrolled participants. AEs include participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.89%
1/112 • Number of events 1 • For adverse events: Up to ~ 1 1/2 years. All-cause mortality (ACM): Up to ~ 5 1/2 years
All-cause mortality includes all enrolled participants. AEs include participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs.
|
0.00%
0/102 • For adverse events: Up to ~ 1 1/2 years. All-cause mortality (ACM): Up to ~ 5 1/2 years
All-cause mortality includes all enrolled participants. AEs include participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
6.2%
7/112 • Number of events 7 • For adverse events: Up to ~ 1 1/2 years. All-cause mortality (ACM): Up to ~ 5 1/2 years
All-cause mortality includes all enrolled participants. AEs include participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs.
|
4.9%
5/102 • Number of events 5 • For adverse events: Up to ~ 1 1/2 years. All-cause mortality (ACM): Up to ~ 5 1/2 years
All-cause mortality includes all enrolled participants. AEs include participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.89%
1/112 • Number of events 1 • For adverse events: Up to ~ 1 1/2 years. All-cause mortality (ACM): Up to ~ 5 1/2 years
All-cause mortality includes all enrolled participants. AEs include participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs.
|
0.98%
1/102 • Number of events 1 • For adverse events: Up to ~ 1 1/2 years. All-cause mortality (ACM): Up to ~ 5 1/2 years
All-cause mortality includes all enrolled participants. AEs include participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.89%
1/112 • Number of events 1 • For adverse events: Up to ~ 1 1/2 years. All-cause mortality (ACM): Up to ~ 5 1/2 years
All-cause mortality includes all enrolled participants. AEs include participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs.
|
3.9%
4/102 • Number of events 4 • For adverse events: Up to ~ 1 1/2 years. All-cause mortality (ACM): Up to ~ 5 1/2 years
All-cause mortality includes all enrolled participants. AEs include participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary haemorrhage
|
0.89%
1/112 • Number of events 1 • For adverse events: Up to ~ 1 1/2 years. All-cause mortality (ACM): Up to ~ 5 1/2 years
All-cause mortality includes all enrolled participants. AEs include participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs.
|
0.00%
0/102 • For adverse events: Up to ~ 1 1/2 years. All-cause mortality (ACM): Up to ~ 5 1/2 years
All-cause mortality includes all enrolled participants. AEs include participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.89%
1/112 • Number of events 1 • For adverse events: Up to ~ 1 1/2 years. All-cause mortality (ACM): Up to ~ 5 1/2 years
All-cause mortality includes all enrolled participants. AEs include participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs.
|
2.0%
2/102 • Number of events 2 • For adverse events: Up to ~ 1 1/2 years. All-cause mortality (ACM): Up to ~ 5 1/2 years
All-cause mortality includes all enrolled participants. AEs include participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
1.8%
2/112 • Number of events 2 • For adverse events: Up to ~ 1 1/2 years. All-cause mortality (ACM): Up to ~ 5 1/2 years
All-cause mortality includes all enrolled participants. AEs include participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs.
|
0.00%
0/102 • For adverse events: Up to ~ 1 1/2 years. All-cause mortality (ACM): Up to ~ 5 1/2 years
All-cause mortality includes all enrolled participants. AEs include participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs.
|
|
Skin and subcutaneous tissue disorders
Toxic epidermal necrolysis
|
0.89%
1/112 • Number of events 1 • For adverse events: Up to ~ 1 1/2 years. All-cause mortality (ACM): Up to ~ 5 1/2 years
All-cause mortality includes all enrolled participants. AEs include participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs.
|
0.00%
0/102 • For adverse events: Up to ~ 1 1/2 years. All-cause mortality (ACM): Up to ~ 5 1/2 years
All-cause mortality includes all enrolled participants. AEs include participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs.
|
|
Vascular disorders
Arterial occlusive disease
|
0.00%
0/112 • For adverse events: Up to ~ 1 1/2 years. All-cause mortality (ACM): Up to ~ 5 1/2 years
All-cause mortality includes all enrolled participants. AEs include participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs.
|
0.98%
1/102 • Number of events 1 • For adverse events: Up to ~ 1 1/2 years. All-cause mortality (ACM): Up to ~ 5 1/2 years
All-cause mortality includes all enrolled participants. AEs include participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs.
|
|
Vascular disorders
Deep vein thrombosis
|
0.89%
1/112 • Number of events 1 • For adverse events: Up to ~ 1 1/2 years. All-cause mortality (ACM): Up to ~ 5 1/2 years
All-cause mortality includes all enrolled participants. AEs include participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs.
|
0.00%
0/102 • For adverse events: Up to ~ 1 1/2 years. All-cause mortality (ACM): Up to ~ 5 1/2 years
All-cause mortality includes all enrolled participants. AEs include participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs.
|
|
Vascular disorders
Embolism
|
0.00%
0/112 • For adverse events: Up to ~ 1 1/2 years. All-cause mortality (ACM): Up to ~ 5 1/2 years
All-cause mortality includes all enrolled participants. AEs include participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs.
|
0.98%
1/102 • Number of events 1 • For adverse events: Up to ~ 1 1/2 years. All-cause mortality (ACM): Up to ~ 5 1/2 years
All-cause mortality includes all enrolled participants. AEs include participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs.
|
|
Vascular disorders
Thrombophlebitis
|
0.89%
1/112 • Number of events 1 • For adverse events: Up to ~ 1 1/2 years. All-cause mortality (ACM): Up to ~ 5 1/2 years
All-cause mortality includes all enrolled participants. AEs include participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs.
