Trial Outcomes & Findings for Study of ONO-4538 in Non-Squamous Non-Small Cell Lung Cancer (TASUKI-52) (NCT NCT03117049)
NCT ID: NCT03117049
Last Updated: 2024-05-06
Results Overview
PFS (as assessed by the IRRC) will be calculated using the following formula : PFS (days) = "date when overall response is assessed as progressive disease (PD) or date of death (for any reason), whichever comes first" - "date of randomization" + 1. Please refer to the protocol, in this study, tumor response will be evaluated by CT, etc. according to the RECIST 1.1 criteria.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
550 participants
Primary outcome timeframe
Approximately 32 months
Results posted on
2024-05-06
Participant Flow
Participant milestones
| Measure |
ONO-4538 Group
ONO-4538: 360 mg solution intravenously for 30 min in every 3 weeks until RECIST 1.1 defined PD, unacceptable toxicity, or withdrawal of consent.
Chemotherapy: Carboplatin at AUC 6 and Paclitaxel at 200 mg/m2 intravenously in every 3 weeks for up to 4 cycles and if deemed safe, Carboplatin and Paclitaxel may continue for up to a maximum of 6 cycles until RECIST 1.1 defined PD, unacceptable toxicity, or withdrawal of consent. Bevacizumab at 15 mg/kg intravenously in every 3 weeks until RECIST 1.1 defined PD, unacceptable toxicity, or withdrawal of consent.
|
Placebo Group
Placebo: Placebo solution intravenously for 30 min in every 3 weeks until RECIST 1.1 defined PD, unacceptable toxicity, or withdrawal of consent.
Chemotherapy: Carboplatin at AUC 6 and Paclitaxel at 200 mg/m2 intravenously in every 3 weeks for up to 4 cycles and if deemed safe, Carboplatin and Paclitaxel may continue for up to a maximum of 6 cycles until RECIST 1.1 defined PD, unacceptable toxicity, or withdrawal of consent. Bevacizumab at 15 mg/kg intravenously in every 3 weeks until RECIST 1.1 defined PD, unacceptable toxicity, or withdrawal of consent.
|
|---|---|---|
|
Overall Study
STARTED
|
275
|
275
|
|
Overall Study
COMPLETED
|
74
|
44
|
|
Overall Study
NOT COMPLETED
|
201
|
231
|
Reasons for withdrawal
| Measure |
ONO-4538 Group
ONO-4538: 360 mg solution intravenously for 30 min in every 3 weeks until RECIST 1.1 defined PD, unacceptable toxicity, or withdrawal of consent.
Chemotherapy: Carboplatin at AUC 6 and Paclitaxel at 200 mg/m2 intravenously in every 3 weeks for up to 4 cycles and if deemed safe, Carboplatin and Paclitaxel may continue for up to a maximum of 6 cycles until RECIST 1.1 defined PD, unacceptable toxicity, or withdrawal of consent. Bevacizumab at 15 mg/kg intravenously in every 3 weeks until RECIST 1.1 defined PD, unacceptable toxicity, or withdrawal of consent.
|
Placebo Group
Placebo: Placebo solution intravenously for 30 min in every 3 weeks until RECIST 1.1 defined PD, unacceptable toxicity, or withdrawal of consent.
Chemotherapy: Carboplatin at AUC 6 and Paclitaxel at 200 mg/m2 intravenously in every 3 weeks for up to 4 cycles and if deemed safe, Carboplatin and Paclitaxel may continue for up to a maximum of 6 cycles until RECIST 1.1 defined PD, unacceptable toxicity, or withdrawal of consent. Bevacizumab at 15 mg/kg intravenously in every 3 weeks until RECIST 1.1 defined PD, unacceptable toxicity, or withdrawal of consent.
|
|---|---|---|
|
Overall Study
Continued the follow-up period
|
109
|
129
|
|
Overall Study
Died
|
82
|
93
|
|
Overall Study
Consent withdrawal
|
7
|
6
|
|
Overall Study
Missing contact
|
3
|
3
|
Baseline Characteristics
Study of ONO-4538 in Non-Squamous Non-Small Cell Lung Cancer (TASUKI-52)
Baseline characteristics by cohort
| Measure |
ONO-4538 Group
n=275 Participants
ONO-4538: 360 mg solution intravenously for 30 min in every 3 weeks until RECIST 1.1 defined PD, unacceptable toxicity, or withdrawal of consent.
Chemotherapy: Carboplatin at AUC 6 and Paclitaxel at 200 mg/m2 intravenously in every 3 weeks for up to 4 cycles and if deemed safe, Carboplatin and Paclitaxel may continue for up to a maximum of 6 cycles until RECIST 1.1 defined PD, unacceptable toxicity, or withdrawal of consent. Bevacizumab at 15 mg/kg intravenously in every 3 weeks until RECIST 1.1 defined PD, unacceptable toxicity, or withdrawal of consent.
|
Placebo Group
n=275 Participants
Placebo: Placebo solution intravenously for 30 min in every 3 weeks until RECIST 1.1 defined PD, unacceptable toxicity, or withdrawal of consent.
Chemotherapy: Carboplatin at AUC 6 and Paclitaxel at 200 mg/m2 intravenously in every 3 weeks for up to 4 cycles and if deemed safe, Carboplatin and Paclitaxel may continue for up to a maximum of 6 cycles until RECIST 1.1 defined PD, unacceptable toxicity, or withdrawal of consent. Bevacizumab at 15 mg/kg intravenously in every 3 weeks until RECIST 1.1 defined PD, unacceptable toxicity, or withdrawal of consent.
