Trial Outcomes & Findings for Efficacy and Safety Evaluation of Sintilimab in Patients With Advanced or Metastatic Non-squamous NSCLC (NCT NCT03607539)
NCT ID: NCT03607539
Last Updated: 2026-05-11
Results Overview
PFS was defined as the time from randomization to the first documented PD or death due to any cause, whichever occurred first. Per RECIST 1.1, PD was defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also have demonstrated an absolute increase of ≥5 mm. The appearance of one or more new lesions was also considered PD
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
397 participants
Primary outcome timeframe
Trough Database Cutoff Date of 15-Nov-2019 (Up to approximately 16 months)
Results posted on
2026-05-11
Participant Flow
Participant milestones
| Measure |
Sintilimab Combination
Sintilimab 200mg, pemetrexed 500mg/m2, cisplatin 75mg/m2 or carboplatin AUC 5 IV infusion q3w for 4 cycles, then sintilimab 200mg, pemetrexed 500mg/m2 IV infusion q3w
|
Placebo Combination
Placebo 200mg, pemetrexed 500mg/m2, cisplatin 75mg/m2 or carboplatin AUC 5 IV infusion q3w for 4 cycles, then placebo, pemetrexed 500mg/m2 IV infusion q3w
|
|---|---|---|
|
Overall Study
STARTED
|
266
|
131
|
|
Overall Study
COMPLETED
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
266
|
131
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Efficacy and Safety Evaluation of Sintilimab in Patients With Advanced or Metastatic Non-squamous NSCLC
Baseline characteristics by cohort
| Measure |
Sintilimab Combination
n=266 Participants
Sintilimab 200mg, pemetrexed 500mg/m2, cisplatin 75mg/m2 or carboplatin AUC 5 IV infusion q3w for 4 cycles, then sintilimab 200mg, pemetrexed 500mg/m2 IV infusion q3w
|
Placebo Combination
n=131 Participants
Placebo 200mg, pemetrexed 500mg/m2, cisplatin 75mg/m2 or carboplatin AUC 5 IV infusion q3w for 4 cycles, then placebo, pemetrexed 500mg/m2 IV infusion q3w
|
Total
n=397 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
59.9 Years
STANDARD_DEVIATION 8.35 • n=44 Participants
|
59.5 Years
STANDARD_DEVIATION 8.73 • n=10 Participants
|
59.8 Years
STANDARD_DEVIATION 8.47 • n=30 Participants
|
|
Sex: Female, Male
Female
|
62 Participants
n=44 Participants
|
32 Participants
n=10 Participants
|
94 Participants
n=30 Participants
|
|
Sex: Female, Male
Male
|
204 Participants
n=44 Participants
|
99 Participants
n=10 Participants
|
303 Participants
n=30 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=44 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=30 Participants
|
|
Race (NIH/OMB)
Asian
|
266 Participants
n=44 Participants
|
131 Participants
n=10 Participants
|
397 Participants
n=30 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=44 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=30 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=44 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=30 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=44 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=30 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=44 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=30 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=44 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=30 Participants
|
|
Programmed Cell Death-Ligand(PD-L1) Tumor Proportion Score(TPS)
PD-L1 <1% (measured by the tumor proportion score [TPS])
|
85 Participants
n=44 Participants
|
44 Participants
n=10 Participants
|
129 Participants
n=30 Participants
|
|
Programmed Cell Death-Ligand(PD-L1) Tumor Proportion Score(TPS)
PD-L1 ≥ 1% (measured by the tumor proportion score[TPS])
|
181 Participants
n=44 Participants
|
87 Participants
n=10 Participants
|
268 Participants
n=30 Participants
|
|
Platinum Chemotherapy
Cisplatin
|
71 Participants
n=44 Participants
|
33 Participants
n=10 Participants
|
104 Participants
n=30 Participants
|
|
Platinum Chemotherapy
Carboplatin
|
195 Participants
n=44 Participants
|
98 Participants
n=10 Participants
|
293 Participants
n=30 Participants
|
PRIMARY outcome
Timeframe: Trough Database Cutoff Date of 15-Nov-2019 (Up to approximately 16 months)Population: The analysis population consisted of all randomized participants.
PFS was defined as the time from randomization to the first documented PD or death due to any cause, whichever occurred first. Per RECIST 1.1, PD was defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also have demonstrated an absolute increase of ≥5 mm. The appearance of one or more new lesions was also considered PD
Outcome measures
| Measure |
Sintilimab Combination
n=266 Participants
Sintilimab 200mg, pemetrexed 500mg/m2, cisplatin 75mg/m2 or carboplatin AUC 5 IV infusion q3w for 4 cycles, then sintilimab 200mg, pemetrexed 500mg/m2 IV infusion q3w
|
Placebo Combination
n=131 Participants
Placebo 200mg, pemetrexed 500mg/m2, cisplatin 75mg/m2 or carboplatin AUC 5 IV infusion q3w for 4 cycles, then placebo, pemetrexed 500mg/m2 IV infusion q3w
|
|---|---|---|
|
Progression-Free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 as Assessed by Independent Radiographic Review Committee (IRRC)
|
8.9 Months
Interval 7.1 to 11.3
|
5.0 Months
Interval 4.8 to 6.2
|
SECONDARY outcome
Timeframe: Trough Database Cutoff Date of 15-Nov-2019 (Up to approximately 16 months)The analysis population consisted of all randomized participants.
Outcome measures
| Measure |
Sintilimab Combination
n=266 Participants
Sintilimab 200mg, pemetrexed 500mg/m2, cisplatin 75mg/m2 or carboplatin AUC 5 IV infusion q3w for 4 cycles, then sintilimab 200mg, pemetrexed 500mg/m2 IV infusion q3w
|
Placebo Combination
n=131 Participants
Placebo 200mg, pemetrexed 500mg/m2, cisplatin 75mg/m2 or carboplatin AUC 5 IV infusion q3w for 4 cycles, then placebo, pemetrexed 500mg/m2 IV infusion q3w
|
|---|---|---|
|
Overall Survival (OS)
|
NA Months
Median OS and OS range lower and upper limit of 95% CI not reached
|
NA Months
Interval 11.4 to
Median OS and OS range upper limit of 95% CI not reached
|
SECONDARY outcome
Timeframe: Trough Database Cutoff Date of 15-Nov-2019 (Up to approximately 16 months)ORR was defined as the percentage of participants in the analysis population who had a confirmed CR (disappearance of all lesions) or PR (at least a 30% decrease in the sum of diameters \[SOD\] of target lesions, taking as reference the baseline SOD) according to RECIST 1.1, which was modified for this study to follow a maximum of 10 target lesions and a maximum of 5 target lesions per organ. The percentage of participants who experienced a confirmed CR or PR according to RECIST 1.1 as assessed by IRC was reported as the ORR
Outcome measures
| Measure |
Sintilimab Combination
n=266 Participants
Sintilimab 200mg, pemetrexed 500mg/m2, cisplatin 75mg/m2 or carboplatin AUC 5 IV infusion q3w for 4 cycles, then sintilimab 200mg, pemetrexed 500mg/m2 IV infusion q3w
|
Placebo Combination
n=131 Participants
Placebo 200mg, pemetrexed 500mg/m2, cisplatin 75mg/m2 or carboplatin AUC 5 IV infusion q3w for 4 cycles, then placebo, pemetrexed 500mg/m2 IV infusion q3w
|
|---|---|---|
|
Objective Response Rate (ORR) by IRRC Assessment
|
51.9 Percentage of Participants
Interval 45.7 to 58.02
|
29.8 Percentage of Participants
Interval 22.1 to 38.38
|
SECONDARY outcome
Timeframe: Trough Database Cutoff Date of 15-Nov-2019 (Up to approximately 16 months)Population: The analysis population consisted of all randomized participants.
Outcome measures
| Measure |
Sintilimab Combination
n=266 Participants
Sintilimab 200mg, pemetrexed 500mg/m2, cisplatin 75mg/m2 or carboplatin AUC 5 IV infusion q3w for 4 cycles, then sintilimab 200mg, pemetrexed 500mg/m2 IV infusion q3w
|
Placebo Combination
n=131 Participants
Placebo 200mg, pemetrexed 500mg/m2, cisplatin 75mg/m2 or carboplatin AUC 5 IV infusion q3w for 4 cycles, then placebo, pemetrexed 500mg/m2 IV infusion q3w
|
|---|---|---|
|
Disease Control Rate (DCR) by IRRC Assessment
|
86.8 Percentage of Participants
Interval 82.18 to 90.66
|
75.6 Percentage of Participants
Interval 67.3 to 82.65
|
SECONDARY outcome
Timeframe: Trough Database Cutoff Date of 15-Nov-2019 (Up to approximately 16 months)Population: The analysis population consisted of all randomized participants.
TTR was defined as the time of participants from the first treatment administration to the first incidence of a confirmed CR (disappearance of all lesions) or PR (at least a 30% decrease in the sum of diameters \[SOD\] of target lesions, taking as reference the baseline SOD) according to RECIST 1.1, which was modified for this study to follow a maximum of 10 target lesions and a maximum of 5 target lesions per organ. The time from first treatment administration to the first incidence of treatment response was reported as the TTR
Outcome measures
| Measure |
Sintilimab Combination
n=266 Participants
Sintilimab 200mg, pemetrexed 500mg/m2, cisplatin 75mg/m2 or carboplatin AUC 5 IV infusion q3w for 4 cycles, then sintilimab 200mg, pemetrexed 500mg/m2 IV infusion q3w
|
Placebo Combination
n=131 Participants
Placebo 200mg, pemetrexed 500mg/m2, cisplatin 75mg/m2 or carboplatin AUC 5 IV infusion q3w for 4 cycles, then placebo, pemetrexed 500mg/m2 IV infusion q3w
|
|---|---|---|
|
Time to Response (TTR) by IRRC Assessment
|
1.51 Months
Interval 1.2 to 7.0
|
2.63 Months
Interval 1.2 to 5.1
|
SECONDARY outcome
Timeframe: From time of first documented evidence of CR or PR trough Database Cutoff Date of 15-Nov-2019 (Up to approximately 16 months)Population: The analysis population consisted of all randomized participants.
