Trial Outcomes & Findings for A Study Comparing the Efficacy and Safety Between IBI308 and Docetaxel in Patients With Advanced or Metastatic NSCLC (NCT NCT03150875)
NCT ID: NCT03150875
Last Updated: 2023-02-28
Results Overview
Overall survival was defined as the time from randomization to death due to any cause.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
290 participants
Primary outcome timeframe
Through database cutoff date of 31-July-2020 (up to approximately 35 months)
Results posted on
2023-02-28
Participant Flow
Final analysis data cutoff date: 31-July-2020. Of the 290 randomized participants, 14 were ongoing. For efficacy analysis, full analysis set (FAS), Sintilimab (145) and Docetaxel (135), was used. 10 participants in the docetaxel arm who initiated immunotherapy before receving docetaxcel or disease progression were excluded from FAS.
Participant milestones
| Measure |
Sintilimab
Sintilimab 200mg Intravenously every 3 weeks
|
Docetaxel
Docetaxel 75mg/m2 Intravenously every 3 weeks
|
|---|---|---|
|
Overall Study
STARTED
|
145
|
145
|
|
Overall Study
Treated
|
144
|
130
|
|
Overall Study
Crossover to Certain Treatment
|
0
|
0
|
|
Overall Study
COMPLETED
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
145
|
145
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study Comparing the Efficacy and Safety Between IBI308 and Docetaxel in Patients With Advanced or Metastatic NSCLC
Baseline characteristics by cohort
| Measure |
Sintilimab
n=145 Participants
Sintilimab 200mg Intravenously every 3 weeks
|
Docetaxel
n=135 Participants
Docetaxel 75mg/m2 Intravenously every 3 weeks
|
Total
n=280 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
60.6 Years
STANDARD_DEVIATION 8.19 • n=5 Participants
|
59.5 Years
STANDARD_DEVIATION 8.41 • n=7 Participants
|
60.1 Years
STANDARD_DEVIATION 8.30 • n=5 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
136 Participants
n=5 Participants
|
122 Participants
n=7 Participants
|
258 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
145 Participants
n=5 Participants
|
135 Participants
n=7 Participants
|
280 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
145 Participants
n=5 Participants
|
135 Participants
n=7 Participants
|
280 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
China
|
145 participants
n=5 Participants
|
135 participants
n=7 Participants
|
280 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Through database cutoff date of 31-July-2020 (up to approximately 35 months)Population: All randomized participants excluding participants in the docetaxel arm who initiated immunotherapy before receiving docetaxel or disease progression.
Overall survival was defined as the time from randomization to death due to any cause.
Outcome measures
| Measure |
Sintilimab
n=145 Participants
Sintilimab 200mg Intravenously every 3 weeks
|
Docetaxel
n=135 Participants
Docetaxel 75mg/m2 Intravenously every 3 weeks
|
|---|---|---|
|
Overall Survival
|
11.79 Months
Interval 10.28 to 15.27
|
8.25 Months
Interval 6.47 to 9.82
|
SECONDARY outcome
Timeframe: Through database cutoff date of 31-July-2020 (up to approximately 35 months)Population: All randomized participants excluding participants in the docetaxel arm who initiated immunotherapy before receiving docetaxel or disease progression.
Progression-free survival (PFS) was defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurred first. Per Response Evaluation Criteria in Solid Tumours (RECIST 1.1), PD was defined as ≥20% increase in the sum of diameters of target lesions, or unequivocal progression of non-target lesion. 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. PFS as assessed by investigators per RECIST 1.1 was reported for each arm.
Outcome measures
| Measure |
Sintilimab
n=145 Participants
Sintilimab 200mg Intravenously every 3 weeks
|
Docetaxel
n=135 Participants
Docetaxel 75mg/m2 Intravenously every 3 weeks
|
|---|---|---|
|
Progression-free Survival by Investigators' Assessment
|
4.3 Months
Interval 4.04 to 5.78
|
2.79 Months
Interval 1.91 to 3.19
|
SECONDARY outcome
Timeframe: Through database cutoff date of 31-July-2020 (up to approximately 35 months)Population: All randomized participants excluding participants in the docetaxel arm who initiated immunotherapy before receiving docetaxel or disease progression.
ORR was defined as the percentage of participants in the analysis population who had a confirmed Complete Response (CR: Disappearance of all target lesions) or a Partial Response (PR: ≥30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters) per RECIST 1.1. The percentage of participants who experienced a CR or PR is presented.
Outcome measures
| Measure |
Sintilimab
n=145 Participants
Sintilimab 200mg Intravenously every 3 weeks
|
Docetaxel
n=135 Participants
Docetaxel 75mg/m2 Intravenously every 3 weeks
|
|---|---|---|
|
Overall Response Rate (ORR) Per RECIST v1.1 as Assessed by Investigators
|
25.5 Percentage of participants
Interval 18.6 to 33.4
|
2.2 Percentage of participants
Interval 0.5 to 6.4
|
SECONDARY outcome
Timeframe: Through database cutoff date of 31-July-2020 (up to approximately 35 months)Population: All responders
For participants who demonstrated a CR (disappearance of all target lesions) or PR (≥30% decrease in the sum of diameters of target lesions) per RECIST 1.1, DOR was defined as the time from first documented evidence of a CR or PR until PD or death. DOR for participants who had not progressed or died at the time of analysis was to be censored at the date of their last tumor assessment. Per RECIST 1.1, PD was defined as ≥20% increase in the sum of diameters of target lesions or unequivoval progression of non-target lesion. In addition to the relative increase of 20%, the sum must also have demonstrated an absolute increase of ≥5 mm. Note: The appearance of one or more new lesions was also considered PD. The DOR per RECIST 1.1 for all participants who experienced a CR or PR is presented.