|
Total
n=550 Participants
Total of all reporting groups
|
|---|---|---|---|
|
PD-L1 expression levels
1%-49%
|
82 Participants
n=39 Participants
|
81 Participants
n=41 Participants
|
163 Participants
n=35 Participants
|
|
PD-L1 expression levels
>=50
|
73 Participants
n=39 Participants
|
74 Participants
n=41 Participants
|
147 Participants
n=35 Participants
|
|
Age, Continuous
|
66 years
n=39 Participants
|
66 years
n=41 Participants
|
66 years
n=35 Participants
|
|
Age, Customized
<65 years
|
131 Participants
n=39 Participants
|
111 Participants
n=41 Participants
|
242 Participants
n=35 Participants
|
|
Age, Customized
65-74 years
|
117 Participants
n=39 Participants
|
131 Participants
n=41 Participants
|
248 Participants
n=35 Participants
|
|
Age, Customized
>=75 years
|
27 Participants
n=39 Participants
|
33 Participants
n=41 Participants
|
60 Participants
n=35 Participants
|
|
Sex: Female, Male
Female
|
70 Participants
n=39 Participants
|
69 Participants
n=41 Participants
|
139 Participants
n=35 Participants
|
|
Sex: Female, Male
Male
|
205 Participants
n=39 Participants
|
206 Participants
n=41 Participants
|
411 Participants
n=35 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Asian
|
275 Participants
n=39 Participants
|
275 Participants
n=41 Participants
|
550 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Country
Japan
|
188 Participants
n=39 Participants
|
183 Participants
n=41 Participants
|
371 Participants
n=35 Participants
|
|
Country
Korea
|
62 Participants
n=39 Participants
|
63 Participants
n=41 Participants
|
125 Participants
n=35 Participants
|
|
Country
Taiwan
|
25 Participants
n=39 Participants
|
29 Participants
n=41 Participants
|
54 Participants
n=35 Participants
|
|
ECOG Performance Score
0
|
129 Participants
n=39 Participants
|
128 Participants
n=41 Participants
|
257 Participants
n=35 Participants
|
|
ECOG Performance Score
1
|
146 Participants
n=39 Participants
|
147 Participants
n=41 Participants
|
293 Participants
n=35 Participants
|
|
Smoking status
Never
|
61 Participants
n=39 Participants
|
54 Participants
n=41 Participants
|
115 Participants
n=35 Participants
|
|
Smoking status
Current
|
18 Participants
n=39 Participants
|
21 Participants
n=41 Participants
|
39 Participants
n=35 Participants
|
|
Smoking status
Former
|
196 Participants
n=39 Participants
|
200 Participants
n=41 Participants
|
396 Participants
n=35 Participants
|
|
Staging (the UICC-TNM classification, 7th edition)
Stage IIIB
|
15 Participants
n=39 Participants
|
14 Participants
n=41 Participants
|
29 Participants
n=35 Participants
|
|
Staging (the UICC-TNM classification, 7th edition)
Stage IV
|
239 Participants
n=39 Participants
|
238 Participants
n=41 Participants
|
477 Participants
n=35 Participants
|
|
Staging (the UICC-TNM classification, 7th edition)
Recurrent
|
21 Participants
n=39 Participants
|
23 Participants
n=41 Participants
|
44 Participants
n=35 Participants
|
|
Metastasis
Bone
|
56 Participants
n=39 Participants
|
83 Participants
n=41 Participants
|
139 Participants
n=35 Participants
|
|
Metastasis
Liver
|
19 Participants
n=39 Participants
|
20 Participants
n=41 Participants
|
39 Participants
n=35 Participants
|
|
Metastasis
Brain
|
36 Participants
n=39 Participants
|
41 Participants
n=41 Participants
|
77 Participants
n=35 Participants
|
|
PD-L1 expression levels
<1% or indeterminate
|
120 Participants
n=39 Participants
|
120 Participants
n=41 Participants
|
240 Participants
n=35 Participants
|
PRIMARY outcome
Timeframe: Approximately 32 monthsPFS (as assessed by the IRRC) will be calculated using the following formula : PFS (days) = "date when overall response is assessed as progressive disease (PD) or date of death (for any reason), whichever comes first" - "date of randomization" + 1. Please refer to the protocol, in this study, tumor response will be evaluated by CT, etc. according to the RECIST 1.1 criteria.
Outcome measures
| Measure |
ONO-4538 Group
n=275 Participants
ONO-4538: 360 mg solution intravenously for 30 min in every 3 weeks until RECIST 1.1 defined PD, unacceptable toxicity, or withdrawal of consent.
Chemotherapy: Carboplatin at AUC 6 and Paclitaxel at 200 mg/m2 intravenously in every 3 weeks for up to 4 cycles and if deemed safe, Carboplatin and Paclitaxel may continue for up to a maximum of 6 cycles until RECIST 1.1 defined PD, unacceptable toxicity, or withdrawal of consent. Bevacizumab at 15 mg/kg intravenously in every 3 weeks until RECIST 1.1 defined PD, unacceptable toxicity, or withdrawal of consent.
|
Placebo Group
n=275 Participants
Placebo: Placebo solution intravenously for 30 min in every 3 weeks until RECIST 1.1 defined PD, unacceptable toxicity, or withdrawal of consent.
Chemotherapy: Carboplatin at AUC 6 and Paclitaxel at 200 mg/m2 intravenously in every 3 weeks for up to 4 cycles and if deemed safe, Carboplatin and Paclitaxel may continue for up to a maximum of 6 cycles until RECIST 1.1 defined PD, unacceptable toxicity, or withdrawal of consent. Bevacizumab at 15 mg/kg intravenously in every 3 weeks until RECIST 1.1 defined PD, unacceptable toxicity, or withdrawal of consent.
|
|---|---|---|
|
Progression Free Survival (PFS) as Assessed by the Independent Radiology Review Committee (IRRC)
|
12.1 months
Interval 9.8 to 14.0
|
8.1 months
Interval 7.0 to 8.5
|
SECONDARY outcome
Timeframe: Approximately 32 monthsOutcome measures
| Measure |
ONO-4538 Group
n=275 Participants
ONO-4538: 360 mg solution intravenously for 30 min in every 3 weeks until RECIST 1.1 defined PD, unacceptable toxicity, or withdrawal of consent.
Chemotherapy: Carboplatin at AUC 6 and Paclitaxel at 200 mg/m2 intravenously in every 3 weeks for up to 4 cycles and if deemed safe, Carboplatin and Paclitaxel may continue for up to a maximum of 6 cycles until RECIST 1.1 defined PD, unacceptable toxicity, or withdrawal of consent. Bevacizumab at 15 mg/kg intravenously in every 3 weeks until RECIST 1.1 defined PD, unacceptable toxicity, or withdrawal of consent.
|
Placebo Group
n=275 Participants
Placebo: Placebo solution intravenously for 30 min in every 3 weeks until RECIST 1.1 defined PD, unacceptable toxicity, or withdrawal of consent.
Chemotherapy: Carboplatin at AUC 6 and Paclitaxel at 200 mg/m2 intravenously in every 3 weeks for up to 4 cycles and if deemed safe, Carboplatin and Paclitaxel may continue for up to a maximum of 6 cycles until RECIST 1.1 defined PD, unacceptable toxicity, or withdrawal of consent. Bevacizumab at 15 mg/kg intravenously in every 3 weeks until RECIST 1.1 defined PD, unacceptable toxicity, or withdrawal of consent.
|
|---|---|---|
|
Overall Survival (OS)
|
25.4 months
Interval 21.8 to
The Upper Limit has not been reached due to insufficient number of participants with events.
|
24.7 months
Interval 20.2 to
The Upper Limit has not been reached due to insufficient number of participants with events.
|
SECONDARY outcome
Timeframe: Approximately 32 monthsORR represents the proportion of subjects whose best overall response was assessed as complete response (CR) or partial response (PR). Please refer to the protocol, in this study, tumor response will be evaluated by CT, etc. according to the RECIST 1.1 criteria.