Outcome measures
| Measure |
Sintilimab Combination
n=266 Participants
Sintilimab 200mg, pemetrexed 500mg/m2, cisplatin 75mg/m2 or carboplatin AUC 5 IV infusion q3w for 4 cycles, then sintilimab 200mg, pemetrexed 500mg/m2 IV infusion q3w
|
Placebo Combination
n=131 Participants
Placebo 200mg, pemetrexed 500mg/m2, cisplatin 75mg/m2 or carboplatin AUC 5 IV infusion q3w for 4 cycles, then placebo, pemetrexed 500mg/m2 IV infusion q3w
|
|---|---|---|
|
Duration of Response (DOR) by IRRC Assessment
|
NA Months
Interval 7.98 to
Median DOR and DOR range upper limit of 95% CI not reached
|
5.52 Months
Interval 4.14 to 10.94
|
Adverse Events
Sintilimab Combination
Serious events: 75 serious events
Other events: 265 other events
Deaths: 51 deaths
Placebo Combination
Serious events: 39 serious events
Other events: 131 other events
Deaths: 39 deaths
Serious adverse events
| Measure |
Sintilimab Combination
n=266 participants at risk
Sintilimab 200mg, pemetrexed 500mg/m2, cisplatin 75mg/m2 or carboplatin AUC 5 IV infusion q3w for 4 cycles, then sintilimab 200mg, pemetrexed 500mg/m2 IV infusion q3w
|
Placebo Combination
n=131 participants at risk
Placebo 200mg, pemetrexed 500mg/m2, cisplatin 75mg/m2 or carboplatin AUC 5 IV infusion q3w for 4 cycles, then placebo, pemetrexed 500mg/m2 IV infusion q3w
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Immune-mediated pneumonitis
|
2.3%
6/266 • Trough Database Cutoff Date of 15-Nov-2019 (Up to approximately 16 months)
The incidence (frequency) and severity (according to NCI CTCAE Version 4.03) of adverse events (AEs). Population: All participants receiving ≥1 dose of randomized study drug. All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
|
0.76%
1/131 • Trough Database Cutoff Date of 15-Nov-2019 (Up to approximately 16 months)
The incidence (frequency) and severity (according to NCI CTCAE Version 4.03) of adverse events (AEs). Population: All participants receiving ≥1 dose of randomized study drug. All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
1.9%
5/266 • Trough Database Cutoff Date of 15-Nov-2019 (Up to approximately 16 months)
The incidence (frequency) and severity (according to NCI CTCAE Version 4.03) of adverse events (AEs). Population: All participants receiving ≥1 dose of randomized study drug. All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
|
0.00%
0/131 • Trough Database Cutoff Date of 15-Nov-2019 (Up to approximately 16 months)
The incidence (frequency) and severity (according to NCI CTCAE Version 4.03) of adverse events (AEs). Population: All participants receiving ≥1 dose of randomized study drug. All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
1.1%
3/266 • Trough Database Cutoff Date of 15-Nov-2019 (Up to approximately 16 months)
The incidence (frequency) and severity (according to NCI CTCAE Version 4.03) of adverse events (AEs). Population: All participants receiving ≥1 dose of randomized study drug. All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
|
0.00%
0/131 • Trough Database Cutoff Date of 15-Nov-2019 (Up to approximately 16 months)
The incidence (frequency) and severity (according to NCI CTCAE Version 4.03) of adverse events (AEs). Population: All participants receiving ≥1 dose of randomized study drug. All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
1.1%
3/266 • Trough Database Cutoff Date of 15-Nov-2019 (Up to approximately 16 months)
The incidence (frequency) and severity (according to NCI CTCAE Version 4.03) of adverse events (AEs). Population: All participants receiving ≥1 dose of randomized study drug. All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
|
0.00%
0/131 • Trough Database Cutoff Date of 15-Nov-2019 (Up to approximately 16 months)
The incidence (frequency) and severity (according to NCI CTCAE Version 4.03) of adverse events (AEs). Population: All participants receiving ≥1 dose of randomized study drug. All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease
|
0.75%
2/266 • Trough Database Cutoff Date of 15-Nov-2019 (Up to approximately 16 months)
The incidence (frequency) and severity (according to NCI CTCAE Version 4.03) of adverse events (AEs). Population: All participants receiving ≥1 dose of randomized study drug. All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
|
0.76%
1/131 • Trough Database Cutoff Date of 15-Nov-2019 (Up to approximately 16 months)
The incidence (frequency) and severity (according to NCI CTCAE Version 4.03) of adverse events (AEs). Population: All participants receiving ≥1 dose of randomized study drug. All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.75%
2/266 • Trough Database Cutoff Date of 15-Nov-2019 (Up to approximately 16 months)
The incidence (frequency) and severity (according to NCI CTCAE Version 4.03) of adverse events (AEs). Population: All participants receiving ≥1 dose of randomized study drug. All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
|
0.00%
0/131 • Trough Database Cutoff Date of 15-Nov-2019 (Up to approximately 16 months)
The incidence (frequency) and severity (according to NCI CTCAE Version 4.03) of adverse events (AEs). Population: All participants receiving ≥1 dose of randomized study drug. All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
|
|
Respiratory, thoracic and mediastinal disorders
Asphyxia
|
0.38%
1/266 • Trough Database Cutoff Date of 15-Nov-2019 (Up to approximately 16 months)
The incidence (frequency) and severity (according to NCI CTCAE Version 4.03) of adverse events (AEs). Population: All participants receiving ≥1 dose of randomized study drug. All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
|
0.00%
0/131 • Trough Database Cutoff Date of 15-Nov-2019 (Up to approximately 16 months)
The incidence (frequency) and severity (according to NCI CTCAE Version 4.03) of adverse events (AEs). Population: All participants receiving ≥1 dose of randomized study drug. All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchitis chronic
|
0.38%
1/266 • Trough Database Cutoff Date of 15-Nov-2019 (Up to approximately 16 months)
The incidence (frequency) and severity (according to NCI CTCAE Version 4.03) of adverse events (AEs). Population: All participants receiving ≥1 dose of randomized study drug. All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
|
0.00%
0/131 • Trough Database Cutoff Date of 15-Nov-2019 (Up to approximately 16 months)
The incidence (frequency) and severity (according to NCI CTCAE Version 4.03) of adverse events (AEs). Population: All participants receiving ≥1 dose of randomized study drug. All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
0.38%
1/266 • Trough Database Cutoff Date of 15-Nov-2019 (Up to approximately 16 months)
The incidence (frequency) and severity (according to NCI CTCAE Version 4.03) of adverse events (AEs). Population: All participants receiving ≥1 dose of randomized study drug. All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
|
0.00%
0/131 • Trough Database Cutoff Date of 15-Nov-2019 (Up to approximately 16 months)
The incidence (frequency) and severity (according to NCI CTCAE Version 4.03) of adverse events (AEs). Population: All participants receiving ≥1 dose of randomized study drug. All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
|
|
Respiratory, thoracic and mediastinal disorders
Obstructive airways disorder
|
0.38%
1/266 • Trough Database Cutoff Date of 15-Nov-2019 (Up to approximately 16 months)
The incidence (frequency) and severity (according to NCI CTCAE Version 4.03) of adverse events (AEs). Population: All participants receiving ≥1 dose of randomized study drug. All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
|
0.00%
0/131 • Trough Database Cutoff Date of 15-Nov-2019 (Up to approximately 16 months)
The incidence (frequency) and severity (according to NCI CTCAE Version 4.03) of adverse events (AEs). Population: All participants receiving ≥1 dose of randomized study drug. All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.38%
1/266 • Trough Database Cutoff Date of 15-Nov-2019 (Up to approximately 16 months)
The incidence (frequency) and severity (according to NCI CTCAE Version 4.03) of adverse events (AEs). Population: All participants receiving ≥1 dose of randomized study drug. All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
|
0.00%
0/131 • Trough Database Cutoff Date of 15-Nov-2019 (Up to approximately 16 months)
The incidence (frequency) and severity (according to NCI CTCAE Version 4.03) of adverse events (AEs). Population: All participants receiving ≥1 dose of randomized study drug. All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
|
|
General disorders
Chest pain
|
0.38%
1/266 • Trough Database Cutoff Date of 15-Nov-2019 (Up to approximately 16 months)
The incidence (frequency) and severity (according to NCI CTCAE Version 4.03) of adverse events (AEs). Population: All participants receiving ≥1 dose of randomized study drug. All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
|
0.00%
0/131 • Trough Database Cutoff Date of 15-Nov-2019 (Up to approximately 16 months)
The incidence (frequency) and severity (according to NCI CTCAE Version 4.03) of adverse events (AEs). Population: All participants receiving ≥1 dose of randomized study drug. All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/266 • Trough Database Cutoff Date of 15-Nov-2019 (Up to approximately 16 months)
The incidence (frequency) and severity (according to NCI CTCAE Version 4.03) of adverse events (AEs). Population: All participants receiving ≥1 dose of randomized study drug. All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
|
0.76%
1/131 • Trough Database Cutoff Date of 15-Nov-2019 (Up to approximately 16 months)
The incidence (frequency) and severity (according to NCI CTCAE Version 4.03) of adverse events (AEs). Population: All participants receiving ≥1 dose of randomized study drug. All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
|
|
Investigations
Platelet count decreased
|
4.5%
12/266 • Trough Database Cutoff Date of 15-Nov-2019 (Up to approximately 16 months)
The incidence (frequency) and severity (according to NCI CTCAE Version 4.03) of adverse events (AEs). Population: All participants receiving ≥1 dose of randomized study drug. All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
|
6.1%
8/131 • Trough Database Cutoff Date of 15-Nov-2019 (Up to approximately 16 months)
The incidence (frequency) and severity (according to NCI CTCAE Version 4.03) of adverse events (AEs). Population: All participants receiving ≥1 dose of randomized study drug. All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
|
|
Investigations
Lymphocyte count decreased
|
1.1%
3/266 • Trough Database Cutoff Date of 15-Nov-2019 (Up to approximately 16 months)
The incidence (frequency) and severity (according to NCI CTCAE Version 4.03) of adverse events (AEs). Population: All participants receiving ≥1 dose of randomized study drug. All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
|
0.00%
0/131 • Trough Database Cutoff Date of 15-Nov-2019 (Up to approximately 16 months)
The incidence (frequency) and severity (according to NCI CTCAE Version 4.03) of adverse events (AEs). Population: All participants receiving ≥1 dose of randomized study drug. All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
|
|
Investigations
Neutrophil count decreased
|
1.1%
3/266 • Trough Database Cutoff Date of 15-Nov-2019 (Up to approximately 16 months)
The incidence (frequency) and severity (according to NCI CTCAE Version 4.03) of adverse events (AEs). Population: All participants receiving ≥1 dose of randomized study drug. All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
|
1.5%
2/131 • Trough Database Cutoff Date of 15-Nov-2019 (Up to approximately 16 months)
The incidence (frequency) and severity (according to NCI CTCAE Version 4.03) of adverse events (AEs). Population: All participants receiving ≥1 dose of randomized study drug. All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
|
|
Investigations
White blood cell count decreased
|
1.1%
3/266 • Trough Database Cutoff Date of 15-Nov-2019 (Up to approximately 16 months)
The incidence (frequency) and severity (according to NCI CTCAE Version 4.03) of adverse events (AEs). Population: All participants receiving ≥1 dose of randomized study drug. All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
|
1.5%
2/131 • Trough Database Cutoff Date of 15-Nov-2019 (Up to approximately 16 months)
The incidence (frequency) and severity (according to NCI CTCAE Version 4.03) of adverse events (AEs). Population: All participants receiving ≥1 dose of randomized study drug. All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
|
|
Investigations
Acid base balance abnormal
|
0.38%
1/266 • Trough Database Cutoff Date of 15-Nov-2019 (Up to approximately 16 months)
The incidence (frequency) and severity (according to NCI CTCAE Version 4.03) of adverse events (AEs). Population: All participants receiving ≥1 dose of randomized study drug. All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
|
0.00%
0/131 • Trough Database Cutoff Date of 15-Nov-2019 (Up to approximately 16 months)
The incidence (frequency) and severity (according to NCI CTCAE Version 4.03) of adverse events (AEs). Population: All participants receiving ≥1 dose of randomized study drug. All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
|
|
Investigations
Alanine aminotransferase increased
|
0.38%
1/266 • Trough Database Cutoff Date of 15-Nov-2019 (Up to approximately 16 months)
The incidence (frequency) and severity (according to NCI CTCAE Version 4.03) of adverse events (AEs). Population: All participants receiving ≥1 dose of randomized study drug. All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
|
0.00%
0/131 • Trough Database Cutoff Date of 15-Nov-2019 (Up to approximately 16 months)