Outcome measures
| Measure |
Sintilimab
n=40 Participants
Sintilimab 200mg Intravenously every 3 weeks
|
Docetaxel
n=7 Participants
Docetaxel 75mg/m2 Intravenously every 3 weeks
|
|---|---|---|
|
Duration of Response (DOR) Per RECIST v1.1 as Assessed by Investigators
|
12.45 Months
Interval 4.86 to 25.33
|
4.14 Months
Interval 1.41 to 7.23
|
SECONDARY outcome
Timeframe: Through database cutoff date of 31-July-2020 (up to approximately 35 months)Population: All participants who received ≥1 dose of study treatment
TEAE is any AE that developed or worsened in severity compared to the baseline during the period from first dose of any study treatment up to 90 days after the last dose of any study treatment. Percentage of participants experiencing TEAE is calculated.
Outcome measures
| Measure |
Sintilimab
n=144 Participants
Sintilimab 200mg Intravenously every 3 weeks
|
Docetaxel
n=130 Participants
Docetaxel 75mg/m2 Intravenously every 3 weeks
|
|---|---|---|
|
Percentage of Participants Experiencing Treatment-emergent Adverse Events (TEAE)
|
97.20 Percentage of participants
|
96.20 Percentage of participants
|
Adverse Events
Sintilimab
Serious events: 56 serious events
Other events: 132 other events
Deaths: 108 deaths
Docetaxel
Serious events: 34 serious events
Other events: 117 other events
Deaths: 101 deaths
Serious adverse events
| Measure |
Sintilimab
n=144 participants at risk
Sintilimab 200mg Intravenously every 3 weeks
|
Docetaxel
n=130 participants at risk
Docetaxel 75mg/m2 Intravenously every 3 weeks
|
|---|---|---|
|
Blood and lymphatic system disorders
Bone marrow failure
|
0.00%
0/144 • Through database cutoff date of 31-July-2020 (up to approximately 35 months)
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
|
0.77%
1/130 • Through database cutoff date of 31-July-2020 (up to approximately 35 months)
All adverse events, including serious adverse events, will be collected since the 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
|
0.69%
1/144 • Through database cutoff date of 31-July-2020 (up to approximately 35 months)
All adverse events, including serious adverse events, will be collected since the 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%
0/130 • Through database cutoff date of 31-July-2020 (up to approximately 35 months)
All adverse events, including serious adverse events, will be collected since the 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
Death
|
1.4%
2/144 • Through database cutoff date of 31-July-2020 (up to approximately 35 months)
All adverse events, including serious adverse events, will be collected since the 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%
0/130 • Through database cutoff date of 31-July-2020 (up to approximately 35 months)
All adverse events, including serious adverse events, will be collected since the 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
|
0.00%
0/144 • Through database cutoff date of 31-July-2020 (up to approximately 35 months)
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
|
0.77%
1/130 • Through database cutoff date of 31-July-2020 (up to approximately 35 months)
All adverse events, including serious adverse events, will be collected since the 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
|
0.69%
1/144 • Through database cutoff date of 31-July-2020 (up to approximately 35 months)
All adverse events, including serious adverse events, will be collected since the 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%
0/130 • Through database cutoff date of 31-July-2020 (up to approximately 35 months)
All adverse events, including serious adverse events, will be collected since the 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
Cardiomyopathy
|
0.69%
1/144 • Through database cutoff date of 31-July-2020 (up to approximately 35 months)
All adverse events, including serious adverse events, will be collected since the 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%
0/130 • Through database cutoff date of 31-July-2020 (up to approximately 35 months)
All adverse events, including serious adverse events, will be collected since the 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
Myocardial infarction
|
0.69%
1/144 • Through database cutoff date of 31-July-2020 (up to approximately 35 months)
All adverse events, including serious adverse events, will be collected since the 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%
0/130 • Through database cutoff date of 31-July-2020 (up to approximately 35 months)
All adverse events, including serious adverse events, will be collected since the 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
Myocarditis
|
0.69%
1/144 • Through database cutoff date of 31-July-2020 (up to approximately 35 months)
All adverse events, including serious adverse events, will be collected since the 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%
0/130 • Through database cutoff date of 31-July-2020 (up to approximately 35 months)
All adverse events, including serious adverse events, will be collected since the 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
Sinus bradycardia
|
0.69%
1/144 • Through database cutoff date of 31-July-2020 (up to approximately 35 months)
All adverse events, including serious adverse events, will be collected since the 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%
0/130 • Through database cutoff date of 31-July-2020 (up to approximately 35 months)
All adverse events, including serious adverse events, will be collected since the 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
Sinus tachycardia
|
0.00%
0/144 • Through database cutoff date of 31-July-2020 (up to approximately 35 months)
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
|
0.77%
1/130 • Through database cutoff date of 31-July-2020 (up to approximately 35 months)
All adverse events, including serious adverse events, will be collected since the 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
|
0.69%
1/144 • Through database cutoff date of 31-July-2020 (up to approximately 35 months)
All adverse events, including serious adverse events, will be collected since the 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%
0/130 • Through database cutoff date of 31-July-2020 (up to approximately 35 months)
All adverse events, including serious adverse events, will be collected since the 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 discomfort
|
0.00%
0/144 • Through database cutoff date of 31-July-2020 (up to approximately 35 months)
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
|
0.77%
1/130 • Through database cutoff date of 31-July-2020 (up to approximately 35 months)
All adverse events, including serious adverse events, will be collected since the 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
|
0.69%
1/144 • Through database cutoff date of 31-July-2020 (up to approximately 35 months)
All adverse events, including serious adverse events, will be collected since the 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%
0/130 • Through database cutoff date of 31-July-2020 (up to approximately 35 months)
All adverse events, including serious adverse events, will be collected since the 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
Fatigue
|
0.69%
1/144 • Through database cutoff date of 31-July-2020 (up to approximately 35 months)