Outcome measures
| Measure |
ONO-4538 Group
n=275 Participants
ONO-4538: 360 mg solution intravenously for 30 min in every 3 weeks until RECIST 1.1 defined PD, unacceptable toxicity, or withdrawal of consent.
Chemotherapy: Carboplatin at AUC 6 and Paclitaxel at 200 mg/m2 intravenously in every 3 weeks for up to 4 cycles and if deemed safe, Carboplatin and Paclitaxel may continue for up to a maximum of 6 cycles until RECIST 1.1 defined PD, unacceptable toxicity, or withdrawal of consent. Bevacizumab at 15 mg/kg intravenously in every 3 weeks until RECIST 1.1 defined PD, unacceptable toxicity, or withdrawal of consent.
|
Placebo Group
n=275 Participants
Placebo: Placebo solution intravenously for 30 min in every 3 weeks until RECIST 1.1 defined PD, unacceptable toxicity, or withdrawal of consent.
Chemotherapy: Carboplatin at AUC 6 and Paclitaxel at 200 mg/m2 intravenously in every 3 weeks for up to 4 cycles and if deemed safe, Carboplatin and Paclitaxel may continue for up to a maximum of 6 cycles until RECIST 1.1 defined PD, unacceptable toxicity, or withdrawal of consent. Bevacizumab at 15 mg/kg intravenously in every 3 weeks until RECIST 1.1 defined PD, unacceptable toxicity, or withdrawal of consent.
|
|---|---|---|
|
Objective Response Rate (ORR [as Assessed by the IRRC])
|
61.5 percentage of participants
Interval 55.4 to 67.2
|
50.5 percentage of participants
Interval 44.5 to 56.6
|
SECONDARY outcome
Timeframe: Approximately 32 monthsDCR represents the proportion of subjects whose best overall response was assessed as CR, PR, or stable disease (SD). Please refer to the protocol, in this study, tumor response will be evaluated by CT, etc. according to the RECIST 1.1 criteria.
Outcome measures
| Measure |
ONO-4538 Group
n=275 Participants
ONO-4538: 360 mg solution intravenously for 30 min in every 3 weeks until RECIST 1.1 defined PD, unacceptable toxicity, or withdrawal of consent.
Chemotherapy: Carboplatin at AUC 6 and Paclitaxel at 200 mg/m2 intravenously in every 3 weeks for up to 4 cycles and if deemed safe, Carboplatin and Paclitaxel may continue for up to a maximum of 6 cycles until RECIST 1.1 defined PD, unacceptable toxicity, or withdrawal of consent. Bevacizumab at 15 mg/kg intravenously in every 3 weeks until RECIST 1.1 defined PD, unacceptable toxicity, or withdrawal of consent.
|
Placebo Group
n=275 Participants
Placebo: Placebo solution intravenously for 30 min in every 3 weeks until RECIST 1.1 defined PD, unacceptable toxicity, or withdrawal of consent.
Chemotherapy: Carboplatin at AUC 6 and Paclitaxel at 200 mg/m2 intravenously in every 3 weeks for up to 4 cycles and if deemed safe, Carboplatin and Paclitaxel may continue for up to a maximum of 6 cycles until RECIST 1.1 defined PD, unacceptable toxicity, or withdrawal of consent. Bevacizumab at 15 mg/kg intravenously in every 3 weeks until RECIST 1.1 defined PD, unacceptable toxicity, or withdrawal of consent.
|
|---|---|---|
|
Disease Control Rate (DCR [as Assessed by the IRRC])
|
87.3 percentage of participants
Interval 82.7 to 91.0
|
89.8 percentage of participants
Interval 85.6 to 93.1
|
SECONDARY outcome
Timeframe: Approximately 32 monthsThe lower and upper limits of 95% CI for the median are censored value in the both groups.
Outcome measures
| Measure |
ONO-4538 Group
n=275 Participants
ONO-4538: 360 mg solution intravenously for 30 min in every 3 weeks until RECIST 1.1 defined PD, unacceptable toxicity, or withdrawal of consent.
Chemotherapy: Carboplatin at AUC 6 and Paclitaxel at 200 mg/m2 intravenously in every 3 weeks for up to 4 cycles and if deemed safe, Carboplatin and Paclitaxel may continue for up to a maximum of 6 cycles until RECIST 1.1 defined PD, unacceptable toxicity, or withdrawal of consent. Bevacizumab at 15 mg/kg intravenously in every 3 weeks until RECIST 1.1 defined PD, unacceptable toxicity, or withdrawal of consent.
|
Placebo Group
n=275 Participants
Placebo: Placebo solution intravenously for 30 min in every 3 weeks until RECIST 1.1 defined PD, unacceptable toxicity, or withdrawal of consent.
Chemotherapy: Carboplatin at AUC 6 and Paclitaxel at 200 mg/m2 intravenously in every 3 weeks for up to 4 cycles and if deemed safe, Carboplatin and Paclitaxel may continue for up to a maximum of 6 cycles until RECIST 1.1 defined PD, unacceptable toxicity, or withdrawal of consent. Bevacizumab at 15 mg/kg intravenously in every 3 weeks until RECIST 1.1 defined PD, unacceptable toxicity, or withdrawal of consent.
|
|---|---|---|
|
Duration of Response (DOR [as Assessed by the IRRC])
|
11.0 months
Interval 1.1 to 25.8
|
7.0 months
Interval 1.2 to 26.0
|
SECONDARY outcome
Timeframe: Approximately 32 monthsPopulation: For best overall response to be assessed as stable disease in this study, at least one stable disease or better rather than progressive disease on or after day 43 should be obtained.
Outcome measures
| Measure |
ONO-4538 Group
n=275 Participants
ONO-4538: 360 mg solution intravenously for 30 min in every 3 weeks until RECIST 1.1 defined PD, unacceptable toxicity, or withdrawal of consent.
Chemotherapy: Carboplatin at AUC 6 and Paclitaxel at 200 mg/m2 intravenously in every 3 weeks for up to 4 cycles and if deemed safe, Carboplatin and Paclitaxel may continue for up to a maximum of 6 cycles until RECIST 1.1 defined PD, unacceptable toxicity, or withdrawal of consent. Bevacizumab at 15 mg/kg intravenously in every 3 weeks until RECIST 1.1 defined PD, unacceptable toxicity, or withdrawal of consent.
|
Placebo Group
n=275 Participants
Placebo: Placebo solution intravenously for 30 min in every 3 weeks until RECIST 1.1 defined PD, unacceptable toxicity, or withdrawal of consent.