|
0.00%
0/102 • For adverse events: Up to ~ 1 1/2 years. All-cause mortality (ACM): Up to ~ 5 1/2 years
All-cause mortality includes all enrolled participants. AEs include participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs.
|
Other adverse events
| Measure |
Pembrolizumab + cCRT + Paclitaxel + Carboplatin
n=112 participants at risk
Participants received 1 cycle of carboplatin area under the curve (AUC) 6 mg/mL/min with paclitaxel 200 mg/m\^2 and pembrolizumab 200 mg on Day 1. Approximately 3 weeks later, participants received carboplatin AUC 2 mg/mL/min with paclitaxel 45 mg/ m\^2 administered weekly for 6 weeks along with 2 cycles of pembrolizumab 200 mg administered every 3 weeks (Q3W) in conjunction with standard thoracic radiotherapy (TRT) (60 Gray \[Gy\] in 2 Gy fractions administered 5 days per week for 6 weeks). Participants then received 14 additional cycles of pembrolizumab 200 mg administered Q3W. 1 cycle=21 days.
|
Pembrolizumab + cCRT + Pemetrexed + Cisplatin
n=102 participants at risk
Participants received 3 cycles of cisplatin 75 mg/m\^2 with pemetrexed 500 mg/m\^2 and pembrolizumab 200 mg on Day 1 of each cycle. Treatment was given in conjunction with standard TRT (60 Gy in 2 Gy fractions administered 5 days per week for 6 weeks) in cycles 2 and 3. Participants then received 14 additional cycles of pembrolizumab 200 mg administered Q3W. 1 cycle=21 days.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
39.3%
44/112 • Number of events 53 • For adverse events: Up to ~ 1 1/2 years. All-cause mortality (ACM): Up to ~ 5 1/2 years
All-cause mortality includes all enrolled participants. AEs include participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs.
|
32.4%
33/102 • Number of events 40 • For adverse events: Up to ~ 1 1/2 years. All-cause mortality (ACM): Up to ~ 5 1/2 years
All-cause mortality includes all enrolled participants. AEs include participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs.
|
|
Blood and lymphatic system disorders
Leukopenia
|
13.4%
15/112 • Number of events 29 • For adverse events: Up to ~ 1 1/2 years. All-cause mortality (ACM): Up to ~ 5 1/2 years
All-cause mortality includes all enrolled participants. AEs include participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs.
|
7.8%
8/102 • Number of events 11 • For adverse events: Up to ~ 1 1/2 years. All-cause mortality (ACM): Up to ~ 5 1/2 years
All-cause mortality includes all enrolled participants. AEs include participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs.
|
|
Blood and lymphatic system disorders
Lymphopenia
|
9.8%
11/112 • Number of events 13 • For adverse events: Up to ~ 1 1/2 years. All-cause mortality (ACM): Up to ~ 5 1/2 years
All-cause mortality includes all enrolled participants. AEs include participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs.
|
11.8%
12/102 • Number of events 16 • For adverse events: Up to ~ 1 1/2 years. All-cause mortality (ACM): Up to ~ 5 1/2 years
All-cause mortality includes all enrolled participants. AEs include participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs.
|
|
Blood and lymphatic system disorders
Neutropenia
|
28.6%
32/112 • Number of events 50 • For adverse events: Up to ~ 1 1/2 years. All-cause mortality (ACM): Up to ~ 5 1/2 years
All-cause mortality includes all enrolled participants. AEs include participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs.
|
22.5%
23/102 • Number of events 29 • For adverse events: Up to ~ 1 1/2 years. All-cause mortality (ACM): Up to ~ 5 1/2 years
All-cause mortality includes all enrolled participants. AEs include participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
15.2%
17/112 • Number of events 22 • For adverse events: Up to ~ 1 1/2 years. All-cause mortality (ACM): Up to ~ 5 1/2 years
All-cause mortality includes all enrolled participants. AEs include participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs.
|
2.9%
3/102 • Number of events 3 • For adverse events: Up to ~ 1 1/2 years. All-cause mortality (ACM): Up to ~ 5 1/2 years
All-cause mortality includes all enrolled participants. AEs include participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs.
|
|
Cardiac disorders
Tachycardia
|
7.1%
8/112 • Number of events 9 • For adverse events: Up to ~ 1 1/2 years. All-cause mortality (ACM): Up to ~ 5 1/2 years
All-cause mortality includes all enrolled participants. AEs include participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs.
|
2.9%
3/102 • Number of events 3 • For adverse events: Up to ~ 1 1/2 years. All-cause mortality (ACM): Up to ~ 5 1/2 years
All-cause mortality includes all enrolled participants. AEs include participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs.
|
|
Ear and labyrinth disorders
Tinnitus
|
0.89%
1/112 • Number of events 1 • For adverse events: Up to ~ 1 1/2 years. All-cause mortality (ACM): Up to ~ 5 1/2 years
All-cause mortality includes all enrolled participants. AEs include participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs.
|
10.8%
11/102 • Number of events 13 • For adverse events: Up to ~ 1 1/2 years. All-cause mortality (ACM): Up to ~ 5 1/2 years
All-cause mortality includes all enrolled participants. AEs include participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs.
|
|
Ear and labyrinth disorders
Vertigo
|
5.4%
6/112 • Number of events 6 • For adverse events: Up to ~ 1 1/2 years. All-cause mortality (ACM): Up to ~ 5 1/2 years
All-cause mortality includes all enrolled participants. AEs include participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs.