The incidence (frequency) and severity (according to NCI CTCAE Version 4.03) of adverse events (AEs). Population: All participants receiving ≥1 dose of randomized study drug. All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
|
|
Investigations
Aspartate aminotransferase increased
|
0.38%
1/266 • Trough Database Cutoff Date of 15-Nov-2019 (Up to approximately 16 months)
The incidence (frequency) and severity (according to NCI CTCAE Version 4.03) of adverse events (AEs). Population: All participants receiving ≥1 dose of randomized study drug. All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
|
0.00%
0/131 • Trough Database Cutoff Date of 15-Nov-2019 (Up to approximately 16 months)
The incidence (frequency) and severity (according to NCI CTCAE Version 4.03) of adverse events (AEs). Population: All participants receiving ≥1 dose of randomized study drug. All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
|
|
Investigations
Eosinophil count increased
|
0.38%
1/266 • Trough Database Cutoff Date of 15-Nov-2019 (Up to approximately 16 months)
The incidence (frequency) and severity (according to NCI CTCAE Version 4.03) of adverse events (AEs). Population: All participants receiving ≥1 dose of randomized study drug. All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
|
0.00%
0/131 • Trough Database Cutoff Date of 15-Nov-2019 (Up to approximately 16 months)
The incidence (frequency) and severity (according to NCI CTCAE Version 4.03) of adverse events (AEs). Population: All participants receiving ≥1 dose of randomized study drug. All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
|
|
Investigations
Gamma-glutamyltransferase increased
|
0.38%
1/266 • Trough Database Cutoff Date of 15-Nov-2019 (Up to approximately 16 months)
The incidence (frequency) and severity (according to NCI CTCAE Version 4.03) of adverse events (AEs). Population: All participants receiving ≥1 dose of randomized study drug. All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
|
0.00%
0/131 • Trough Database Cutoff Date of 15-Nov-2019 (Up to approximately 16 months)
The incidence (frequency) and severity (according to NCI CTCAE Version 4.03) of adverse events (AEs). Population: All participants receiving ≥1 dose of randomized study drug. All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
|
|
Investigations
Haemoglobin decreased
|
0.38%
1/266 • Trough Database Cutoff Date of 15-Nov-2019 (Up to approximately 16 months)
The incidence (frequency) and severity (according to NCI CTCAE Version 4.03) of adverse events (AEs). Population: All participants receiving ≥1 dose of randomized study drug. All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
|
0.00%
0/131 • Trough Database Cutoff Date of 15-Nov-2019 (Up to approximately 16 months)
The incidence (frequency) and severity (according to NCI CTCAE Version 4.03) of adverse events (AEs). Population: All participants receiving ≥1 dose of randomized study drug. All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
|
|
Investigations
Troponin I increased
|
0.38%
1/266 • Trough Database Cutoff Date of 15-Nov-2019 (Up to approximately 16 months)
The incidence (frequency) and severity (according to NCI CTCAE Version 4.03) of adverse events (AEs). Population: All participants receiving ≥1 dose of randomized study drug. All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
|
0.00%
0/131 • Trough Database Cutoff Date of 15-Nov-2019 (Up to approximately 16 months)
The incidence (frequency) and severity (according to NCI CTCAE Version 4.03) of adverse events (AEs). Population: All participants receiving ≥1 dose of randomized study drug. All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/266 • Trough Database Cutoff Date of 15-Nov-2019 (Up to approximately 16 months)
The incidence (frequency) and severity (according to NCI CTCAE Version 4.03) of adverse events (AEs). Population: All participants receiving ≥1 dose of randomized study drug. All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
|
0.76%
1/131 • Trough Database Cutoff Date of 15-Nov-2019 (Up to approximately 16 months)
The incidence (frequency) and severity (according to NCI CTCAE Version 4.03) of adverse events (AEs). Population: All participants receiving ≥1 dose of randomized study drug. All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
|
|
Blood and lymphatic system disorders
Anaemia
|
4.5%
12/266 • Trough Database Cutoff Date of 15-Nov-2019 (Up to approximately 16 months)
The incidence (frequency) and severity (according to NCI CTCAE Version 4.03) of adverse events (AEs). Population: All participants receiving ≥1 dose of randomized study drug. All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
|
3.1%
4/131 • Trough Database Cutoff Date of 15-Nov-2019 (Up to approximately 16 months)
The incidence (frequency) and severity (according to NCI CTCAE Version 4.03) of adverse events (AEs). Population: All participants receiving ≥1 dose of randomized study drug. All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.75%
2/266 • Trough Database Cutoff Date of 15-Nov-2019 (Up to approximately 16 months)
The incidence (frequency) and severity (according to NCI CTCAE Version 4.03) of adverse events (AEs). Population: All participants receiving ≥1 dose of randomized study drug. All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
|
0.00%
0/131 • Trough Database Cutoff Date of 15-Nov-2019 (Up to approximately 16 months)
The incidence (frequency) and severity (according to NCI CTCAE Version 4.03) of adverse events (AEs). Population: All participants receiving ≥1 dose of randomized study drug. All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.38%
1/266 • Trough Database Cutoff Date of 15-Nov-2019 (Up to approximately 16 months)
The incidence (frequency) and severity (according to NCI CTCAE Version 4.03) of adverse events (AEs). Population: All participants receiving ≥1 dose of randomized study drug. All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
|
0.00%
0/131 • Trough Database Cutoff Date of 15-Nov-2019 (Up to approximately 16 months)
The incidence (frequency) and severity (according to NCI CTCAE Version 4.03) of adverse events (AEs). Population: All participants receiving ≥1 dose of randomized study drug. All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.38%
1/266 • Trough Database Cutoff Date of 15-Nov-2019 (Up to approximately 16 months)
The incidence (frequency) and severity (according to NCI CTCAE Version 4.03) of adverse events (AEs). Population: All participants receiving ≥1 dose of randomized study drug. All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
|
0.00%
0/131 • Trough Database Cutoff Date of 15-Nov-2019 (Up to approximately 16 months)
The incidence (frequency) and severity (according to NCI CTCAE Version 4.03) of adverse events (AEs). Population: All participants receiving ≥1 dose of randomized study drug. All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
|
|
Infections and infestations
Pneumonia
|
2.6%
7/266 • Trough Database Cutoff Date of 15-Nov-2019 (Up to approximately 16 months)
The incidence (frequency) and severity (according to NCI CTCAE Version 4.03) of adverse events (AEs). Population: All participants receiving ≥1 dose of randomized study drug. All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
|
4.6%
6/131 • Trough Database Cutoff Date of 15-Nov-2019 (Up to approximately 16 months)
The incidence (frequency) and severity (according to NCI CTCAE Version 4.03) of adverse events (AEs). Population: All participants receiving ≥1 dose of randomized study drug. All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
|
|
Infections and infestations
Erysipelas
|
0.38%
1/266 • Trough Database Cutoff Date of 15-Nov-2019 (Up to approximately 16 months)
The incidence (frequency) and severity (according to NCI CTCAE Version 4.03) of adverse events (AEs). Population: All participants receiving ≥1 dose of randomized study drug. All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
|
0.00%
0/131 • Trough Database Cutoff Date of 15-Nov-2019 (Up to approximately 16 months)
The incidence (frequency) and severity (according to NCI CTCAE Version 4.03) of adverse events (AEs). Population: All participants receiving ≥1 dose of randomized study drug. All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
|
|
Infections and infestations
Febrile infection
|
0.38%
1/266 • Trough Database Cutoff Date of 15-Nov-2019 (Up to approximately 16 months)
The incidence (frequency) and severity (according to NCI CTCAE Version 4.03) of adverse events (AEs). Population: All participants receiving ≥1 dose of randomized study drug. All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
|
0.00%
0/131 • Trough Database Cutoff Date of 15-Nov-2019 (Up to approximately 16 months)
The incidence (frequency) and severity (according to NCI CTCAE Version 4.03) of adverse events (AEs). Population: All participants receiving ≥1 dose of randomized study drug. All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
|
|
Infections and infestations
Gastrointestinal infection
|
0.38%
1/266 • Trough Database Cutoff Date of 15-Nov-2019 (Up to approximately 16 months)
The incidence (frequency) and severity (according to NCI CTCAE Version 4.03) of adverse events (AEs). Population: All participants receiving ≥1 dose of randomized study drug. All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
|
0.00%
0/131 • Trough Database Cutoff Date of 15-Nov-2019 (Up to approximately 16 months)
The incidence (frequency) and severity (according to NCI CTCAE Version 4.03) of adverse events (AEs). Population: All participants receiving ≥1 dose of randomized study drug. All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
|
|
Infections and infestations
Herpes zoster
|
0.38%
1/266 • Trough Database Cutoff Date of 15-Nov-2019 (Up to approximately 16 months)
The incidence (frequency) and severity (according to NCI CTCAE Version 4.03) of adverse events (AEs). Population: All participants receiving ≥1 dose of randomized study drug. All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
|
0.00%
0/131 • Trough Database Cutoff Date of 15-Nov-2019 (Up to approximately 16 months)
The incidence (frequency) and severity (according to NCI CTCAE Version 4.03) of adverse events (AEs). Population: All participants receiving ≥1 dose of randomized study drug. All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
|
|
Infections and infestations
Purulent pericarditis
|
0.38%
1/266 • Trough Database Cutoff Date of 15-Nov-2019 (Up to approximately 16 months)
The incidence (frequency) and severity (according to NCI CTCAE Version 4.03) of adverse events (AEs). Population: All participants receiving ≥1 dose of randomized study drug. All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
|
0.00%
0/131 • Trough Database Cutoff Date of 15-Nov-2019 (Up to approximately 16 months)
The incidence (frequency) and severity (according to NCI CTCAE Version 4.03) of adverse events (AEs). Population: All participants receiving ≥1 dose of randomized study drug. All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
|
|
Infections and infestations
Respiratory tract infection
|
0.38%
1/266 • Trough Database Cutoff Date of 15-Nov-2019 (Up to approximately 16 months)
The incidence (frequency) and severity (according to NCI CTCAE Version 4.03) of adverse events (AEs). Population: All participants receiving ≥1 dose of randomized study drug. All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
|
0.00%
0/131 • Trough Database Cutoff Date of 15-Nov-2019 (Up to approximately 16 months)
The incidence (frequency) and severity (according to NCI CTCAE Version 4.03) of adverse events (AEs). Population: All participants receiving ≥1 dose of randomized study drug. All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
|
|
Infections and infestations
Enteritis infectious
|
0.00%
0/266 • Trough Database Cutoff Date of 15-Nov-2019 (Up to approximately 16 months)
The incidence (frequency) and severity (according to NCI CTCAE Version 4.03) of adverse events (AEs). Population: All participants receiving ≥1 dose of randomized study drug. All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
|
0.76%
1/131 • Trough Database Cutoff Date of 15-Nov-2019 (Up to approximately 16 months)
The incidence (frequency) and severity (according to NCI CTCAE Version 4.03) of adverse events (AEs). Population: All participants receiving ≥1 dose of randomized study drug. All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
|
|
Infections and infestations
Infectious pleural effusion
|
0.00%
0/266 • Trough Database Cutoff Date of 15-Nov-2019 (Up to approximately 16 months)
The incidence (frequency) and severity (according to NCI CTCAE Version 4.03) of adverse events (AEs). Population: All participants receiving ≥1 dose of randomized study drug. All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
|
0.76%
1/131 • Trough Database Cutoff Date of 15-Nov-2019 (Up to approximately 16 months)
The incidence (frequency) and severity (according to NCI CTCAE Version 4.03) of adverse events (AEs). Population: All participants receiving ≥1 dose of randomized study drug. All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
|
|
Infections and infestations
Myelitis
|
0.00%
0/266 • Trough Database Cutoff Date of 15-Nov-2019 (Up to approximately 16 months)
The incidence (frequency) and severity (according to NCI CTCAE Version 4.03) of adverse events (AEs). Population: All participants receiving ≥1 dose of randomized study drug. All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
|
0.76%
1/131 • Trough Database Cutoff Date of 15-Nov-2019 (Up to approximately 16 months)