All adverse events, including serious adverse events, will be collected since the 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%
0/130 • Through database cutoff date of 31-July-2020 (up to approximately 35 months)
All adverse events, including serious adverse events, will be collected since the 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
Dysphagia
|
0.69%
1/144 • Through database cutoff date of 31-July-2020 (up to approximately 35 months)
All adverse events, including serious adverse events, will be collected since the 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%
0/130 • Through database cutoff date of 31-July-2020 (up to approximately 35 months)
All adverse events, including serious adverse events, will be collected since the 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
Gastric varices haemorrhage
|
0.00%
0/144 • Through database cutoff date of 31-July-2020 (up to approximately 35 months)
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
|
0.77%
1/130 • Through database cutoff date of 31-July-2020 (up to approximately 35 months)
All adverse events, including serious adverse events, will be collected since the 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
Pain
|
0.00%
0/144 • Through database cutoff date of 31-July-2020 (up to approximately 35 months)
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
|
0.77%
1/130 • Through database cutoff date of 31-July-2020 (up to approximately 35 months)
All adverse events, including serious adverse events, will be collected since the 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
Gastritis
|
0.69%
1/144 • Through database cutoff date of 31-July-2020 (up to approximately 35 months)
All adverse events, including serious adverse events, will be collected since the 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%
0/130 • Through database cutoff date of 31-July-2020 (up to approximately 35 months)
All adverse events, including serious adverse events, will be collected since the 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
|
0.69%
1/144 • Through database cutoff date of 31-July-2020 (up to approximately 35 months)
All adverse events, including serious adverse events, will be collected since the 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%
0/130 • Through database cutoff date of 31-July-2020 (up to approximately 35 months)
All adverse events, including serious adverse events, will be collected since the 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
|
1.4%
2/144 • Through database cutoff date of 31-July-2020 (up to approximately 35 months)
All adverse events, including serious adverse events, will be collected since the 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%
0/130 • Through database cutoff date of 31-July-2020 (up to approximately 35 months)
All adverse events, including serious adverse events, will be collected since the 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
|
1.4%
2/144 • Through database cutoff date of 31-July-2020 (up to approximately 35 months)
All adverse events, including serious adverse events, will be collected since the 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%
2/130 • Through database cutoff date of 31-July-2020 (up to approximately 35 months)
All adverse events, including serious adverse events, will be collected since the 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
|
3.5%
5/144 • Through database cutoff date of 31-July-2020 (up to approximately 35 months)
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
|
2.3%
3/130 • Through database cutoff date of 31-July-2020 (up to approximately 35 months)
All adverse events, including serious adverse events, will be collected since the 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
Cholecystitis acute
|
0.00%
0/144 • Through database cutoff date of 31-July-2020 (up to approximately 35 months)
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
|
0.77%
1/130 • Through database cutoff date of 31-July-2020 (up to approximately 35 months)
All adverse events, including serious adverse events, will be collected since the 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
Drug-induced liver injury
|
0.69%
1/144 • Through database cutoff date of 31-July-2020 (up to approximately 35 months)
All adverse events, including serious adverse events, will be collected since the 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%
0/130 • Through database cutoff date of 31-July-2020 (up to approximately 35 months)
All adverse events, including serious adverse events, will be collected since the 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
Anal abscess
|
0.69%
1/144 • Through database cutoff date of 31-July-2020 (up to approximately 35 months)
All adverse events, including serious adverse events, will be collected since the 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%
2/130 • Through database cutoff date of 31-July-2020 (up to approximately 35 months)
All adverse events, including serious adverse events, will be collected since the 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
Bronchitis
|
0.00%
0/144 • Through database cutoff date of 31-July-2020 (up to approximately 35 months)
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
|
0.77%
1/130 • Through database cutoff date of 31-July-2020 (up to approximately 35 months)
All adverse events, including serious adverse events, will be collected since the 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
Encephalitis
|
0.69%
1/144 • Through database cutoff date of 31-July-2020 (up to approximately 35 months)
All adverse events, including serious adverse events, will be collected since the 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%
0/130 • Through database cutoff date of 31-July-2020 (up to approximately 35 months)
All adverse events, including serious adverse events, will be collected since the 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
Influenza
|
1.4%
2/144 • Through database cutoff date of 31-July-2020 (up to approximately 35 months)
All adverse events, including serious adverse events, will be collected since the 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%
0/130 • Through database cutoff date of 31-July-2020 (up to approximately 35 months)
All adverse events, including serious adverse events, will be collected since the 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
|
0.69%
1/144 • Through database cutoff date of 31-July-2020 (up to approximately 35 months)
All adverse events, including serious adverse events, will be collected since the 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%
0/130 • Through database cutoff date of 31-July-2020 (up to approximately 35 months)
All adverse events, including serious adverse events, will be collected since the 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%
12/144 • Through database cutoff date of 31-July-2020 (up to approximately 35 months)
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
|
10.8%
14/130 • Through database cutoff date of 31-July-2020 (up to approximately 35 months)
All adverse events, including serious adverse events, will be collected since the 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 fungal
|
0.69%
1/144 • Through database cutoff date of 31-July-2020 (up to approximately 35 months)