|
2.9%
3/102 • Number of events 3 • For adverse events: Up to ~ 1 1/2 years. All-cause mortality (ACM): Up to ~ 5 1/2 years
All-cause mortality includes all enrolled participants. AEs include participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs.
|
|
Endocrine disorders
Hyperthyroidism
|
8.0%
9/112 • Number of events 9 • For adverse events: Up to ~ 1 1/2 years. All-cause mortality (ACM): Up to ~ 5 1/2 years
All-cause mortality includes all enrolled participants. AEs include participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs.
|
7.8%
8/102 • Number of events 9 • For adverse events: Up to ~ 1 1/2 years. All-cause mortality (ACM): Up to ~ 5 1/2 years
All-cause mortality includes all enrolled participants. AEs include participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs.
|
|
Endocrine disorders
Hypothyroidism
|
16.1%
18/112 • Number of events 19 • For adverse events: Up to ~ 1 1/2 years. All-cause mortality (ACM): Up to ~ 5 1/2 years
All-cause mortality includes all enrolled participants. AEs include participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs.
|
14.7%
15/102 • Number of events 16 • For adverse events: Up to ~ 1 1/2 years. All-cause mortality (ACM): Up to ~ 5 1/2 years
All-cause mortality includes all enrolled participants. AEs include participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs.
|
|
Gastrointestinal disorders
Abdominal pain
|
7.1%
8/112 • Number of events 8 • For adverse events: Up to ~ 1 1/2 years. All-cause mortality (ACM): Up to ~ 5 1/2 years
All-cause mortality includes all enrolled participants. AEs include participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs.
|
5.9%
6/102 • Number of events 7 • For adverse events: Up to ~ 1 1/2 years. All-cause mortality (ACM): Up to ~ 5 1/2 years
All-cause mortality includes all enrolled participants. AEs include participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
2.7%
3/112 • Number of events 4 • For adverse events: Up to ~ 1 1/2 years. All-cause mortality (ACM): Up to ~ 5 1/2 years
All-cause mortality includes all enrolled participants. AEs include participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs.
|
6.9%
7/102 • Number of events 7 • For adverse events: Up to ~ 1 1/2 years. All-cause mortality (ACM): Up to ~ 5 1/2 years
All-cause mortality includes all enrolled participants. AEs include participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs.
|
|
Gastrointestinal disorders
Constipation
|
21.4%
24/112 • Number of events 28 • For adverse events: Up to ~ 1 1/2 years. All-cause mortality (ACM): Up to ~ 5 1/2 years
All-cause mortality includes all enrolled participants. AEs include participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs.
|
26.5%
27/102 • Number of events 32 • For adverse events: Up to ~ 1 1/2 years. All-cause mortality (ACM): Up to ~ 5 1/2 years
All-cause mortality includes all enrolled participants. AEs include participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs.
|
|
Gastrointestinal disorders
Diarrhoea
|
24.1%
27/112 • Number of events 37 • For adverse events: Up to ~ 1 1/2 years. All-cause mortality (ACM): Up to ~ 5 1/2 years
All-cause mortality includes all enrolled participants. AEs include participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs.
|
21.6%
22/102 • Number of events 27 • For adverse events: Up to ~ 1 1/2 years. All-cause mortality (ACM): Up to ~ 5 1/2 years
All-cause mortality includes all enrolled participants. AEs include participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs.
|
|
Gastrointestinal disorders
Dyspepsia
|
13.4%
15/112 • Number of events 17 • For adverse events: Up to ~ 1 1/2 years. All-cause mortality (ACM): Up to ~ 5 1/2 years
All-cause mortality includes all enrolled participants. AEs include participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs.
|
6.9%
7/102 • Number of events 9 • For adverse events: Up to ~ 1 1/2 years. All-cause mortality (ACM): Up to ~ 5 1/2 years
All-cause mortality includes all enrolled participants. AEs include participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs.
|
|
Gastrointestinal disorders
Dysphagia
|
24.1%
27/112 • Number of events 31 • For adverse events: Up to ~ 1 1/2 years. All-cause mortality (ACM): Up to ~ 5 1/2 years
All-cause mortality includes all enrolled participants. AEs include participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs.
|
15.7%
16/102 • Number of events 16 • For adverse events: Up to ~ 1 1/2 years. All-cause mortality (ACM): Up to ~ 5 1/2 years
All-cause mortality includes all enrolled participants. AEs include participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
4.5%
5/112 • Number of events 5 • For adverse events: Up to ~ 1 1/2 years. All-cause mortality (ACM): Up to ~ 5 1/2 years
All-cause mortality includes all enrolled participants. AEs include participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs.
|
5.9%
6/102 • Number of events 6 • For adverse events: Up to ~ 1 1/2 years. All-cause mortality (ACM): Up to ~ 5 1/2 years
All-cause mortality includes all enrolled participants. AEs include participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs.
|
|
Gastrointestinal disorders
Nausea
|
25.0%
28/112 • Number of events 36 • For adverse events: Up to ~ 1 1/2 years. All-cause mortality (ACM): Up to ~ 5 1/2 years
All-cause mortality includes all enrolled participants. AEs include participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs.
|
52.0%
53/102 • Number of events 77 • For adverse events: Up to ~ 1 1/2 years. All-cause mortality (ACM): Up to ~ 5 1/2 years
All-cause mortality includes all enrolled participants. AEs include participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs.