The incidence (frequency) and severity (according to NCI CTCAE Version 4.03) of adverse events (AEs). Population: All participants receiving ≥1 dose of randomized study drug. All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
|
|
Infections and infestations
Peripheral nerve infection
|
0.00%
0/266 • Trough Database Cutoff Date of 15-Nov-2019 (Up to approximately 16 months)
The incidence (frequency) and severity (according to NCI CTCAE Version 4.03) of adverse events (AEs). Population: All participants receiving ≥1 dose of randomized study drug. All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
|
0.76%
1/131 • Trough Database Cutoff Date of 15-Nov-2019 (Up to approximately 16 months)
The incidence (frequency) and severity (according to NCI CTCAE Version 4.03) of adverse events (AEs). Population: All participants receiving ≥1 dose of randomized study drug. All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/266 • Trough Database Cutoff Date of 15-Nov-2019 (Up to approximately 16 months)
The incidence (frequency) and severity (according to NCI CTCAE Version 4.03) of adverse events (AEs). Population: All participants receiving ≥1 dose of randomized study drug. All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
|
0.76%
1/131 • Trough Database Cutoff Date of 15-Nov-2019 (Up to approximately 16 months)
The incidence (frequency) and severity (according to NCI CTCAE Version 4.03) of adverse events (AEs). Population: All participants receiving ≥1 dose of randomized study drug. All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/266 • Trough Database Cutoff Date of 15-Nov-2019 (Up to approximately 16 months)
The incidence (frequency) and severity (according to NCI CTCAE Version 4.03) of adverse events (AEs). Population: All participants receiving ≥1 dose of randomized study drug. All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
|
1.5%
2/131 • Trough Database Cutoff Date of 15-Nov-2019 (Up to approximately 16 months)
The incidence (frequency) and severity (according to NCI CTCAE Version 4.03) of adverse events (AEs). Population: All participants receiving ≥1 dose of randomized study drug. All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
|
|
Gastrointestinal disorders
Nausea
|
1.1%
3/266 • Trough Database Cutoff Date of 15-Nov-2019 (Up to approximately 16 months)
The incidence (frequency) and severity (according to NCI CTCAE Version 4.03) of adverse events (AEs). Population: All participants receiving ≥1 dose of randomized study drug. All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
|
0.00%
0/131 • Trough Database Cutoff Date of 15-Nov-2019 (Up to approximately 16 months)
The incidence (frequency) and severity (according to NCI CTCAE Version 4.03) of adverse events (AEs). Population: All participants receiving ≥1 dose of randomized study drug. All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.75%
2/266 • Trough Database Cutoff Date of 15-Nov-2019 (Up to approximately 16 months)
The incidence (frequency) and severity (according to NCI CTCAE Version 4.03) of adverse events (AEs). Population: All participants receiving ≥1 dose of randomized study drug. All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
|
0.00%
0/131 • Trough Database Cutoff Date of 15-Nov-2019 (Up to approximately 16 months)
The incidence (frequency) and severity (according to NCI CTCAE Version 4.03) of adverse events (AEs). Population: All participants receiving ≥1 dose of randomized study drug. All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
0.75%
2/266 • Trough Database Cutoff Date of 15-Nov-2019 (Up to approximately 16 months)
The incidence (frequency) and severity (according to NCI CTCAE Version 4.03) of adverse events (AEs). Population: All participants receiving ≥1 dose of randomized study drug. All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
|
0.00%
0/131 • Trough Database Cutoff Date of 15-Nov-2019 (Up to approximately 16 months)
The incidence (frequency) and severity (according to NCI CTCAE Version 4.03) of adverse events (AEs). Population: All participants receiving ≥1 dose of randomized study drug. All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
|
|
Gastrointestinal disorders
Vomiting
|
0.75%
2/266 • Trough Database Cutoff Date of 15-Nov-2019 (Up to approximately 16 months)
The incidence (frequency) and severity (according to NCI CTCAE Version 4.03) of adverse events (AEs). Population: All participants receiving ≥1 dose of randomized study drug. All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
|
0.00%
0/131 • Trough Database Cutoff Date of 15-Nov-2019 (Up to approximately 16 months)
The incidence (frequency) and severity (according to NCI CTCAE Version 4.03) of adverse events (AEs). Population: All participants receiving ≥1 dose of randomized study drug. All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.38%
1/266 • Trough Database Cutoff Date of 15-Nov-2019 (Up to approximately 16 months)
The incidence (frequency) and severity (according to NCI CTCAE Version 4.03) of adverse events (AEs). Population: All participants receiving ≥1 dose of randomized study drug. All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
|
0.00%
0/131 • Trough Database Cutoff Date of 15-Nov-2019 (Up to approximately 16 months)
The incidence (frequency) and severity (according to NCI CTCAE Version 4.03) of adverse events (AEs). Population: All participants receiving ≥1 dose of randomized study drug. All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.38%
1/266 • Trough Database Cutoff Date of 15-Nov-2019 (Up to approximately 16 months)
The incidence (frequency) and severity (according to NCI CTCAE Version 4.03) of adverse events (AEs). Population: All participants receiving ≥1 dose of randomized study drug. All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
|
0.00%
0/131 • Trough Database Cutoff Date of 15-Nov-2019 (Up to approximately 16 months)
The incidence (frequency) and severity (according to NCI CTCAE Version 4.03) of adverse events (AEs). Population: All participants receiving ≥1 dose of randomized study drug. All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/266 • Trough Database Cutoff Date of 15-Nov-2019 (Up to approximately 16 months)
The incidence (frequency) and severity (according to NCI CTCAE Version 4.03) of adverse events (AEs). Population: All participants receiving ≥1 dose of randomized study drug. All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
|
0.76%
1/131 • Trough Database Cutoff Date of 15-Nov-2019 (Up to approximately 16 months)
The incidence (frequency) and severity (according to NCI CTCAE Version 4.03) of adverse events (AEs). Population: All participants receiving ≥1 dose of randomized study drug. All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
|
|
Cardiac disorders
Atrial fibrillation
|
0.75%
2/266 • Trough Database Cutoff Date of 15-Nov-2019 (Up to approximately 16 months)
The incidence (frequency) and severity (according to NCI CTCAE Version 4.03) of adverse events (AEs). Population: All participants receiving ≥1 dose of randomized study drug. All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
|
0.00%
0/131 • Trough Database Cutoff Date of 15-Nov-2019 (Up to approximately 16 months)
The incidence (frequency) and severity (according to NCI CTCAE Version 4.03) of adverse events (AEs). Population: All participants receiving ≥1 dose of randomized study drug. All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
|
|
Cardiac disorders
Cardiac failure
|
0.75%
2/266 • Trough Database Cutoff Date of 15-Nov-2019 (Up to approximately 16 months)
The incidence (frequency) and severity (according to NCI CTCAE Version 4.03) of adverse events (AEs). Population: All participants receiving ≥1 dose of randomized study drug. All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
|
0.76%
1/131 • Trough Database Cutoff Date of 15-Nov-2019 (Up to approximately 16 months)
The incidence (frequency) and severity (according to NCI CTCAE Version 4.03) of adverse events (AEs). Population: All participants receiving ≥1 dose of randomized study drug. All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
|
|
Cardiac disorders
Cardiovascular disorder
|
0.38%
1/266 • Trough Database Cutoff Date of 15-Nov-2019 (Up to approximately 16 months)
The incidence (frequency) and severity (according to NCI CTCAE Version 4.03) of adverse events (AEs). Population: All participants receiving ≥1 dose of randomized study drug. All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
|
0.00%
0/131 • Trough Database Cutoff Date of 15-Nov-2019 (Up to approximately 16 months)
The incidence (frequency) and severity (according to NCI CTCAE Version 4.03) of adverse events (AEs). Population: All participants receiving ≥1 dose of randomized study drug. All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
|
|
Cardiac disorders
Immune-mediated myocarditis
|
0.38%
1/266 • Trough Database Cutoff Date of 15-Nov-2019 (Up to approximately 16 months)
The incidence (frequency) and severity (according to NCI CTCAE Version 4.03) of adverse events (AEs). Population: All participants receiving ≥1 dose of randomized study drug. All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
|
0.00%
0/131 • Trough Database Cutoff Date of 15-Nov-2019 (Up to approximately 16 months)
The incidence (frequency) and severity (according to NCI CTCAE Version 4.03) of adverse events (AEs). Population: All participants receiving ≥1 dose of randomized study drug. All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
|
|
Cardiac disorders
Pericardial effusion
|
0.38%
1/266 • Trough Database Cutoff Date of 15-Nov-2019 (Up to approximately 16 months)
The incidence (frequency) and severity (according to NCI CTCAE Version 4.03) of adverse events (AEs). Population: All participants receiving ≥1 dose of randomized study drug. All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
|
0.00%
0/131 • Trough Database Cutoff Date of 15-Nov-2019 (Up to approximately 16 months)
The incidence (frequency) and severity (according to NCI CTCAE Version 4.03) of adverse events (AEs). Population: All participants receiving ≥1 dose of randomized study drug. All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.38%
1/266 • Trough Database Cutoff Date of 15-Nov-2019 (Up to approximately 16 months)
The incidence (frequency) and severity (according to NCI CTCAE Version 4.03) of adverse events (AEs). Population: All participants receiving ≥1 dose of randomized study drug. All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
|
0.00%
0/131 • Trough Database Cutoff Date of 15-Nov-2019 (Up to approximately 16 months)
The incidence (frequency) and severity (according to NCI CTCAE Version 4.03) of adverse events (AEs). Population: All participants receiving ≥1 dose of randomized study drug. All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
|
|
Cardiac disorders
Palpitations
|
0.00%
0/266 • Trough Database Cutoff Date of 15-Nov-2019 (Up to approximately 16 months)
The incidence (frequency) and severity (according to NCI CTCAE Version 4.03) of adverse events (AEs). Population: All participants receiving ≥1 dose of randomized study drug. All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
|
0.76%
1/131 • Trough Database Cutoff Date of 15-Nov-2019 (Up to approximately 16 months)
The incidence (frequency) and severity (according to NCI CTCAE Version 4.03) of adverse events (AEs). Population: All participants receiving ≥1 dose of randomized study drug. All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
|
|
Cardiac disorders
Pericarditis constrictive
|
0.00%
0/266 • Trough Database Cutoff Date of 15-Nov-2019 (Up to approximately 16 months)
The incidence (frequency) and severity (according to NCI CTCAE Version 4.03) of adverse events (AEs). Population: All participants receiving ≥1 dose of randomized study drug. All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
|
0.76%
1/131 • Trough Database Cutoff Date of 15-Nov-2019 (Up to approximately 16 months)
The incidence (frequency) and severity (according to NCI CTCAE Version 4.03) of adverse events (AEs). Population: All participants receiving ≥1 dose of randomized study drug. All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
|
|
General disorders
Asthenia
|
0.38%
1/266 • Trough Database Cutoff Date of 15-Nov-2019 (Up to approximately 16 months)
The incidence (frequency) and severity (according to NCI CTCAE Version 4.03) of adverse events (AEs). Population: All participants receiving ≥1 dose of randomized study drug. All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
|
0.00%
0/131 • Trough Database Cutoff Date of 15-Nov-2019 (Up to approximately 16 months)
The incidence (frequency) and severity (according to NCI CTCAE Version 4.03) of adverse events (AEs). Population: All participants receiving ≥1 dose of randomized study drug. All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
|
|
General disorders
Chest discomfort
|
0.38%
1/266 • Trough Database Cutoff Date of 15-Nov-2019 (Up to approximately 16 months)
The incidence (frequency) and severity (according to NCI CTCAE Version 4.03) of adverse events (AEs). Population: All participants receiving ≥1 dose of randomized study drug. All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
|
0.00%
0/131 • Trough Database Cutoff Date of 15-Nov-2019 (Up to approximately 16 months)
The incidence (frequency) and severity (according to NCI CTCAE Version 4.03) of adverse events (AEs). Population: All participants receiving ≥1 dose of randomized study drug. All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
|
|
General disorders
Oedema peripheral
|
0.38%
1/266 • Trough Database Cutoff Date of 15-Nov-2019 (Up to approximately 16 months)
The incidence (frequency) and severity (according to NCI CTCAE Version 4.03) of adverse events (AEs). Population: All participants receiving ≥1 dose of randomized study drug. All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