All adverse events, including serious adverse events, will be collected since the 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%
0/130 • Through database cutoff date of 31-July-2020 (up to approximately 35 months)
All adverse events, including serious adverse events, will be collected since the 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
Sepsis
|
0.69%
1/144 • Through database cutoff date of 31-July-2020 (up to approximately 35 months)
All adverse events, including serious adverse events, will be collected since the 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%
0/130 • Through database cutoff date of 31-July-2020 (up to approximately 35 months)
All adverse events, including serious adverse events, will be collected since the 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
|
1.4%
2/144 • Through database cutoff date of 31-July-2020 (up to approximately 35 months)
All adverse events, including serious adverse events, will be collected since the 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%
2/130 • Through database cutoff date of 31-July-2020 (up to approximately 35 months)
All adverse events, including serious adverse events, will be collected since the 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
|
0.69%
1/144 • Through database cutoff date of 31-July-2020 (up to approximately 35 months)
All adverse events, including serious adverse events, will be collected since the 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%
0/130 • Through database cutoff date of 31-July-2020 (up to approximately 35 months)
All adverse events, including serious adverse events, will be collected since the 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
Humerus fracture
|
0.69%
1/144 • Through database cutoff date of 31-July-2020 (up to approximately 35 months)
All adverse events, including serious adverse events, will be collected since the 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%
0/130 • Through database cutoff date of 31-July-2020 (up to approximately 35 months)
All adverse events, including serious adverse events, will be collected since the 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
Infusion related reaction
|
0.69%
1/144 • Through database cutoff date of 31-July-2020 (up to approximately 35 months)
All adverse events, including serious adverse events, will be collected since the 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%
0/130 • Through database cutoff date of 31-July-2020 (up to approximately 35 months)
All adverse events, including serious adverse events, will be collected since the 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
Urethral injury
|
0.69%
1/144 • Through database cutoff date of 31-July-2020 (up to approximately 35 months)
All adverse events, including serious adverse events, will be collected since the 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%
0/130 • Through database cutoff date of 31-July-2020 (up to approximately 35 months)
All adverse events, including serious adverse events, will be collected since the 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
|
1.4%
2/144 • Through database cutoff date of 31-July-2020 (up to approximately 35 months)
All adverse events, including serious adverse events, will be collected since the 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%
0/130 • Through database cutoff date of 31-July-2020 (up to approximately 35 months)
All adverse events, including serious adverse events, will be collected since the 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
|
1.4%
2/144 • Through database cutoff date of 31-July-2020 (up to approximately 35 months)
All adverse events, including serious adverse events, will be collected since the 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%
0/130 • Through database cutoff date of 31-July-2020 (up to approximately 35 months)
All adverse events, including serious adverse events, will be collected since the 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
|
0.69%
1/144 • Through database cutoff date of 31-July-2020 (up to approximately 35 months)
All adverse events, including serious adverse events, will be collected since the 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%
0/130 • Through database cutoff date of 31-July-2020 (up to approximately 35 months)
All adverse events, including serious adverse events, will be collected since the 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
|
0.69%
1/144 • Through database cutoff date of 31-July-2020 (up to approximately 35 months)
All adverse events, including serious adverse events, will be collected since the 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%
0/130 • Through database cutoff date of 31-July-2020 (up to approximately 35 months)
All adverse events, including serious adverse events, will be collected since the 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
|
0.00%
0/144 • Through database cutoff date of 31-July-2020 (up to approximately 35 months)
All adverse events, including serious adverse events, will be collected since the 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%
4/130 • Through database cutoff date of 31-July-2020 (up to approximately 35 months)
All adverse events, including serious adverse events, will be collected since the 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 increased
|
0.00%
0/144 • Through database cutoff date of 31-July-2020 (up to approximately 35 months)
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
|
0.77%
1/130 • Through database cutoff date of 31-July-2020 (up to approximately 35 months)
All adverse events, including serious adverse events, will be collected since the 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
Transaminases increased
|
0.69%
1/144 • Through database cutoff date of 31-July-2020 (up to approximately 35 months)
All adverse events, including serious adverse events, will be collected since the 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%
0/130 • Through database cutoff date of 31-July-2020 (up to approximately 35 months)
All adverse events, including serious adverse events, will be collected since the 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
|
0.00%
0/144 • Through database cutoff date of 31-July-2020 (up to approximately 35 months)
All adverse events, including serious adverse events, will be collected since the 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%
5/130 • Through database cutoff date of 31-July-2020 (up to approximately 35 months)
All adverse events, including serious adverse events, will be collected since the 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
|
0.00%
0/144 • Through database cutoff date of 31-July-2020 (up to approximately 35 months)
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
|
0.77%
1/130 • Through database cutoff date of 31-July-2020 (up to approximately 35 months)
All adverse events, including serious adverse events, will be collected since the 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
Hypercalcaemia
|
0.00%
0/144 • Through database cutoff date of 31-July-2020 (up to approximately 35 months)
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
|
0.77%
1/130 • Through database cutoff date of 31-July-2020 (up to approximately 35 months)