Chemotherapy: Carboplatin at AUC 6 and Paclitaxel at 200 mg/m2 intravenously in every 3 weeks for up to 4 cycles and if deemed safe, Carboplatin and Paclitaxel may continue for up to a maximum of 6 cycles until RECIST 1.1 defined PD, unacceptable toxicity, or withdrawal of consent. Bevacizumab at 15 mg/kg intravenously in every 3 weeks until RECIST 1.1 defined PD, unacceptable toxicity, or withdrawal of consent.
|
|---|---|---|
|
Best Overall Response (BOR [as Assessed by the IRRC])
Complete response
|
14 Participants
|
8 Participants
|
|
Best Overall Response (BOR [as Assessed by the IRRC])
Partial response
|
155 Participants
|
131 Participants
|
|
Best Overall Response (BOR [as Assessed by the IRRC])
Stable disease
|
71 Participants
|
108 Participants
|
|
Best Overall Response (BOR [as Assessed by the IRRC])
Progressive disease
|
5 Participants
|
11 Participants
|
|
Best Overall Response (BOR [as Assessed by the IRRC])
Not evaluable
|
30 Participants
|
17 Participants
|
Adverse Events
ONO-4538 Group
Serious events: 154 serious events
Other events: 271 other events
Deaths: 82 deaths
Placebo Group
Serious events: 118 serious events
Other events: 274 other events
Deaths: 93 deaths
Serious adverse events
| Measure |
ONO-4538 Group
n=273 participants at risk
ONO-4538: 360 mg solution intravenously for 30 min in every 3 weeks until RECIST 1.1 defined PD, unacceptable toxicity, or withdrawal of consent.
Chemotherapy: Carboplatin at AUC 6 and Paclitaxel at 200 mg/m2 intravenously in every 3 weeks for up to 4 cycles and if deemed safe, Carboplatin and Paclitaxel may continue for up to a maximum of 6 cycles until RECIST 1.1 defined PD, unacceptable toxicity, or withdrawal of consent. Bevacizumab at 15 mg/kg intravenously in every 3 weeks until RECIST 1.1 defined PD, unacceptable toxicity, or withdrawal of consent.
|
Placebo Group
n=275 participants at risk
Placebo: Placebo solution intravenously for 30 min in every 3 weeks until RECIST 1.1 defined PD, unacceptable toxicity, or withdrawal of consent.
Chemotherapy: Carboplatin at AUC 6 and Paclitaxel at 200 mg/m2 intravenously in every 3 weeks for up to 4 cycles and if deemed safe, Carboplatin and Paclitaxel may continue for up to a maximum of 6 cycles until RECIST 1.1 defined PD, unacceptable toxicity, or withdrawal of consent. Bevacizumab at 15 mg/kg intravenously in every 3 weeks until RECIST 1.1 defined PD, unacceptable toxicity, or withdrawal of consent.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
1.8%
5/273 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
0.36%
1/275 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
|
Blood and lymphatic system disorders
Bone marrow failure
|
0.37%
1/273 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
0.00%
0/275 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
9.9%
27/273 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
4.4%
12/275 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.37%
1/273 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
0.36%
1/275 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.73%
2/273 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
0.36%
1/275 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
|
Blood and lymphatic system disorders
Splenic haemorrhage
|
0.00%
0/273 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
0.36%
1/275 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.73%
2/273 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
0.00%
0/275 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
|
Cardiac disorders
Acute coronary syndrome
|
0.00%
0/273 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
0.36%
1/275 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.37%
1/273 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
0.73%
2/275 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
|
Cardiac disorders
Angina unstable
|
0.00%
0/273 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
0.36%
1/275 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
|
Cardiac disorders
Cardiac arrest
|
0.37%
1/273 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
0.36%
1/275 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
|
Cardiac disorders
Cardiac ventricular thrombosis
|
0.37%
1/273 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
0.00%
0/275 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
|
Cardiac disorders
Cardio-respiratory arrest
|
0.37%
1/273 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
0.00%
0/275 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
|
Cardiac disorders
Myocardial infarction
|
0.37%
1/273 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
0.36%
1/275 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
|
Cardiac disorders
Myocardial ischaemia
|
0.00%
0/273 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
0.36%
1/275 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
|
Cardiac disorders
Pericardial effusion
|
0.37%
1/273 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
0.36%
1/275 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.00%
0/273 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
0.36%
1/275 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
|
Endocrine disorders
Adrenal insufficiency
|
2.6%
7/273 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
0.36%
1/275 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
|
Endocrine disorders
Adrenocorticotropic hormone deficiency
|
0.37%
1/273 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
0.00%
0/275 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
|
Endocrine disorders
Hypopituitarism
|
1.5%
4/273 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
0.00%
0/275 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/273 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
0.36%
1/275 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.37%
1/273 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
0.00%
0/275 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
|
Gastrointestinal disorders
Anal fistula
|
0.37%
1/273 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
0.00%
0/275 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
|
Gastrointestinal disorders
Anal ulcer
|
0.00%
0/273 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
0.36%
1/275 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
|
Gastrointestinal disorders
Colitis
|
2.9%
8/273 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
0.36%
1/275 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
|
Gastrointestinal disorders
Colitis microscopic
|
0.37%
1/273 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
0.00%
0/275 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
|
Gastrointestinal disorders
Constipation
|
0.37%
1/273 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
0.36%
1/275 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
|
Gastrointestinal disorders
Diarrhoea
|
1.8%
5/273 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
0.36%
1/275 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
|
Gastrointestinal disorders
Diverticular perforation
|
0.37%
1/273 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
0.00%
0/275 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
|
Gastrointestinal disorders
Duodenal ulcer
|
0.37%
1/273 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
0.00%
0/275 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
|
Gastrointestinal disorders
Enterocolitis
|
0.37%
1/273 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
0.00%
0/275 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
|
Gastrointestinal disorders
Gastric ulcer
|
0.00%
0/273 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
0.36%
1/275 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
|
Gastrointestinal disorders
Gastritis
|
0.37%
1/273 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
0.00%
0/275 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.37%
1/273 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
0.00%
0/275 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.37%
1/273 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
0.00%
0/275 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
|
Gastrointestinal disorders
Ileus
|
0.00%
0/273 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
0.36%
1/275 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.37%
1/273 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
0.00%
0/275 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
|
Gastrointestinal disorders
Intestinal perforation
|
0.00%
0/273 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
0.36%
1/275 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
|
Gastrointestinal disorders
Intra-abdominal haemorrhage
|
0.00%
0/273 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
0.36%
1/275 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
|
Gastrointestinal disorders
Large intestine perforation
|
0.00%
0/273 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
0.73%
2/275 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
|
Gastrointestinal disorders
Lower gastrointestinal haemorrhage
|
0.00%
0/273 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
0.36%
1/275 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
|
Gastrointestinal disorders
Nausea
|
0.73%
2/273 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
1.1%
3/275 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
|
Gastrointestinal disorders
Oesophageal stenosis
|
0.00%
0/273 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
0.36%
1/275 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
|
Gastrointestinal disorders
Pancreatic fistula
|
0.00%
0/273 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
0.36%
1/275 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
|
Gastrointestinal disorders
Pancreatitis
|
0.37%
1/273 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
0.00%
0/275 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
|
Gastrointestinal disorders
Periodontal disease
|
0.37%
1/273 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
0.00%
0/275 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
|
Gastrointestinal disorders
Rectal prolapse
|
0.00%
0/273 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
0.36%
1/275 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
|
Gastrointestinal disorders
Small intestinal perforation
|
0.00%
0/273 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
0.36%
1/275 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
|
Gastrointestinal disorders
Stomatitis
|
0.73%
2/273 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
0.00%
0/275 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
0.00%
0/273 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
0.36%
1/275 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
|
General disorders
Asthenia
|
0.73%
2/273 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
1.1%
3/275 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
|
General disorders
Chest pain
|
0.00%
0/273 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
0.36%
1/275 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
|
General disorders
Death
|
0.37%
1/273 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