|
0.00%
0/131 • Trough Database Cutoff Date of 15-Nov-2019 (Up to approximately 16 months)
The incidence (frequency) and severity (according to NCI CTCAE Version 4.03) of adverse events (AEs). Population: All participants receiving ≥1 dose of randomized study drug. All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
|
|
General disorders
Pyrexia
|
0.38%
1/266 • Trough Database Cutoff Date of 15-Nov-2019 (Up to approximately 16 months)
The incidence (frequency) and severity (according to NCI CTCAE Version 4.03) of adverse events (AEs). Population: All participants receiving ≥1 dose of randomized study drug. All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
|
0.76%
1/131 • Trough Database Cutoff Date of 15-Nov-2019 (Up to approximately 16 months)
The incidence (frequency) and severity (according to NCI CTCAE Version 4.03) of adverse events (AEs). Population: All participants receiving ≥1 dose of randomized study drug. All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
1.9%
5/266 • Trough Database Cutoff Date of 15-Nov-2019 (Up to approximately 16 months)
The incidence (frequency) and severity (according to NCI CTCAE Version 4.03) of adverse events (AEs). Population: All participants receiving ≥1 dose of randomized study drug. All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
|
0.00%
0/131 • Trough Database Cutoff Date of 15-Nov-2019 (Up to approximately 16 months)
The incidence (frequency) and severity (according to NCI CTCAE Version 4.03) of adverse events (AEs). Population: All participants receiving ≥1 dose of randomized study drug. All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.38%
1/266 • Trough Database Cutoff Date of 15-Nov-2019 (Up to approximately 16 months)
The incidence (frequency) and severity (according to NCI CTCAE Version 4.03) of adverse events (AEs). Population: All participants receiving ≥1 dose of randomized study drug. All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
|
0.00%
0/131 • Trough Database Cutoff Date of 15-Nov-2019 (Up to approximately 16 months)
The incidence (frequency) and severity (according to NCI CTCAE Version 4.03) of adverse events (AEs). Population: All participants receiving ≥1 dose of randomized study drug. All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
|
|
Musculoskeletal and connective tissue disorders
Myositis
|
0.38%
1/266 • Trough Database Cutoff Date of 15-Nov-2019 (Up to approximately 16 months)
The incidence (frequency) and severity (according to NCI CTCAE Version 4.03) of adverse events (AEs). Population: All participants receiving ≥1 dose of randomized study drug. All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
|
0.00%
0/131 • Trough Database Cutoff Date of 15-Nov-2019 (Up to approximately 16 months)
The incidence (frequency) and severity (according to NCI CTCAE Version 4.03) of adverse events (AEs). Population: All participants receiving ≥1 dose of randomized study drug. All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
0.38%
1/266 • Trough Database Cutoff Date of 15-Nov-2019 (Up to approximately 16 months)
The incidence (frequency) and severity (according to NCI CTCAE Version 4.03) of adverse events (AEs). Population: All participants receiving ≥1 dose of randomized study drug. All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
|
0.00%
0/131 • Trough Database Cutoff Date of 15-Nov-2019 (Up to approximately 16 months)
The incidence (frequency) and severity (according to NCI CTCAE Version 4.03) of adverse events (AEs). Population: All participants receiving ≥1 dose of randomized study drug. All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
|
|
Metabolism and nutrition disorders
Hypophagia
|
0.38%
1/266 • Trough Database Cutoff Date of 15-Nov-2019 (Up to approximately 16 months)
The incidence (frequency) and severity (according to NCI CTCAE Version 4.03) of adverse events (AEs). Population: All participants receiving ≥1 dose of randomized study drug. All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
|
0.00%
0/131 • Trough Database Cutoff Date of 15-Nov-2019 (Up to approximately 16 months)
The incidence (frequency) and severity (according to NCI CTCAE Version 4.03) of adverse events (AEs). Population: All participants receiving ≥1 dose of randomized study drug. All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.00%
0/266 • Trough Database Cutoff Date of 15-Nov-2019 (Up to approximately 16 months)
The incidence (frequency) and severity (according to NCI CTCAE Version 4.03) of adverse events (AEs). Population: All participants receiving ≥1 dose of randomized study drug. All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
|
0.76%
1/131 • Trough Database Cutoff Date of 15-Nov-2019 (Up to approximately 16 months)
The incidence (frequency) and severity (according to NCI CTCAE Version 4.03) of adverse events (AEs). Population: All participants receiving ≥1 dose of randomized study drug. All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/266 • Trough Database Cutoff Date of 15-Nov-2019 (Up to approximately 16 months)
The incidence (frequency) and severity (according to NCI CTCAE Version 4.03) of adverse events (AEs). Population: All participants receiving ≥1 dose of randomized study drug. All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
|
0.76%
1/131 • Trough Database Cutoff Date of 15-Nov-2019 (Up to approximately 16 months)
The incidence (frequency) and severity (according to NCI CTCAE Version 4.03) of adverse events (AEs). Population: All participants receiving ≥1 dose of randomized study drug. All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
|
|
Metabolism and nutrition disorders
Hypoproteinaemia
|
0.00%
0/266 • Trough Database Cutoff Date of 15-Nov-2019 (Up to approximately 16 months)
The incidence (frequency) and severity (according to NCI CTCAE Version 4.03) of adverse events (AEs). Population: All participants receiving ≥1 dose of randomized study drug. All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
|
0.76%
1/131 • Trough Database Cutoff Date of 15-Nov-2019 (Up to approximately 16 months)
The incidence (frequency) and severity (according to NCI CTCAE Version 4.03) of adverse events (AEs). Population: All participants receiving ≥1 dose of randomized study drug. All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
|
|
Nervous system disorders
Brain oedema
|
0.38%
1/266 • Trough Database Cutoff Date of 15-Nov-2019 (Up to approximately 16 months)
The incidence (frequency) and severity (according to NCI CTCAE Version 4.03) of adverse events (AEs). Population: All participants receiving ≥1 dose of randomized study drug. All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
|
0.00%
0/131 • Trough Database Cutoff Date of 15-Nov-2019 (Up to approximately 16 months)
The incidence (frequency) and severity (according to NCI CTCAE Version 4.03) of adverse events (AEs). Population: All participants receiving ≥1 dose of randomized study drug. All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
|
|
Nervous system disorders
Cerebral haemorrhage
|
0.38%
1/266 • Trough Database Cutoff Date of 15-Nov-2019 (Up to approximately 16 months)
The incidence (frequency) and severity (according to NCI CTCAE Version 4.03) of adverse events (AEs). Population: All participants receiving ≥1 dose of randomized study drug. All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
|
0.00%
0/131 • Trough Database Cutoff Date of 15-Nov-2019 (Up to approximately 16 months)
The incidence (frequency) and severity (according to NCI CTCAE Version 4.03) of adverse events (AEs). Population: All participants receiving ≥1 dose of randomized study drug. All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
|
|
Nervous system disorders
Cerebral artery embolism
|
0.00%
0/266 • Trough Database Cutoff Date of 15-Nov-2019 (Up to approximately 16 months)
The incidence (frequency) and severity (according to NCI CTCAE Version 4.03) of adverse events (AEs). Population: All participants receiving ≥1 dose of randomized study drug. All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
|
0.76%
1/131 • Trough Database Cutoff Date of 15-Nov-2019 (Up to approximately 16 months)
The incidence (frequency) and severity (according to NCI CTCAE Version 4.03) of adverse events (AEs). Population: All participants receiving ≥1 dose of randomized study drug. All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
|
|
Nervous system disorders
Cerebral infarction
|
0.00%
0/266 • Trough Database Cutoff Date of 15-Nov-2019 (Up to approximately 16 months)
The incidence (frequency) and severity (according to NCI CTCAE Version 4.03) of adverse events (AEs). Population: All participants receiving ≥1 dose of randomized study drug. All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
|
1.5%
2/131 • Trough Database Cutoff Date of 15-Nov-2019 (Up to approximately 16 months)
The incidence (frequency) and severity (according to NCI CTCAE Version 4.03) of adverse events (AEs). Population: All participants receiving ≥1 dose of randomized study drug. All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/266 • Trough Database Cutoff Date of 15-Nov-2019 (Up to approximately 16 months)
The incidence (frequency) and severity (according to NCI CTCAE Version 4.03) of adverse events (AEs). Population: All participants receiving ≥1 dose of randomized study drug. All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
|
0.76%
1/131 • Trough Database Cutoff Date of 15-Nov-2019 (Up to approximately 16 months)
The incidence (frequency) and severity (according to NCI CTCAE Version 4.03) of adverse events (AEs). Population: All participants receiving ≥1 dose of randomized study drug. All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
|
|
Nervous system disorders
Haemorrhage intracranial
|
0.00%
0/266 • Trough Database Cutoff Date of 15-Nov-2019 (Up to approximately 16 months)
The incidence (frequency) and severity (according to NCI CTCAE Version 4.03) of adverse events (AEs). Population: All participants receiving ≥1 dose of randomized study drug. All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
|
0.76%
1/131 • Trough Database Cutoff Date of 15-Nov-2019 (Up to approximately 16 months)
The incidence (frequency) and severity (according to NCI CTCAE Version 4.03) of adverse events (AEs). Population: All participants receiving ≥1 dose of randomized study drug. All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
|
|
Psychiatric disorders
Confusional state
|
0.38%
1/266 • Trough Database Cutoff Date of 15-Nov-2019 (Up to approximately 16 months)
The incidence (frequency) and severity (according to NCI CTCAE Version 4.03) of adverse events (AEs). Population: All participants receiving ≥1 dose of randomized study drug. All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
|
0.00%
0/131 • Trough Database Cutoff Date of 15-Nov-2019 (Up to approximately 16 months)
The incidence (frequency) and severity (according to NCI CTCAE Version 4.03) of adverse events (AEs). Population: All participants receiving ≥1 dose of randomized study drug. All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
|
|
Skin and subcutaneous tissue disorders
Henoch-Schonlein purpura
|
0.38%
1/266 • Trough Database Cutoff Date of 15-Nov-2019 (Up to approximately 16 months)
The incidence (frequency) and severity (according to NCI CTCAE Version 4.03) of adverse events (AEs). Population: All participants receiving ≥1 dose of randomized study drug. All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
|
0.00%
0/131 • Trough Database Cutoff Date of 15-Nov-2019 (Up to approximately 16 months)
The incidence (frequency) and severity (according to NCI CTCAE Version 4.03) of adverse events (AEs). Population: All participants receiving ≥1 dose of randomized study drug. All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
|
|
Skin and subcutaneous tissue disorders
Toxic epidermal necrolysis
|
0.38%
1/266 • Trough Database Cutoff Date of 15-Nov-2019 (Up to approximately 16 months)
The incidence (frequency) and severity (according to NCI CTCAE Version 4.03) of adverse events (AEs). Population: All participants receiving ≥1 dose of randomized study drug. All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
|
0.00%
0/131 • Trough Database Cutoff Date of 15-Nov-2019 (Up to approximately 16 months)
The incidence (frequency) and severity (according to NCI CTCAE Version 4.03) of adverse events (AEs). Population: All participants receiving ≥1 dose of randomized study drug. All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
|
|
Skin and subcutaneous tissue disorders
Dermatomyositis
|
0.00%
0/266 • Trough Database Cutoff Date of 15-Nov-2019 (Up to approximately 16 months)
The incidence (frequency) and severity (according to NCI CTCAE Version 4.03) of adverse events (AEs). Population: All participants receiving ≥1 dose of randomized study drug. All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
|
0.76%
1/131 • Trough Database Cutoff Date of 15-Nov-2019 (Up to approximately 16 months)
The incidence (frequency) and severity (according to NCI CTCAE Version 4.03) of adverse events (AEs). Population: All participants receiving ≥1 dose of randomized study drug. All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
|
|
Vascular disorders
Embolism arterial
|
0.38%
1/266 • Trough Database Cutoff Date of 15-Nov-2019 (Up to approximately 16 months)
The incidence (frequency) and severity (according to NCI CTCAE Version 4.03) of adverse events (AEs). Population: All participants receiving ≥1 dose of randomized study drug. All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
|
0.00%
0/131 • Trough Database Cutoff Date of 15-Nov-2019 (Up to approximately 16 months)