All adverse events, including serious adverse events, will be collected since the 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
Type 2 diabetes mellitus
|
0.69%
1/144 • Through database cutoff date of 31-July-2020 (up to approximately 35 months)
All adverse events, including serious adverse events, will be collected since the 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%
0/130 • Through database cutoff date of 31-July-2020 (up to approximately 35 months)
All adverse events, including serious adverse events, will be collected since the 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
Myalgia
|
0.00%
0/144 • Through database cutoff date of 31-July-2020 (up to approximately 35 months)
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
|
0.77%
1/130 • Through database cutoff date of 31-July-2020 (up to approximately 35 months)
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer pain
|
0.69%
1/144 • Through database cutoff date of 31-July-2020 (up to approximately 35 months)
All adverse events, including serious adverse events, will be collected since the 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%
0/130 • Through database cutoff date of 31-July-2020 (up to approximately 35 months)
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon adenoma
|
0.69%
1/144 • Through database cutoff date of 31-July-2020 (up to approximately 35 months)
All adverse events, including serious adverse events, will be collected since the 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%
0/130 • Through database cutoff date of 31-July-2020 (up to approximately 35 months)
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastric cancer
|
0.69%
1/144 • Through database cutoff date of 31-July-2020 (up to approximately 35 months)
All adverse events, including serious adverse events, will be collected since the 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%
0/130 • Through database cutoff date of 31-July-2020 (up to approximately 35 months)
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pituitary tumour
|
0.00%
0/144 • Through database cutoff date of 31-July-2020 (up to approximately 35 months)
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
|
0.77%
1/130 • Through database cutoff date of 31-July-2020 (up to approximately 35 months)
All adverse events, including serious adverse events, will be collected since the 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
Lacunar infarction
|
0.69%
1/144 • Through database cutoff date of 31-July-2020 (up to approximately 35 months)
All adverse events, including serious adverse events, will be collected since the 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%
0/130 • Through database cutoff date of 31-July-2020 (up to approximately 35 months)
All adverse events, including serious adverse events, will be collected since the 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
Myasthenia gravis
|
0.69%
1/144 • Through database cutoff date of 31-July-2020 (up to approximately 35 months)
All adverse events, including serious adverse events, will be collected since the 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%
0/130 • Through database cutoff date of 31-July-2020 (up to approximately 35 months)
All adverse events, including serious adverse events, will be collected since the 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
Acute kidney injury
|
0.69%
1/144 • Through database cutoff date of 31-July-2020 (up to approximately 35 months)
All adverse events, including serious adverse events, will be collected since the 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%
0/130 • Through database cutoff date of 31-July-2020 (up to approximately 35 months)
All adverse events, including serious adverse events, will be collected since the 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
Nephrolithiasis
|
0.69%
1/144 • Through database cutoff date of 31-July-2020 (up to approximately 35 months)
All adverse events, including serious adverse events, will be collected since the 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%
0/130 • Through database cutoff date of 31-July-2020 (up to approximately 35 months)
All adverse events, including serious adverse events, will be collected since the 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
Chronic obstructive pulmonary disease
|
1.4%
2/144 • Through database cutoff date of 31-July-2020 (up to approximately 35 months)
All adverse events, including serious adverse events, will be collected since the 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%
0/130 • Through database cutoff date of 31-July-2020 (up to approximately 35 months)
All adverse events, including serious adverse events, will be collected since the 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
|
0.69%
1/144 • Through database cutoff date of 31-July-2020 (up to approximately 35 months)
All adverse events, including serious adverse events, will be collected since the 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%
2/130 • Through database cutoff date of 31-July-2020 (up to approximately 35 months)
All adverse events, including serious adverse events, will be collected since the 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
|
2.8%
4/144 • Through database cutoff date of 31-July-2020 (up to approximately 35 months)
All adverse events, including serious adverse events, will be collected since the 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%
2/130 • Through database cutoff date of 31-July-2020 (up to approximately 35 months)
All adverse events, including serious adverse events, will be collected since the 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
Immune-mediated pneumonitis
|
2.1%
3/144 • Through database cutoff date of 31-July-2020 (up to approximately 35 months)
All adverse events, including serious adverse events, will be collected since the 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%
0/130 • Through database cutoff date of 31-July-2020 (up to approximately 35 months)
All adverse events, including serious adverse events, will be collected since the 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
|
2.8%
4/144 • Through database cutoff date of 31-July-2020 (up to approximately 35 months)
All adverse events, including serious adverse events, will be collected since the 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%
0/130 • Through database cutoff date of 31-July-2020 (up to approximately 35 months)
All adverse events, including serious adverse events, will be collected since the 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
|
2.1%
3/144 • Through database cutoff date of 31-July-2020 (up to approximately 35 months)
All adverse events, including serious adverse events, will be collected since the 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%
0/130 • Through database cutoff date of 31-July-2020 (up to approximately 35 months)
All adverse events, including serious adverse events, will be collected since the 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
|
0.69%
1/144 • Through database cutoff date of 31-July-2020 (up to approximately 35 months)
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
|
0.77%
1/130 • Through database cutoff date of 31-July-2020 (up to approximately 35 months)