|
|
Gastrointestinal disorders
Odynophagia
|
9.8%
11/112 • Number of events 14 • For adverse events: Up to ~ 1 1/2 years. All-cause mortality (ACM): Up to ~ 5 1/2 years
All-cause mortality includes all enrolled participants. AEs include participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs.
|
4.9%
5/102 • Number of events 5 • For adverse events: Up to ~ 1 1/2 years. All-cause mortality (ACM): Up to ~ 5 1/2 years
All-cause mortality includes all enrolled participants. AEs include participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs.
|
|
Gastrointestinal disorders
Oesophagitis
|
15.2%
17/112 • Number of events 20 • For adverse events: Up to ~ 1 1/2 years. All-cause mortality (ACM): Up to ~ 5 1/2 years
All-cause mortality includes all enrolled participants. AEs include participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs.
|
23.5%
24/102 • Number of events 25 • For adverse events: Up to ~ 1 1/2 years. All-cause mortality (ACM): Up to ~ 5 1/2 years
All-cause mortality includes all enrolled participants. AEs include participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs.
|
|
Gastrointestinal disorders
Stomatitis
|
6.2%
7/112 • Number of events 8 • For adverse events: Up to ~ 1 1/2 years. All-cause mortality (ACM): Up to ~ 5 1/2 years
All-cause mortality includes all enrolled participants. AEs include participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs.
|
5.9%
6/102 • Number of events 7 • For adverse events: Up to ~ 1 1/2 years. All-cause mortality (ACM): Up to ~ 5 1/2 years
All-cause mortality includes all enrolled participants. AEs include participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs.
|
|
Gastrointestinal disorders
Vomiting
|
8.9%
10/112 • Number of events 11 • For adverse events: Up to ~ 1 1/2 years. All-cause mortality (ACM): Up to ~ 5 1/2 years
All-cause mortality includes all enrolled participants. AEs include participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs.
|
19.6%
20/102 • Number of events 23 • For adverse events: Up to ~ 1 1/2 years. All-cause mortality (ACM): Up to ~ 5 1/2 years
All-cause mortality includes all enrolled participants. AEs include participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs.
|
|
General disorders
Asthenia
|
17.9%
20/112 • Number of events 26 • For adverse events: Up to ~ 1 1/2 years. All-cause mortality (ACM): Up to ~ 5 1/2 years
All-cause mortality includes all enrolled participants. AEs include participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs.
|
40.2%
41/102 • Number of events 60 • For adverse events: Up to ~ 1 1/2 years. All-cause mortality (ACM): Up to ~ 5 1/2 years
All-cause mortality includes all enrolled participants. AEs include participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs.
|
|
General disorders
Chest pain
|
6.2%
7/112 • Number of events 7 • For adverse events: Up to ~ 1 1/2 years. All-cause mortality (ACM): Up to ~ 5 1/2 years
All-cause mortality includes all enrolled participants. AEs include participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs.
|
9.8%
10/102 • Number of events 12 • For adverse events: Up to ~ 1 1/2 years. All-cause mortality (ACM): Up to ~ 5 1/2 years
All-cause mortality includes all enrolled participants. AEs include participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs.
|
|
General disorders
Chills
|
5.4%
6/112 • Number of events 6 • For adverse events: Up to ~ 1 1/2 years. All-cause mortality (ACM): Up to ~ 5 1/2 years
All-cause mortality includes all enrolled participants. AEs include participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs.
|
2.9%
3/102 • Number of events 3 • For adverse events: Up to ~ 1 1/2 years. All-cause mortality (ACM): Up to ~ 5 1/2 years
All-cause mortality includes all enrolled participants. AEs include participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs.
|
|
General disorders
Fatigue
|
34.8%
39/112 • Number of events 49 • For adverse events: Up to ~ 1 1/2 years. All-cause mortality (ACM): Up to ~ 5 1/2 years
All-cause mortality includes all enrolled participants. AEs include participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs.
|
32.4%
33/102 • Number of events 38 • For adverse events: Up to ~ 1 1/2 years. All-cause mortality (ACM): Up to ~ 5 1/2 years
All-cause mortality includes all enrolled participants. AEs include participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs.
|
|
General disorders
Mucosal inflammation
|
5.4%
6/112 • Number of events 6 • For adverse events: Up to ~ 1 1/2 years. All-cause mortality (ACM): Up to ~ 5 1/2 years
All-cause mortality includes all enrolled participants. AEs include participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs.
|
9.8%
10/102 • Number of events 10 • For adverse events: Up to ~ 1 1/2 years. All-cause mortality (ACM): Up to ~ 5 1/2 years
All-cause mortality includes all enrolled participants. AEs include participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs.
|
|
General disorders
Pyrexia
|
19.6%
22/112 • Number of events 30 • For adverse events: Up to ~ 1 1/2 years. All-cause mortality (ACM): Up to ~ 5 1/2 years
All-cause mortality includes all enrolled participants. AEs include participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs.
|
12.7%
13/102 • Number of events 14 • For adverse events: Up to ~ 1 1/2 years. All-cause mortality (ACM): Up to ~ 5 1/2 years
All-cause mortality includes all enrolled participants. AEs include participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs.
|
|
Infections and infestations
Pneumonia
|
10.7%
12/112 • Number of events 14 • For adverse events: Up to ~ 1 1/2 years. All-cause mortality (ACM): Up to ~ 5 1/2 years
All-cause mortality includes all enrolled participants. AEs include participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs.