The incidence (frequency) and severity (according to NCI CTCAE Version 4.03) of adverse events (AEs). Population: All participants receiving ≥1 dose of randomized study drug. All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
|
|
Vascular disorders
Superior vena cava syndrome
|
0.00%
0/266 • Trough Database Cutoff Date of 15-Nov-2019 (Up to approximately 16 months)
The incidence (frequency) and severity (according to NCI CTCAE Version 4.03) of adverse events (AEs). Population: All participants receiving ≥1 dose of randomized study drug. All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
|
0.76%
1/131 • Trough Database Cutoff Date of 15-Nov-2019 (Up to approximately 16 months)
The incidence (frequency) and severity (according to NCI CTCAE Version 4.03) of adverse events (AEs). Population: All participants receiving ≥1 dose of randomized study drug. All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
|
|
Injury, poisoning and procedural complications
Femoral neck fracture
|
0.00%
0/266 • Trough Database Cutoff Date of 15-Nov-2019 (Up to approximately 16 months)
The incidence (frequency) and severity (according to NCI CTCAE Version 4.03) of adverse events (AEs). Population: All participants receiving ≥1 dose of randomized study drug. All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
|
0.76%
1/131 • Trough Database Cutoff Date of 15-Nov-2019 (Up to approximately 16 months)
The incidence (frequency) and severity (according to NCI CTCAE Version 4.03) of adverse events (AEs). Population: All participants receiving ≥1 dose of randomized study drug. All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
|
|
Injury, poisoning and procedural complications
Spinal compression fracture
|
0.00%
0/266 • Trough Database Cutoff Date of 15-Nov-2019 (Up to approximately 16 months)
The incidence (frequency) and severity (according to NCI CTCAE Version 4.03) of adverse events (AEs). Population: All participants receiving ≥1 dose of randomized study drug. All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
|
0.76%
1/131 • Trough Database Cutoff Date of 15-Nov-2019 (Up to approximately 16 months)
The incidence (frequency) and severity (according to NCI CTCAE Version 4.03) of adverse events (AEs). Population: All participants receiving ≥1 dose of randomized study drug. All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc disorder
|
0.38%
1/266 • Trough Database Cutoff Date of 15-Nov-2019 (Up to approximately 16 months)
The incidence (frequency) and severity (according to NCI CTCAE Version 4.03) of adverse events (AEs). Population: All participants receiving ≥1 dose of randomized study drug. All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
|
0.00%
0/131 • Trough Database Cutoff Date of 15-Nov-2019 (Up to approximately 16 months)
The incidence (frequency) and severity (according to NCI CTCAE Version 4.03) of adverse events (AEs). Population: All participants receiving ≥1 dose of randomized study drug. All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
|
Other adverse events
| Measure |
Sintilimab Combination
n=266 participants at risk
Sintilimab 200mg, pemetrexed 500mg/m2, cisplatin 75mg/m2 or carboplatin AUC 5 IV infusion q3w for 4 cycles, then sintilimab 200mg, pemetrexed 500mg/m2 IV infusion q3w
|
Placebo Combination
n=131 participants at risk
Placebo 200mg, pemetrexed 500mg/m2, cisplatin 75mg/m2 or carboplatin AUC 5 IV infusion q3w for 4 cycles, then placebo, pemetrexed 500mg/m2 IV infusion q3w
|
|---|---|---|
|
Investigations
Neutrophil count decreased
|
71.1%
189/266 • Trough Database Cutoff Date of 15-Nov-2019 (Up to approximately 16 months)
The incidence (frequency) and severity (according to NCI CTCAE Version 4.03) of adverse events (AEs). Population: All participants receiving ≥1 dose of randomized study drug. All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
|
62.6%
82/131 • Trough Database Cutoff Date of 15-Nov-2019 (Up to approximately 16 months)
The incidence (frequency) and severity (according to NCI CTCAE Version 4.03) of adverse events (AEs). Population: All participants receiving ≥1 dose of randomized study drug. All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
|
|
General disorders
Asthenia
|
32.7%
87/266 • Trough Database Cutoff Date of 15-Nov-2019 (Up to approximately 16 months)
The incidence (frequency) and severity (according to NCI CTCAE Version 4.03) of adverse events (AEs). Population: All participants receiving ≥1 dose of randomized study drug. All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
|
32.1%
42/131 • Trough Database Cutoff Date of 15-Nov-2019 (Up to approximately 16 months)
The incidence (frequency) and severity (according to NCI CTCAE Version 4.03) of adverse events (AEs). Population: All participants receiving ≥1 dose of randomized study drug. All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
|
|
Investigations
White blood cell count decreased
|
67.7%
180/266 • Trough Database Cutoff Date of 15-Nov-2019 (Up to approximately 16 months)
The incidence (frequency) and severity (according to NCI CTCAE Version 4.03) of adverse events (AEs). Population: All participants receiving ≥1 dose of randomized study drug. All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
|
64.1%
84/131 • Trough Database Cutoff Date of 15-Nov-2019 (Up to approximately 16 months)
The incidence (frequency) and severity (according to NCI CTCAE Version 4.03) of adverse events (AEs). Population: All participants receiving ≥1 dose of randomized study drug. All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
|
|
Investigations
Platelet count decreased
|
42.5%
113/266 • Trough Database Cutoff Date of 15-Nov-2019 (Up to approximately 16 months)
The incidence (frequency) and severity (according to NCI CTCAE Version 4.03) of adverse events (AEs). Population: All participants receiving ≥1 dose of randomized study drug. All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
|
31.3%
41/131 • Trough Database Cutoff Date of 15-Nov-2019 (Up to approximately 16 months)
The incidence (frequency) and severity (according to NCI CTCAE Version 4.03) of adverse events (AEs). Population: All participants receiving ≥1 dose of randomized study drug. All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
|
|
Investigations
Aspartate aminotransferase increased
|
41.0%
109/266 • Trough Database Cutoff Date of 15-Nov-2019 (Up to approximately 16 months)
The incidence (frequency) and severity (according to NCI CTCAE Version 4.03) of adverse events (AEs). Population: All participants receiving ≥1 dose of randomized study drug. All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
|
38.9%
51/131 • Trough Database Cutoff Date of 15-Nov-2019 (Up to approximately 16 months)
The incidence (frequency) and severity (according to NCI CTCAE Version 4.03) of adverse events (AEs). Population: All participants receiving ≥1 dose of randomized study drug. All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
|
|
Investigations
Alanine aminotransferase increased
|
40.6%
108/266 • Trough Database Cutoff Date of 15-Nov-2019 (Up to approximately 16 months)
The incidence (frequency) and severity (according to NCI CTCAE Version 4.03) of adverse events (AEs). Population: All participants receiving ≥1 dose of randomized study drug. All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
|
38.9%
51/131 • Trough Database Cutoff Date of 15-Nov-2019 (Up to approximately 16 months)
The incidence (frequency) and severity (according to NCI CTCAE Version 4.03) of adverse events (AEs). Population: All participants receiving ≥1 dose of randomized study drug. All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
|
|
Investigations
Lymphocyte count decreased
|
12.8%
34/266 • Trough Database Cutoff Date of 15-Nov-2019 (Up to approximately 16 months)
The incidence (frequency) and severity (according to NCI CTCAE Version 4.03) of adverse events (AEs). Population: All participants receiving ≥1 dose of randomized study drug. All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
|
7.6%
10/131 • Trough Database Cutoff Date of 15-Nov-2019 (Up to approximately 16 months)
The incidence (frequency) and severity (according to NCI CTCAE Version 4.03) of adverse events (AEs). Population: All participants receiving ≥1 dose of randomized study drug. All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
|
|
Investigations
Gamma-glutamyltransferase increased
|
12.4%
33/266 • Trough Database Cutoff Date of 15-Nov-2019 (Up to approximately 16 months)
The incidence (frequency) and severity (according to NCI CTCAE Version 4.03) of adverse events (AEs). Population: All participants receiving ≥1 dose of randomized study drug. All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
|
10.7%
14/131 • Trough Database Cutoff Date of 15-Nov-2019 (Up to approximately 16 months)
The incidence (frequency) and severity (according to NCI CTCAE Version 4.03) of adverse events (AEs). Population: All participants receiving ≥1 dose of randomized study drug. All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
|
|
Investigations
Blood glucose increased
|
10.2%
27/266 • Trough Database Cutoff Date of 15-Nov-2019 (Up to approximately 16 months)
The incidence (frequency) and severity (according to NCI CTCAE Version 4.03) of adverse events (AEs). Population: All participants receiving ≥1 dose of randomized study drug. All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
|
6.1%
8/131 • Trough Database Cutoff Date of 15-Nov-2019 (Up to approximately 16 months)
The incidence (frequency) and severity (according to NCI CTCAE Version 4.03) of adverse events (AEs). Population: All participants receiving ≥1 dose of randomized study drug. All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
|
|
Investigations
Weight increased
|
9.0%
24/266 • Trough Database Cutoff Date of 15-Nov-2019 (Up to approximately 16 months)
The incidence (frequency) and severity (according to NCI CTCAE Version 4.03) of adverse events (AEs). Population: All participants receiving ≥1 dose of randomized study drug. All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
|
3.1%
4/131 • Trough Database Cutoff Date of 15-Nov-2019 (Up to approximately 16 months)
The incidence (frequency) and severity (according to NCI CTCAE Version 4.03) of adverse events (AEs). Population: All participants receiving ≥1 dose of randomized study drug. All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
|
|
Investigations
Amylase increased
|
8.3%
22/266 • Trough Database Cutoff Date of 15-Nov-2019 (Up to approximately 16 months)
The incidence (frequency) and severity (according to NCI CTCAE Version 4.03) of adverse events (AEs). Population: All participants receiving ≥1 dose of randomized study drug. All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
|
9.9%
13/131 • Trough Database Cutoff Date of 15-Nov-2019 (Up to approximately 16 months)
The incidence (frequency) and severity (according to NCI CTCAE Version 4.03) of adverse events (AEs). Population: All participants receiving ≥1 dose of randomized study drug. All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
|
|
Investigations
Blood creatinine increased
|
8.3%
22/266 • Trough Database Cutoff Date of 15-Nov-2019 (Up to approximately 16 months)
The incidence (frequency) and severity (according to NCI CTCAE Version 4.03) of adverse events (AEs). Population: All participants receiving ≥1 dose of randomized study drug. All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
|
8.4%
11/131 • Trough Database Cutoff Date of 15-Nov-2019 (Up to approximately 16 months)
The incidence (frequency) and severity (according to NCI CTCAE Version 4.03) of adverse events (AEs). Population: All participants receiving ≥1 dose of randomized study drug. All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
|
|
Investigations
Weight decreased
|
8.3%
22/266 • Trough Database Cutoff Date of 15-Nov-2019 (Up to approximately 16 months)
The incidence (frequency) and severity (according to NCI CTCAE Version 4.03) of adverse events (AEs). Population: All participants receiving ≥1 dose of randomized study drug. All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
|
17.6%
23/131 • Trough Database Cutoff Date of 15-Nov-2019 (Up to approximately 16 months)
The incidence (frequency) and severity (according to NCI CTCAE Version 4.03) of adverse events (AEs). Population: All participants receiving ≥1 dose of randomized study drug. All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
|
|
Investigations
Blood alkaline phosphatase increased
|
6.4%
17/266 • Trough Database Cutoff Date of 15-Nov-2019 (Up to approximately 16 months)
The incidence (frequency) and severity (according to NCI CTCAE Version 4.03) of adverse events (AEs). Population: All participants receiving ≥1 dose of randomized study drug. All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
|
5.3%
7/131 • Trough Database Cutoff Date of 15-Nov-2019 (Up to approximately 16 months)
The incidence (frequency) and severity (according to NCI CTCAE Version 4.03) of adverse events (AEs). Population: All participants receiving ≥1 dose of randomized study drug. All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
|
|
Investigations
Haemoglobin decreased
|
6.0%
16/266 • Trough Database Cutoff Date of 15-Nov-2019 (Up to approximately 16 months)
The incidence (frequency) and severity (according to NCI CTCAE Version 4.03) of adverse events (AEs). Population: All participants receiving ≥1 dose of randomized study drug. All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
|
4.6%
6/131 • Trough Database Cutoff Date of 15-Nov-2019 (Up to approximately 16 months)
The incidence (frequency) and severity (according to NCI CTCAE Version 4.03) of adverse events (AEs). Population: All participants receiving ≥1 dose of randomized study drug. All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
|
|
Investigations
Blood thyroid stimulating hormone increased