All adverse events, including serious adverse events, will be collected since the 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
Pulmonary embolism
|
0.00%
0/144 • Through database cutoff date of 31-July-2020 (up to approximately 35 months)
All adverse events, including serious adverse events, will be collected since the 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%
2/130 • Through database cutoff date of 31-July-2020 (up to approximately 35 months)
All adverse events, including serious adverse events, will be collected since the 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
|
2.1%
3/144 • Through database cutoff date of 31-July-2020 (up to approximately 35 months)
All adverse events, including serious adverse events, will be collected since the 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%
0/130 • Through database cutoff date of 31-July-2020 (up to approximately 35 months)
All adverse events, including serious adverse events, will be collected since the 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
Shock
|
0.69%
1/144 • Through database cutoff date of 31-July-2020 (up to approximately 35 months)
All adverse events, including serious adverse events, will be collected since the 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%
0/130 • Through database cutoff date of 31-July-2020 (up to approximately 35 months)
All adverse events, including serious adverse events, will be collected since the 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
Venous thrombosis limb
|
0.00%
0/144 • Through database cutoff date of 31-July-2020 (up to approximately 35 months)
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
|
0.77%
1/130 • Through database cutoff date of 31-July-2020 (up to approximately 35 months)
All adverse events, including serious adverse events, will be collected since the 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
n=144 participants at risk
Sintilimab 200mg Intravenously every 3 weeks
|
Docetaxel
n=130 participants at risk
Docetaxel 75mg/m2 Intravenously every 3 weeks
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
33.3%
48/144 • Through database cutoff date of 31-July-2020 (up to approximately 35 months)
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
|
33.1%
43/130 • Through database cutoff date of 31-July-2020 (up to approximately 35 months)
All adverse events, including serious adverse events, will be collected since the 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
Sinus tachycardia
|
8.3%
12/144 • Through database cutoff date of 31-July-2020 (up to approximately 35 months)
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
|
5.4%
7/130 • Through database cutoff date of 31-July-2020 (up to approximately 35 months)
All adverse events, including serious adverse events, will be collected since the 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
|
7.6%
11/144 • Through database cutoff date of 31-July-2020 (up to approximately 35 months)
All adverse events, including serious adverse events, will be collected since the 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%
0/130 • Through database cutoff date of 31-July-2020 (up to approximately 35 months)
All adverse events, including serious adverse events, will be collected since the 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
|
18.8%
27/144 • Through database cutoff date of 31-July-2020 (up to approximately 35 months)
All adverse events, including serious adverse events, will be collected since the 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%
2/130 • Through database cutoff date of 31-July-2020 (up to approximately 35 months)
All adverse events, including serious adverse events, will be collected since the 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
|
16.0%
23/144 • Through database cutoff date of 31-July-2020 (up to approximately 35 months)
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
|
10.8%
14/130 • Through database cutoff date of 31-July-2020 (up to approximately 35 months)
All adverse events, including serious adverse events, will be collected since the 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
|
8.3%
12/144 • Through database cutoff date of 31-July-2020 (up to approximately 35 months)
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
|
10.0%
13/130 • Through database cutoff date of 31-July-2020 (up to approximately 35 months)
All adverse events, including serious adverse events, will be collected since the 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
|
11.1%
16/144 • Through database cutoff date of 31-July-2020 (up to approximately 35 months)
All adverse events, including serious adverse events, will be collected since the 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%
12/130 • Through database cutoff date of 31-July-2020 (up to approximately 35 months)
All adverse events, including serious adverse events, will be collected since the 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
|
7.6%
11/144 • Through database cutoff date of 31-July-2020 (up to approximately 35 months)
All adverse events, including serious adverse events, will be collected since the 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%
6/130 • Through database cutoff date of 31-July-2020 (up to approximately 35 months)
All adverse events, including serious adverse events, will be collected since the 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
|
17.4%
25/144 • Through database cutoff date of 31-July-2020 (up to approximately 35 months)
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
|
25.4%
33/130 • Through database cutoff date of 31-July-2020 (up to approximately 35 months)
All adverse events, including serious adverse events, will be collected since the 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
|
5.6%
8/144 • Through database cutoff date of 31-July-2020 (up to approximately 35 months)
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
|
6.2%
8/130 • Through database cutoff date of 31-July-2020 (up to approximately 35 months)
All adverse events, including serious adverse events, will be collected since the 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
Pain
|
6.2%
9/144 • Through database cutoff date of 31-July-2020 (up to approximately 35 months)
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
|
2.3%
3/130 • Through database cutoff date of 31-July-2020 (up to approximately 35 months)
All adverse events, including serious adverse events, will be collected since the 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
|
21.5%
31/144 • Through database cutoff date of 31-July-2020 (up to approximately 35 months)
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
|
16.2%
21/130 • Through database cutoff date of 31-July-2020 (up to approximately 35 months)
All adverse events, including serious adverse events, will be collected since the 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
Nasopharyngitis
|
6.2%
9/144 • Through database cutoff date of 31-July-2020 (up to approximately 35 months)
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
|
0.77%
1/130 • Through database cutoff date of 31-July-2020 (up to approximately 35 months)
All adverse events, including serious adverse events, will be collected since the 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
|
7.6%