|
4.9%
5/102 • Number of events 5 • For adverse events: Up to ~ 1 1/2 years. All-cause mortality (ACM): Up to ~ 5 1/2 years
All-cause mortality includes all enrolled participants. AEs include participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs.
|
|
Infections and infestations
Upper respiratory tract infection
|
7.1%
8/112 • Number of events 9 • For adverse events: Up to ~ 1 1/2 years. All-cause mortality (ACM): Up to ~ 5 1/2 years
All-cause mortality includes all enrolled participants. AEs include participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs.
|
4.9%
5/102 • Number of events 5 • For adverse events: Up to ~ 1 1/2 years. All-cause mortality (ACM): Up to ~ 5 1/2 years
All-cause mortality includes all enrolled participants. AEs include participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs.
|
|
Infections and infestations
Urinary tract infection
|
6.2%
7/112 • Number of events 8 • For adverse events: Up to ~ 1 1/2 years. All-cause mortality (ACM): Up to ~ 5 1/2 years
All-cause mortality includes all enrolled participants. AEs include participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs.
|
2.0%
2/102 • Number of events 2 • For adverse events: Up to ~ 1 1/2 years. All-cause mortality (ACM): Up to ~ 5 1/2 years
All-cause mortality includes all enrolled participants. AEs include participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs.
|
|
Injury, poisoning and procedural complications
Radiation oesophagitis
|
11.6%
13/112 • Number of events 13 • For adverse events: Up to ~ 1 1/2 years. All-cause mortality (ACM): Up to ~ 5 1/2 years
All-cause mortality includes all enrolled participants. AEs include participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs.
|
13.7%
14/102 • Number of events 15 • For adverse events: Up to ~ 1 1/2 years. All-cause mortality (ACM): Up to ~ 5 1/2 years
All-cause mortality includes all enrolled participants. AEs include participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs.
|
|
Injury, poisoning and procedural complications
Radiation pneumonitis
|
16.1%
18/112 • Number of events 18 • For adverse events: Up to ~ 1 1/2 years. All-cause mortality (ACM): Up to ~ 5 1/2 years
All-cause mortality includes all enrolled participants. AEs include participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs.
|
11.8%
12/102 • Number of events 12 • For adverse events: Up to ~ 1 1/2 years. All-cause mortality (ACM): Up to ~ 5 1/2 years
All-cause mortality includes all enrolled participants. AEs include participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs.
|
|
Injury, poisoning and procedural complications
Radiation skin injury
|
4.5%
5/112 • Number of events 5 • For adverse events: Up to ~ 1 1/2 years. All-cause mortality (ACM): Up to ~ 5 1/2 years
All-cause mortality includes all enrolled participants. AEs include participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs.
|
7.8%
8/102 • Number of events 8 • For adverse events: Up to ~ 1 1/2 years. All-cause mortality (ACM): Up to ~ 5 1/2 years
All-cause mortality includes all enrolled participants. AEs include participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs.
|
|
Investigations
Alanine aminotransferase increased
|
7.1%
8/112 • Number of events 9 • For adverse events: Up to ~ 1 1/2 years. All-cause mortality (ACM): Up to ~ 5 1/2 years
All-cause mortality includes all enrolled participants. AEs include participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs.
|
7.8%
8/102 • Number of events 9 • For adverse events: Up to ~ 1 1/2 years. All-cause mortality (ACM): Up to ~ 5 1/2 years
All-cause mortality includes all enrolled participants. AEs include participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs.
|
|
Investigations
Aspartate aminotransferase increased
|
7.1%
8/112 • Number of events 8 • For adverse events: Up to ~ 1 1/2 years. All-cause mortality (ACM): Up to ~ 5 1/2 years
All-cause mortality includes all enrolled participants. AEs include participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs.
|
3.9%
4/102 • Number of events 6 • For adverse events: Up to ~ 1 1/2 years. All-cause mortality (ACM): Up to ~ 5 1/2 years
All-cause mortality includes all enrolled participants. AEs include participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs.
|
|
Investigations
Blood creatinine increased
|
5.4%
6/112 • Number of events 7 • For adverse events: Up to ~ 1 1/2 years. All-cause mortality (ACM): Up to ~ 5 1/2 years
All-cause mortality includes all enrolled participants. AEs include participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs.
|
12.7%
13/102 • Number of events 17 • For adverse events: Up to ~ 1 1/2 years. All-cause mortality (ACM): Up to ~ 5 1/2 years
All-cause mortality includes all enrolled participants. AEs include participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs.
|
|
Investigations
Blood urea increased
|
2.7%
3/112 • Number of events 3 • For adverse events: Up to ~ 1 1/2 years. All-cause mortality (ACM): Up to ~ 5 1/2 years
All-cause mortality includes all enrolled participants. AEs include participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs.
|
6.9%
7/102 • Number of events 9 • For adverse events: Up to ~ 1 1/2 years. All-cause mortality (ACM): Up to ~ 5 1/2 years
All-cause mortality includes all enrolled participants. AEs include participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs.
|
|
Investigations
Lymphocyte count decreased
|
9.8%
11/112 • Number of events 16 • For adverse events: Up to ~ 1 1/2 years. All-cause mortality (ACM): Up to ~ 5 1/2 years
All-cause mortality includes all enrolled participants. AEs include participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs.
|
7.8%
8/102 • Number of events 12 • For adverse events: Up to ~ 1 1/2 years. All-cause mortality (ACM): Up to ~ 5 1/2 years
All-cause mortality includes all enrolled participants. AEs include participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs.