|
5.6%
15/266 • Trough Database Cutoff Date of 15-Nov-2019 (Up to approximately 16 months)
The incidence (frequency) and severity (according to NCI CTCAE Version 4.03) of adverse events (AEs). Population: All participants receiving ≥1 dose of randomized study drug. All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
|
3.8%
5/131 • Trough Database Cutoff Date of 15-Nov-2019 (Up to approximately 16 months)
The incidence (frequency) and severity (according to NCI CTCAE Version 4.03) of adverse events (AEs). Population: All participants receiving ≥1 dose of randomized study drug. All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
|
|
Blood and lymphatic system disorders
Anaemia
|
74.1%
197/266 • Trough Database Cutoff Date of 15-Nov-2019 (Up to approximately 16 months)
The incidence (frequency) and severity (according to NCI CTCAE Version 4.03) of adverse events (AEs). Population: All participants receiving ≥1 dose of randomized study drug. All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
|
78.6%
103/131 • Trough Database Cutoff Date of 15-Nov-2019 (Up to approximately 16 months)
The incidence (frequency) and severity (according to NCI CTCAE Version 4.03) of adverse events (AEs). Population: All participants receiving ≥1 dose of randomized study drug. All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
|
|
Gastrointestinal disorders
Nausea
|
40.6%
108/266 • Trough Database Cutoff Date of 15-Nov-2019 (Up to approximately 16 months)
The incidence (frequency) and severity (according to NCI CTCAE Version 4.03) of adverse events (AEs). Population: All participants receiving ≥1 dose of randomized study drug. All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
|
42.0%
55/131 • Trough Database Cutoff Date of 15-Nov-2019 (Up to approximately 16 months)
The incidence (frequency) and severity (according to NCI CTCAE Version 4.03) of adverse events (AEs). Population: All participants receiving ≥1 dose of randomized study drug. All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
|
|
Gastrointestinal disorders
Vomiting
|
28.9%
77/266 • Trough Database Cutoff Date of 15-Nov-2019 (Up to approximately 16 months)
The incidence (frequency) and severity (according to NCI CTCAE Version 4.03) of adverse events (AEs). Population: All participants receiving ≥1 dose of randomized study drug. All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
|
31.3%
41/131 • Trough Database Cutoff Date of 15-Nov-2019 (Up to approximately 16 months)
The incidence (frequency) and severity (according to NCI CTCAE Version 4.03) of adverse events (AEs). Population: All participants receiving ≥1 dose of randomized study drug. All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
|
|
Gastrointestinal disorders
Constipation
|
26.7%
71/266 • Trough Database Cutoff Date of 15-Nov-2019 (Up to approximately 16 months)
The incidence (frequency) and severity (according to NCI CTCAE Version 4.03) of adverse events (AEs). Population: All participants receiving ≥1 dose of randomized study drug. All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
|
32.1%
42/131 • Trough Database Cutoff Date of 15-Nov-2019 (Up to approximately 16 months)
The incidence (frequency) and severity (according to NCI CTCAE Version 4.03) of adverse events (AEs). Population: All participants receiving ≥1 dose of randomized study drug. All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
|
|
Gastrointestinal disorders
Diarrhoea
|
13.2%
35/266 • Trough Database Cutoff Date of 15-Nov-2019 (Up to approximately 16 months)
The incidence (frequency) and severity (according to NCI CTCAE Version 4.03) of adverse events (AEs). Population: All participants receiving ≥1 dose of randomized study drug. All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
|
11.5%
15/131 • Trough Database Cutoff Date of 15-Nov-2019 (Up to approximately 16 months)
The incidence (frequency) and severity (according to NCI CTCAE Version 4.03) of adverse events (AEs). Population: All participants receiving ≥1 dose of randomized study drug. All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
|
|
Gastrointestinal disorders
Abdominal distension
|
6.8%
18/266 • Trough Database Cutoff Date of 15-Nov-2019 (Up to approximately 16 months)
The incidence (frequency) and severity (according to NCI CTCAE Version 4.03) of adverse events (AEs). Population: All participants receiving ≥1 dose of randomized study drug. All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
|
9.2%
12/131 • Trough Database Cutoff Date of 15-Nov-2019 (Up to approximately 16 months)
The incidence (frequency) and severity (according to NCI CTCAE Version 4.03) of adverse events (AEs). Population: All participants receiving ≥1 dose of randomized study drug. All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
38.0%
101/266 • Trough Database Cutoff Date of 15-Nov-2019 (Up to approximately 16 months)
The incidence (frequency) and severity (according to NCI CTCAE Version 4.03) of adverse events (AEs). Population: All participants receiving ≥1 dose of randomized study drug. All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
|
31.3%
41/131 • Trough Database Cutoff Date of 15-Nov-2019 (Up to approximately 16 months)
The incidence (frequency) and severity (according to NCI CTCAE Version 4.03) of adverse events (AEs). Population: All participants receiving ≥1 dose of randomized study drug. All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
19.9%
53/266 • Trough Database Cutoff Date of 15-Nov-2019 (Up to approximately 16 months)
The incidence (frequency) and severity (according to NCI CTCAE Version 4.03) of adverse events (AEs). Population: All participants receiving ≥1 dose of randomized study drug. All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
|
16.8%
22/131 • Trough Database Cutoff Date of 15-Nov-2019 (Up to approximately 16 months)
The incidence (frequency) and severity (according to NCI CTCAE Version 4.03) of adverse events (AEs). Population: All participants receiving ≥1 dose of randomized study drug. All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
10.5%
28/266 • Trough Database Cutoff Date of 15-Nov-2019 (Up to approximately 16 months)
The incidence (frequency) and severity (according to NCI CTCAE Version 4.03) of adverse events (AEs). Population: All participants receiving ≥1 dose of randomized study drug. All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
|
9.2%
12/131 • Trough Database Cutoff Date of 15-Nov-2019 (Up to approximately 16 months)
The incidence (frequency) and severity (according to NCI CTCAE Version 4.03) of adverse events (AEs). Population: All participants receiving ≥1 dose of randomized study drug. All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
10.5%
28/266 • Trough Database Cutoff Date of 15-Nov-2019 (Up to approximately 16 months)
The incidence (frequency) and severity (according to NCI CTCAE Version 4.03) of adverse events (AEs). Population: All participants receiving ≥1 dose of randomized study drug. All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
|
12.2%
16/131 • Trough Database Cutoff Date of 15-Nov-2019 (Up to approximately 16 months)
The incidence (frequency) and severity (according to NCI CTCAE Version 4.03) of adverse events (AEs). Population: All participants receiving ≥1 dose of randomized study drug. All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
|
|
Metabolism and nutrition disorders
Hypophagia
|
7.5%
20/266 • Trough Database Cutoff Date of 15-Nov-2019 (Up to approximately 16 months)
The incidence (frequency) and severity (according to NCI CTCAE Version 4.03) of adverse events (AEs). Population: All participants receiving ≥1 dose of randomized study drug. All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
|
9.9%
13/131 • Trough Database Cutoff Date of 15-Nov-2019 (Up to approximately 16 months)
The incidence (frequency) and severity (according to NCI CTCAE Version 4.03) of adverse events (AEs). Population: All participants receiving ≥1 dose of randomized study drug. All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
|
|
Metabolism and nutrition disorders
Hypoproteinaemia
|
6.0%
16/266 • Trough Database Cutoff Date of 15-Nov-2019 (Up to approximately 16 months)
The incidence (frequency) and severity (according to NCI CTCAE Version 4.03) of adverse events (AEs). Population: All participants receiving ≥1 dose of randomized study drug. All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
|
10.7%
14/131 • Trough Database Cutoff Date of 15-Nov-2019 (Up to approximately 16 months)
The incidence (frequency) and severity (according to NCI CTCAE Version 4.03) of adverse events (AEs). Population: All participants receiving ≥1 dose of randomized study drug. All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
5.6%
15/266 • Trough Database Cutoff Date of 15-Nov-2019 (Up to approximately 16 months)
The incidence (frequency) and severity (according to NCI CTCAE Version 4.03) of adverse events (AEs). Population: All participants receiving ≥1 dose of randomized study drug. All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
|
4.6%
6/131 • Trough Database Cutoff Date of 15-Nov-2019 (Up to approximately 16 months)
The incidence (frequency) and severity (according to NCI CTCAE Version 4.03) of adverse events (AEs). Population: All participants receiving ≥1 dose of randomized study drug. All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
5.3%
14/266 • Trough Database Cutoff Date of 15-Nov-2019 (Up to approximately 16 months)
The incidence (frequency) and severity (according to NCI CTCAE Version 4.03) of adverse events (AEs). Population: All participants receiving ≥1 dose of randomized study drug. All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
|
7.6%
10/131 • Trough Database Cutoff Date of 15-Nov-2019 (Up to approximately 16 months)
The incidence (frequency) and severity (according to NCI CTCAE Version 4.03) of adverse events (AEs). Population: All participants receiving ≥1 dose of randomized study drug. All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
|
|
Metabolism and nutrition disorders
Hypertriglyceridaemia
|
4.5%
12/266 • Trough Database Cutoff Date of 15-Nov-2019 (Up to approximately 16 months)
The incidence (frequency) and severity (according to NCI CTCAE Version 4.03) of adverse events (AEs). Population: All participants receiving ≥1 dose of randomized study drug. All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
|
5.3%
7/131 • Trough Database Cutoff Date of 15-Nov-2019 (Up to approximately 16 months)
The incidence (frequency) and severity (according to NCI CTCAE Version 4.03) of adverse events (AEs). Population: All participants receiving ≥1 dose of randomized study drug. All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
|
|
General disorders
Pyrexia
|
21.1%
56/266 • Trough Database Cutoff Date of 15-Nov-2019 (Up to approximately 16 months)
The incidence (frequency) and severity (according to NCI CTCAE Version 4.03) of adverse events (AEs). Population: All participants receiving ≥1 dose of randomized study drug. All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
|
14.5%
19/131 • Trough Database Cutoff Date of 15-Nov-2019 (Up to approximately 16 months)
The incidence (frequency) and severity (according to NCI CTCAE Version 4.03) of adverse events (AEs). Population: All participants receiving ≥1 dose of randomized study drug. All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
|
|
General disorders
Oedema peripheral
|
7.9%
21/266 • Trough Database Cutoff Date of 15-Nov-2019 (Up to approximately 16 months)
The incidence (frequency) and severity (according to NCI CTCAE Version 4.03) of adverse events (AEs). Population: All participants receiving ≥1 dose of randomized study drug. All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
|
6.9%
9/131 • Trough Database Cutoff Date of 15-Nov-2019 (Up to approximately 16 months)
The incidence (frequency) and severity (according to NCI CTCAE Version 4.03) of adverse events (AEs). Population: All participants receiving ≥1 dose of randomized study drug. All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
|
|
General disorders
Chest discomfort
|
5.6%
15/266 • Trough Database Cutoff Date of 15-Nov-2019 (Up to approximately 16 months)
The incidence (frequency) and severity (according to NCI CTCAE Version 4.03) of adverse events (AEs). Population: All participants receiving ≥1 dose of randomized study drug. All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
|
3.8%
5/131 • Trough Database Cutoff Date of 15-Nov-2019 (Up to approximately 16 months)
The incidence (frequency) and severity (according to NCI CTCAE Version 4.03) of adverse events (AEs). Population: All participants receiving ≥1 dose of randomized study drug. All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
12.4%
33/266 • Trough Database Cutoff Date of 15-Nov-2019 (Up to approximately 16 months)
The incidence (frequency) and severity (according to NCI CTCAE Version 4.03) of adverse events (AEs). Population: All participants receiving ≥1 dose of randomized study drug. All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
|
12.2%
16/131 • Trough Database Cutoff Date of 15-Nov-2019 (Up to approximately 16 months)
The incidence (frequency) and severity (according to NCI CTCAE Version 4.03) of adverse events (AEs). Population: All participants receiving ≥1 dose of randomized study drug. All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
7.1%
19/266 • Trough Database Cutoff Date of 15-Nov-2019 (Up to approximately 16 months)
The incidence (frequency) and severity (according to NCI CTCAE Version 4.03) of adverse events (AEs). Population: All participants receiving ≥1 dose of randomized study drug. All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
|
13.0%