0.36%
1/275 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
|
General disorders
Fatigue
|
0.00%
0/273 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
0.36%
1/275 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
|
General disorders
Haemorrhagic cyst
|
0.00%
0/273 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
0.36%
1/275 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
|
General disorders
Malaise
|
0.37%
1/273 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
0.00%
0/275 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
|
General disorders
Pyrexia
|
5.9%
16/273 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
1.5%
4/275 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
|
General disorders
Sudden death
|
0.73%
2/273 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
0.36%
1/275 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
|
Hepatobiliary disorders
Biloma
|
0.00%
0/273 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
0.36%
1/275 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
|
Hepatobiliary disorders
Cholangitis
|
0.73%
2/273 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
0.36%
1/275 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.37%
1/273 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
0.36%
1/275 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.37%
1/273 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
0.00%
0/275 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
|
Hepatobiliary disorders
Drug-induced liver injury
|
0.37%
1/273 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
0.36%
1/275 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
1.5%
4/273 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
0.36%
1/275 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
|
Immune system disorders
Anaphylactic reaction
|
0.73%
2/273 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
0.36%
1/275 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
|
Infections and infestations
Anal abscess
|
0.37%
1/273 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
0.00%
0/275 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
|
Infections and infestations
Appendicitis
|
1.1%
3/273 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
0.00%
0/275 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
|
Infections and infestations
Bronchitis
|
0.37%
1/273 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
0.36%
1/275 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
|
Infections and infestations
Clostridium difficile colitis
|
0.00%
0/273 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
0.36%
1/275 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
|
Infections and infestations
Device related infection
|
0.00%
0/273 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
0.36%
1/275 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
|
Infections and infestations
Diverticulitis
|
0.73%
2/273 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
0.00%
0/275 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
|
Infections and infestations
Enteritis infectious
|
0.37%
1/273 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
0.36%
1/275 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/273 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
0.36%
1/275 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
|
Infections and infestations
Gastroenteritis bacterial
|
0.37%
1/273 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
0.00%
0/275 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
|
Infections and infestations
Haematoma infection
|
0.37%
1/273 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
0.00%
0/275 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
|
Infections and infestations
Infection
|
0.37%
1/273 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
0.73%
2/275 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
|
Infections and infestations
Infectious pleural effusion
|
0.37%
1/273 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
0.00%
0/275 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
|
Infections and infestations
Large intestine infection
|
0.37%
1/273 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
0.00%
0/275 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
|
Infections and infestations
Lung abscess
|
0.37%
1/273 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
0.36%
1/275 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
|
Infections and infestations
Osteomyelitis acute
|
0.37%
1/273 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
0.00%
0/275 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
|
Infections and infestations
Otitis media chronic
|
0.00%
0/273 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
0.36%
1/275 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
|
Infections and infestations
Pharyngotonsillitis
|
0.00%
0/273 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
0.36%
1/275 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
|
Infections and infestations
Pleural infection bacterial
|
0.00%
0/273 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
0.36%
1/275 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
|
Infections and infestations
Pneumonia
|
7.7%
21/273 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
5.5%
15/275 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
|
Infections and infestations
Pneumonia bacterial
|
0.73%
2/273 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
0.36%
1/275 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
|
Infections and infestations
Pneumonia klebsiella
|
0.00%
0/273 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
0.36%
1/275 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
|
Infections and infestations
Pseudomembranous colitis
|
0.00%
0/273 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
0.36%
1/275 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
|
Infections and infestations
Pseudomonal bacteraemia
|
0.37%
1/273 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
0.36%
1/275 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
|
Infections and infestations
Sepsis
|
0.73%
2/273 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
1.1%
3/275 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
|
Infections and infestations
Septic shock
|
0.00%
0/273 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
0.36%
1/275 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
|
Infections and infestations
Sinusitis
|
0.37%
1/273 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
0.00%
0/275 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
|
Infections and infestations
Skin infection
|
0.37%
1/273 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
0.00%
0/275 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
|
Infections and infestations
Tonsillitis
|
0.00%
0/273 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
0.36%
1/275 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/273 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
0.36%
1/275 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.00%
0/273 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
0.36%
1/275 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
|
Injury, poisoning and procedural complications
Femoral neck fracture
|
0.00%
0/273 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
0.36%
1/275 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
0.00%
0/273 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
0.36%
1/275 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
0.37%
1/273 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
0.00%
0/275 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
|
Injury, poisoning and procedural complications
Post procedural fistula
|
0.37%
1/273 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
0.00%
0/275 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
|
Injury, poisoning and procedural complications
Post procedural haemorrhage
|
0.37%
1/273 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
0.00%
0/275 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
|
Injury, poisoning and procedural complications
Spinal compression fracture
|
0.00%
0/273 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
0.36%
1/275 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
|
Injury, poisoning and procedural complications
Vascular pseudoaneurysm
|
0.37%
1/273 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
0.00%
0/275 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
|
Injury, poisoning and procedural complications
Wound complication
|
0.00%
0/273 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
0.36%
1/275 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
|
Investigations
Angiocardiogram
|
0.37%
1/273 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
0.00%
0/275 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
|
Investigations
Blood bilirubin increased
|
0.37%
1/273 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
0.00%
0/275 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
|
Investigations
Blood creatine phosphokinase increased
|
0.37%
1/273 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
0.00%
0/275 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
|
Investigations
Hepatic enzyme increased
|
0.37%
1/273 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
0.00%
0/275 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
|
Investigations
Neutrophil count decreased
|
2.2%
6/273 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
0.00%
0/275 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
|
Investigations
Platelet count decreased
|
0.00%
0/273 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
0.36%
1/275 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
|
Investigations
Weight increased
|
0.00%
0/273 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
0.36%
1/275 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
|
Investigations
White blood cell count decreased
|
0.37%
1/273 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
0.36%
1/275 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
1.8%
5/273 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
2.9%
8/275 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.73%
2/273 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
0.73%
2/275 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.37%
1/273 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
0.00%
0/275 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
|
Metabolism and nutrition disorders
Fulminant type 1 diabetes mellitus
|
0.37%
1/273 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
0.00%
0/275 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
|
Metabolism and nutrition disorders
Glucose tolerance impaired
|
0.37%
1/273 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
0.00%
0/275 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/273 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
0.36%
1/275 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/273 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
0.36%
1/275 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.37%