|
|
Investigations
Neutrophil count decreased
|
17.0%
19/112 • Number of events 23 • For adverse events: Up to ~ 1 1/2 years. All-cause mortality (ACM): Up to ~ 5 1/2 years
All-cause mortality includes all enrolled participants. AEs include participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs.
|
12.7%
13/102 • Number of events 15 • For adverse events: Up to ~ 1 1/2 years. All-cause mortality (ACM): Up to ~ 5 1/2 years
All-cause mortality includes all enrolled participants. AEs include participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs.
|
|
Investigations
Platelet count decreased
|
14.3%
16/112 • Number of events 18 • For adverse events: Up to ~ 1 1/2 years. All-cause mortality (ACM): Up to ~ 5 1/2 years
All-cause mortality includes all enrolled participants. AEs include participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs.
|
8.8%
9/102 • Number of events 15 • For adverse events: Up to ~ 1 1/2 years. All-cause mortality (ACM): Up to ~ 5 1/2 years
All-cause mortality includes all enrolled participants. AEs include participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs.
|
|
Investigations
Weight decreased
|
14.3%
16/112 • Number of events 16 • For adverse events: Up to ~ 1 1/2 years. All-cause mortality (ACM): Up to ~ 5 1/2 years
All-cause mortality includes all enrolled participants. AEs include participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs.
|
13.7%
14/102 • Number of events 14 • For adverse events: Up to ~ 1 1/2 years. All-cause mortality (ACM): Up to ~ 5 1/2 years
All-cause mortality includes all enrolled participants. AEs include participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs.
|
|
Investigations
White blood cell count decreased
|
9.8%
11/112 • Number of events 17 • For adverse events: Up to ~ 1 1/2 years. All-cause mortality (ACM): Up to ~ 5 1/2 years
All-cause mortality includes all enrolled participants. AEs include participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs.
|
10.8%
11/102 • Number of events 19 • For adverse events: Up to ~ 1 1/2 years. All-cause mortality (ACM): Up to ~ 5 1/2 years
All-cause mortality includes all enrolled participants. AEs include participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
21.4%
24/112 • Number of events 29 • For adverse events: Up to ~ 1 1/2 years. All-cause mortality (ACM): Up to ~ 5 1/2 years
All-cause mortality includes all enrolled participants. AEs include participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs.
|
29.4%
30/102 • Number of events 34 • For adverse events: Up to ~ 1 1/2 years. All-cause mortality (ACM): Up to ~ 5 1/2 years
All-cause mortality includes all enrolled participants. AEs include participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs.
|
|
Metabolism and nutrition disorders
Dehydration
|
4.5%
5/112 • Number of events 6 • For adverse events: Up to ~ 1 1/2 years. All-cause mortality (ACM): Up to ~ 5 1/2 years
All-cause mortality includes all enrolled participants. AEs include participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs.
|
5.9%
6/102 • Number of events 7 • For adverse events: Up to ~ 1 1/2 years. All-cause mortality (ACM): Up to ~ 5 1/2 years
All-cause mortality includes all enrolled participants. AEs include participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
8.0%
9/112 • Number of events 13 • For adverse events: Up to ~ 1 1/2 years. All-cause mortality (ACM): Up to ~ 5 1/2 years
All-cause mortality includes all enrolled participants. AEs include participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs.
|
5.9%
6/102 • Number of events 11 • For adverse events: Up to ~ 1 1/2 years. All-cause mortality (ACM): Up to ~ 5 1/2 years
All-cause mortality includes all enrolled participants. AEs include participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
5.4%
6/112 • Number of events 8 • For adverse events: Up to ~ 1 1/2 years. All-cause mortality (ACM): Up to ~ 5 1/2 years
All-cause mortality includes all enrolled participants. AEs include participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs.
|
2.0%
2/102 • Number of events 2 • For adverse events: Up to ~ 1 1/2 years. All-cause mortality (ACM): Up to ~ 5 1/2 years
All-cause mortality includes all enrolled participants. AEs include participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
8.0%
9/112 • Number of events 10 • For adverse events: Up to ~ 1 1/2 years. All-cause mortality (ACM): Up to ~ 5 1/2 years
All-cause mortality includes all enrolled participants. AEs include participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs.
|
5.9%
6/102 • Number of events 8 • For adverse events: Up to ~ 1 1/2 years. All-cause mortality (ACM): Up to ~ 5 1/2 years
All-cause mortality includes all enrolled participants. AEs include participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
8.9%
10/112 • Number of events 15 • For adverse events: Up to ~ 1 1/2 years. All-cause mortality (ACM): Up to ~ 5 1/2 years
All-cause mortality includes all enrolled participants. AEs include participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs.
|
2.9%
3/102 • Number of events 5 • For adverse events: Up to ~ 1 1/2 years. All-cause mortality (ACM): Up to ~ 5 1/2 years
All-cause mortality includes all enrolled participants. AEs include participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
15.2%
17/112 • Number of events 22 • For adverse events: Up to ~ 1 1/2 years. All-cause mortality (ACM): Up to ~ 5 1/2 years
All-cause mortality includes all enrolled participants. AEs include participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs.
|
10.8%
11/102 • Number of events 13 • For adverse events: Up to ~ 1 1/2 years. All-cause mortality (ACM): Up to ~ 5 1/2 years
All-cause mortality includes all enrolled participants. AEs include participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
5.4%
6/112 • Number of events 8 • For adverse events: Up to ~ 1 1/2 years. All-cause mortality (ACM): Up to ~ 5 1/2 years
All-cause mortality includes all enrolled participants. AEs include participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs.