17/131 • Trough Database Cutoff Date of 15-Nov-2019 (Up to approximately 16 months)
The incidence (frequency) and severity (according to NCI CTCAE Version 4.03) of adverse events (AEs). Population: All participants receiving ≥1 dose of randomized study drug. All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
6.0%
16/266 • Trough Database Cutoff Date of 15-Nov-2019 (Up to approximately 16 months)
The incidence (frequency) and severity (according to NCI CTCAE Version 4.03) of adverse events (AEs). Population: All participants receiving ≥1 dose of randomized study drug. All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
|
4.6%
6/131 • Trough Database Cutoff Date of 15-Nov-2019 (Up to approximately 16 months)
The incidence (frequency) and severity (according to NCI CTCAE Version 4.03) of adverse events (AEs). Population: All participants receiving ≥1 dose of randomized study drug. All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
5.3%
14/266 • Trough Database Cutoff Date of 15-Nov-2019 (Up to approximately 16 months)
The incidence (frequency) and severity (according to NCI CTCAE Version 4.03) of adverse events (AEs). Population: All participants receiving ≥1 dose of randomized study drug. All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
|
6.9%
9/131 • Trough Database Cutoff Date of 15-Nov-2019 (Up to approximately 16 months)
The incidence (frequency) and severity (according to NCI CTCAE Version 4.03) of adverse events (AEs). Population: All participants receiving ≥1 dose of randomized study drug. All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
|
|
Respiratory, thoracic and mediastinal disorders
Tachypnoea
|
5.3%
14/266 • Trough Database Cutoff Date of 15-Nov-2019 (Up to approximately 16 months)
The incidence (frequency) and severity (according to NCI CTCAE Version 4.03) of adverse events (AEs). Population: All participants receiving ≥1 dose of randomized study drug. All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
|
6.1%
8/131 • Trough Database Cutoff Date of 15-Nov-2019 (Up to approximately 16 months)
The incidence (frequency) and severity (according to NCI CTCAE Version 4.03) of adverse events (AEs). Population: All participants receiving ≥1 dose of randomized study drug. All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
4.1%
11/266 • Trough Database Cutoff Date of 15-Nov-2019 (Up to approximately 16 months)
The incidence (frequency) and severity (according to NCI CTCAE Version 4.03) of adverse events (AEs). Population: All participants receiving ≥1 dose of randomized study drug. All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
|
6.1%
8/131 • Trough Database Cutoff Date of 15-Nov-2019 (Up to approximately 16 months)
The incidence (frequency) and severity (according to NCI CTCAE Version 4.03) of adverse events (AEs). Population: All participants receiving ≥1 dose of randomized study drug. All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
|
|
Infections and infestations
Upper respiratory tract infection
|
10.2%
27/266 • Trough Database Cutoff Date of 15-Nov-2019 (Up to approximately 16 months)
The incidence (frequency) and severity (according to NCI CTCAE Version 4.03) of adverse events (AEs). Population: All participants receiving ≥1 dose of randomized study drug. All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
|
9.2%
12/131 • Trough Database Cutoff Date of 15-Nov-2019 (Up to approximately 16 months)
The incidence (frequency) and severity (according to NCI CTCAE Version 4.03) of adverse events (AEs). Population: All participants receiving ≥1 dose of randomized study drug. All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
|
|
Infections and infestations
Pneumonia
|
8.3%
22/266 • Trough Database Cutoff Date of 15-Nov-2019 (Up to approximately 16 months)
The incidence (frequency) and severity (according to NCI CTCAE Version 4.03) of adverse events (AEs). Population: All participants receiving ≥1 dose of randomized study drug. All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
|
11.5%
15/131 • Trough Database Cutoff Date of 15-Nov-2019 (Up to approximately 16 months)
The incidence (frequency) and severity (according to NCI CTCAE Version 4.03) of adverse events (AEs). Population: All participants receiving ≥1 dose of randomized study drug. All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
|
|
Infections and infestations
Urinary tract infection
|
4.9%
13/266 • Trough Database Cutoff Date of 15-Nov-2019 (Up to approximately 16 months)
The incidence (frequency) and severity (according to NCI CTCAE Version 4.03) of adverse events (AEs). Population: All participants receiving ≥1 dose of randomized study drug. All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
|
6.1%
8/131 • Trough Database Cutoff Date of 15-Nov-2019 (Up to approximately 16 months)
The incidence (frequency) and severity (according to NCI CTCAE Version 4.03) of adverse events (AEs). Population: All participants receiving ≥1 dose of randomized study drug. All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
|
|
Skin and subcutaneous tissue disorders
Rash
|
14.3%
38/266 • Trough Database Cutoff Date of 15-Nov-2019 (Up to approximately 16 months)
The incidence (frequency) and severity (according to NCI CTCAE Version 4.03) of adverse events (AEs). Population: All participants receiving ≥1 dose of randomized study drug. All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
|
13.7%
18/131 • Trough Database Cutoff Date of 15-Nov-2019 (Up to approximately 16 months)
The incidence (frequency) and severity (according to NCI CTCAE Version 4.03) of adverse events (AEs). Population: All participants receiving ≥1 dose of randomized study drug. All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
|
|
Nervous system disorders
Dizziness
|
10.5%
28/266 • Trough Database Cutoff Date of 15-Nov-2019 (Up to approximately 16 months)
The incidence (frequency) and severity (according to NCI CTCAE Version 4.03) of adverse events (AEs). Population: All participants receiving ≥1 dose of randomized study drug. All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
|
6.1%
8/131 • Trough Database Cutoff Date of 15-Nov-2019 (Up to approximately 16 months)
The incidence (frequency) and severity (according to NCI CTCAE Version 4.03) of adverse events (AEs). Population: All participants receiving ≥1 dose of randomized study drug. All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
|
|
Nervous system disorders
Headache
|
5.6%
15/266 • Trough Database Cutoff Date of 15-Nov-2019 (Up to approximately 16 months)
The incidence (frequency) and severity (according to NCI CTCAE Version 4.03) of adverse events (AEs). Population: All participants receiving ≥1 dose of randomized study drug. All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
|
3.8%
5/131 • Trough Database Cutoff Date of 15-Nov-2019 (Up to approximately 16 months)
The incidence (frequency) and severity (according to NCI CTCAE Version 4.03) of adverse events (AEs). Population: All participants receiving ≥1 dose of randomized study drug. All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
|
|
Nervous system disorders
Hypoaesthesia
|
4.5%
12/266 • Trough Database Cutoff Date of 15-Nov-2019 (Up to approximately 16 months)
The incidence (frequency) and severity (according to NCI CTCAE Version 4.03) of adverse events (AEs). Population: All participants receiving ≥1 dose of randomized study drug. All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
|
6.1%
8/131 • Trough Database Cutoff Date of 15-Nov-2019 (Up to approximately 16 months)
The incidence (frequency) and severity (according to NCI CTCAE Version 4.03) of adverse events (AEs). Population: All participants receiving ≥1 dose of randomized study drug. All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
4.5%
12/266 • Trough Database Cutoff Date of 15-Nov-2019 (Up to approximately 16 months)
The incidence (frequency) and severity (according to NCI CTCAE Version 4.03) of adverse events (AEs). Population: All participants receiving ≥1 dose of randomized study drug. All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
|
5.3%
7/131 • Trough Database Cutoff Date of 15-Nov-2019 (Up to approximately 16 months)
The incidence (frequency) and severity (according to NCI CTCAE Version 4.03) of adverse events (AEs). Population: All participants receiving ≥1 dose of randomized study drug. All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
3.8%
10/266 • Trough Database Cutoff Date of 15-Nov-2019 (Up to approximately 16 months)
The incidence (frequency) and severity (according to NCI CTCAE Version 4.03) of adverse events (AEs). Population: All participants receiving ≥1 dose of randomized study drug. All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
|
5.3%
7/131 • Trough Database Cutoff Date of 15-Nov-2019 (Up to approximately 16 months)
The incidence (frequency) and severity (according to NCI CTCAE Version 4.03) of adverse events (AEs). Population: All participants receiving ≥1 dose of randomized study drug. All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
|
|
Renal and urinary disorders
Proteinuria
|
10.5%
28/266 • Trough Database Cutoff Date of 15-Nov-2019 (Up to approximately 16 months)
The incidence (frequency) and severity (according to NCI CTCAE Version 4.03) of adverse events (AEs). Population: All participants receiving ≥1 dose of randomized study drug. All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
|
9.9%
13/131 • Trough Database Cutoff Date of 15-Nov-2019 (Up to approximately 16 months)
The incidence (frequency) and severity (according to NCI CTCAE Version 4.03) of adverse events (AEs). Population: All participants receiving ≥1 dose of randomized study drug. All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
|
|
Renal and urinary disorders
Haematuria
|
4.5%
12/266 • Trough Database Cutoff Date of 15-Nov-2019 (Up to approximately 16 months)
The incidence (frequency) and severity (according to NCI CTCAE Version 4.03) of adverse events (AEs). Population: All participants receiving ≥1 dose of randomized study drug. All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
|
6.9%
9/131 • Trough Database Cutoff Date of 15-Nov-2019 (Up to approximately 16 months)
The incidence (frequency) and severity (according to NCI CTCAE Version 4.03) of adverse events (AEs). Population: All participants receiving ≥1 dose of randomized study drug. All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
|
|
Psychiatric disorders
Insomnia
|
11.3%
30/266 • Trough Database Cutoff Date of 15-Nov-2019 (Up to approximately 16 months)
The incidence (frequency) and severity (according to NCI CTCAE Version 4.03) of adverse events (AEs). Population: All participants receiving ≥1 dose of randomized study drug. All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
|
6.9%
9/131 • Trough Database Cutoff Date of 15-Nov-2019 (Up to approximately 16 months)
The incidence (frequency) and severity (according to NCI CTCAE Version 4.03) of adverse events (AEs). Population: All participants receiving ≥1 dose of randomized study drug. All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
|
|
Endocrine disorders
Hypothyroidism
|
10.5%
28/266 • Trough Database Cutoff Date of 15-Nov-2019 (Up to approximately 16 months)
The incidence (frequency) and severity (according to NCI CTCAE Version 4.03) of adverse events (AEs). Population: All participants receiving ≥1 dose of randomized study drug. All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
|
10.7%
14/131 • Trough Database Cutoff Date of 15-Nov-2019 (Up to approximately 16 months)
The incidence (frequency) and severity (according to NCI CTCAE Version 4.03) of adverse events (AEs). Population: All participants receiving ≥1 dose of randomized study drug. All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
|
|
Endocrine disorders
Hyperthyroidism
|
5.6%
15/266 • Trough Database Cutoff Date of 15-Nov-2019 (Up to approximately 16 months)
The incidence (frequency) and severity (according to NCI CTCAE Version 4.03) of adverse events (AEs). Population: All participants receiving ≥1 dose of randomized study drug. All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
|
3.1%
4/131 • Trough Database Cutoff Date of 15-Nov-2019 (Up to approximately 16 months)
The incidence (frequency) and severity (according to NCI CTCAE Version 4.03) of adverse events (AEs). Population: All participants receiving ≥1 dose of randomized study drug. All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
7.5%
20/266 • Trough Database Cutoff Date of 15-Nov-2019 (Up to approximately 16 months)
The incidence (frequency) and severity (according to NCI CTCAE Version 4.03) of adverse events (AEs). Population: All participants receiving ≥1 dose of randomized study drug. All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
|
3.8%
5/131 • Trough Database Cutoff Date of 15-Nov-2019 (Up to approximately 16 months)
The incidence (frequency) and severity (according to NCI CTCAE Version 4.03) of adverse events (AEs). Population: All participants receiving ≥1 dose of randomized study drug. All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
|
|
Vascular disorders
Hypertension
|
5.3%
14/266 • Trough Database Cutoff Date of 15-Nov-2019 (Up to approximately 16 months)
The incidence (frequency) and severity (according to NCI CTCAE Version 4.03) of adverse events (AEs). Population: All participants receiving ≥1 dose of randomized study drug. All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
|
3.1%
4/131 • Trough Database Cutoff Date of 15-Nov-2019 (Up to approximately 16 months)
The incidence (frequency) and severity (according to NCI CTCAE Version 4.03) of adverse events (AEs). Population: All participants receiving ≥1 dose of randomized study drug. All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place