1/273 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
0.00%
0/275 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.73%
2/273 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
0.36%
1/275 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
|
Metabolism and nutrition disorders
Tumour lysis syndrome
|
0.00%
0/273 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
0.36%
1/275 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
|
Metabolism and nutrition disorders
Type 1 diabetes mellitus
|
0.73%
2/273 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
0.00%
0/275 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.37%
1/273 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
0.36%
1/275 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/273 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
0.36%
1/275 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/273 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
0.36%
1/275 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/273 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
0.36%
1/275 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.37%
1/273 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
0.00%
0/275 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.37%
1/273 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
0.00%
0/275 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
|
Musculoskeletal and connective tissue disorders
Myositis
|
0.37%
1/273 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
0.00%
0/275 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Brain cancer metastatic
|
0.00%
0/273 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
0.36%
1/275 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastric cancer
|
0.37%
1/273 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
0.36%
1/275 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastrointestinal stromal tumour
|
0.00%
0/273 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
0.36%
1/275 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant neoplasm progression
|
0.37%
1/273 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
0.00%
0/275 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to central nervous system
|
0.00%
0/273 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
0.36%
1/275 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Papillary thyroid cancer
|
0.00%
0/273 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
0.36%
1/275 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Small intestine carcinoma metastatic
|
0.37%
1/273 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
0.00%
0/275 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour haemorrhage
|
0.37%
1/273 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
0.00%
0/275 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour pain
|
0.00%
0/273 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
0.36%
1/275 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
|
Nervous system disorders
Ataxia
|
0.00%
0/273 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
0.36%
1/275 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
|
Nervous system disorders
Brain stem infarction
|
0.00%
0/273 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
0.36%
1/275 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
|
Nervous system disorders
Cerebral infarction
|
0.73%
2/273 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
0.73%
2/275 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
|
Nervous system disorders
Depressed level of consciousness
|
0.73%
2/273 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
0.00%
0/275 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
|
Nervous system disorders
Dizziness
|
0.37%
1/273 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
0.36%
1/275 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
|
Nervous system disorders
Epilepsy
|
0.37%
1/273 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
0.36%
1/275 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
|
Nervous system disorders
Haemorrhage intracranial
|
0.00%
0/273 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
0.36%
1/275 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
|
Nervous system disorders
Headache
|
0.00%
0/273 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
0.36%
1/275 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
|
Nervous system disorders
Ischaemic stroke
|
0.37%
1/273 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
0.00%
0/275 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
0.00%
0/273 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
0.73%
2/275 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
|
Nervous system disorders
Polyneuropathy
|
0.37%
1/273 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
0.00%
0/275 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
|
Nervous system disorders
Posterior reversible encephalopathy syndrome
|
0.37%
1/273 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
0.00%
0/275 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
|
Nervous system disorders
Postresuscitation encephalopathy
|
0.00%
0/273 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
0.36%
1/275 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
|
Nervous system disorders
Presyncope
|
0.37%
1/273 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
0.00%
0/275 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
|
Nervous system disorders
Seizure
|
0.73%
2/273 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
0.36%
1/275 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
|
Nervous system disorders
Subarachnoid haemorrhage
|
0.00%
0/273 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
0.36%
1/275 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
|
Nervous system disorders
Transient ischaemic attack
|
0.37%
1/273 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
0.00%
0/275 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/273 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
0.36%
1/275 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
|
Psychiatric disorders
Psychotic disorder
|
0.00%
0/273 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
0.36%
1/275 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
|
Renal and urinary disorders
Acute kidney injury
|
1.8%
5/273 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
0.36%
1/275 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
|
Renal and urinary disorders
Haematuria
|
0.37%
1/273 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
0.00%
0/275 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
|
Renal and urinary disorders
Renal impairment
|
0.37%
1/273 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
0.00%
0/275 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
|
Renal and urinary disorders
Ureterolithiasis
|
0.00%
0/273 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
0.36%
1/275 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
|
Reproductive system and breast disorders
Prostatitis
|
0.37%
1/273 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
0.00%
0/275 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
|
Respiratory, thoracic and mediastinal disorders
Acute interstitial pneumonitis
|
0.00%
0/273 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
0.36%
1/275 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
0.37%
1/273 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
0.00%
0/275 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.37%
1/273 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
0.00%
0/275 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.37%
1/273 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
0.36%
1/275 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.73%
2/273 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
0.36%
1/275 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.37%
1/273 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
0.36%
1/275 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease
|
2.2%
6/273 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
1.1%
3/275 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/273 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
1.1%
3/275 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
|
Respiratory, thoracic and mediastinal disorders
Pleurisy
|
0.00%
0/273 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
0.36%
1/275 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
3.3%
9/273 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
0.00%
0/275 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
2.9%
8/273 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
1.8%
5/275 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
1.1%
3/273 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
0.36%
1/275 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary thrombosis
|
0.00%
0/273 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
0.36%
1/275 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
|
Skin and subcutaneous tissue disorders
Erythema multiforme
|
1.5%
4/273 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
0.00%
0/275 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
|
Skin and subcutaneous tissue disorders
Pemphigoid
|
0.37%
1/273 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
0.00%
0/275 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
|
Skin and subcutaneous tissue disorders
Rash
|
1.5%
4/273 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
0.00%
0/275 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
2.2%
6/273 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
0.00%
0/275 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
|
Skin and subcutaneous tissue disorders
Skin burning sensation
|
0.00%
0/273 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
0.36%
1/275 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
|
Skin and subcutaneous tissue disorders
Stevens-Johnson syndrome
|
0.37%
1/273 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
0.00%
0/275 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
|
Skin and subcutaneous tissue disorders
Toxic epidermal necrolysis
|
0.37%
1/273 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
0.00%
0/275 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.37%
1/273 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
0.00%
0/275 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
|
Vascular disorders
Deep vein thrombosis
|
0.37%
1/273 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
0.00%
0/275 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
|
Vascular disorders
Embolism
|
1.1%
3/273 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
0.73%
2/275 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
|
Vascular disorders
Peripheral arterial occlusive disease
|
0.00%
0/273 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
0.36%
1/275 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
Other adverse events
| Measure |
ONO-4538 Group
n=273 participants at risk
ONO-4538: 360 mg solution intravenously for 30 min in every 3 weeks until RECIST 1.1 defined PD, unacceptable toxicity, or withdrawal of consent.