|
4.9%
5/102 • Number of events 7 • For adverse events: Up to ~ 1 1/2 years. All-cause mortality (ACM): Up to ~ 5 1/2 years
All-cause mortality includes all enrolled participants. AEs include participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
5.4%
6/112 • Number of events 8 • For adverse events: Up to ~ 1 1/2 years. All-cause mortality (ACM): Up to ~ 5 1/2 years
All-cause mortality includes all enrolled participants. AEs include participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs.
|
2.9%
3/102 • Number of events 3 • For adverse events: Up to ~ 1 1/2 years. All-cause mortality (ACM): Up to ~ 5 1/2 years
All-cause mortality includes all enrolled participants. AEs include participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
9.8%
11/112 • Number of events 14 • For adverse events: Up to ~ 1 1/2 years. All-cause mortality (ACM): Up to ~ 5 1/2 years
All-cause mortality includes all enrolled participants. AEs include participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs.
|
7.8%
8/102 • Number of events 9 • For adverse events: Up to ~ 1 1/2 years. All-cause mortality (ACM): Up to ~ 5 1/2 years
All-cause mortality includes all enrolled participants. AEs include participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs.
|
|
Nervous system disorders
Dizziness
|
8.0%
9/112 • Number of events 11 • For adverse events: Up to ~ 1 1/2 years. All-cause mortality (ACM): Up to ~ 5 1/2 years
All-cause mortality includes all enrolled participants. AEs include participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs.
|
8.8%
9/102 • Number of events 11 • For adverse events: Up to ~ 1 1/2 years. All-cause mortality (ACM): Up to ~ 5 1/2 years
All-cause mortality includes all enrolled participants. AEs include participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs.
|
|
Nervous system disorders
Dysgeusia
|
8.9%
10/112 • Number of events 11 • For adverse events: Up to ~ 1 1/2 years. All-cause mortality (ACM): Up to ~ 5 1/2 years
All-cause mortality includes all enrolled participants. AEs include participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs.
|
7.8%
8/102 • Number of events 8 • For adverse events: Up to ~ 1 1/2 years. All-cause mortality (ACM): Up to ~ 5 1/2 years
All-cause mortality includes all enrolled participants. AEs include participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs.
|
|
Nervous system disorders
Headache
|
8.0%
9/112 • Number of events 9 • For adverse events: Up to ~ 1 1/2 years. All-cause mortality (ACM): Up to ~ 5 1/2 years
All-cause mortality includes all enrolled participants. AEs include participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs.
|
12.7%
13/102 • Number of events 18 • For adverse events: Up to ~ 1 1/2 years. All-cause mortality (ACM): Up to ~ 5 1/2 years
All-cause mortality includes all enrolled participants. AEs include participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs.
|
|
Nervous system disorders
Neuropathy peripheral
|
13.4%
15/112 • Number of events 15 • For adverse events: Up to ~ 1 1/2 years. All-cause mortality (ACM): Up to ~ 5 1/2 years
All-cause mortality includes all enrolled participants. AEs include participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs.
|
4.9%
5/102 • Number of events 5 • For adverse events: Up to ~ 1 1/2 years. All-cause mortality (ACM): Up to ~ 5 1/2 years
All-cause mortality includes all enrolled participants. AEs include participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs.
|
|
Nervous system disorders
Paraesthesia
|
5.4%
6/112 • Number of events 7 • For adverse events: Up to ~ 1 1/2 years. All-cause mortality (ACM): Up to ~ 5 1/2 years
All-cause mortality includes all enrolled participants. AEs include participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs.
|
3.9%
4/102 • Number of events 4 • For adverse events: Up to ~ 1 1/2 years. All-cause mortality (ACM): Up to ~ 5 1/2 years
All-cause mortality includes all enrolled participants. AEs include participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
10.7%
12/112 • Number of events 13 • For adverse events: Up to ~ 1 1/2 years. All-cause mortality (ACM): Up to ~ 5 1/2 years
All-cause mortality includes all enrolled participants. AEs include participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs.
|
0.98%
1/102 • Number of events 1 • For adverse events: Up to ~ 1 1/2 years. All-cause mortality (ACM): Up to ~ 5 1/2 years
All-cause mortality includes all enrolled participants. AEs include participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs.
|
|
Psychiatric disorders
Insomnia
|
16.1%
18/112 • Number of events 21 • For adverse events: Up to ~ 1 1/2 years. All-cause mortality (ACM): Up to ~ 5 1/2 years
All-cause mortality includes all enrolled participants. AEs include participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs.
|
6.9%
7/102 • Number of events 8 • For adverse events: Up to ~ 1 1/2 years. All-cause mortality (ACM): Up to ~ 5 1/2 years
All-cause mortality includes all enrolled participants. AEs include participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
27.7%
31/112 • Number of events 36 • For adverse events: Up to ~ 1 1/2 years. All-cause mortality (ACM): Up to ~ 5 1/2 years
All-cause mortality includes all enrolled participants. AEs include participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs.
|
28.4%
29/102 • Number of events 37 • For adverse events: Up to ~ 1 1/2 years. All-cause mortality (ACM): Up to ~ 5 1/2 years
All-cause mortality includes all enrolled participants. AEs include participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
21.4%
24/112 • Number of events 28 • For adverse events: Up to ~ 1 1/2 years. All-cause mortality (ACM): Up to ~ 5 1/2 years
All-cause mortality includes all enrolled participants. AEs include participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs.