11/144 • Through database cutoff date of 31-July-2020 (up to approximately 35 months)
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
|
8.5%
11/130 • Through database cutoff date of 31-July-2020 (up to approximately 35 months)
All adverse events, including serious adverse events, will be collected since the 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
|
11.8%
17/144 • Through database cutoff date of 31-July-2020 (up to approximately 35 months)
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
|
5.4%
7/130 • Through database cutoff date of 31-July-2020 (up to approximately 35 months)
All adverse events, including serious adverse events, will be collected since the 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
|
7.6%
11/144 • Through database cutoff date of 31-July-2020 (up to approximately 35 months)
All adverse events, including serious adverse events, will be collected since the 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%
4/130 • Through database cutoff date of 31-July-2020 (up to approximately 35 months)
All adverse events, including serious adverse events, will be collected since the 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
|
17.4%
25/144 • Through database cutoff date of 31-July-2020 (up to approximately 35 months)
All adverse events, including serious adverse events, will be collected since the 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%
6/130 • Through database cutoff date of 31-July-2020 (up to approximately 35 months)
All adverse events, including serious adverse events, will be collected since the 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
|
16.0%
23/144 • Through database cutoff date of 31-July-2020 (up to approximately 35 months)
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
|
5.4%
7/130 • Through database cutoff date of 31-July-2020 (up to approximately 35 months)
All adverse events, including serious adverse events, will be collected since the 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
|
6.2%
9/144 • Through database cutoff date of 31-July-2020 (up to approximately 35 months)
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
|
0.77%
1/130 • Through database cutoff date of 31-July-2020 (up to approximately 35 months)
All adverse events, including serious adverse events, will be collected since the 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 urine present
|
5.6%
8/144 • Through database cutoff date of 31-July-2020 (up to approximately 35 months)
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
|
0.77%
1/130 • Through database cutoff date of 31-July-2020 (up to approximately 35 months)
All adverse events, including serious adverse events, will be collected since the 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
|
9.7%
14/144 • Through database cutoff date of 31-July-2020 (up to approximately 35 months)
All adverse events, including serious adverse events, will be collected since the 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%
5/130 • Through database cutoff date of 31-July-2020 (up to approximately 35 months)
All adverse events, including serious adverse events, will be collected since the 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
|
2.1%
3/144 • Through database cutoff date of 31-July-2020 (up to approximately 35 months)
All adverse events, including serious adverse events, will be collected since the 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%
9/130 • Through database cutoff date of 31-July-2020 (up to approximately 35 months)
All adverse events, including serious adverse events, will be collected since the 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
|
5.6%
8/144 • Through database cutoff date of 31-July-2020 (up to approximately 35 months)
All adverse events, including serious adverse events, will be collected since the 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%
9/130 • Through database cutoff date of 31-July-2020 (up to approximately 35 months)
All adverse events, including serious adverse events, will be collected since the 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
|
4.9%
7/144 • Through database cutoff date of 31-July-2020 (up to approximately 35 months)
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
|
29.2%
38/130 • Through database cutoff date of 31-July-2020 (up to approximately 35 months)
All adverse events, including serious adverse events, will be collected since the 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
|
4.2%
6/144 • Through database cutoff date of 31-July-2020 (up to approximately 35 months)
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
|
6.2%
8/130 • Through database cutoff date of 31-July-2020 (up to approximately 35 months)
All adverse events, including serious adverse events, will be collected since the 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
|
20.1%
29/144 • Through database cutoff date of 31-July-2020 (up to approximately 35 months)
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
|
10.8%
14/130 • Through database cutoff date of 31-July-2020 (up to approximately 35 months)
All adverse events, including serious adverse events, will be collected since the 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
|
6.9%
10/144 • Through database cutoff date of 31-July-2020 (up to approximately 35 months)
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
|
5.4%
7/130 • Through database cutoff date of 31-July-2020 (up to approximately 35 months)
All adverse events, including serious adverse events, will be collected since the 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
|
4.2%
6/144 • Through database cutoff date of 31-July-2020 (up to approximately 35 months)
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
|
30.0%
39/130 • Through database cutoff date of 31-July-2020 (up to approximately 35 months)
All adverse events, including serious adverse events, will be collected since the 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
|
23.6%
34/144 • Through database cutoff date of 31-July-2020 (up to approximately 35 months)
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
|
17.7%
23/130 • Through database cutoff date of 31-July-2020 (up to approximately 35 months)
All adverse events, including serious adverse events, will be collected since the 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
|
10.4%
15/144 • Through database cutoff date of 31-July-2020 (up to approximately 35 months)
All adverse events, including serious adverse events, will be collected since the 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%
6/130 • Through database cutoff date of 31-July-2020 (up to approximately 35 months)
All adverse events, including serious adverse events, will be collected since the 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
Hyperuricaemia
|
6.2%
9/144 • Through database cutoff date of 31-July-2020 (up to approximately 35 months)
All adverse events, including serious adverse events, will be collected since the 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%
2/130 • Through database cutoff date of 31-July-2020 (up to approximately 35 months)
All adverse events, including serious adverse events, will be collected since the 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
|
12.5%
18/144 • Through database cutoff date of 31-July-2020 (up to approximately 35 months)