Chemotherapy: Carboplatin at AUC 6 and Paclitaxel at 200 mg/m2 intravenously in every 3 weeks for up to 4 cycles and if deemed safe, Carboplatin and Paclitaxel may continue for up to a maximum of 6 cycles until RECIST 1.1 defined PD, unacceptable toxicity, or withdrawal of consent. Bevacizumab at 15 mg/kg intravenously in every 3 weeks until RECIST 1.1 defined PD, unacceptable toxicity, or withdrawal of consent.
|
Placebo Group
n=275 participants at risk
Placebo: Placebo solution intravenously for 30 min in every 3 weeks until RECIST 1.1 defined PD, unacceptable toxicity, or withdrawal of consent.
Chemotherapy: Carboplatin at AUC 6 and Paclitaxel at 200 mg/m2 intravenously in every 3 weeks for up to 4 cycles and if deemed safe, Carboplatin and Paclitaxel may continue for up to a maximum of 6 cycles until RECIST 1.1 defined PD, unacceptable toxicity, or withdrawal of consent. Bevacizumab at 15 mg/kg intravenously in every 3 weeks until RECIST 1.1 defined PD, unacceptable toxicity, or withdrawal of consent.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
32.2%
88/273 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
37.1%
102/275 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
7.0%
19/273 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
5.5%
15/275 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
|
Blood and lymphatic system disorders
Leukopenia
|
9.5%
26/273 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
6.9%
19/275 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
|
Blood and lymphatic system disorders
Neutropenia
|
19.0%
52/273 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
13.8%
38/275 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
6.2%
17/273 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
7.6%
21/275 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
|
Ear and labyrinth disorders
Tinnitus
|
0.37%
1/273 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
2.5%
7/275 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
|
Endocrine disorders
Adrenal insufficiency
|
3.3%
9/273 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
1.8%
5/275 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
|
Endocrine disorders
Hyperthyroidism
|
5.5%
15/273 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
1.5%
4/275 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
|
Endocrine disorders
Hypothyroidism
|
9.9%
27/273 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
2.9%
8/275 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
|
Eye disorders
Cataract
|
0.73%
2/273 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
2.2%
6/275 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
|
Gastrointestinal disorders
Abdominal distension
|
2.6%
7/273 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
1.5%
4/275 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
|
Gastrointestinal disorders
Abdominal pain
|
3.3%
9/273 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
4.0%
11/275 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
4.8%
13/273 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
2.9%
8/275 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
|
Gastrointestinal disorders
Cheilitis
|
2.2%
6/273 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
0.73%
2/275 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
|
Gastrointestinal disorders
Constipation
|
54.9%
150/273 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
48.7%
134/275 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
|
Gastrointestinal disorders
Dental caries
|
4.4%
12/273 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
0.73%
2/275 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
|
Gastrointestinal disorders
Diarrhoea
|
29.7%
81/273 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
24.0%
66/275 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
|
Gastrointestinal disorders
Dry mouth
|
2.6%
7/273 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
0.36%
1/275 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
|
Gastrointestinal disorders
Dyspepsia
|
5.1%
14/273 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
4.7%
13/275 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
|
Gastrointestinal disorders
Gastritis
|
2.9%
8/273 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
1.1%
3/275 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
2.2%
6/273 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
2.9%
8/275 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
|
Gastrointestinal disorders
Gingival pain
|
2.9%
8/273 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
0.36%
1/275 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
|
Gastrointestinal disorders
Haemorrhoidal haemorrhage
|
1.8%
5/273 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
2.2%
6/275 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
|
Gastrointestinal disorders
Haemorrhoids
|
2.6%
7/273 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
3.6%
10/275 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
|
Gastrointestinal disorders
Nausea
|
31.5%
86/273 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
36.4%
100/275 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
|
Gastrointestinal disorders
Periodontal disease
|
1.8%
5/273 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
2.9%
8/275 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
|
Gastrointestinal disorders
Stomatitis
|
22.0%
60/273 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
21.5%
59/275 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
|
Gastrointestinal disorders
Vomiting
|
11.7%
32/273 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
10.2%
28/275 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
|
General disorders
Asthenia
|
2.9%
8/273 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
4.7%
13/275 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
|
General disorders
Fatigue
|
8.8%
24/273 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
11.3%
31/275 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
|
General disorders
Infusion site extravasation
|
3.3%
9/273 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
2.5%
7/275 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
|
General disorders
Malaise
|
26.4%
72/273 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
28.4%
78/275 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
|
General disorders
Oedema peripheral
|
5.9%
16/273 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
4.7%
13/275 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
|
General disorders
Pain
|
2.6%
7/273 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
1.8%
5/275 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
|
General disorders
Pyrexia
|
23.4%
64/273 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
14.9%
41/275 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
7.3%
20/273 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
3.3%
9/275 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
|
Infections and infestations
Bronchitis
|
3.3%
9/273 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
2.9%
8/275 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
|
Infections and infestations
Conjunctivitis
|
1.8%
5/273 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
2.2%
6/275 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
|
Infections and infestations
Gingivitis
|
1.8%
5/273 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
3.3%
9/275 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
|
Infections and infestations
Herpes zoster
|
1.8%
5/273 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
2.5%
7/275 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
|
Infections and infestations
Influenza
|
2.6%
7/273 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
1.5%
4/275 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
|
Infections and infestations
Nasopharyngitis
|
8.1%
22/273 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
6.9%
19/275 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
|
Infections and infestations
Paronychia
|
1.1%
3/273 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
2.5%
7/275 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
|
Infections and infestations
Periodontitis
|
4.4%
12/273 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
2.5%
7/275 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
|
Infections and infestations
Pharyngitis
|
4.8%
13/273 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
3.3%
9/275 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
|
Infections and infestations
Pneumonia
|
6.2%
17/273 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
4.7%
13/275 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
|
Infections and infestations
Rhinitis
|
2.2%
6/273 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
2.2%
6/275 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
|
Infections and infestations
Upper respiratory tract infection
|
8.8%
24/273 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
6.5%
18/275 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
|
Infections and infestations
Urinary tract infection
|
1.5%
4/273 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
3.6%
10/275 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
3.3%
9/273 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
2.2%
6/275 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
|
Investigations
Alanine aminotransferase increased
|
12.1%
33/273 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
12.7%
35/275 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
|
Investigations
Amylase increased
|
3.7%
10/273 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
0.00%
0/275 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
|
Investigations
Aspartate aminotransferase increased
|
13.6%
37/273 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
10.2%
28/275 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
|
Investigations
Blood alkaline phosphatase increased
|
3.7%
10/273 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
4.4%
12/275 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
|
Investigations
Blood bilirubin increased
|
2.6%
7/273 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
2.9%
8/275 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
|
Investigations
Blood creatine phosphokinase increased
|
1.5%