|
17.6%
18/102 • Number of events 19 • For adverse events: Up to ~ 1 1/2 years. All-cause mortality (ACM): Up to ~ 5 1/2 years
All-cause mortality includes all enrolled participants. AEs include participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
1.8%
2/112 • Number of events 2 • For adverse events: Up to ~ 1 1/2 years. All-cause mortality (ACM): Up to ~ 5 1/2 years
All-cause mortality includes all enrolled participants. AEs include participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs.
|
7.8%
8/102 • Number of events 8 • For adverse events: Up to ~ 1 1/2 years. All-cause mortality (ACM): Up to ~ 5 1/2 years
All-cause mortality includes all enrolled participants. AEs include participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
7.1%
8/112 • Number of events 8 • For adverse events: Up to ~ 1 1/2 years. All-cause mortality (ACM): Up to ~ 5 1/2 years
All-cause mortality includes all enrolled participants. AEs include participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs.
|
2.0%
2/102 • Number of events 2 • For adverse events: Up to ~ 1 1/2 years. All-cause mortality (ACM): Up to ~ 5 1/2 years
All-cause mortality includes all enrolled participants. AEs include participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
14.3%
16/112 • Number of events 19 • For adverse events: Up to ~ 1 1/2 years. All-cause mortality (ACM): Up to ~ 5 1/2 years
All-cause mortality includes all enrolled participants. AEs include participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs.
|
16.7%
17/102 • Number of events 19 • For adverse events: Up to ~ 1 1/2 years. All-cause mortality (ACM): Up to ~ 5 1/2 years
All-cause mortality includes all enrolled participants. AEs include participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
7.1%
8/112 • Number of events 8 • For adverse events: Up to ~ 1 1/2 years. All-cause mortality (ACM): Up to ~ 5 1/2 years
All-cause mortality includes all enrolled participants. AEs include participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs.
|
8.8%
9/102 • Number of events 9 • For adverse events: Up to ~ 1 1/2 years. All-cause mortality (ACM): Up to ~ 5 1/2 years
All-cause mortality includes all enrolled participants. AEs include participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
31.2%
35/112 • Number of events 35 • For adverse events: Up to ~ 1 1/2 years. All-cause mortality (ACM): Up to ~ 5 1/2 years
All-cause mortality includes all enrolled participants. AEs include participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs.
|
5.9%
6/102 • Number of events 6 • For adverse events: Up to ~ 1 1/2 years. All-cause mortality (ACM): Up to ~ 5 1/2 years
All-cause mortality includes all enrolled participants. AEs include participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
13.4%
15/112 • Number of events 19 • For adverse events: Up to ~ 1 1/2 years. All-cause mortality (ACM): Up to ~ 5 1/2 years
All-cause mortality includes all enrolled participants. AEs include participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs.
|
15.7%
16/102 • Number of events 18 • For adverse events: Up to ~ 1 1/2 years. All-cause mortality (ACM): Up to ~ 5 1/2 years
All-cause mortality includes all enrolled participants. AEs include participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs.
|
|
Skin and subcutaneous tissue disorders
Rash
|
19.6%
22/112 • Number of events 27 • For adverse events: Up to ~ 1 1/2 years. All-cause mortality (ACM): Up to ~ 5 1/2 years
All-cause mortality includes all enrolled participants. AEs include participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs.
|
13.7%
14/102 • Number of events 16 • For adverse events: Up to ~ 1 1/2 years. All-cause mortality (ACM): Up to ~ 5 1/2 years
All-cause mortality includes all enrolled participants. AEs include participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
5.4%
6/112 • Number of events 6 • For adverse events: Up to ~ 1 1/2 years. All-cause mortality (ACM): Up to ~ 5 1/2 years
All-cause mortality includes all enrolled participants. AEs include participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs.
|
2.0%
2/102 • Number of events 2 • For adverse events: Up to ~ 1 1/2 years. All-cause mortality (ACM): Up to ~ 5 1/2 years
All-cause mortality includes all enrolled participants. AEs include participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs.
|
|
Vascular disorders
Hypertension
|
5.4%
6/112 • Number of events 6 • For adverse events: Up to ~ 1 1/2 years. All-cause mortality (ACM): Up to ~ 5 1/2 years
All-cause mortality includes all enrolled participants. AEs include participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs.
|
4.9%
5/102 • Number of events 7 • For adverse events: Up to ~ 1 1/2 years. All-cause mortality (ACM): Up to ~ 5 1/2 years
All-cause mortality includes all enrolled participants. AEs include participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs.
|
|
Vascular disorders
Hypotension
|
9.8%
11/112 • Number of events 11 • For adverse events: Up to ~ 1 1/2 years. All-cause mortality (ACM): Up to ~ 5 1/2 years
All-cause mortality includes all enrolled participants. AEs include participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs.
|
5.9%
6/102 • Number of events 7 • For adverse events: Up to ~ 1 1/2 years. All-cause mortality (ACM): Up to ~ 5 1/2 years
All-cause mortality includes all enrolled participants. AEs include participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs.
|
Additional Information
Senior Vice President, Global Clinical Development
Merck Sharp & Dohme LLC
Phone: 1-800-672-6372
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee If publication activity is not directed by the Sponsor, the investigator agrees to submit all manuscripts or abstracts to the Sponsor before submission. This allows the Sponsor to protect proprietary information and to provide comments.
- Publication restrictions are in place
Restriction type: OTHER