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
|
10.0%
13/130 • Through database cutoff date of 31-July-2020 (up to approximately 35 months)
All adverse events, including serious adverse events, will be collected since the 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
Hypochloraemia
|
9.0%
13/144 • Through database cutoff date of 31-July-2020 (up to approximately 35 months)
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
|
2.3%
3/130 • Through database cutoff date of 31-July-2020 (up to approximately 35 months)
All adverse events, including serious adverse events, will be collected since the 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
|
9.7%
14/144 • Through database cutoff date of 31-July-2020 (up to approximately 35 months)
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
|
5.4%
7/130 • Through database cutoff date of 31-July-2020 (up to approximately 35 months)
All adverse events, including serious adverse events, will be collected since the 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
|
17.4%
25/144 • Through database cutoff date of 31-July-2020 (up to approximately 35 months)
All adverse events, including serious adverse events, will be collected since the 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%
5/130 • Through database cutoff date of 31-July-2020 (up to approximately 35 months)
All adverse events, including serious adverse events, will be collected since the 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
Arthralgia
|
5.6%
8/144 • Through database cutoff date of 31-July-2020 (up to approximately 35 months)
All adverse events, including serious adverse events, will be collected since the 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%
4/130 • Through database cutoff date of 31-July-2020 (up to approximately 35 months)
All adverse events, including serious adverse events, will be collected since the 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
|
4.2%
6/144 • Through database cutoff date of 31-July-2020 (up to approximately 35 months)
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
|
7.7%
10/130 • Through database cutoff date of 31-July-2020 (up to approximately 35 months)
All adverse events, including serious adverse events, will be collected since the 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
Musculoskeletal pain
|
4.2%
6/144 • Through database cutoff date of 31-July-2020 (up to approximately 35 months)
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
|
5.4%
7/130 • Through database cutoff date of 31-July-2020 (up to approximately 35 months)
All adverse events, including serious adverse events, will be collected since the 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
|
6.9%
10/144 • Through database cutoff date of 31-July-2020 (up to approximately 35 months)
All adverse events, including serious adverse events, will be collected since the 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%
6/130 • Through database cutoff date of 31-July-2020 (up to approximately 35 months)
All adverse events, including serious adverse events, will be collected since the 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
|
5.6%
8/144 • Through database cutoff date of 31-July-2020 (up to approximately 35 months)
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
|
2.3%
3/130 • Through database cutoff date of 31-July-2020 (up to approximately 35 months)
All adverse events, including serious adverse events, will be collected since the 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
|
3.5%
5/144 • Through database cutoff date of 31-July-2020 (up to approximately 35 months)
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
|
5.4%
7/130 • Through database cutoff date of 31-July-2020 (up to approximately 35 months)
All adverse events, including serious adverse events, will be collected since the 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
|
14.6%
21/144 • Through database cutoff date of 31-July-2020 (up to approximately 35 months)
All adverse events, including serious adverse events, will be collected since the 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%
4/130 • Through database cutoff date of 31-July-2020 (up to approximately 35 months)
All adverse events, including serious adverse events, will be collected since the 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
|
20.1%
29/144 • Through database cutoff date of 31-July-2020 (up to approximately 35 months)
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
|
14.6%
19/130 • Through database cutoff date of 31-July-2020 (up to approximately 35 months)
All adverse events, including serious adverse events, will be collected since the 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
|
7.6%
11/144 • Through database cutoff date of 31-July-2020 (up to approximately 35 months)
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
|
5.4%
7/130 • Through database cutoff date of 31-July-2020 (up to approximately 35 months)
All adverse events, including serious adverse events, will be collected since the 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
|
13.2%
19/144 • Through database cutoff date of 31-July-2020 (up to approximately 35 months)
All adverse events, including serious adverse events, will be collected since the 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%
9/130 • Through database cutoff date of 31-July-2020 (up to approximately 35 months)
All adverse events, including serious adverse events, will be collected since the 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
Alopecia
|
0.00%
0/144 • Through database cutoff date of 31-July-2020 (up to approximately 35 months)
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
|
34.6%
45/130 • Through database cutoff date of 31-July-2020 (up to approximately 35 months)
All adverse events, including serious adverse events, will be collected since the 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
Pruritus
|
6.9%
10/144 • Through database cutoff date of 31-July-2020 (up to approximately 35 months)
All adverse events, including serious adverse events, will be collected since the 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%
0/130 • Through database cutoff date of 31-July-2020 (up to approximately 35 months)
All adverse events, including serious adverse events, will be collected since the 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
|
16.7%
24/144 • Through database cutoff date of 31-July-2020 (up to approximately 35 months)
All adverse events, including serious adverse events, will be collected since the 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%
5/130 • Through database cutoff date of 31-July-2020 (up to approximately 35 months)
All adverse events, including serious adverse events, will be collected since the 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
|
8.3%
12/144 • Through database cutoff date of 31-July-2020 (up to approximately 35 months)
All adverse events, including serious adverse events, will be collected since the 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%
2/130 • Through database cutoff date of 31-July-2020 (up to approximately 35 months)
All adverse events, including serious adverse events, will be collected since the 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