4/273 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
3.6%
10/275 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
|
Investigations
Blood creatinine increased
|
8.1%
22/273 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
6.5%
18/275 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
|
Investigations
Gamma-glutamyltransferase increased
|
8.4%
23/273 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
4.0%
11/275 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
|
Investigations
Lymphocyte count decreased
|
5.5%
15/273 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
3.3%
9/275 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
|
Investigations
Neutrophil count decreased
|
42.9%
117/273 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
51.3%
141/275 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
|
Investigations
Platelet count decreased
|
22.7%
62/273 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
24.4%
67/275 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
|
Investigations
Weight decreased
|
8.4%
23/273 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
5.8%
16/275 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
|
Investigations
White blood cell count decreased
|
34.4%
94/273 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
36.0%
99/275 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
35.9%
98/273 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
39.3%
108/275 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
|
Metabolism and nutrition disorders
Dehydration
|
1.5%
4/273 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
2.9%
8/275 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
4.4%
12/273 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
1.1%
3/275 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
4.8%
13/273 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
5.1%
14/275 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
4.0%
11/273 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
4.0%
11/275 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
6.6%
18/273 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
5.5%
15/275 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
4.0%
11/273 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
4.0%
11/275 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
5.1%
14/273 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
6.9%
19/275 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
26.4%
72/273 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
30.5%
84/275 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
1.8%
5/273 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
2.5%
7/275 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
9.5%
26/273 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
6.9%
19/275 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
2.6%
7/273 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
1.1%
3/275 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
1.5%
4/273 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
2.2%
6/275 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.37%
1/273 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
2.5%
7/275 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
4.0%
11/273 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
3.6%
10/275 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
27.8%
76/273 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
33.5%
92/275 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
3.7%
10/273 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
5.8%
16/275 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
|
Nervous system disorders
Dizziness
|
3.7%
10/273 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
7.6%
21/275 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
|
Nervous system disorders
Dysgeusia
|
12.1%
33/273 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
7.3%
20/275 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
|
Nervous system disorders
Headache
|
12.8%
35/273 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
10.2%
28/275 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
|
Nervous system disorders
Hypoaesthesia
|
3.7%
10/273 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
4.4%
12/275 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
|
Nervous system disorders
Neuropathy peripheral
|
21.6%
59/273 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
23.3%
64/275 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
|
Nervous system disorders
Paraesthesia
|
5.5%
15/273 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
6.5%
18/275 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
44.3%
121/273 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
42.2%
116/275 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
|
Nervous system disorders
Somnolence
|
0.37%
1/273 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
2.5%
7/275 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
|
Psychiatric disorders
Delirium
|
1.5%
4/273 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
2.5%
7/275 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
|
Psychiatric disorders
Insomnia
|
16.5%
45/273 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
17.8%
49/275 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
|
Renal and urinary disorders
Dysuria
|
0.73%
2/273 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
2.2%
6/275 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
|
Renal and urinary disorders
Proteinuria
|
24.5%
67/273 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
26.9%
74/275 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
|
Renal and urinary disorders
Renal impairment
|
2.2%
6/273 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
0.36%
1/275 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
7.7%
21/273 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
12.4%
34/275 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
2.9%
8/273 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
4.7%
13/275 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
3.3%
9/273 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
2.5%
7/275 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
18.7%
51/273 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
17.5%
48/275 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
4.0%
11/273 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
4.4%
12/275 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
16.5%
45/273 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
13.1%
36/275 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
5.1%
14/273 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
4.7%
13/275 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
2.2%
6/273 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
2.2%
6/275 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
4.8%
13/273 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
4.0%
11/275 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
2.2%
6/273 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
5.8%
16/275 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
52.4%
143/273 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
54.5%
150/275 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
|
Skin and subcutaneous tissue disorders
Dermatitis acneiform
|
8.4%
23/273 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
6.2%
17/275 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
|
Skin and subcutaneous tissue disorders
Drug eruption
|
2.6%
7/273 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
0.36%
1/275 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
11.7%
32/273 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
8.7%
24/275 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
2.2%
6/273 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
1.1%
3/275 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
22.3%
61/273 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
17.5%
48/275 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
|
Skin and subcutaneous tissue disorders
Rash
|
35.2%
96/273 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
17.5%
48/275 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
10.6%
29/273 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
5.1%
14/275 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
5.9%
16/273 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
2.5%
7/275 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
|
Vascular disorders
Hypertension
|
27.1%
74/273 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
32.4%
89/275 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
|
Vascular disorders
Hypotension
|
2.6%
7/273 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
|
3.3%
9/275 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
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Vascular disorders
Vasculitis
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2.6%
7/273 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
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4.0%
11/275 • For each randomised subject, adverse events(AEs) were collected from the start date of administration of the investigational product to 30 days after the last dose of any of the study treatment (The maximum was about 30 months). Drug-related AEs or AEs leading to discontinuation reported at the start of follow-up should be investigated at appropriate intervals until no further follow-up is required because the events have resolved or are resolving, or the symptoms become stable.
All-Cause Mortality indicates the number of patients who died by any cause (e.g. Primary disease) from the start of the study to data cut off (approximately 32 months). Overall Number of Participants Analyzed in efficacy and All-cause Mortality is among ITT, whereas the risk population (AEs) is among SAF. Above is the reason of the gap b/w 275 and 273. ITT: consist of all randomized subjects. SAF: consist of all subjects who received the investigational product or chemotherapy at least once.
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Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The Sponsor must have the opportunity to review all proposed abstracts, manuscripts or presentations regarding this tiral prior to submission for publication/presentation.
- Publication restrictions are in place
Restriction type: OTHER